StemCell Therapy

Clockwise from top left, Dmitri Basov, Lawrence Goldstein, Terence Hwa, Clifford Kubiak, Kimberly Prather

The National Academy of Sciences elected five professors affiliated with the University of California San Diego to membership in the prestigious National Academy of Sciences, one of the highest honors bestowed on U.S. scientists and engineers.

UC San Diego faculty members Dmitri Basov, Lawrence Goldstein, Terence Hwa, Clifford Kubiak, and Kimberly Prather whose work spans fields ranging from medicine and biological sciences to atmospheric chemistry and physics were recognized Monday in recognition of their distinguished and continuing achievements in original research, according to the Academy. They were among 120 American scientists and 26 international members named this year.

For a young institution such as ours, having five professors inducted into the National Academy of Sciences speaks volumes of the innovative and visionary nature of this university and our well-respected and accomplished faculty, said UC San Diego Chancellor Pradeep K. Khosla. I am proud to see the career accomplishments of these five professors recognized on such a distinguished national platform, alongside the countrys other leading researchers.

This brings the total number of National Academy of Sciences members from UC San Diego to 86.

Dmitri Basov is an affiliated UC San Diego professor in the Department of Physics, where he served as chair between 2010 and 2015. He is also a Higgins professor in the Department of Physics at Columbia University, where he is the principal investigator of the Basov Infrared Laboratory, the director of the DOE Energy Frontiers Research Center on Programmable Quantum Materials and co-director of the Max Planck Society New York Center for Nonequilibrium Quantum Phenomena. His research interests include physics of quantum materials, superconductivity, two-dimensional materials and infrared nano-optics. Basov has received numerous prizes and awards including a Sloan Fellowship (1999), the Genzel Prize (2014), a Humboldt research award (2009), the Frank Isakson Prize, American Physical Society (2012), Moore Investigator (2014), the K.J. Button Prize (2019) and the Vannevar Bush Faculty Fellowship (U.S. Department of Defense, 2019).

Basov earned his PhD at the Lebedev Physical Institute of the Russian Academy of Sciences (1991). He served as postdoctoral research associate at McMaster University (1992-96) and as an assistant physicist at Brookhaven National Laboratory (1996) before joining UC San Diego.

Lawrence Goldstein, PhD, is Distinguished Professor in the Department of Cellular and Molecular Medicine and Department of Neurosciences in the UC San Diego School of Medicine. He founded and directed the UC San Diego Stem Cell Program and the Sanford Stem Cell Clinical Center at UC San Diego Health and is founding scientific director of the Sanford Consortium for Regenerative Medicine. He was instrumental in the development and passage of Proposition 71 in 2004, which created an unprecedented $3 billion fund and infrastructure for stem cell medical research in California.

For more than 25 years, Goldsteins research focus has been to unravel how molecular motors interact with and control the behavior of axonal vesicles in neurons, and how defects in these processes underlie neurological conditions, such as Alzheimers disease (AD).In 2012, his lab was the first to create stem cell-derived in vitro neurons of sporadic and hereditary AD, giving researchers a much-needed method for studying the diseases causes and pathologies and a new tool for developing and testing drugs to treat a disorder that afflicts 5.4 million Americans.

More recently, this work has led to the identification of new cellular targets in AD drug development and a deeper understanding of AD genetics and disease progression. He is among the nations leading scientific figures in promoting AD research and evidence-based treatments.

Terence Hwa is the Presidential Chair and Distinguished Professor in the Department of Physics with a joint appointment in the Division of Biological Sciences. Trained in theoretical physics, Hwa launched a biology wet-lab 15 years ago and developed a unique quantitative approach to studying bacterial physiology. During this time, the Hwa Research Group established a number of bacterial growth laws and formulated a principle of proteomic resource allocation. This line of study culminated in a theory of bacterial growth control, accurately predicting bacterial behaviors and gene expression for a variety of environmental and genetic perturbations, and resolving a number of long-standing mysteries in microbiology. Hwas research team continues to extend its quantitative approaches to characterize bacterial species singly and in consortium, to uncover underlying principles governing the spatiotemporal dynamics of microbial communities.

Hwa is a champion of interdisciplinary research. In 2001, he launched an extended program at the Kavli Institute of Theoretical Physics in Santa Barbara, which has been regarded as a watershed event in bringing physicists to post-genome biology. He is also the founder and co-director of the Quantitative Biology specialization program at UC San Diego. Hwa received fellowships and awards from the Sloan, Beckman, Guggenheim and Burroughs-Wellcome Foundations, and is a Fellow of the American Physical Society and the American Academy of Microbiology. Hwa received his PhD in physics from MIT. After postdoctoral research at Harvard University in condensed-matter physics, he joined UC San Diegos physics faculty in 1995.

Clifford Kubiak is a Distinguished Professor and former chair of the Department of Chemistry and Biochemistry, who holds the Harold C. Urey Chair in Chemistry. His Kubiak Research Group at UC San Diego is especially known for its work on developing catalysts for the electrochemical reduction of carbon dioxide. Kubiak is also a fellow of the American Academy of Arts and Sciences and the American Chemical Society (ACS). He has received several awards including the prestigious ACS Award in Organometallic Chemistry (2018), the Tolman Medal (2018), the Basolo Medal for Outstanding Research in Inorganic Chemistry (2015), the Inter-American Photochemical Society, Award in Photochemistry (2013) and the ACS Award in Inorganic Chemistry (2012). Kubiak has held visiting appointments at Tohoku University, University of Chicago and University of Erlangen, and he was a visiting associate in chemistry at the Joint Center for Artificial Photosynthesis at Caltech. He has served on the Editorial Advisory Boards of Accounts of Chemical Research, Inorganic Chemistry and Materials Science in Semiconductor Processing. He is the author of more than 290 scientific articles.

Before joining UC San Diego in 1998, Kubiak was a faculty member at Purdue University (1982-98). Before that he was a postdoctoral associate with Mark S. Wrighton at MIT (1980-81). He received his PhD in chemistry from the University of Rochester (1980), where he worked with Richard Eisenberg.

Kimberly Prather is a Distinguished Professor who holds a joint appointment between UC San Diegos Scripps Institution of Oceanography and the Department of Chemistry and Biochemistry. Prathers research focuses on understanding the influence of atmospheric aerosols on clouds, human health, and climate. Early in her career, she developed a technique known as aerosol time-of-flight mass spectrometry that is widely used in atmospheric field studies around the world to determine the origin and chemistry of aerosols. She is the founding director of the National Science Foundation Center for Aerosol Impacts on Chemistry of the Environment (CAICE), the largest federally funded center in the history of UC San Diego. CAICE researchers replicate ocean/atmosphere interactions in a laboratory setting to study the influence of ocean biology on atmospheric chemistry, clouds, and climate.

Prather joined UC San Diego in 2001. She was elected as a member of the American Academy of Arts and Sciences and a fellow of the American Geophysical Union in 2010. In 2019, she became the first woman at UC San Diego to be elected as a member of the National Academy of Engineering. Previously this year, she won the 2020 Frank H. Field and Joe L. Franklin Award for Outstanding Achievement in Mass Spectrometry from the American Chemical Society. She received her PhD in chemistry from the University of California, Davis.

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Five UC San Diego Professors Elected to National Academy of Sciences - UC San Diego Health

The Hemolung Respiratory Assist System is a minimally invasive device that does the work of the lungs by removing carbon dioxide directly from the blood.

A device designed at the University of Pittsburgh could help improve outcomes as a treatment for COVID-19 when used in conjunction with non-invasive or mechanical ventilation, and it recentlyreceived Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration. Health records from a New York study showed that close to 90 percent of patients who were placed on mechanical ventilation did not survive. Some intensive care units are now considering mechanical ventilation as a last resort because of the complications and side effects associated with the process, and researchers believe this device could help.

The Hemolung Respiratory Assist System is a minimally invasive device that does the work of the lungs by removing carbon dioxide directly from the blood, much as a dialysis machine does the work of the kidneys. The device was developed by William Federspiel, PhD, professor of bioengineering at Pitts Swanson School of Engineering, and the Pittsburgh-based lung-assist device company ALung Technologies, co-founded by Federspiel.

A public health emergency related to COVID-19 was declared by the Secretary of Health and Human Services on February 4, 2020, and the FDA issued ALung the EUA to treat lung failure caused by the disease. Hemolung could help eliminate damage to the lungs caused by ventilators and does not require intubation or sedation, which allows patients to remain mobile during treatment.

Ventilation can cause serious issues in lungs that are already being damaged by the disease itself, said Federspiel. The Hemolung would allow the lung to rest and heal during the ventilation process by allowing for gentler ventilation. It could also prevent certain patients, who have less severe symptoms, from having to go on ventilation in the first place.

Mechanical ventilation requires patients to be sedated and intubated, and a myriad of complications can arise from the treatment, including collapsed lung, alveolar damage, and ventilator-associated pneumonia. For these more critically ill patients, the Hemolung could be used to help remove CO2, which would allow the mechanical ventilation process to be done more gently.

Before resorting to mechanical ventilation, less severe COVID-19 cases can use non-invasive ventilation, which uses a mask to help support breathing, but sometimes this treatment is not sufficient. In this case, the Hemolung device could be used to support the non-invasive methods and prevent mechanical ventilation altogether.

Peter M. DeComo, Chairman and CEO of ALung Technologies, stated, With published mortality rates as high as 90% for patients receiving invasive mechanical ventilation (IMV), we believe that the Hemolung can be a valuable tool for physicians to be used in conjunction with IMV, by reducing or eliminating the potential of further lung damage caused by high ventilator driving pressures, often referred to as Ventilator Induced Lung Injury. Many of the academic medical centers involved with our clinical trial have already requested the use of the Hemolung RAS for treatment of their COVID-19 patients.

Created to help chronic obstructive pulmonary disease (COPD) and acute respiratory distress syndrome (ARDS) patients, Hemolung has already been used on thousands of patients in Europe, where it was approved in 2013, and it is currently in clinical trials in the United States.

Since the onset of the pandemic, the device has been used on some COVID-19 patients with success; however, set-up of the Hemolung is not trivial. Medical professionals would need to be trained to use the technology, and it would take time to supply a significant number of devices.

Federspiel also holds appointments in the School of Medicine and the McGowan Institute for Regenerative Medicine (MIRM) at Pitt and is a Fellow of the National Academy of Inventors.

This technology developed by Dr. Federspiel and ALung Technologies is a perfect example of how collaborative research at the McGowan Institute can impact human lives, said William Wagner, director of MIRM and professor of surgery, bioengineering and chemical engineering at Pitt. A clinical viewpoint is necessary, but medical training doesnt give you an engineers perspective of design and manufacturing. You need a solid foot in both camps to make progress.

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Giving Distressed Lungs a Safer Fighting Chance - Global Health News Wire

EIB, kENUP Foundation and Pluristem Will Host Investor & Analyst Call

HAIFA, Israel, April 27, 2020 (GLOBE NEWSWIRE) -- Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing a platform of novel biological therapeutic products, cordially invites investors, the media, and the public to join a signing ceremony and analyst & investor call on Thursday, April 30, 2020.

Signing Ceremony: 10:00h CEST / 11:00 IDT/ 4:00 am EDT

Signing of a Memorandum of Understanding on Bio-Convergence in Health between the European Investment Bank and Israel Innovation Authority of the State of Israel

&

Signing of Finance Contract on Innovation Cell Therapies (EGFF) between the European Investment Bank and Pluristem.

Bio-Convergence Health is a collaboration between Israel and Europe to advance technological and investment alliances.

As previously announced, the European Investment Bank is providing a 50 million non-dilutive financing to Pluristem in support of the Companys research and development in the EU to further advance its regenerative cell therapy platform, and to assist moving the products in its pipeline to market, with a special focus on clinical development of PLX cells as a treatment for complications associated with COVID-19.

The half-hour signing ceremony will be live streamed at: https://signing-ceremony.eu/

Investor & Analyst Call: 15:00h CEST / 16:00h IDT / 09:00 am EDTThe European Investment Bank, kENUP Foundation and Pluristem will conduct a call to discuss the 50 million financing. Analysts are invited to ask questions during the Q&A session. The public is invited to listen to the call at: https://signing-ceremony.eu/

About the European Investment BankThe European Investment Bank (EIB) is the long-term lending institution of the European Union, owned by its Member States. It makes long-term finance available for sound investment in order to contribute towards EU policy goals.

Investment Plan for EuropeThe Investment Plan for Europe (the Juncker Plan) is one of the EU's key actions to boost investment in Europe, thereby creating jobs and fostering growth. To this end, smarter use will be made of new and existing financial resources. The EIB Group, consisting of the European Investment Bank and the European Investment Fund, is playing a vital role in this investment plan. With guarantees from the European Fund for Strategic Investments (EFSI), the EIB and EIF are able to take on a higher share of project risk, encouraging private investors to participate in the projects. In addition to EFSI, the new European Investment Advisory Hub (EIAH) helps public and private sector project promoters to structure investment projects more professionally. The projects and agreements approved under EFSI (European Fund for Strategic Investments) so far are expected to mobilise almost 466 billion of investments and will benefit over 1 million start-ups and SMEs (Small Medium Enterprises) in the 27 Member States.

About kENUP FoundationkENUP is a global partnership in innovation, promoting research based innovation for Europe with public and societal benefit. kENUP develops projects to pursue market-leading positions for European innovation businesses. In this capacity, kENUP is supporting the execution of the European Fund for Strategic Investments (EFSI, the so-called Juncker Plan), alongside its successor EFSI 2.0 and of the current InvestEU Fund. kENUP is a not-for-profit organization established as a foundation in the Republic of Malta by Public Deed on November 6, 2014. kENUPs activities are published in the European Transparency Register.

About Pluristem TherapeuticsPluristem Therapeutics Inc. is a leading regenerative medicine company developing novel placenta-based cell therapy product candidates. The Company has reported robust clinical trial data in multiple indications for its patented PLX cell product candidates and is currently conducting late stage clinical trials in several indications. PLX cell product candidates are believed to release a range of therapeutic proteins in response to inflammation, ischemia, muscle trauma, hematological disorders and radiation damage. The cells are grown using the Company's proprietary three-dimensional expansion technology and can be administered to patients off-the-shelf, without tissue matching. Pluristem has a strong intellectual property position; a Company-owned and operated GMP-certified manufacturing and research facility; strategic relationships with major research institutions; and a seasoned management team.

Safe Harbor StatementThis press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws. For example, Pluristem is using forward-looking statements when it discusses its expectation to receive the financing from the EIB, the belief that the financing will support its research and development in the EU to further advance its regenerative cell therapy platform, to assist moving the products in its pipeline to market, with a special focus on clinical development of PLX cells as a treatment for complications associated with COVID-19. These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; Pluristem may encounter delays or obstacles in launching and/or successfully completing its clinical trials; Pluristems products may not be approved by regulatory agencies, Pluristems technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; Pluristem may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with Pluristems process; Pluristems products may wind up being more expensive than it anticipates; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; Pluristems patents may not be sufficient; Pluristems products may harm recipients; changes in legislation may adversely impact Pluristem; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem's reports filed from time to time with the Securities and Exchange Commission.

Contact:Dana RubinDirector of Investor Relations972-74-7107194danar@pluristem.com

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The European Investment Bank (EIB), EU Delegation to Israel, the Israel Innovation Authority, and Pluristem Cordially Invite the Public to an Online...

HAIFA, Israel, April 24, 2020 (GLOBE NEWSWIRE) -- Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing a platform of novel biological therapeutic products, announced today that the European Investment Bank (EIB) has approved a 50 million non-dilutive financing for the Company (the Approved Financing). This Approved Financing, once received, will support Pluristems research and development in the EU to further advance its regenerative cell therapy platform, and to assist moving the products in its pipeline to market, with a special focus on clinical development of PLX cells as a treatment for complications associated with COVID-19. The Approved Financing will be deployed in three tranches, subject to the achievement of certain clinical, regulatory and scaling up milestones, with the first tranche consisting of 20 million. The expected signing date of the financing agreement relating to the Approved Financing is April 30, 2020.

Pluristem recently formed a wholly-owned subsidiary in Berlin, Germany, underscoring the Companys commitment to having a physical presence in Europe to advance research and development, and to prepare for commercialization, for its product candidates.

The Approved Financing is backed by a guarantee from the European Fund for Strategic Investments (EFSI), the financial pillar of the Investment Plan for Europe, under which the EIB and the European Commission are working together as strategic partners to boost Europes economic competitiveness. The transaction has been initiated by kENUP Foundation, a global partnership in innovation, promoting research-based innovation for Europe with public and societal benefit.

The Approved Financing, once granted, will not be secured and will be payable to the EIB in a single payment following five years from the disbursement of the first and second tranches and in two annual payments starting on the fourth year from disbursement of the third tranche, with each tranche having an interest rate of between 3% to 4%. The Approved Financing will support up to 50% of Pluristems R&D project cost. In addition, the EIB would be entitled to receive royalties from future revenues for a period of seven years starting 2024, at a rate of 0.2% to 2.3%, pro-rated to the amounts that the Company received from the Approved Financing.

We are extremely honored to have been selected by the EIB for this prestigious financing. We believe that this financing will allow us to significantly advance the clinical development of our lead product candidates, which if successful we expect will improve the quality of life for millions of patients around the world. Having established research partnerships with leading European institutions such as Charit University of Medicine Berlin, BIH Center for Regenerative Therapy (BCRT) and the Berlin Center for Advanced Therapies (BeCAT), as well as formed a subsidiary in Berlin, we understand the importance of having a physical presence in key markets, stated Pluristem CEO and President, Yaky Yanay. As we move forward into a multinational clinical trial for PLX cells to treat patients suffering from complications associated with COVID-19, we expect this EIB financing will accelerate our path to approval and to making a potentially effective COVID-19 treatment available worldwide.

About the European Investment Bank The European Investment Bank (EIB) is the long-term lending institution of the European Union, owned by its Member States. It makes long-term finance available for sound investment in order to contribute towards EU policy goals.

Investment Plan for Europe The Investment Plan for Europe (the Juncker Plan) is one of the EU's key actions to boost investment in Europe, thereby creating jobs and fostering growth. To this end, smarter use will be made of new and existing financial resources. The EIB Group, consisting of the European Investment Bank and the European Investment Fund, is playing a vital role in this investment plan. With guarantees from the European Fund for Strategic Investments (EFSI), the EIB and EIF are able to take on a higher share of project risk, encouraging private investors to participate in the projects. In addition to EFSI, the new European Investment Advisory Hub (EIAH) helps public and private sector project promoters to structure investment projects more professionally. The projects and agreements approved under EFSI (European Fund for Strategic Investments) so far are expected to mobilise almost 466 billion of investments and will benefit over 1 million start-ups and SMEs (Small Medium Enterprises) in the 27 Member States.

About Pluristem TherapeuticsPluristem Therapeutics Inc. is a leading regenerative medicine company developing novel placenta-based cell therapy product candidates. The Company has reported robust clinical trial data in multiple indications for its patented PLX cell product candidates and is currently conducting late stage clinical trials in several indications. PLX cell product candidates are believed to release a range of therapeutic proteins in response to inflammation, ischemia, muscle trauma, hematological disorders and radiation damage. The cells are grown using the Company's proprietary three-dimensional expansion technology and can be administered to patients off-the-shelf, without tissue matching. Pluristem has a strong intellectual property position; a Company-owned and operated GMP-certified manufacturing and research facility; strategic relationships with major research institutions; and a seasoned management team.

Safe Harbor Statement This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws. For example, Pluristem is using forward-looking statements when it discusses its expectation that it will execute a definitive agreement for the Approved Financing and the proposed terms of such Approved Financing, the belief that the Approved Financing will support its research and development in the EU to further advance its regenerative cell therapy platform, to assist moving the products in its pipeline to market, with a special focus on clinical development of PLX cells as a treatment for complications associated with COVID-19, that such Approved Financing will allow it to significantly advance its clinical development of its lead product candidates which it expects will improve the quality of life for millions of patients around the world and the expectation that the Approved Financing will accelerate its path to approval of its COVID-19 multinational clinical trial and to making a potentially effective COVID-19 treatment available worldwide. While the EIB has announced the approval of the Approved Financing, there is no guarantee that the Company and the EIB will execute the definitive agreement on April 30, 2020, if at all, or that it will achieve the milestones necessary to receive any or all of the three tranches. These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; Pluristem may encounter delays or obstacles in launching and/or successfully completing its clinical trials; Pluristems products may not be approved by regulatory agencies, Pluristems technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; Pluristem may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with Pluristems process; Pluristems products may wind up being more expensive than it anticipates; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; Pluristems patents may not be sufficient; Pluristems products may harm recipients; changes in legislation may adversely impact Pluristem; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem's reports filed from time to time with the Securities and Exchange Commission.

Contact:Dana RubinDirector of Investor Relations+972-74-7107194danar@pluristem.com

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Pluristem Secures 50 Million Non-Dilutive Financing from the European Investment Bank to Support its COVID-19 Project and Phase III StudiesEXPECTED...

PHILADELPHIA and OXFORDSHIRE, United Kingdom, April 28, 2020 (GLOBE NEWSWIRE) -- Adaptimmune Therapeutics plc (ADAP), a leader in cell therapy to treat cancer, announced that the European Medicine Agencys (EMA) Committee for Orphan Medicinal Products (COMP) has adopted a positive opinion for Orphan Drug Designation for ADP-A2M4 for the treatment of soft tissue sarcomas.

Adaptimmunes SPEARHEAD-1 trial with ADP-A2M4 for people with synovial sarcoma and myxoid/round cell liposarcoma (MRCLS) is actively enrolling at approximately 25 clinical sites in Canada, France, Spain, the United Kingdom, and the US. The SPEARHEAD-1 trial is intended to support the registration of ADPA2M4 for the treatment of advanced synovial sarcoma and MRCLS.

Outcomes with currently available treatments remain unsatisfactory for patients with inoperable or metastatic soft tissue sarcoma, and there is a high unmet medical need for new treatment options for patients with this disease, said Dennis Williams, PharmD, Adaptimmunes SVP, Late Stage Development. ADP-A2M4 has the potential to offer substantial improvement in the treatment of advanced soft tissue sarcoma and the COMPs adoption of a positive opinion for Orphan Drug Designation for ADP-A2M4 is another important milestone for this program.

The COMP adopts an opinion on the granting of orphan drug designation, after which the opinion is submitted to theEuropean Commissionfor endorsement. This designation by theEuropean Commissionprovides certain regulatory and financial incentives for companies to develop and market therapies that treat a life-threatening or chronically debilitating condition affecting no more than five in 10,000 persons in theEuropean Union, and where the treatment provides a significant benefit to those affected by the condition or no satisfactory treatment is available.

Earlier this year, the United States (US) Food and Drug Administration (FDA) granted Orphan Drug Designation (ODD) to SPEAR T-cells targeting MAGE-A4 for the treatment of soft tissue sarcomas and Regenerative Medicine Advanced Therapy (RMAT) designation for the treatment of synovial sarcoma.

About AdaptimmuneAdaptimmune is a clinical-stage biopharmaceutical company focused on the development of novel cancer immunotherapy products for people with cancer. The Companys unique SPEAR (Specific Peptide Enhanced Affinity Receptor) T-cell platform enables the engineering of T-cells to target and destroy cancer across multiple solid tumors.

Forward-Looking StatementsThis release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 (PSLRA). These forward-looking statements involve certain risks and uncertainties. Such risks and uncertainties could cause our actual results to differ materially from those indicated by such forward-looking statements, and include, without limitation: the success, cost and timing of our product development activities and clinical trials and our ability to successfully advance our TCR therapeutic candidates through the regulatory and commercialization processes. For a further description of the risks and uncertainties that could cause our actual results to differ materially from those expressed in these forward-looking statements, as well as risks relating to our business in general, we refer you to our Annual Report on Form 10-K filed with the SEC on February 27, 2020, and our other SEC filings. The forward-looking statements contained in this press release speak only as of the date the statements were made and we do not undertake any obligation to update such forward-looking statements to reflect subsequent events or circumstances.

Adaptimmune Contacts:

Media Relations:

Sbastien Desprez VP, Communications and Investor RelationsT: +44 1235 430 583M: +44 7718 453 176Sebastien.Desprez@adaptimmune.com

Investor Relations:

Juli P. Miller, Ph.D. Senior Director, Investor RelationsT: +1 215 825 9310M: +1 215 460 8920Juli.Miller@adaptimmune.com

Excerpt from:
Positive Opinion for Orphan Drug Designation for ADP-A2M4 in the European Union for the Treatment of Soft Tissue Sarcoma from EMA' Committee of Orphan...

Timothy Chan, M.D., Ph.D.

Timothy Chan, M.D., Ph.D., has been appointed director of the Center for Immunotherapy and Precision Immuno-Oncology at Cleveland Clinic.

A renowned immuno-oncology and cancer genomics expert, Dr. Chan leads the new center which brings together multidisciplinary experts from across the Cleveland Clinic enterprise to advance research and treatment related to the rapidly growing field of immuno-oncology.

The center will comprise four arms, including a Cleveland cell therapy program in collaboration with the Case Comprehensive Cancer Center, and will recruit national and international experts in computational science, immunotherapy and cancer immunology. The new center will initially have sites in Cleveland and the soon-to-open Cleveland Clinic Florida Research and Innovation Center in Port St. Lucie, Florida, both focused on immunotherapy research and developmental therapeutics.

Dr. Chan will also collaborate with experts in the new Center for Global and Emerging Pathogens Research, which is focused on broadening understanding of immunology and microbial pathogenesis with the goal of improving treatment for a variety of diseases, including virus-induced cancers.

Immunotherapy is the future of research in cancer and various other diseases and Cleveland Clinic has made it a priority by establishing this new center, said Serpil Erzurum, M.D., chair of Cleveland Clinics Lerner Research Institute. The Center for Immunotherapy and Precision Immuno-Oncology will empower clinicians and scientists throughout the enterprise to advance personalized cancer care and breakthrough immunotherapy research at Cleveland Clinic.

Dr. Chan joins Cleveland Clinic from Memorial Sloan Kettering Cancer Center and Weill Cornell School of Medicine, where he leads the Immunogenomics and Precision Oncology Platform and was a tenured professor, the PaineWebber Chair, and the Translational Oncology Division chair. He is an internationally recognized expert in precision immuno-oncology and a pioneer in using genomics to determine which patients will respond best to certain types of immunotherapies. He has published over 200 articles in peer-reviewed journals, has made landmark discoveries in his field, and has received numerous awards, including the National Cancer Institute Outstanding Investigator Award in 2018.

Innovation in precision immunotherapy is one of the most exciting areas in cancer research, said Brian Bolwell, M.D., chairman of Taussig Cancer Institute, Cleveland Clinic Cancer Center. The addition of Dr. Chan, a pioneer in cancer genomics, and the new centers focus on research and clinical trials will strengthen our ability to provide advanced treatment options for our patients.

Dr. Chan also joins the leadership of the National Center for Regenerative Medicine of Case Western Reserve University. Dr. Chan is also on staff in the Genomic Medicine Institute of the Lerner Research Institute; and the Department of Radiation Oncology of the Taussig Cancer Institute.

Dr. Chan earned his M.D. and Ph.D. in genetics from Johns Hopkins University, where he also completed a residency in radiation oncology and a postdoctoral fellowship in the division of tumor biology. He is board certified in radiation oncology and is an elected member of the Association of American Physicians (AAP).

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Cleveland Clinic Appoints Timothy Chan, M.D., Ph.D., as Director of Center for Immunotherapy and Precision Immuno-Oncology - Health Essentials from...

DUBLIN, April 28, 2020 /PRNewswire/ --

NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION, IN WHOLE OR IN PART, IN, INTO OR FROM ANY JURISDICTION WHERE TO DO SO WOULD CONSTITUTE A VIOLATION OF THE RELEVANT LAWS OR REGULATIONS OF SUCH JURISDICTION

Allergan plc (NYSE: AGN) ("Allergan") announced today that it has notified the New York Stock Exchange ("NYSE") of its intention to voluntarily withdraw from listing on the NYSE and from registration under Section 12(b) of the Securities Exchange Act of 1934, as amended (the "Exchange Act") any and all outstanding notes and related guarantees of the following series issued by Allergan Funding SCS, a subsidiary of Allergan: (i) Floating Rate Notes due 2020 (NYSE: AGN20A), (ii) 0.500% Senior Notes due 2021 (NYSE: AGN21), (iii) 1.500% Senior Notes due 2023 (NYSE: AGN23A), (iv) 1.250% Senior Notes due 2024 (NYSE: AGN24A), (v) 2.625% Senior Notes due 2028 (NYSE: AGN28) and (vi) 2.125% Senior Notes due 2029 (NYSE: AGN29) (clauses (i)-(vi) collectively, the "Allergan Funding SCS Notes") in each case, following the consummation of the previously announced proposed acquisition (the "Transaction") of Allergan by AbbVie Inc. ("AbbVie") by means of a scheme of arrangement (the "Scheme") under Chapter 1 of Part 9 of the Irish Companies Act 2014. The proposed delisting of the Allergan Funding SCS Notes and related guarantees is contingent upon the closing of the Transaction, which is subject to, among other conditions, the receipt of necessary regulatory approvals. To effect the delisting, Allergan expects Allergan Funding SCS and each guarantor of the Allergan Funding SCS Notes to file a Form 25 in respect of the Allergan Funding SCS Notes with the Securities and Exchange Commission. Allergan reserves the right to delay the filing of the Form 25 or to withdraw such filing for any reason prior to its effectiveness, including, without limitation, in the event that the Transaction is delayed or is not completed for any reason.

Allergan Funding SCS's decision to withdraw the Allergan Funding SCS Notes and related guarantees from listing on the NYSE and from registration under the Exchange Act was based on its determination that, following the completion of the Transaction, Allergan's ordinary shares will also be delisted from the NYSE and removed from registration under the Exchange Act and Allergan will become a wholly-owned subsidiary of AbbVie.

ABOUT ALLERGAN

Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a global pharmaceutical leader focused on developing, manufacturing and commercializing branded pharmaceutical, device, biologic, surgical and regenerative medicine products for patients around the world. Allergan markets a portfolio of leading brands and best-in-class products primarily focused on four key therapeutic areas including medical aesthetics, eye care, central nervous system and gastroenterology. As part of its approach to delivering innovation for better patient care, Allergan has built one of the broadest pharmaceutical and device research and development pipelines in the industry.

With colleagues and commercial operations located in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives every day.

Story continues

For more information, visit Allergan's website at http://www.Allergan.com.

ENQUIRIES

Allergan

Media:

Lisa Brown

+1 862 261 7320

Investors:

Manisha Narasimhan, PhD

+ 1 862 261 7162

FORWARD-LOOKING STATEMENTS

This announcement contains certain forward-looking statements, including with respect to the pending acquisition involving AbbVie and Allergan and AbbVie's, Allergan's and/or the combined group's estimated or anticipated future business, performance and results of operations and financial condition, including estimates, forecasts, targets and plans for AbbVie and, following the acquisition, if completed, the combined group. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. These forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, the possibility that the pending acquisition will not be pursued, failure to obtain necessary regulatory approvals or required financing or to satisfy any of the other conditions to the pending acquisition, adverse effects on the market price of AbbVie's shares of common stock or Allergan's ordinary shares and on AbbVie's or Allergan's operating results because of a failure to complete the pending acquisition, failure to realize the expected benefits of the pending acquisition, failure to promptly and effectively integrate Allergan's businesses, negative effects relating to the announcement of the pending acquisition or any further announcements relating to the pending acquisition or the consummation of the pending acquisition on the market price of AbbVie's shares of common stock or Allergan's ordinary shares, significant transaction costs and/or unknown or inestimable liabilities, potential litigation associated with the pending acquisition, general economic and business conditions that affect the combined companies following the consummation of the pending acquisition, changes in global, political, economic, business, competitive, market and regulatory forces, future exchange and interest rates, changes in tax laws, regulations, rates and policies, future business acquisitions or disposals and competitive developments. These forward-looking statements are based on numerous assumptions and assessments made in light of AbbVie's or, as the case may be, Allergan's experience and perception of historical trends, current conditions, business strategies, operating environment, future developments and other factors it believes appropriate. By their nature, forward-looking statements involve known and unknown risks and uncertainties because they relate to events and depend on circumstances that will occur in the future. The factors described in the context of such forward-looking statements in this announcement could cause AbbVie's plans with respect to Allergan or AbbVie's or Allergan's actual results, performance or achievements, industry results and developments to differ materially from those expressed in or implied by such forward-looking statements. Although it is believed that the expectations reflected in such forward-looking statements are reasonable, no assurance can be given that such expectations will prove to have been correct and persons reading this announcement are therefore cautioned not to place undue reliance on these forward-looking statements which speak only as of the date of this announcement. Additional information about economic, competitive, governmental, technological and other factors that may affect AbbVie or Allergan is set forth in AbbVie's and Allergan's periodic public filings with the U.S. Securities and Exchange Commission, including, but not limited to, AbbVie's and Allergan's Annual Report on Form 10-K for the year ended December 31, 2019, and, from time to time, AbbVie's and Allergan's other investor communications, in each case, the contents of which are not incorporated by reference into, nor do they form part of, this announcement.

Any forward-looking statements in this announcement are based upon information available to AbbVie, Allergan and/or their respective board of directors, as the case may be, as of the date of this announcement and, while believed to be true when made, may ultimately prove to be incorrect. Subject to any obligations under applicable law, none of AbbVie, Allergan or any member of their respective board of directors undertakes any obligation to update any forward-looking statement whether as a result of new information, future developments or otherwise, or to conform any forward-looking statement to actual results, future events, or to changes in expectations. All subsequent written and oral forward-looking statements attributable to AbbVie, Allergan or their respective board of directors or any person acting on behalf of any of them are expressly qualified in their entirety by this paragraph.

Statement Required by the Irish Takeover Rules

The Allergan directors accept responsibility for the information contained in this announcement. To the best of the knowledge and belief of the Allergan directors (who have taken all reasonable care to ensure such is the case), the information contained in this announcement for which they accept responsibility is in accordance with the facts and does not omit anything likely to affect the import of such information.

Any holder of 1% or more of any class of relevant securities of Allergan or AbbVie may have disclosure obligations under Rule 8.3 of the Irish Takeover Panel Act, 1997, Takeover Rules 2013 (the "Irish Takeover Rules").

General

The release, publication or distribution of this announcement in or into certain jurisdictions may be restricted by the laws of those jurisdictions (the "Restricted Jurisdictions"). Accordingly, copies of this announcement and all other documents relating to the acquisition are not being, and must not be, released, published, mailed or otherwise forwarded, distributed or sent in, into or from any Restricted Jurisdictions. Persons receiving such documents (including, without limitation, nominees, trustees and custodians) should observe these restrictions. Failure to do so may constitute a violation of the securities laws of any such jurisdiction. To the fullest extent permitted by applicable law, the companies involved in the acquisition disclaim any responsibility or liability for the violations of any such restrictions by any person.

A copy of this announcement will be available, free of charge (subject to certain restrictions relating to persons resident in Restricted Jurisdictions) on the Allergan website at http://www.allergan.com. The contents of the Allergan website are not incorporated into, and do not form part of, this announcement.

This announcement has been prepared for the purpose of complying with the laws of Ireland and the Takeover Rules and the information disclosed may not be the same as that which would have been disclosed if this announcement had been prepared in accordance with the laws of jurisdictions outside of Ireland.

View original content to download multimedia:http://www.prnewswire.com/news-releases/announcement-relating-to-the-voluntary-delisting-of-allergan-notes-301048694.html

SOURCE Allergan plc

Read more:
Announcement relating to the voluntary delisting of Allergan Notes - Yahoo Finance

Analysis of the Global Regenerative Medicine Products Market

The report on the global Regenerative Medicine Products market reveals that the market is expected to grow at a CAGR of ~XX% during the considered forecast period (2019-2029) and estimated to reach a value of ~US$XX by the end of 2029. The latest report is a valuable tool for stakeholders, established market players, emerging players, and other entities to devise effective strategies to combat the impact of COVID-19

Further, by leveraging the insights enclosed in the report, market players can devise concise, impactful, and highly effective growth strategies to solidify their position in the Regenerative Medicine Products market.

Research on the Regenerative Medicine Products Market Addresses the Following Queries

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Competitive Landscape

The competitive landscape section offers valuable insights related to the business prospects of leading market players operating in the Regenerative Medicine Products market. The market share, product portfolio, pricing strategy, and growth strategies adopted by each market player is included in the report. The major steps taken by key players to address the business challenges put forward by the novel COVID-19 pandemic is discussed in the report.

Regional Landscape

The regional landscape section provides a deep understanding of the regulatory framework, current market trends, opportunities, and challenges faced by market players in each regional market. The various regions covered in the report include:

End-User Assessment

The report bifurcates the Regenerative Medicine Products market based on different end users. The supply-demand ratio and consumption volume of each end-user is accurately depicted in the report.

Market Segment AnalysisThe research report includes specific segments by Type and by Application. This study provides information about the sales and revenue during the historic and forecasted period of 2015 to 2026. Understanding the segments helps in identifying the importance of different factors that aid the market growth.Segment by Type, the Regenerative Medicine Products market is segmented intoCell TherapyTissue EngineeringBiomaterialOthers

Segment by ApplicationDermatologyCardiovascularCNSOrthopedicOthers

Global Regenerative Medicine Products Market: Regional AnalysisThe Regenerative Medicine Products market is analysed and market size information is provided by regions (countries). The report includes country-wise and region-wise market size for the period 2015-2026. It also includes market size and forecast by Type and by Application segment in terms of sales and revenue for the period 2015-2026.The key regions covered in the Regenerative Medicine Products market report are:North AmericaU.S.CanadaEuropeGermanyFranceU.K.ItalyRussiaAsia-PacificChinaJapanSouth KoreaIndiaAustraliaTaiwanIndonesiaThailandMalaysiaPhilippinesVietnamLatin AmericaMexicoBrazilArgentinaMiddle East & AfricaTurkeySaudi ArabiaU.A.EGlobal Regenerative Medicine Products Market: Competitive AnalysisThis section of the report identifies various key manufacturers of the market. It helps the reader understand the strategies and collaborations that players are focusing on combat competition in the market. The comprehensive report provides a significant microscopic look at the market. The reader can identify the footprints of the manufacturers by knowing about the global revenue of manufacturers, the global price of manufacturers, and sales by manufacturers during the forecast period of 2015 to 2019.The major players in global Regenerative Medicine Products market include:AcelityDePuy SynthesMedtronicZimmerBiometStrykerMiMedx GroupOrganogenesisUniQureCellular Dynamics InternationalOsiris TherapeuticsVcanbioGamida CellGolden MeditechCytori TherapeuticsCelgeneVericel CorporationGuanhao BiotechMesoblastStemcell TechnologesBellicum Pharmaceuticals

Do You Have Any Query Or Specific Requirement? Ask to Our Industry [emailprotected] https://www.researchmoz.com/enquiry.php?type=E&repid=2630513&source=atm

Essential Findings of the Regenerative Medicine Products Market Report:

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Excerpt from:
How Coronavirus Pandemic Will Impact Regenerative Medicine Products Market, Share, Growth, Trends And Forecast To 2026 - Jewish Life News

Officially established on September 30th 2013 by Chinas Ministry of Education, ShanghaiTech University is a small-scale research university of academic excellence jointly established by Shanghai Municipal Government and Chinese Academy of Sciences (CAS). ShanghaiTech focuses on science and engineering. The university consists of four schools and two research institutes: School of Physical Science and Technology (SPST), School of Information Science and Technology (SIST), School of Life Science and Technology (SLST), School of Entrepreneurship and Management (SEM), Shanghai Institute for Advanced Immunochemical Studies (SIAIS) and iHuman Institute.

Qualifications

SLST is seeking applications focused on, but not limited to, genomics and proteomics, epigenetics, RNA biology, systems and computational biology, stem cell biology and regenerative medicine, super-resolution microscopy, chemical biology and drug discovery, and translational medicine. Successful applicants should have an exceptional track record of research in life science or technology in the last five years. The recruited faculty members are expected to develop a first-rate research program and contribute to the educational missions of SLSTs undergraduate and graduate prog

Salary Package

Salary is highly competitive and commensurate with experience and academic accomplishments. ShanghaiTech also offers a comprehensive benefit package. On-campus professor apartment is provided.

ShanghaiTech will provide internationally competitive start-up funds, including support for Research Associates and Post-Doctoral fellows. Laboratory space will be provided to match research needs.

Application Procedure

Submit a cover letter (Firstname_Lastname_Cover_Letter.pdf), a 2-page research plan (Firstname_Lastname_Research_Plan.pdf), a CV (Firstname_Lastname_CV.pdf), up to 3 copies of most significant publications (Firstname_Lastname_Paper1-3.pdf), and the names of three references to SLST@shanghaitech.edu.cn.

Review of applications will start immediately and will continue until positions are filled.

The rest is here:
Assistant / Associate / Professor for School of Life Science and Technology job with SHANGHAITECH UNIVERSITY | 205309 - Times Higher Education (THE)

Bellicum Pharmaceuticals

Global Regenerative Medicine Products Market Segmentation

This market was divided into types, applications and regions. The growth of each segment provides an accurate calculation and forecast of sales by type and application in terms of volume and value for the period between 2020 and 2026. This analysis can help you develop your business by targeting niche markets. Market share data are available at global and regional levels. The regions covered by the report are North America, Europe, the Asia-Pacific region, the Middle East, and Africa and Latin America. Research analysts understand the competitive forces and provide competitive analysis for each competitor separately.

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Regenerative Medicine Products Market Region Coverage (Regional Production, Demand & Forecast by Countries etc.):

North America (U.S., Canada, Mexico)

Europe (Germany, U.K., France, Italy, Russia, Spain etc.)

Asia-Pacific (China, India, Japan, Southeast Asia etc.)

South America (Brazil, Argentina etc.)

Middle East & Africa (Saudi Arabia, South Africa etc.)

Some Notable Report Offerings:

-> We will give you an assessment of the extent to which the market acquire commercial characteristics along with examples or instances of information that helps your assessment.

-> We will also support to identify standard/customary terms and conditions such as discounts, warranties, inspection, buyer financing, and acceptance for the Regenerative Medicine Products industry.

-> We will further help you in finding any price ranges, pricing issues, and determination of price fluctuation of products in Regenerative Medicine Products industry.

-> Furthermore, we will help you to identify any crucial trends to predict Regenerative Medicine Products market growth rate up to 2026.

-> Lastly, the analyzed report will predict the general tendency for supply and demand in the Regenerative Medicine Products market.

Have Any Query? Ask Our Expert@ https://www.marketresearchintellect.com/need-customization/?rid=222856&utm_source=LHN&utm_medium=888

Table of Contents:

Study Coverage: It includes study objectives, years considered for the research study, growth rate and Regenerative Medicine Products market size of type and application segments, key manufacturers covered, product scope, and highlights of segmental analysis.

Executive Summary: In this section, the report focuses on analysis of macroscopic indicators, market issues, drivers, and trends, competitive landscape, CAGR of the global Regenerative Medicine Products market, and global production. Under the global production chapter, the authors of the report have included market pricing and trends, global capacity, global production, and global revenue forecasts.

Regenerative Medicine Products Market Size by Manufacturer: Here, the report concentrates on revenue and production shares of manufacturers for all the years of the forecast period. It also focuses on price by manufacturer and expansion plans and mergers and acquisitions of companies.

Production by Region: It shows how the revenue and production in the global market are distributed among different regions. Each regional market is extensively studied here on the basis of import and export, key players, revenue, and production.

About Us:

Market Research Intellect provides syndicated and customized research reports to clients from various industries and organizations with the aim of delivering functional expertise. We provide reports for all industries including Energy, Technology, Manufacturing and Construction, Chemicals and Materials, Food and Beverage and more. These reports deliver an in-depth study of the market with industry analysis, market value for regions and countries and trends that are pertinent to the industry.

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Tags: Regenerative Medicine Products Market Size, Regenerative Medicine Products Market Growth, Regenerative Medicine Products Market Forecast, Regenerative Medicine Products Market Analysis

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New collective voice for the ecosystem launches first white paper

TORONTO, April 28, 2020 /CNW/ - The founders of the newly established Innovation Economy Council (IEC) MaRS, OCE, Communitech, DMZ, Invest Ottawa and CCRM have published the group's first white paper: The post-viral pivot: How Canada's tech startups can drive the recovery from COVID-19.

The IEC was formed as an informal coalition of industry leaders advocating on behalf of startup ventures at the beginning of the COVID-19 crisis, and is looking at how Canada's established companies should work with innovators to navigate a post-COVID-19 world. Going forward, the new council will produce white papers and host events to help shape a new industrial innovation policy for the country.

The IEC's inaugural report was authored by Barrie McKenna, former Globe and Mail columnist, with data and analytics by Nigel Biggar. It examines how Canada's startups are best positioned to lead Canada's post-COVID-19 recovery, well beyond the bounds of the startup ecosystem itself and the consequences if they aren't adequately supported. The report findings show that all sectors of the Canadian economy depend on a vast supply chain of technology companies to meet needs in such areas as cybersecurity, artificial intelligence, data privacy, e-commerce, clean technology and advanced manufacturing. These companies also have some of the highest rates of productivity and generate more economic output for every hour worked. A disproportionate share of job losses in these advanced industries would damage productivity nationwide.

The white paper also highlights essential startups that have shifted gears during the pandemic to meet new demands and opportunities. Companies that pivot with their clients are best positioned to help the Canadian economy bounce back. The IEC recommends that governments work together to design a new industrial innovation policy that supports the leading startups and industries that can help fuel the economic recovery post-pandemic.

Key findings include:

Tech startups already drive employment and growth

Startups help advanced industries punch above their weight

After COVID-19, startups will help established corporations pivot

The IEC recommends the federal and provincial governments collaborate to implement stimulus measures that will build the physical and digital infrastructure that serve as the foundation for Canada's economy over the coming decades and incentivize technology adoption. In addition to ensuring that Canada has the necessary channels to get products to market, Canadian companies must be leaders in the global digital marketplace. Policies should also focus on enhancing the resilience of domestic supply chains and promote collaboration between Canadian firms.

IEC Founders:

"Canada's economic recovery from COVID-19 will be led by our high growth, tech and innovation companies. If you map the ventures we work with to employment growth, the tech and innovation sectors have grown dramatically over the past two years, materially outpacing traditional industries. All sectors of our economy depend on our purpose-driven ventures to stay connected and nimble in times of enormous change. And we must have a cohesive game plan that is informed by data and evidence-based insights, reflecting the voices of our entrepreneurs, to drive smart policy decisions that give entrepreneurs every possible opportunity as they create sustainable economic advantage for our nation. Now more than ever, we need innovators to chart a bold new future for Canada."

Yung Wu, CEO, MaRS

"The health of our economy is inextricably linked to the health of our innovation ecosystem highlighting the critical role the tech sector plays in the robust, interconnected supply chain that drives our economic strength. As global supply chains experience massive disruption, the ability of our startups and SMEs to collaborate and pivot is a central force in fostering economic recovery and resilience. By ensuring Ontario companies have the support, talent and tools they need, we can accelerate our transformation to the digital economy, fuel development of Made-in-Ontario solutions and expand the local talent required to emerge as a global leader in technology innovation."

Claudia Krywiak, president and CEO, Ontario Centres of Excellence

"The Innovation Economy Council represents a crucial next step in the development of Canada's innovation sector, so we can help our province and country win in the new economy. We intend to play a leading role in helping our country transition to a more secure, technologically advanced economy that breeds highly successful and dynamic firms, sectors, and supply chains."

Iain Klugman, president and CEO, Communitech

"Canada's startup community galvanized to create common good in order to support its ecosystem through the COVID-19 pandemic. As a result, our lobbying efforts have seen more inclusive programming for small businesses across the country. We are the nation with the greatest immediate capabilities to make a positive difference. We can't miss the opportunity to focus on the positive difference we can make and continue to bring our talent and innovation to the world."

Abdullah Snobar, executive director, DMZ

"As the COVID-19 pandemic emerged, the world was well into the fourth industrial revolution, characterized by the fusion of digital, physical and biological worlds. Startups were driving specialized tech into every facet of our economy. This is an economic watershed moment for Canada. As a nation, we can re-emerge as leaders, building on years of systematic tech startup cultivation and investment. To lead in this new world economy, we must protect and leverage Canada's tech startups to drive innovation, growth and job creation. The choices we make today will define Canada's economic future."

Michael Tremblay, president and CEO, Invest Ottawa and Bayview Yards

"Canada is a leader in the science of regenerative medicine, including cell and gene therapy. Our growing ability to offer biomanufacturing and health care delivery in this sector will help propel the nation beyond being generators of licensable IP towards sustainable economic and health benefits and global leadership in the life sciences."

Michael May, president and CEO, CCRM

About the Innovation Economy Council The Innovation Economy Council is an independent voice for the innovation ecosystem founded by MaRS Discovery District, Ontario Centres of Excellence, Communitech, DMZ, CCRM and Invest Ottawa. It brings together entrepreneurs and leaders from industry, academia and the investment community to drive Canada's industrial innovation policy.

SOURCE Innovation Economy Council

For further information: Media Contact: MaRS, [emailprotected]

Continue reading here:
Innovation Economy Council formed to drive Canada's technology economy post-pandemic - Canada NewsWire

What to know

The CDC is recommending that everyone wear a cloth mask when going out in public. The Manufacturing Development Center at the Wake Forest Institute for Regenerative Medicine, part of Wake Forest Baptist, recently conducted tests of about 400 cloth masks made by community volunteers. The tests looked at how well various types of material filtered out particles the size of many viruses and bacteria (0.3-1.0 microns in diameter). The effectiveness of the masks varied widely, with the best reaching 79% filtration compared to surgical masks at 62% to 65% filtration and N95 masks at 97%. However, according to Dr. Scott Segal, the chair of anesthesiology at Wake Forest Baptist and the originator of the tests, the worst-performing masks filtered out only 1% of particles. Here are some of the findings and other recommendations from Segal.

Tight weave fabric that doesnt show much light passing through is a good performing design.

Best materials and designs

Two layers of high-quality, heavyweight quilters cotton with a thread count of 180 or more

Fabrics with an especially tight weave and thicker thread, such as batiks or heavy T-shirt fabric

Double-layer mask with a simple cotton outer layer and an inner layer of flannel

A lower grade cotton (more open weave) with light passing through is a poorer performing design.

Inferior materials and designs

Single-layer masks

Double-layer designs using lower quality, lightweight cotton

Fabric used in breathable T-shirts designed to be porous

How can you tell suitable fabric?

Use the light test: If you hold the fabric up to a bright light, it shouldnt be easy to see light coming through it, and you shouldnt see a lot of light outlining the weave.

Other things to know

Masks are mostly to protect other people by reducing the chance an infected wearer can spread virus droplets by sneezing or coughing, even before they show other symptoms. However, masks can provide some protection for an uninfected wearer, depending on effectiveness.

Segal recommends using a design with ties over elastic loops, because ties can provide a tighter and more customizable fit. It can also be difficult to find elastic, and elastic can break down with repeated washings.

A well-fitting mask is likely to feel a bit uncomfortable and stuffy when wearing it. Wearing a mask takes some getting used to even for medical professionals, Segal said. You could try wearing a mask in your house first to get adjusted to it.

Dont touch your face after positioning the mask, and dont adjust the mask while youre out. This could spread any virus particles that get on the mask.

Its important to be able to breathe through the mask, and very thick fabric or HEPA vacuum bags could make that difficult. If a person cant breathe through the mask, theyre likely either to ditch the mask or to breathe around the sides of it, Segal said, defeating the purpose of wearing a mask.

Some vacuum bags and filter materials contain fiberglass threads, which could be dangerous to inhale.

Some mask designs utilize a pocket for a replaceable filter. The Baptist study didnt find that a filter added much more effectiveness to already good designs, but Segal said that some places have had success with them, so they are an option.

Even if a masks material isnt the best, something is generally better than nothing when it comes to covering your face.

NOTE

Homemade masks are no substitute for staying home, social distancing and proper handwashing technique (at least 20 seconds with soap and water). Those are still the best ways to fight the COVID-19 virus. Dont let wearing a mask give you a false sense of security or entice you to relax your social distancing.

What youll need

Removing and caring for masks

Wash hands after removing the mask and after changing the interior filter, if your mask has one. Change the filter after every time you go out.

Moisture from your breath makes the mask less effective, so dont reuse a wet mask.

Untie by the straps. Dont touch the front of the mask as you remove it.

Wash masks in the washing machine with detergent in hot water after use.

Read more:
Face Masks: What to know, and how to sew your own - Greensboro News & Record

MIAMI, April 16, 2020 /PRNewswire/ -- TissueTech, Inc., the pioneer in the development and clinical application of regenerative human birth tissue products, announced today that the U.S. Food and Drug Administration (FDA) has granted their cryopreserved human umbilical cord investigational biologic product TTAX02 RMAT designation for the treatment of spina bifida in-utero.

This designation aims to streamline development of regenerative medical products used in the FDA's Investigational New Drug (IND) program for the treatment of serious or life-threatening diseases such as spina bifida. In spina bifida, the spinal canal opens along vertebrae in the lower or middle back of the fetus. It is the most common neural tube defect in the U.S. and is characterized by incomplete development of the brain, spinal cord, and/or protective covering around the brain and spinal cord.1

"Although rare, patients who suffer from open spina bifida have a ten times greater death rate than the national average from ages five to 40 years,"2 said Amy Tseng, TissueTech Co-Founder, President and Chief Executive Officer. "This RMAT designation highlights the need for an effective treatment for this life-threatening condition and the great potential TTAX02 holds."

The benefits of in-utero fetal surgery are promising and include less exposure of the vulnerable spinal nerve tissue and bone to the intrauterine environment. Additionally, doctors have discovered that in-utero fetal surgical repair of spina bifida may positively affect fetal hindbrain development in-utero, decreasing the severity of certain complicationssuch as Chiari II and hydrocephalusor reduce the need for surgery to implant a shunt.1

In addition to the RMAT designation, TissueTech is also planning to conduct a Phase 3 clinical trial to demonstrate the safety and efficacy of TTAX02 when used as a single patch to cover the neural placode, or a dual patch to close both the skin and meningeal defects during in-utero fetal surgical repair of spina bifida, to determine if it may improve clinically meaningful neurological outcomes after birth.

About TissueTech, Inc.TissueTech, Inc.,the parent company of Amniox Medical, Inc. and Bio-Tissue, Inc., pioneered the development and clinical application of human birth tissue-based products. Founded in 1997, Bio-Tissue markets products for the ophthalmology and optometry markets; and Amniox markets products for use in the musculoskeletal and wound care markets. Clinicians have performed more than 500,000 human implants with the company's products and published more than 360 peer-reviewed studies supporting its technology platform. The Company's first product, AmnioGraft, is the only tissue graft designated by the FDA as homologous use for promoting ophthalmic wound healing as acting as an anti-scarring, anti-inflammatory and anti-angiogenic agent and supporting epithelial adhesion and differentiation. Learn more at https://tissuetech.com/.

Physicians are encouraged to visit the TissueTech Physician Portalto learn more about TissueTech's platform technology, review product application guides, and view educational webinars.

1 https://www.ninds.nih.gov/Disorders/Patient-Caregiver-Education/Fact-Sheets/Spina-Bifida-Fact-Sheet

2 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2786149/

SOURCE TissueTech

tissuetech.com

View post:
TissueTech Receives Regenerative Medicine Advanced Therapy (RMAT) Designation from US Food and Drug Administration - PRNewswire

NEW YORK, April 15, 2020 /PRNewswire/ -- The stem cell therapy market was valued at US$ 1,534.55 million in 2019 and is estimated to reach US$ 5,129.66 million by 2027; it is expected to grow at a CAGR of 16.7% from 2020 to 2027.

Read the full report: https://www.reportlinker.com/p05882135/?utm_source=PRN

The increasing awareness related to the stem cells therapy in effective disease management and growing demand for regenerative medicines are the key factor driving the stem cell therapy market. However, high cost related of the stem cell therapy limits the growth of the market.Stem cell research has been widely investigated globally for various medical applications, especially for the treatment of humans.This raises the importance of creating public awareness about stem cell research and its clinical potential.

The main role of stem cells is in the replacement of dying cells and reconstruction of damaged tissues. Based on the extensive stem cell research, many scientists have claimed that these cells could probably be used in the treatment of various diseases, including cancer and cardiovascular disease.There is a large number of potential treatment procedures that are undergoing clinical trials, and a notably few stem cell therapies have won FDA (i.e., US Food and Drug Administration) approval for clinical usage. For instance, in 2019, the FDA approved Fedratinib for the first-line treatment for myelofibrosis. Moreover, stem cell therapies are widely used in bone marrow transplantation, and these therapies have benefited thousands of people suffering from leukemia. Hematopoietic stem cells are used for treating more than 80 medical diseases, including immune system disorders, blood disorders, neurological disorders, metabolic disorders, genetic disorders, and several types of cancers, such as leukemia and lymphoma; this is also likely to boost the demand for this treatment procedure during the forecast period. Researchers are further investigating the use of stem cell therapies in the treatment of autoimmune disorders.

The global stem cell therapy market has been segmented on the basis of type, treatment, application type, and end user.Based on type, the market has been segmented into adult stem cell therapy, induced pluripotent stem cell therapy, embryonic stem cell therapy, and others.

The adult stem cell therapy held the largest share of the market in 2019; however, induced pluripotent stem cell therapy is estimated to register the highest CAGR in the market during the forecast period.Based on treatment, the stem cell therapy market has been segmented into allogeneic and autologous.

The allogeneic segment held a larger share of the market in 2019; however, the market for the autologous segment is expected to grow at a higher CAGR during the forecast period.Based on application type, the stem cell therapy market has been segmented into musculoskeletal, dermatology, cardiology, drug discovery and development, and other applications.

The musculoskeletal segment held the largest share of the stem cell therapy market in 2019, whereas the drug discovery and development segment is expected to report the highest CAGR during 20202027. Based on end user, the market has been segmented into academic and research institutes, and hospitals and specialty clinics. The academic & research institutes held the largest share of the market in 2019, and it is also expected to report the highest CAGR during the forecast period.Several essential secondary sources referred to for preparing this report are the FDA, World Health Organization (WHO), Organisation for Economic Co-operation and Development, National Institutes of Health, Spanish Agency for Medicines (AEMPS), Japanese Society for Regenerative Medicine, and Indian Council of Medical Research, among others.

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Stem Cell Therapy Market to 2027 - Global Analysis and Forecasts by Type; Treatment; Application; End User, and Geography - P&T Community

MELBOURNE, Australia, April 17, 2020 (GLOBE NEWSWIRE) --Cynata Therapeutics Limited (ASX: CYP), a clinical-stage biotechnology company specialising in cell therapeutics, is pleased to announce that a scientific paper describing the use of Cymerus mesenchymal stem cells (MSCs) in a model of Acute Respiratory Distress Syndrome (ARDS) has been accepted for publication in the American Journal of Respiratory and Critical Care Medicine (AJRCCM).1The AJRCCM, commonly known as The Blue Journal, is widely regarded as the foremost peer-reviewed journal in the field of respiratory and critical care medicine.

Background

The study was conducted in 14 sheep with severe ARDS supported by extracorporeal membrane oxygenation (ECMO), which were given an endobronchial infusion of either Cymerus MSCs (n=7) or placebo (n=7). Animals were monitored and supported for 24 hours, at which time the study concluded.

ARDS is an inflammatory process leading to build-up of fluid in the lungs and respiratory failure. It can occur due to a range of insults, including infection, trauma and inhalation of noxious substances. It has received significant global attention in recent times, as it is one of the most serious complications experienced by patients suffering from COVID-19. ARDS accounts for approximately 10% of all ICU admissions and almost 25% of patients requiring mechanical ventilation, and results in hospital mortality ofup to 46%.2 In addition, survivors of ARDS are often left with severe long-term illness and disability.3

ECMO is a last-line intervention used in patients whose lungs are unable to provide an adequate amount of oxygen to the blood, despite the use of ventilators and other interventions. ECMO circulates blood through an artificial lung, oxygenating the blood before returning it to the patients circulation. ECMO can help support the vital organs in patients with severe ARDS, but it is not in itself a treatment for ARDS and the mortality among patients supported by it remains high.

This study was conducted independently of Cynata by a group of leading academics known as the Combining Extracorporeal Life Support and Cell Therapy in Critical Illness (CELTIC)Investigators, led by Professor John Fraser of the Critical Care Research Group, The Prince Charles Hospital, Brisbane. The study was funded by the Queensland Government, the National Health and Medical Research Council (NHMRC), the Intensive Care Society UK, and the Prince Charles Hospital Foundation.

Key Results

Cymerus MSC treatment was shown to exert a number of important beneficial effects in this study:

There were no statistically significant differences in oxygenation index between groups. The authors of the paper suggested that this may have been due to the severity of the lung injury induced; the fact that the observation period may have been too short to observe all beneficial effects of the treatment; and practical challenges performing these assessments during ECMO.

The authors also observed that a different dose regimen and/or route of administration could lead to further improved outcomes.

The study also found that MSCs adhere to the membranes in the ECMO device, resulting in a significant increase in pressure, and there was a higher incidence of thrombosis in the lungs observed post-mortem. While this did not lead to failure of the ECMO device or other observed adverse events, the study team considered that it could potentially do so, and therefore concluded that they cannot currently recommend the use of MSCs in combination with ECMO. It is important to note that this finding is relevant to MSCs in general (regardless of source), as it is related to the propensity of MSCs to adhere to plastic, but it does not have implications for the treatment of patients with ARDS who are NOT receiving ECMO.

Dr Kilian Kelly, Cynatas Chief Operating Officer, commented:

We are very encouraged by the beneficial effects of Cymerus MSCs on a number of important, clinically-relevant endpoints in this model of ARDS. These results provide valuable guidance on the potential clinical utility of Cymerus MSCs in the treatment of ARDS. It is also very useful to learn more about the practical mechanical challenges associated with administering MSCs at the same time as ECMO, but it is important to note that most patients with ARDS do not receive ECMO. Furthermore, in humans with ARDS who are not receiving ECMO, we expect to be able to administer repeated intravenous infusions of MSCs, which may have advantages compared to the approach that was taken in this preclinical study. We are currently in discussions with leading key opinion leaders about a possible clinical trial in human patients with ARDS, including those who have developed ARDS as a result of the devastating COVID19 pandemic.

Authorised for release by Dr Ross Macdonald, Managing Director & CEO

About Cynata Therapeutics (ASX: CYP)

Cynata Therapeutics Limited (ASX: CYP) is an Australian clinical-stage stem cell and regenerative medicine company focused on the development of therapies based on Cymerus, a proprietary therapeutic stem cell platform technology. Cymerus overcomes the challenges of other production methods by using induced pluripotent stem cells (iPSCs) and a precursor cell known as mesenchymoangioblast (MCA) to achieve economic manufacture of cell therapy products, including mesenchymal stem cells (MSCs), at commercial scale without the limitation of multiple donors.

Cynatas lead product candidate CYP-001 met all clinical endpoints and demonstrated positive safety and efficacy data for the treatment of steroid-resistant acute graft-versus-host disease (GvHD) in a Phase 1 trial. Cynata plans to advance its Cymerus MSCs into Phase 2 trials for GvHD, critical limb ischemia and osteoarthritis. In addition, Cynata has demonstrated utility of its Cymerus MSC technology in preclinical models of asthma, diabetic wounds, sepsis, heart attack and cytokine release syndrome, a life-threatening condition stemming from cancer immunotherapy.

______________________

1 Millar JE, Bartnikowski N, Passmore MR, et al. Combined Mesenchymal Stromal Cell Therapy and ECMO in ARDS: A Controlled Experimental Study in Sheep. Am J Crit Care Med, 2020.2 Bellani G, Laffey JG, Pham T, et al. Epidemiology, Patterns of Care, and Mortality for Patients With Acute Respiratory Distress Syndrome in Intensive Care Units in 50 Countries. Jama. 2016;315(8):788.3 Herridge MS, Tansey CM, Matte A, et al. Functional disability 5 years after acute respiratory distress syndrome. N Engl J Med. 2011;364(14):1293-304.

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Preclinical Study Showing Beneficial Effects of Cymerus MSCs in Acute Respiratory Distress Syndrome Accepted for Publication in Leading Peer-Reviewed...

Gene Therapy R&D and Revenue Forecasts 2020-2030

Retroviruses, Lentiviruses, Adenoviruses, Adeno Associated Virus, Herpes Simplex Virus, Poxvirus, Vaccinia Virus, Naked/Plasmid Vectors, Gene Gun, Electroporation, Lipofection, Cancer, Rare Diseases, Cardiovascular Disorders, Ophthalmologic Conditions, Infectious Disease, Neurological Disorders, Diabetes Mellitus

LONDON, April 17, 2020 /PRNewswire/ -- The gene therapy market is projected to grow at a CAGR of 32% in the first half of the forecast period. In 2019, the cancer treatment submarket accounted for 55.8% of the gene therapy drug market. Visiongain estimated that gene therapy for rare diseases will be the driver for market growth in the first half of the forecast period.

How this report will benefit youRead on to discover how you can exploit the future business opportunities emerging in this sector.

In this brand-new 215-page report you will receive 157 charts all unavailable elsewhere.

The 215-page Visiongain report provides clear detailed insight into the gene therapy market. Discover the key drivers and challenges affecting the market.

By ordering and reading our brand-new report today you stay better informed and ready to act.

To request sample pages from this report please contact Sara Peerun at sara.peerun@visiongain.com or refer to our website: https://www.visiongain.com/report/gene-therapy-rd-and-revenue-forecasts-2020-2030/#download_sampe_div

Report Scope

Gene Therapy market forecasts from2020-2030

This report assesses the approved gene therapy products in the market and gives revenue to 2030

Provides qualitative analysis and forecast of the submarket by indication for the period 2020-2030: Cancer Cardiovascular disorders Rare diseases Ophthalmological diseases Infectious Diseases Neurological Disorders Diabetes Mellitus Other therapeutic uses

Profiles leading companies that will be important in the development of the gene therapy market. For each company, developments and outlooks are discussed and companies covered in this chapter include: UniQure Biogen Bluebird Bio Spark Therapeutics Applied Genetics Technologies Corporation Oxford Biomedica GenSight Biologics & Other Companies

Assesses the outlook for the leading gene treatment R&D pipeline for 2019 and discusses technological progress and potential. Profiles appear for gene therapy drug candidates, with revenue forecasts for four leading agents: Collategene (AMG0001, AnGes MG/Vical) BC-819 (BioCancell) BC-821 BioCancell SPK-CHM Spark Therapeutics SPK-FIX Spark Therapeutics/Pfizer SPK-TPP1- Spark Therapeutics Lenti-D (Bluebird Bio) LentiGlobin (Bluebird Bio) VM202-DPN ViroMed

Provides qualitative analysis of trends that will affect the gene therapies market, from the perspective of pharmaceutical companies, during the period 2020 to 2030. SWOT analysis is provided and an overview of regulation of the gene therapy market by leading region given.

Our study discusses factors that influence the market including these: Translation of research into marketable products modifying human DNA gene transfer for therapeutic use, altering the nuclear genome Genomic editing technology and other supporting components Collaborations to develop and launch gene-based products acquisitions and licensing deals Supporting technologies for human genetic modification, gene replacement and targeted drug delivery Gene therapies for ophthalmologic diseases next-generation medicines Regulations in the United States, the European Union and Japan overcoming technological and medical challenges to pass clinical trials.

To request a report overview of this report please contact Sara Peerun at sara.peerun@visiongain.com or refer to our website: https://www.visiongain.com/report/gene-therapy-rd-and-revenue-forecasts-2020-2030/

Did you know that we also offer a report add-on service? Email sara.peerun@visiongain.comto discuss any customized research needs you may have.

Companies covered in the report include:

4DMT (4D Molecular Therapeutics)AbeonaAGTC (Applied Genetics Technologies Corporation)AMT (Amsterdam Molecular Therapeutics) AnGes MGAsklepios BioPharmaAstraZenecaAudentes TherapeuticsAvalanche BiotechBayer HealthcareBeijing Northland Biotech CoBenda PharmaceuticalBenitec BiopharmaBioCancellBiogenBiogen IdecBluebird BioBMS (Bristol-Myers Squibb)Broad Institute/Whitehead InstituteCelgeneCell Therapy CatapultCellectisChiesi Farmaceutici Clearside BiomedicalConvergence PharmaceuticalsDaiichi Sankyo Dimension TherapeuticsEditas MedicineFondazione TelethonFrancis Crick Institute Genable Technologies LtdGenethonGenSight BiologicsGenVecGoogleGSK (GlaxoSmithKline)Henry Ford Health SystemHSCI (Human Stem Cells Institute)HSR-TIGET (San Raffaele Telethon Institute for Gene Therapy), ImaginAbImmune Design Corp InoCardInovioIntellia TherapeuticsInvetechKite PharmaKolon GroupKolon Life ScienceLysogeneMitsubishi Tanabe Pharma Corporation NeuralgeneNightstaRxNorthwestern Memorial HospitalNovartisOXB (Oxford Biomedica)PfizerPNP TherapeuticsPrecision Genome Engineering Inc aka PregenenProNaiProtek GroupRaffaele HospitalREGENX BiosciencesRenova TherapeuticsRocheRoszdravnadzorSangamo BiosciencesSanofiSarepta TherapeuticsShanghai Sunway BiotechShenzhen SiBiono GeneTechSotex Pharm Firm Spark TherapeuticsSynerGene TherapeuticsTakara BioTAP BiosystemsThermo Fisher ScientificTissueGeneToolGenUC BerkeleyUC San Francisco uniQureUS Business Innovation Network Vertex PharmaceuticalsVical IncorporatedViroMedVM BiopharmaVoyage Therapeutics

List of Organisation Mentioned ASCO (American Society of Clinical Oncology)ASI (Agency for Strategic Initiatives) CAT (Committee for Advanced Therapies) CBER (Center for Biologics Evaluation and Research)CHMP (Committee for Medicinal Products for Human Use)CHOP (The Children's Hospital of Philadelphia)DCGI (Drugs Controller General of India)DHHS (Department of Health and Human Services)EMA (European Medicines Agency)FDA (US Food and Drug Administration)INSERM (Institut National de la Sant et de la Recherche Mdicale) IRB (Institutional Review Boards) MFDS (Korean Ministry of Food and Drug Safety) MHLW (Ministry of Health, Labour, and Welfare)MHRA (Medicines and Healthcare Products Regulatory Agency)Ministry of Health Commission NHS (National Health Service)NICE (the National Institute for Health and Care Excellence)NIH (National Institutes of Health) OHRP (Office for Human Research Protections)PMDA (Pharmaceuticals and Medical Devices Agency) RCGM (Review Committee of Genetic Manipulation) Russian Ministry of Healthcare and Social DevelopmentSFDA (State Food and Drug Administration of China) SMC (Scottish Medicines Consortium) The Fund for Promotion of Small Innovative Enterprises in Science and TechnologyThe IGI (Innovative Genomics Initiative)The Innovative Genomics Initiative The Walter and Eliza Hall Institute The Wellcome Trust Sanger Institute WFH (World Federation of Hemophilia)WHO (World Health Organization)

To see a report overview please e-mail Sara Peerun on sara.peerun@visiongain.com

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Translational Regenerative Medicine Market Forecast 2020-2030

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Visiongain Report: The Gene Therapy Market is Projected to Grow at a CAGR of 32% in the First Half of the Forecast Period - P&T Community

MARLBOROUGH, Mass.--(BUSINESS WIRE)--Sunovion Pharmaceuticals Inc. (Sunovion) today announced that results of a four-week pivotal study (SEP361-201) evaluating the safety and efficacy of SEP-363856 in patients with schizophrenia were published online in the New England Journal of Medicine (NEJM).

In this study, once-daily, flexible-dose (50-75 mg) treatment with SEP-363856 demonstrated a statistically significant and clinically meaningful improvement in the Positive and Negative Syndrome Scale (PANSS) total score compared to placebo after four weeks of treatment (-17.2 vs. -9.7, respectively; p=0.001). Patients treated with SEP-363856 also showed improvement in the overall severity of illness as assessed by the Clinical Global Impression Scale - Severity (CGI-S) (p<0.001). In addition, improvement was observed in all major PANSS (positive, negative and general psychopathology) subscales (p<0.02). SEP-363856 was well tolerated throughout the study and the overall discontinuation rate was comparable for SEP-363856 and placebo.1

These data represent an exciting step forward in schizophrenia research. The steps that led to identifying this new mechanism of action, targeting TAAR1, were very novel and they reflected a courageous and innovative approach by Sunovion to identifying new ways to treat schizophrenia, said John Krystal, M.D., Chair of Psychiatry and Co-Director, Yale Center for Clinical Investigation at Yale School of Medicine and co-author of the NEJM publication. For the last 60 years, antipsychotics that bind to dopamine receptors have been the standard of care, despite their side effect profile. It is my hope that these results for SEP-363856 support a new schizophrenia treatment for people who have been diagnosed with this serious mental health condition. SEP-363856 could have a big impact on people with schizophrenia, their families, and on the public health burden posed by schizophrenia.

SEP-363856 is a novel trace amine-associated receptor 1 (TAAR1) agonist with serotonin 1A (5-HT1A) agonist activity that is being evaluated in patients with schizophrenia. SEP-363856 does not bind to dopamine 2 (D2) or serotonin 2A (5-HT2A) receptors, which are thought to mediate the effects of currently available atypical antipsychotic medicines. SEP-363856 is being studied in the DIAMOND (Developing Innovative Approaches for Mental Disorders) Phase 3 global development program for schizophrenia with additional indications under consideration. The U.S. FDA granted Breakthrough Therapy Designation for SEP-363856 for the treatment of schizophrenia in May 2019.

Publication of these findings in the New England Journal of Medicine demonstrates the potential of SEP-363856 to be the first TAAR1 agonist for the treatment of schizophrenia, said Kenneth Koblan, PhD, Chief Scientific Officer of Sunovion. This innovative approach to the treatment of schizophrenia may provide a completely new option for the 23 million people worldwide who live with this serious mental health condition. Sunovion is committed to developing new treatment options for these patients and continuing to study SEP-363856 to further evaluate its clinical benefit in schizophrenia and other neuropsychiatric conditions.

As noted in the NEJM publication, in the six-month, open-label extension study, SEP-363856 demonstrated continued improvement across efficacy measures, including the PANSS total score, the CGI-S score, and the Brief Negative Symptom Scale (BNSS) total score and appeared to be safe and well-tolerated.

About SEP-363856SEP-363856 is a TAAR1 agonist with 5-HT1A agonist activity that is under investigation for the treatment of schizophrenia and other psychiatric conditions. Sunovion discovered SEP-363856 in collaboration with PsychoGenics based in part on a mechanism-independent approach using the in vivo phenotypic SmartCube platform and associated artificial intelligence algorithms. SEP-363856 is being studied in a global Phase 3 development program for schizophrenia (DIAMOND) with additional indications under consideration. The U.S. FDA granted Breakthrough Therapy Designation for SEP-363856 for schizophrenia in May 2019.

About SchizophreniaSchizophrenia is a chronic, serious and often severely disabling brain disorder that affects more than 23 million people worldwide2 and approximately one in 100 adults (about 2.4 million people) in the United States.3 It is characterized by positive symptoms, such as hallucinations, delusions and disorganized thinking as well as negative symptoms, such as lack of emotion, social withdrawal, lack of spontaneity and cognitive impairment that includes problems with memory, attention and the ability to plan, organize and make decisions.2

About Sunovion Pharmaceuticals Inc. (Sunovion)Sunovion is a global biopharmaceutical company focused on the innovative application of science and medicine to help people with serious medical conditions. Sunovions vision is to lead the way to a healthier world. The companys spirit of innovation is driven by the conviction that scientific excellence paired with meaningful advocacy and relevant education can improve lives. With patients at the center of everything it does, Sunovion has charted new paths to life-transforming treatments that reflect ongoing investments in research and development and an unwavering commitment to support people with psychiatric, neurological and respiratory conditions.

Headquartered in Marlborough, Mass., Sunovion is an indirect, wholly-owned subsidiary of Sumitomo Dainippon Pharma Co., Ltd. Sunovion Pharmaceuticals Europe Ltd., based in London, England, and Sunovion Pharmaceuticals Canada Inc., based in Mississauga, Ontario, are wholly-owned direct subsidiaries of Sunovion Pharmaceuticals Inc. Additional information can be found on the companys websites: http://www.sunovion.com, http://www.sunovion.eu and http://www.sunovion.ca. Connect with Sunovion on Twitter, LinkedIn, Facebook and YouTube.

About Sumitomo Dainippon Pharma Co., Ltd.Sumitomo Dainippon Pharma is among the top-10 listed pharmaceutical companies in Japan, operating globally in major pharmaceutical markets, including Japan, the U.S., China, and the European Union. Sumitomo Dainippon Pharma aims to create innovative pharmaceutical products in the Psychiatry & Neurology area, the Oncology area and Regenerative medicine/Cell therapy field, which have been designated as the focus therapeutic areas. Sumitomo Dainippon Pharma is based on the merger in 2005 between Dainippon Pharmaceutical Co., Ltd., and Sumitomo Pharmaceuticals Co., Ltd. Today, Sumitomo Dainippon Pharma has more than 6,000 employees worldwide. Additional information about Sumitomo Dainippon Pharma is available through its corporate website at https://www.ds-pharma.com.

SUNOVION is a registered trademark of Sumitomo Dainippon Pharma Co., Ltd.

Sunovion Pharmaceuticals Inc. is a U.S. subsidiary of Sumitomo Dainippon Pharma Co., Ltd. 2020 Sunovion Pharmaceuticals Inc. All rights reserved.

For a copy of this release, visit Sunovions website at http://www.sunovion.com

References

1 Koblan, K., Kent, J., Hopkins, S., Krystal, J., Cheng, H., Goldman, R., Loebel, A., A non-D2 Binding Drug for the Treatment of Schizophrenia. New England Journal of Medicine. April 16, 2020, Vol. 382, Issue 16, p. 1497-1506. Available online: https://www.nejm.org/doi/full/10.1056/NEJMoa1911772. Accessed April 2020.2 World Health Organization. Mental Disorders. [Internet]. Available from: https://www.who.int/news-room/fact-sheets/detail/mental-disorders. Accessed September 2018.3 National Institute of Mental Health. Schizophrenia. [Internet]. Available from: https://www.nimh.nih.gov/health/topics/schizophrenia/index.shtml. Accessed September 2018.

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New England Journal of Medicine Publishes Pivotal Results Evaluating Sunovion's SEP-363856 for the Treatment of Schizophrenia - Business Wire

SALT LAKE CITY, April 13, 2020 (GLOBE NEWSWIRE) -- Predictive Biology, a wholly owned subsidiary of Predictive Technology Group (OTC PINK: PRED) (Predictive or The Company), announced that on April 9th it submitted an Emergency Use Authorization (EUA) application with the U.S. Food and Drug Administration (FDA) for the immediate use of mesenchymal stem cells (MSCs) derived from umbilical cord tissue for the treatment of Acute Respiratory Distress Syndrome (ARDS), secondary to SARS-CoV-2, coronavirus disease 2019 (COVID-19).

The pandemic caused by COVID-19 has shown to develop into severe ARDS in 30% of hospitalized patients with a 22%-62% mortality rate (Murthy et al., 2020) for those requiring hospitalization in an intensive care unit. Currently, there is no confirmed treatment that can demonstrate safety or efficacy for the treatment of COVID-19.

Coronavirus can be deadly, in large part because the virus can cause cytokine storms in which the patients own immune system triggers a runaway response causing more damage to the patient, than to the virus it's trying to eliminate, said John Sorrentino, Chairman of Predictive Technology Group. Respiratory distress kills hundreds of thousands of people each year worldwide. There is clinical data from early clinical trials that seem to indicate that the avoidance of the cytokine storm utilizing MSCs may be a critical component for the treatment of COVID-19 infected patients.

A recent review article published in Pain Physician, concluded that, The limited but emerging evidence regarding UC MSC [umbilical cord mesenchymal stem cells] in managing COVID-19 suggests that it might be considered for compassionate use in critically ill patients to reduce morbidity and mortality in the United States.

The proposed IND clinical trial will utilize Predictives proprietary core technology of naturally occurring MSCs derived from umbilical cord tissue (UC-MSCs) to assess the efficacy as an add-on therapy to standard treatment of patients with severe Acute Respiratory Distress Syndrome (ARDS) secondary to COVID-19.

Predictives UC MSC product, CoreCyte, [currently regulated by the FDA as a tissue-based product under 21 CFR 1271.3(d)(1) and Section 361 of the Public Health Service Act] has already beenused as an allograft in over50,000 patients. Physicians have reported to Predictive that over 1,100 patients have been treated with CoreCyte via intravenous administration. No serious adverse events have been reported with CoreCyte regardless of the route of administration. If Predictives EUA request is approved, CoreCyte would be available immediately to critically ill patients with ARDS due to COVID-19 infections.

About Predictive Technology Group, Inc.

Predictive Technology Group aims to revolutionize and personalize precision patient care. The Companys entities harness predictive gene-based analytics to develop genetic and molecular diagnostic tests and companion therapeutics in order to support a patient from diagnosis through treatment.

Dedicated to identifying the barriers that impact lifelong health through our genetic library, genomic mapping and individualized diagnostics, Predictives tests and products empower clinicians to provide their patients with the highest level of care. For more information, visit http://www.predtechgroup.com

About Predictive Biotech, Inc.

Predictive Biotech is a leader in regenerative medicine, its products are derived from tissue sources rich in properties that support the bodys natural ability to heal itself. All products are safely, ethically and minimally processed to deliver allografts that preserve the naturally occurring characteristics and factors of the donor tissue. Predictives signature products are uniquely born from the Whartons jelly layer of the umbilical cord and amniotic fluid and tissue.

With over 100,000 units delivered, product safety and consistency has been realized by thousands of practices throughout the United States. A national network of clinics, health systems, researchers and physicians leverage Predictives four proprietary products: AmnioCyte, AmnioCyte Plus, PolyCyte, and CoreCyte.

Forward-Looking Statements:

To the extent any statements made in this release contain information that is not historical, these statements are essentially forward-looking and are subject to risks and uncertainties, including the difficulty of predicting FDA approvals, acceptance and demand for human cell and tissue products and other pharmaceutical products, the impact of competitive products and pricing, new product development and launch, reliance on key strategic alliances, availability of raw materials, availability of additional intellectual property rights, availability of future financing sources, the regulatory environment, and other risks The Company may identify from time to time in the future. These forward-looking statements are based on the current plans and expectations of management and are subject to a number of uncertainties and risks that could significantly affect The Company's current plans and expectations, as well as future results of operations and financial condition. A more extensive listing of risks and factors that may affect The Company's business prospects and cause actual results to differ materially from those described in the forward-looking statements can be found in the reports and other documents filed by The Company with the Securities and Exchange Commission. The company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Contacts:

Predictive BiotechInfo@predictivebiotech.com888-407-9761

Investor ContactJeremy FefferLifeSci Advisorsjeremy@lifesciadvisors.com212-915-2568

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Predictive Submits Emergency Use Authorization Application for Treatment of Acute Respiratory Distress Syndrome Secondary to COVID -19 with Umbilical...

NEW YORK, April 15, 2020 /PRNewswire/ -- The stem cell therapy market was valued at US$ 1,534.55 million in 2019 and is estimated to reach US$ 5,129.66 million by 2027; it is expected to grow at a CAGR of 16.7% from 2020 to 2027.

Read the full report: https://www.reportlinker.com/p05882135/?utm_source=PRN

The increasing awareness related to the stem cells therapy in effective disease management and growing demand for regenerative medicines are the key factor driving the stem cell therapy market. However, high cost related of the stem cell therapy limits the growth of the market.Stem cell research has been widely investigated globally for various medical applications, especially for the treatment of humans.This raises the importance of creating public awareness about stem cell research and its clinical potential.

The main role of stem cells is in the replacement of dying cells and reconstruction of damaged tissues. Based on the extensive stem cell research, many scientists have claimed that these cells could probably be used in the treatment of various diseases, including cancer and cardiovascular disease.There is a large number of potential treatment procedures that are undergoing clinical trials, and a notably few stem cell therapies have won FDA (i.e., US Food and Drug Administration) approval for clinical usage. For instance, in 2019, the FDA approved Fedratinib for the first-line treatment for myelofibrosis. Moreover, stem cell therapies are widely used in bone marrow transplantation, and these therapies have benefited thousands of people suffering from leukemia. Hematopoietic stem cells are used for treating more than 80 medical diseases, including immune system disorders, blood disorders, neurological disorders, metabolic disorders, genetic disorders, and several types of cancers, such as leukemia and lymphoma; this is also likely to boost the demand for this treatment procedure during the forecast period. Researchers are further investigating the use of stem cell therapies in the treatment of autoimmune disorders.

The global stem cell therapy market has been segmented on the basis of type, treatment, application type, and end user.Based on type, the market has been segmented into adult stem cell therapy, induced pluripotent stem cell therapy, embryonic stem cell therapy, and others.

The adult stem cell therapy held the largest share of the market in 2019; however, induced pluripotent stem cell therapy is estimated to register the highest CAGR in the market during the forecast period.Based on treatment, the stem cell therapy market has been segmented into allogeneic and autologous.

The allogeneic segment held a larger share of the market in 2019; however, the market for the autologous segment is expected to grow at a higher CAGR during the forecast period.Based on application type, the stem cell therapy market has been segmented into musculoskeletal, dermatology, cardiology, drug discovery and development, and other applications.

The musculoskeletal segment held the largest share of the stem cell therapy market in 2019, whereas the drug discovery and development segment is expected to report the highest CAGR during 20202027. Based on end user, the market has been segmented into academic and research institutes, and hospitals and specialty clinics. The academic & research institutes held the largest share of the market in 2019, and it is also expected to report the highest CAGR during the forecast period.Several essential secondary sources referred to for preparing this report are the FDA, World Health Organization (WHO), Organisation for Economic Co-operation and Development, National Institutes of Health, Spanish Agency for Medicines (AEMPS), Japanese Society for Regenerative Medicine, and Indian Council of Medical Research, among others.

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Stem Cell Therapy Market to 2027 - Global Analysis and Forecasts by Type; Treatment; Application; End User, and Geography - Salamanca Press

Gum recession puts patients at risk of developing decay, causes tooth sensitivity, and creates an unattractive smile. "Gum recession is most commonly caused by gum disease, which affects nearly 65 million Americans annually. Many patients avoid treatment because of the painful, invasive nature of a gum graft that typically uses gum tissue from the roof of the mouth, increasing post-operative pain and suffering. The RejuvaGum Lift offers patients a gentle yet effective alternative to gum grafting, with less recovery time and enhanced healing," says Dr. Alina Krivitsky.

The Brentwood periodontists utilize cutting-edge technology to offer their patients advanced periodontal care. "Several samples of a patient's blood are spun in a centrifuge to separate the platelets, white blood cells and fibrin. When applied directly to a wound, the proteins in the fibrin encourage faster healing by causing the wound to close more quickly, and increase blood flow to the site. The extra boost of stem cells and growth factors assist in soft tissue regeneration around the exposed roots, and by utilizing the patient's own immune system to heal, the risk of infection is almost none," says Dr. Aalam.

To learn more about the RejuvaGum Lift treatment for gum recession, please visit https://implantperiocenter.com/or contact them at 310-504-1845.

About the CENTER for Advanced Periodontal & Implant Therapy

At the CENTER for Advanced Periodontal & Implant Therapy, Dr. Aalam and Dr. Krivitsky utilize advanced technology coupled with cutting-edge techniques to provide minimally-invasive, comfortable and effective periodontal care. As the only dual-board certified practice in Brentwood, California, they are committed to providing restorative periodontal therapies to rejuvenate the aesthetics, health, and function of the gums and teeth, to help patients achieve a healthier smile.

Contact: Charlene Yashouafar, Marketing DirectorSocial Lighthouse[emailprotected](213) 403-1407

SOURCE The CENTER for Advanced Periodontal & Implant Therapy

WELCOME TO YOUR LOS ANGELES PERIODONTISTS

Link:
Los Angeles Periodontists use blood-derived growth factors as an alternative to treating gum recession - PRNewswire