StemCell Therapy

Company founded by four pioneers of Treg cell biology and cell therapy and financed by a syndicate of leading biotech investors

SOUTH SAN FRANCISCO, Calif. and SEATTLE, Feb. 6, 2020 /PRNewswire/ -- Sonoma Biotherapeutics, a privately held company developing regulatory T cell (Treg) therapies for autoimmune and degenerative diseases, launched today in South San Francisco, CA and Seattle, WA with $40 million in its Series A financing. Sonoma brings together next-generation research, development and manufacturing capabilities in cell therapy and genetic engineering with an accomplished team of executives, scientists, board members and investors with extensive experience in the fields of cell therapy and drug discovery.

"With this team and our assembled expertise and technologies, we are in an ideal position to move adoptive cell therapy beyond cancer, to establish safe, effective and long-lasting treatments for a range of conditions where current drugs and biologics are simply not good enough," said founder and CEO Jeffrey Bluestone, PhD. "As the immune system's master regulators of protecting the body against self-destruction, Treg cell therapy is perhaps the ideal means to shut down unwanted immune reactions and provide meaningful treatment for patients."

The financing involves an investor syndicate that includes Lyell Immunopharma, ARCH Venture Partners, Milky Way Ventures and 8VC. "Treg therapies have the potential to transform the treatment of autoimmune and degenerative diseases," said Robert Nelsen, managing partner and co-founder of ARCH Ventures Partners. "Sonoma Biotherapeutics has assembled the team and capabilities required to make this vision a reality for patients and their families."

The goal of Treg therapy is to restore a state of self-tolerance by halting harmful inflammatory responses in autoimmune diseases such as rheumatoid arthritis, inflammatory bowel disease and multiple sclerosis, along with degenerative diseases including amyotrophic lateral sclerosis (ALS) and Alzheimer's. Over 50 million Americans currently live with an autoimmune disease, and millions more with some form of degenerative diseases. For many, existing therapies are ineffective at controlling their disease.

Tregs have a clear role in many of these conditions. These cells' natural ability to migrate to inflamed tissues and control harmful immune responses make them ideal for treating a range of conditions. In addition, the ability to engineer Treg cells to target specific disease-causing antigens reduces the potential for unwanted systemic effects. The role of Tregs in tissue maintenance and repair offers the potential for effective, durable and restorative treatments.

Sonoma Biotherapeutics is co-founded by four of the foundational scientists in the Treg field:

Collectively, the founding team brings expertise and proprietary methodologies across the Treg drug discovery and development process, including selection, manipulation, editing, regulation and translation for clinical use. Together, Drs. Bluestone and Tang have pioneered adoptive Treg cell therapy in some of its first clinical uses in type 1 diabetes, lupus and organ transplantation. Drs. Rudensky and Ramsdell co-discovered FOXP3, a critical transcription factor for Treg development and function, and in 2017 were awarded the Crafoord Prize by the Royal Swedish Academy of Sciences for their landmark studies. They are complemented by an experienced senior management team and seasoned board of directors.

"The Sonoma Biotherapeutics leadership are responsible for a significant portion of our understanding of the nature of Treg cells, their role in disease and their potential for use as a cell therapy," said Dr. Rick Klausner, CEO of Lyell Immunopharma and newly appointed Chair of the Sonoma Biotherapeutics Board of Directors. "Perhaps more importantly, they understand the requirements of a successful cell therapeutic and the corresponding challenges in defining the pathway to market. We look forward to a strong partnership between Lyell and Sonoma Biotherapeutics."

In this regard, Sonoma Biotherapeutics has entered into a strategic partnership with Lyell that provides both parties with access to technologies and know-how to enhance the durability, stability and specificity of cell therapies in their respective indications of focus. This partnership will further enable Sonoma's rapid translation of Treg therapies from target identification and discovery, through preclinical and clinical development.

Senior Management Team

Jeffrey Bluestone, PhD, Founder, CEO & PresidentFred Ramsdell, PhD, Founder & CSOPeter DiLaura, Chief Business & Strategy OfficerJoshua Beilke, MBA, PhD, VP Translational Development

Board of Directors

Rick Klausner, MD (Chair) Founder & CEO, Lyell Immunopharma, Inc.Maggie Wilderotter CEO, Grand Reserve Inn; former board member, Juno TherapeuticsToni Hoover, PhD Director, Strategy, Planning and Management for Global Health, Bill & Melinda Gates FoundationTerry Rosen, PhD CEO, Arcus BiosciencesDavid Moskowitz, PhD Principal, 8VC (observer)Jeffrey Bluestone, PhD, CEO & President, Sonoma Biotherapeutics

About Sonoma Biotherapeutics

Sonoma Biotherapeutics is a privately held, San Francisco and Seattle-based company leading the development of adoptive Treg therapies cell for autoimmune and degenerative diseases. Using next generation genome editing and target-specific cell therapy, Sonoma is focused on developing its best-in-class platform across the entire spectrum of Treg cell therapeutic capabilities. Founded by pioneers in Treg biology and cell therapy, the company brings together leading expertise and proprietary methodologies for the discovery and development of disease modifying and curative therapies.

Contact: media@sonomabio.com

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Sonoma Biotherapeutics launches with $40 million in Series A funding to advance regulatory T cell therapy in autoimmune and degenerative diseases -...

Following the spread of the coronavirus in China and other countries, several writers in the Arab press wrote that this virus and others, such as the SARS and swine flu viruses, were deliberately created and spread by the U.S. in order to make a profit by selling vaccines against these diseases. Others wrote that the virus was part of an economic and psychological war waged by the U.S. against China with the aim of weakening it and presenting it as a backward country and a source of diseases.

Coronavirus sparks war between the U.S. and China (source: baladnaelyoum.com, February 2, 2020)

The following are translated excerpts from some of these articles:

Saudi Writer: It's No Coincidence That The Coronavirus Has Skipped Over Israel And The U.S.

In Saudi daily Al-Watan, writer Sa'ud Al-Shehry claimed that the coronavirus was a plot by American and Israeli drug companies aimed at increasing their profits. He wrote: "A 'wonder' virus was discovered yesterday in China; tomorrow it will be discovered in Egypt, but it will not be discovered either today, tomorrow or the day after tomorrow in the U.S. or Israel, nor in poor countries such as Burundi or the Comoro Islands

"The corona[virus] is a known virus, and we know that it was discovered in 1960 and that it causes ordinary respiratory diseases. Its symptoms are like those of any other virus: coughing, congestion, and perhaps also diarrhea and fever. [Therefore,] it is strange to hear that the World Health Organization is saying that 'this is a virus first discovered in 2012 in Saudi Arabia, in a camel...'

"And here is something else that's strange: As soon as Egypt announced, a few years ago, that it would rely on poultry [raised in the country], and that it would even export [poultry] abroad that is, that it no longer needed poultry from the U.S., France, and so on [suddenly] there appeared, from underneath the ground, the avian flu virus with the aim of nipping [Egypt's economic] awakening in the bud. Helpless, the world searched for a serum [i.e. vaccine] for this miserable avian [flu] virus. Out of the blue, like a miracle, Merck Sharp appeared like an innocent lamb, with the longed-for medicine in its hand, as if it knew nothing and as if one of its managers, Donald Rumsfeld, knew nothing and thought that the world too knew nothing. And maybe [the world] really did not know that this Donald Rumsfeld had served as [U.S.] secretary of defense for five years, into 2006. This secret member of the army brought the 'hidden' serum in the form of [the antiviral medication] Tamiflu, and thus he and his company raked in tens of billions of dollars from this miserable swine flu. The question is, what is the [U.S.] Department of Defense's connection to medical treatments?!

"Even before this, the same thing was done in China when in 2003 [the country] announced that it had [the [world's] largest dollar reserves [and] they [the Americans] introduced coronavirus' cousin, SARS, into [the country] [along with] the [vaccine] serum, [saying] 'We are the only ones who have this and you'll pay for it.' There was also the anthrax experiment, with the same company, Merck Sharp, and the same fraud and roundabout methods and it happened also with the swine flu, when Novartis and many other companies made $6 billion from this.

"Dear reader, when you read these scenarios, you will surely agree that behind the [outbreak of] corona[virus] there is a plan of deceit aimed at making a profit, and nothing more. The whole thing is a virus industry, a world of tiny creatures viruses and genetic engineering that culminate in the manufacture of a virus that is transferred to wealthy countries that can buy the [vaccine] serum. It is transferred through food, beverages, animals, the air, or perhaps via cosmetics and other means that don't come to mind. At the same time, the appropriate [vaccine] serum is being prepared for this virus, and it is held until the people need it badly because of the severity of the disease [caused by] this virus, which is genetically engineered. Then the patient grasps at any straw and pays all his money to buy this artificial treatment that was created at the same time as the virus [itself].

"And perhaps, dear reader, you will look at the statistics on the rate of contagion with the corona[virus] worldwide, and you will learn that the Gulf states hold the first places [in this list], followed by European countries, and you will never find [in these statistics] [either] the U.S. or Israel. This is a question mark that I leave for you to hypothesize about. You will also not find [the virus] in a poor country. I will solve the riddle [of why this is so], but don't tell a soul it is because [a poor country] cannot pay the price of the serum.

"Finally, rest assured that your country will pay a high price. Rest assured [also] that this is an 'ordinary' disease and not highly contagious only when [people] gather in large crowds. Long live Saudi Arabia and be strong and healthy."[1]

Syrian Writer: The Coronavirus Epidemic Is An Artificial Crisis Intended ToUndermine China's Economy

Hussein Saqer, a columnist for the Syrian daily Al-Thawra, made similar claims in a February 3, 2020 column, saying that the coronavirus was part of a commercial-biological-psychological war waged by the U.S. against China. He wrote: "From Ebola, zika, SARS, avian flu and swine flu, through anthrax and mad cow disease to the corona[virus] [all these] deadly viruses were manufactured by the U.S. and threaten to annihilate the peoples of the world. [The U.S.] has turned biological warfare into a new type of war, by means of which it intends to change the rules of play and shift the conflict with the peoples [of the world] away from the conventional path. What was reportedly said recently by the Finnish Minister of Health and Social Affairs was not fake news of the kind that features in counter-propaganda and in the tabloids. It was an authentic video with sound and image...[2] [The Finnish minister] said that the U.S. was acting to reduce the population of the world by two thirds in a way that would not cause it any losses. In fact, [the U.S.] would earn billions after forcing the World Health Organization to designate these diseases as deadly plagues so that [getting] the vaccine would be obligatory rather than voluntary, especially for the most vulnerable populations that constitute the next generation: pregnant women and children.

"The announcement of the Finnish minister firmly proves that the U.S. has a schedule for manufacturing viruses of this kind, and that the coronavirus is [another] link in the chain of deadly biological [agents] that it means to use, after mad cow disease, avian flu and the other diseases mentioned above. It embarked on this path of war after losing the commercial and financial competition, so as to punish and crush the economies of the countries that surpass it [economically],and after acting to strengthen the pharmaceutical companies owned by [its] Congressmen and ministers and placing [these companies] at the service of the vaccine industry. The World Health Organization, for its part, is willing to market the disease and the treatment together, according to the instructions of the White House, using the so-called 'good news' about new vaccines discovered for these diseases.

"The discourse, then, currently revolves around an artificial crisis of a new sort, which was created by the U.S., just like the many [other] crises it invents for its own benefit. After American economic advisors began to fear [that the U.S. would be unable] to compete with China or even match it, they came up with the virus, so as to preoccupy the Chinese officials on the one hand, and market [American] medicines and increase the panic among the Chinese people, on the other. This is therefore a war that has commercial, biological and psychological [aspects] simultaneously, and it is far removed from the conventional kind of confrontation."[3]

Egyptian Writer: The U.S. Spread The Virus To Harm China's Economy And Reputation

On the Egyptian news website Vetogate.com, Egyptian journalist Ahmad Rif'at explained why the U.S. chose the Chinese city of Wuhan as the epicenter of the disease: "American factories are the first to manufacture every kind of virus and bacteria, from the virulent smallpox virus and the bubonic plague virus to all the viruses we saw in the recent years, such as mad cow disease and swine flu. Wuhan, the city that has now been struck by the corona [disease], is an industrial town, but it is nevertheless the eighth-richest city in China, after Shanghai, Guangzhou

Guangzhou, Beijing, Tianjin and Hong Kong, which are the country's major cities. Its place at the bottom of the list [of China's major cities] is what makes it a suitable [site] for an American crime... for it is not a focus of attention, and the level of healthcare there is surely lower than in the larger and more important cities.

"All that is needed in order to let a virus spread quickly is to release it from some bag, using an ordinary syringe or in any other way. But the really interesting fact is the large number of Americans who were staying in Wuhan and decided to leave it immediately and quickly, [as was shown] on American news channels, among them a CNN reporter, even though none of them contracted [the disease]! We don't know what that [CNN reporter] was doing there. Did he come to report on the events? If so, why did he leave so dramatically? Did he come there before [the outbreak of the epidemic]? [If so,] what caused him to go there before the coronavirus crisis began?...

"This war is not only intended to worry China, trouble it and cause it to spend billions of dollars on emergency measures and medicines which, by the way, will be manufactured by an Israeli company... The U.S. wants to inform the world, and especially China itself, as part of a propaganda war targeting [China's] prestige and status, that [China] is still a backward country whose citizens eat bat soup and which exports diseases and epidemics to the rest of the world!"[4]

[1] Al-Watan (Saudi Arabia), February 2, 2020.

[2] The reference is apparently to Finnish physician and conspiracy theorist Rauni-Leena Luukanen-Kilde, who claimed that the swine flu epidemic was a hoax created by Big Pharma in order to market the vaccine, which is actually poisonous and threatens to depopulate the world.

[3] Al-Thawra (Syria), February 3, 2020.

[4] Vetogate.com, January 27, 2020.

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Arab Writers: The Coronavirus Is Part Of Biological Warfare Waged By The U.S. Against China - Middle East Media Research Institute

Future Market Insights has announced the addition of the "DNA Synthesis Market: Global Industry Analysis 2012 - 2016 and Opportunity Assessment; 2017 - 2027" report to their offering

This press release was orginally distributed by SBWire

Valley Cottage, NY -- (SBWIRE) -- 02/06/2020 -- DNA synthesis is the natural creation of nucleic acid strands through the process of DNA replication. Artificially, they are synthesized using genetic engineering and enzyme chemistry in the laboratory to be used for various applications such as therapeutic, diagnostics as well as academic and industrial research. DNA synthesis services provided by different companies varies greatly by the cost of per base pair, error rates, lengths, throughput, etc. DNA synthesis market further includes the oligonucleotide synthesis and gene synthesis which has various end users such as agricultural science, food science, antibody discovery, immunology, cancer research, infectious disease, synthetic biology. Market for the therapeutic applications is mostly distributed only among the biopharmaceutical industries which is driven by their continuous research in the respective domain.

The market for DNA synthesis got the surge form Human Genome Project leading to several advancements in the technological processes for production and reduces the time of production which made possible the synthesis of high throughput custom nucleotides. Nowadays, it is possible to do the customizations and get the required sequence online and at required time. The commercial availability of DNA synthesis machines has also a great impact in the synthesis services market.

Download Sample Copy@ https://www.futuremarketinsights.com/reports/sample/rep-gb-5900

DNA Synthesis Market: Drivers & Restraints

Growing number of research & developments in the field of genomics and next generation sequencing supports the market growth of DNA synthesis services over the globe. The growing numbers of mergers and collaborations by the market players also strengthening the market growth. Along with this, the developments in the synthetic biology segment promotes the market progression of DNA synthesis services. A robust growth in the oligonucleotide therapeutic segment as antisense oligos, siRNAs, miRNA inhibitors and mimics also supports the market growth of DNA synthesis for the commercial end. However, cuts in the federal fundings for the research purpose, stringent regulatory requirements in the therapeutic applications for DNA also limits the market to expand across the globe.

DNA Synthesis Market: Segmentation -

Segmentation by Service Type:

-Oligonucleotide Synthesis -Gene Synthesis

Segmentation by Application:

-Research and Development -Diagnosis-Therapeutics

Segmentation by End User

-Biopharmaceutical Companies-Academic and Research Institutes-Contract Research Organizations

Download Table of Contents@ https://www.futuremarketinsights.com/toc/rep-gb-5900

DNA Synthesis Market: Overview

Companies involved in the DNA synthesis services market are involved in continuous updation of their manufacturing technologies for high throughput synthesis with cost control. Recently, Twist biosciences also gathered $82 million investment from Illumina for developing a new technology platform for synthesizing DNA on silicon. These market players are also focusing on their brand improvement and market penetration by focusing on their sales force, geographical expansion as well as expansion of manufacturing facilities.

Moreover, synthetic DNA costs are anticipated to decrease owing to the introduction of advanced technology. Intensifying competition in the synthetic biology services also leads to price reduction per base pair. However, the multi-billion dollar PCR industry constantly supports the market growth of DNA synthesis services. With the increasing outsourcing services for the life science research activities, the market has huge potential of growth opportunities. The availability of research funds also had a great impact in the DNA synthesis market size and growth rate in different regions over the globe.

DNA Synthesis Market: Region-wise Outlook

Geographically, North America leads the market for DNA synthesis services owing to the high requirement in the academic research as well as biopharmaceutical industries for research and therapeutic production. This is followed by the Western Europe region supported by the high availability of research fundings in universities and commercial availability of therapeutic drugs made of DNA active pharmaceutical ingredients. Eastern Europe region shares a low market share and slow growth rate comparatively to other regions over the forecast period. Asia Pacific region represents the significant growth rate in the DNA synthesis market with highest market growth in research applications. Recent trends shows China to be leading the market in the region in terms of market size as well as growth rate. Latin America and Middle East & Africa has been observed the least market share over the forecast period.

Download Segment-wise Analysis@ https://www.futuremarketinsights.com/checkout/5900

DNA Synthesis Market Treatment Market: Key Players

Some of the players in the DNA Synthesis market includes -

-Bioneer Corporation-IBA GmbH-Eurofins Scientific-Integrated DNA Technologies Inc.-LGC Biosearch Technologies-Eton Bioscience Inc.-GenScript Biotech Corporation-Eurogentec-Thermo Fisher Scientific Inc.-Quintara Biosciences

For more information on this press release visit: http://www.sbwire.com/press-releases/dna-synthesis-market-report-with-executive-summary-introduction-sizing-analysis-and-forecast-to-2027-1274866.htm

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DNA Synthesis Market Report with Executive Summary, Introduction, Sizing, Analysis and Forecast to 2027 - Press Release - Digital Journal

NEW YORK, Feb. 6, 2020 /PRNewswire/ --

Gene Therapy Market by Vector Type (Viral Vector and Non-viral Vector), Gene Type (Antigen, Cytokine, Tumor Suppressor, Suicide, Deficiency, Growth Factors, Receptors, and Others), and Application (Oncological Disorders, Rare Diseases, Cardiovascular Diseases, Neurological Disorders, Infectious Disease, and Other Diseases): Global Opportunity Analysis and Industry Forecast, 20192026

Read the full report: https://www.reportlinker.com/p05844072/?utm_source=PRN

The global gene therapy market was valued at $393.35 million in 2018, and is estimated to reach $6,205.85 million by 2026, registering a CAGR of 34.8% from 2019 to 2026.Gene therapy is a technique that involves the delivery of nucleic acid polymers into a patient's cells as a drug to treat diseases. It fixes a genetic problem at its source. The process involves modifying the protein either to change the genetic expression or to correct a mutation. The emergence of this technology meets the rise in needs for better diagnostics and targeted therapy tools. For instance, genetic engineering can be used to modify physical appearance, metabolism, physical capabilities, and mental abilities such as memory and intelligence. In addition, it is also used for infertility treatment. Gene therapy offers a ray of hope for patients, who either have no treatment options or show no benefits with drugs currently available. The ongoing success has strongly supported upcoming researches and has carved ways for enhancement of gene therapy.Recently, a new technique has been developed, where new genes are introduced into the body to help fight against cancer cells. Gene therapies are regarded as a potential revolution in the health sciences and pharmaceutical fields. The number of clinical trials investigating gene therapies is on an increase, despite the limited number of products that have successfully reached the market. In addition, benefits of gene therapy over conventional cancer therapies and increase in government support fuel the growth of the gene therapy market.The gene therapy market is a widely expanding field in the pharmaceutical industry with new opportunities. This has piqued the interests of venture capitalists to explore this market and its commercial potential. Major factors that drive the growth of this market include high demands for DNA vaccines to treat genetic diseases, targeted drug delivery, and high incidence of genetic disorders. However, the stringent regulatory approval process for gene therapy and the high costs of gene therapy drugs are expected to hinder the growth of the market. On the contrary, increase in the pipeline developments for gene therapy market are expected to provide lucrative opportunity during the forecast period.The global gene therapy market is segmented based on vector type, gene type, application, and geography. Based on vector type, it is categorized into viral vector and non-viral vector. Viral vector is further segmented into retroviruses, lentiviruses, adenoviruses, adeno associated virus, herpes simplex virus, poxvirus, vaccinia virus, and others. Non-viral vector is further categorized into naked/plasmid vectors, gene gun, electroporation, lipofection, and others. Based on gene type, the market is classified into antigen, cytokine, tumor suppressor, suicide, deficiency, growth factors, receptors, and others. Based on application, the market is divided into oncological disorders, rare diseases, cardiovascular diseases, neurological disorders, infectious disease, and other diseases. Based on region, it is analyzed across North America, Europe, Asia-Pacific, and LAMEA.

KEY MARKET BENEFITS FOR STAKEHOLDERS This report offers a detailed quantitative analysis of the current market trends from 2018 to 2026 to identify the prevailing opportunities. The market estimations provided in this report are based on comprehensive analysis of the key developments in the industry. In-depth analysis based on geography facilitates in analyzing the regional market to assist in strategic business planning. The development strategies adopted by key manufacturers are enlisted in the report to understand the competitive scenario of the market.

KEY MARKET SEGMENTS

By Vector Type Viral vectoro Retroviruseso Lentiviruseso Adenoviruseso Adeno Associated Viruso Herpes Simplex Viruso Poxviruso Vaccinia Viruso Others Non-viral vectoro Naked/Plasmid Vectorso Gene Guno Electroporationo Lipofectiono Others

By Gene Type Antigen Cytokine Tumor Suppressor Suicide Deficiency Growth factors Receptors Others

By Application Oncological Disorders Rare Diseases Cardiovascular Diseases Neurological Disorders Infectious disease Other Diseases

By Region North Americao U.S.o Canadao Mexico Europeo Germanyo UKo Franceo Spaino Italyo Rest of Europe Asia-Pacifico Japano Chinao Australiao Indiao South Koreao Rest of Asia-Pacific LAMEAo Brazilo South Africao Saudi Arabiao Rest of LAMEA

KEY PLAYERS PROFILED Adaptimmune Therapeutics Plc. Anchiano Therapeutics Ltd. Achieve Life Sciences, Inc. Adverum Biotechnologies, Inc. Abeona Therapeutics Inc. Applied Genetic Technologies Corporation Arbutus Biopharma Corporation, Audentes Therapeutics, Inc. AveXis, Inc. Bluebird Bio, Inc. Celgene Corporation CRISPR Therapeutics AG Editas Medicine, Inc. Editas Medicine, Inc. GlaxoSmithKline Plc. Intellia Therapeutics, Inc. Merck & Co., Inc. Novartis AG REGENXBIO Inc. Spark Therapeutics, Inc. Sangamo Therapeutics, Inc. Uniqure N. V.Voyager Therapeutics, Inc

The other players of the gene therapy market include (companies not profiled in the report): Amgen Epeius Biotechnologies Sanofi Juno Therapeutics Advantagene

Read the full report: https://www.reportlinker.com/p05844072/?utm_source=PRN

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The global gene therapy market was valued at $393.35 million in 2018, and is estimated to reach $6205.85 million by 2026, registering a CAGR of 34.8%...

The cell and gene therapy sector is booming. At the end of 2019, there were 1,069 registered clinical trials in the field. By 2024, the cell and gene therapy market is estimated to reach revenues of $6.6B (5.9B). But there is a problem. As a result of the rapid growth of gene and cell therapies, the demand for plasmids is skyrocketing. And the industry is struggling to meet it.

Plasmids are the key building blocks needed to manufacture viral vectors, which are the most common strategy to develop gene therapies, explains Stefano Baila, Director of Operations and Business Development at Anemocyte. Plasmids are not only crucial for the development of gene therapies, but also for therapies that involve the genetic modification of cells, such as CAR-T. This has greatly increased the demand for plasmids and I would say that the industry was probably not ready to address this demand.

While the industry is struggling with the lack of plasmids on the market, another challenge is quality. Those providers that can meet the high-quality requirements for plasmids have long waiting lists of up to 12 months, says Baila. For companies moving into phase 3 or commercial production, it becomes crucial that the good manufacturing practice (GMP) requirements are met.

But another result of the rapidly evolving gene and cell therapy space is the fact that the regulatory requirements are not quite up to scratch. The regulatory framework around plasmid production is very confusing for the industry at the moment, says Baila. The main guidelines refer to the quality of the product, but the level of quality remains open to interpretation. More clarity would definitely help once and for all to define the exact quality levels required at different stages of drug development.

Consequently, plasmid providers have to be able to address all quality levels required at each stage of drug development. As the first biotech manufacturing organization (BMO) worldwide, Italian company Anemocyte has met this challenge by focusing greatly on the industrys needs. Their keyword is flexibility.

Before starting their work on plasmid manufacturing, the team spent several months interviewing companies about their difficulties and needs regarding the bottleneck in plasmid production and regulatory issues.

For us, it was key to understand the needs of the industry and find a possible solution, Baila explains. Our research resulted in a brand new facility, which is designed with adaptable manufacturing spaces that enable flexible time management. This ensures that the manufacturing process continues to roll without creating a bottleneck.

As a next step, the Anemocyte team had to decide whether to use a classified cleanroom or just a regular lab for the manufacturing process. We decided to keep the bar pretty high, so we are working with a cleanroom facility where we apply the GMP standard, says Baila. We maintain a high quality and also address the time issues that all companies seem to share as their main challenge in cell and gene therapy development.

The flexibility of its manufacturing facility allows the Anemocyte team to easily adapt to its customers needs. Our customers have control over what we do, explains Marco Ferrari, CEO of Anemocyte. They have the opportunity to be involved in the process, and decisions and actions are discussed and shared with them to ensure their product is produced at the high standard they expect.

Moreover, Anemocyte pays attention to new technologies and innovations. The fast evolution of the cell and gene therapy industry greatly increases the demand for new solutions, Ferrari explains. Staying on top of innovation is therefore mandatory today. Our approach is to stay ahead of the trends and be capable of deploying useful solutions for our customers.

Anemocytes manufacturing facility is built in such a modular way that it can be replicated and adapted to meet the rising demand for plasmids. This, as Ferrari puts it, ensures that the Anemocyte team will not be caught off guard when more companies come knocking at our door. This is an advantage for long-term customers because the manufacturing facility can be duplicated and built according to the customers needs.

As the worlds first BMO, Anemocyte pays specific attention to innovation and the ongoing trends in the industry. One of the emerging trends is the use of nonviral vectors for the development of gene therapies.

Even in the nonviral approach, plasmids play a key role, explains Baila. A part of the nonviral strategy is the transfer of plasmids into cells via mechanical or chemical methods. So, in one way or another, plasmids will always be needed.

Our investment in the nonviral gene modification space is an example of how we are tackling potential future trends that are still under the radar or explored at an academic level, adds Ferrari.

Dont sit on a waiting list to get your plasmids produced! Get in touch with the team at Anemocyte or learn more about the company and the development of plasmids for cell and gene therapies here!

Images via Shutterstock.com

Author: Larissa Warneck, Science Journalist at Labiotech.eu

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How Can We Tackle the Bottleneck in Plasmid Production for Gene... - Labiotech.eu

The collaboration with Childrens Medical Research Institute will boost the efficiency of AAV purification, leading to increased access to the viral vectors needed to manufacture gene therapies

GE Healthcare Life SciencesandChildrens Medical Research Institutewill jointly drive the development of new affinity ligands for the purification of adeno-associated viral (AAV) vectors used in gene therapies. The focus of the collaboration is to bring to market-specific ligands for multiple AAV types, enhancing the chromatographic separation of AAV-based vectors. This will improve the manufacturing efficiency and scalability of gene therapies, enabling the availability of viral vectors on a global scale.

With more than 800 gene therapies currently in clinical trials, there is an increasing demand for the raw materials needed in the manufacturing process of viral vectors. AAVs are viral vectors used in more than 70% of the in vivo gene therapy clinical trials. According to GlobalData, the 2025 gene therapy in vivo therapeutic market is expected to reach USD 32 billion with an estimated CAGR of 105% between 2019-2025.

The collaboration combines the expertise from the latest available research on AAVs with application testing, advancing a comprehensive understanding of the clinical functionality and the commercial opportunities of AAV-based gene therapies. Childrens Medical Research Institute will share with GE Healthcare Life Sciences AAV capsid variants targeting different tissues. GE Healthcare Life Sciences will then design and test ligand prototypes, which Childrens Medical Research Institute will assess. Based on the performance results, GE Healthcare Life Sciences will manufacture and commercialize novel improved AAV affinity ligands.

Dr Leszek Lisowski, the lead gene therapy scientist at Childrens Medical Research Institute, says: Bringing the fruits of our work to the patients requires a joint effort between academia and the industry. The collaboration with GE Healthcare Life Sciences will allow us to expedite the development of novel clinical options at a lower cost.

Olivier Loeillot, General Manager, Bioprocess at GE Healthcare Life Sciences, says: The industry needs better and more personalized technologies to speed biopharmaceuticals through clinical trials and bring them to market. Our long biomanufacturing expertise combined with Childrens Medical Research Institutes pioneering research will lead to purification technologies that will streamline the production of gene therapies.

Catarina Flyborg, General Manager, Cell and Gene Therapy at GE Healthcare Life Sciences, says: Collaborations with organizations such as Childrens Medical Research Institute are critical to developing the technologies needed to move the industry forward. By working directly with world-class researchers, GE Healthcare Life Sciences can develop the purification technologies that will contribute to increasing the availability of viral vectors globally.

Childrens Medical Research Institute in Australia is globally recognized for its work on microsurgery, cancer research, neurobiology, embryology and gene therapy. The AAV affinity ligands resulting from this collaboration will be compatible with GE Healthcare Life Sciences resin-based chromatography portfolio used in the purification of most FDA-approved biopharmaceuticals.

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GE Healthcare joins CMRI to optimize gene therapy manufacturing - BSA bureau

With more than 900 investigational new drug (IND) applications for ongoing clinical studies related to gene therapies, and with the number of advanced therapy medicinal products at clinical stage worldwide exceeding 1,000, the US Food and Drug Administration (FDA) this week released a number of policies.

The policies, addressed to developers and manufacturers, include six final guidance documents on gene therapy manufacturing and clinical development of products, following up to respective draft guidance documents released in 2018, and a draft guidance related to orphan drug designations for therapeutic candidates.

Scientific development in this area is fast-paced, complex, and poses many unique questions during a product review, commented Peter Marks, director of the FDAs Center for Biologics Evaluation and Research, adding The framework we construct for product development and review will set the stage for continued advancement of this cutting-edge field.

Regarding the draft guidanceInterpreting Sameness of Gene Therapy Products Under the Orphan Drug Regulations, the agency explained that it focuses on how the FDA will evaluate differences between gene therapy products when they are intended to treat the same disease.

The final guidance titled Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs) aims to inform sponsors on how to provide sufficient CMC information, in order to assure product safety, identity, quality, purity, and strength (including potency) of the investigational product and to be able to claim market authorization from the regulatory body.

Addressed to developers and manufacturers of retroviral vector-based human gene therapy products, the second document titled Testing of Retroviral Vector-Based Gene Therapy Products for Replication Competent Retrovirus (RCR) during Product Manufacture and Patient Follow-up determines testing for RCR during manufacture, as well as the regulations for follow-up monitoring of patients who have received such treatments.

Titled Long-Term Follow-Up After Administration of Human Gene Therapy Products, the third document includes recommendations by the FDA regarding the design of long-term follow-up studies for the collection of data on delayed adverse events.

Specifically, the FDA suggests that, as a result of long-term exposure to an investigational gene therapy, patients may be at increased risk of undesirable and unpredictable outcomes, and therefore they may be monitored for an extended period of time past the active follow-up period. The document outlines several factors based on which a risk assessment should be performed to determine the necessity of long-term monitoring for each product.

Another guidance of the FDA is focused on Human Gene Therapy for Hemophilia, and it provides recommendations regarding the clinical trial design for such therapies, as well as addressing discrepancies between Hemophilia A and B coagulation factors activity assays.

Focusing on Human Gene Therapy for Retinal Disorders, the fourth FDA guidance includes recommendations related to product development, preclinical testing, and clinical trial design for such gene therapy products.

Finally, the guidance on Human Gene Therapy for Rare Diseases, with suggestions on the clinical design for such products, is needed, according to the FDA, due to the limited study population size and potential feasibility and safety issues. Moreover, the FDA cites issues related to the interpretability of bioactivity/efficacy outcomes that may be unique to rare diseases or to the nature of the product.

Read more from the original source:
FDA guidance on gene therapies development and manufacturing - BioPharma-Reporter.com

Nationwide Childrens Hospital is asking for tax abatements on a new for-profit gene therapy center. If granted, it would exempt the company from paying money to Columbus City Schools for 15 years.

Andelyn Biosciences has been proposed as a for-profit company that would manufacture gene therapy products.

Those products would be developed and distributed to companies that sell them for medical treatment, explains Libbey Hoang, vice president of planning and business development with Nationwide Childrens.

"Our focus will be to bring rare genetic disorder treatment for children to the market," Hoang says. "We believe that theres a great opportunity for Nationwide Childrens to be the leader in that because of our transformational science that has occurred here."

The center would be part of Ohio State Universitys West Innovation Campus, at the corner of Lane and Carmac. Hoang says it will be specifically designed for biologics manufacturing.

That combined with having to hire an expected 150 employees before they can turn a profit is why theyre asking for a 15-year, 100% tax abatement.

"The facility cost us about $64 million in improvements to construct," Hoang says. "Because the company will take approximately four years to actually then produce treatment, we will have nearly $30 million in taxable payroll with very limited income, so thats the major reason were seeking the tax abatement."

However, Nationwide Children's ask is drawing criticism.

"Our stance has always been that we oppose tax abatements for corporations that dont need them," says John Coniglio, president of the Columbus Education Association.

The teachers union has long opposed the city forfeiting tax dollars to spur development. He points to Nationwide Childrens hospitals profit margin an average of about $327 million per year.

"The first thing that comes to my mind is: Does Childrens Hospital really need this tax abatement?" he says.

The hospital runs several programs in partnership with Columbus City Schools, including STEM programs and primary care services. Nationwide Childrens is also offering an estimated $53 million in health care services in the schools during the 15-year abatement period.

"Childrens Hospital does do good things in Columbus City Schools," Coniglio says. "But my question would be: Are you doing this just because you dont want to take the risk that regular individuals have to take every time they want to open a business or do something new?"

Michael Stevens, interim director of development for the City of Columbus, says the land proposed for Andelyn Biosciences is owned by the state, so its not currently producing any tax revenue.

"Without this incentive there would not be the project," Stevens says. "And at this point this parcel does not generate any revenue for the schools or the city, and as a result of incentivizing and making this investment, then were going to see revenue coming into the income tax for the city that then we share with the schools over the 15-year period."

Stevens says the city and the schools will split land and income taxes from Andelyn Biosciences projected to be about $2.5 million each. That price is still significantly less than would have been collected if the project went through without the abatement.

To receive the tax abatement, Nationwide Childrens needs approval from both the Columbus Board of Education and Columbus City Council.

The proposal hasnt been presented to City Council, yet so member Elizabeth Brown declined to make a judgement. But Brown says its important to consider the motivation behind Andelyn Biosciences.

"The genetic disorders are so narrowly presented in the average population that pharmaceutical companies cant make money on developing those things," she says. "Which is why Childrens Hospital is going after it, to my understanding."

The school board plans to take up the abatements on Tuesday. In a statement, board president Jennifer Adair says Nationwide Children's has a strong partnership with the district, and they are considering the abatement. Council will have the final say.

Read more:
Nationwide Children's Seeks City Tax Breaks On For-Profit Gene Therapy Facility - WOSU

The two big pharma companies joined, among others, the investing group for Vineti, the developer of a digital platform for personalized therapeutics enabling the distribution of regenerative medicine, both at clinical and commercial scale.

More specifically, the cloud-based digital platform connects healthcare providers, suppliers, and biopharmaceutical developers by providing them with real-time access to data.

Focusing on personalized medicine, the platform is designed to provide simplicity to end users. Vinetis CEO, Amy DuRoss explained to us why simplicity is important for such treatments:Cell and gene therapies have many, many different types of people involved in the manufacturing and delivery process, including healthcare providers who arent typically part of manufacturing supply chains.

These unfamiliar, highly regulated processes need to be as simple for healthcare providers and other stakeholders as possible, so that these therapies can be produced for patients quickly and without error, she added.

According to the company, Vineti is the only platform of record currently enabling both clinical and commercial personalized therapeutics, such as chimeric antigen receptor (CAR) T-cell therapies and allogeneic cell therapies, into the supply chain.

Both Gilead and Novartis hold assets at commercial stage, the marketing of which can benefit from the use of the platform. Such assets are Novartis gene therapy Zolgensma (onasemnogene abeparvovec-xioi) and Kymriah (tisagenlecleucel), as well as Gileads Yescarta (axicabtagene ciloleucel).

Vinetis Series C financing round closed at $35m (31.8m), with the software developer announcing that it will use the funding for the expansion of its business, including new software product development and commercial expansion in Europe and Asia-Pacific.

The financing was led by Cardinal Health, with participation from Novartis and Gilead, through its subsidiary, Kite, as well as existing investors. Following the completion of the funding, representatives of Novartis and Kite will join Vinetis leadership as board observers.

Kites global head of technical operations, Charles Calderaro, stated that Kite played a foundational role as Vineti's first biopharma partner, when the company prepared for the launch of Yescarta.

Asked about how the platform will be expanded after the funding, DuRoss explained that it will offer improved configurability, enabling users to add new or updated features and adjust them at will, ultimately saving them cost and time.

In biopharma, its all about speed to market, and our configuration approach supports that, DuRoss told us.

Moreover, the platform will position the company towards global expansion, by including more languages as well as support for more regional regulations and standards.

According to DuRoss, the companys partnersincreasingly operate worldwide, in international medical centers and manufacturing sites, and many patient-based drug products cross borders on their journey to becoming a therapy.

Additionally, the company plans to add to the platform more of the standards and integrations required to industrialize cell and gene therapies. Vinetis CEO told us that It may sound contradictory to standardize such deeply personalized drug products, but for scale, standardization is absolutely essential.

DuRoss claimed that even though its still early days in cell and gene therapy, some standard approaches are emerging, as are pre-built integrations that connect critical technology stacks.

We want to help our partners focus on the uniqueness of their science, and not have to reinvent the wheel on supply chain management with every new drug product, she added.

Finally, the company plans to expand the range of therapies that the platform supports to include other high-value therapeutics. Well keep our focus on cell therapy, gene therapy, and personalized cancer vaccines, but expand into other therapeutic areas requiring precision coordination, said DuRoss.

Read more:
Novartis and Gilead provide funding to Vineti - BioPharma-Reporter.com

Thought leaders in cancer cell and gene therapy research will share the latest advances, address the greatest challenges and showcase the most innovative programs in progress today.

Alliance for Cancer Gene Therapy (ACGT) will host its inaugural ACGT 2020 Cancer Summit on April 16, 2020 at the Alexandria Center for Life Science in New York City. The ACGT 2020 Cancer Summit which launches ACGTs 20th anniversary will bring together researchers, companies, investors and advocates in cancer cell and gene therapy to discuss the latest advances, with a focus on combating solid tumors.

A partial list of ACGT 2020 Cancer Summit speakers includes:

Presenting sponsors include Alexandria Real Estate Equities, Inc./Alexandria Venture Investment. Additionally, STAT will be a media partner for the ACGT 2020 Cancer Summit. For more sponsorship information and early bird registration, please visit https://summit2020.acgtfoundation.org

Media Registration

Media registration is free of charge for all valid press card holders or via provision of formal journalist credentials. Register early by contacting ACGT.pr@HDMZ.com to begin receiving advance meeting materials, media alerts, and access to meeting presenters.

About Alliance for Cancer Gene Therapy

For nearly 20 years, Alliance for Cancer Gene Therapy (ACGT) has funded research that is bringing innovative treatment options to people living with deadly cancers treatments that save lives and offer new hope to all cancer patients. Founded by Barbara and Edward Netter after their daughter-in-laws death from breast cancer, ACGT funds researchers who are pioneering the potential of cancer cell and gene therapy talented visionaries whose scientific advancements are driving the development of groundbreaking treatments for ovarian, prostate, sarcoma, glioblastoma, melanoma and pancreatic cancers. One hundred percent of all public funds raised by ACGT directly support program and research, thanks to separate funding to support administrative expenses.

For more information, visit acgtfoundation.org, call 203-358-5055, or join the ACGT community on Facebook, Twitter, Instagram and YouTube.

View source version on businesswire.com: https://www.businesswire.com/news/home/20200203005084/en/

Contacts

Media Inquiries: Emily Maxwell 312-506-5220emily.maxwell@hdmz.com

Continued here:
Save the Date: Alliance for Cancer Gene Therapy 2020 Cancer Summit to be Held in New York City - Yahoo Finance

RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--Aperio Clinical Outcomes, a leading clinical research organization (CRO), announced today that Jonathan Yusi, an expert in the coordination and management of cell and gene therapy clinical trials, has joined the company as Senior Clinical Trials Manager to support their biotechnology clients in the immuno-oncology space.

Yusi has been managing immune-based therapy trials for over seven years. Prior to joining Aperio, he was a program manager for CAR-T studies and oversaw the first CAR-T program at a large CRO. He has provided independent trial management consulting for CAR-T trials, and his expertise has resulted in lasting KOL relationships within the immuno-oncology space. In addition to his adoptive cell therapy knowledge, Yusi brings over 20 years of clinical research experience to Aperio, with a focus on trial logistics, management, and monitoring of targeted and immune therapies in oncology trials.

Says Suzanne Kincaid, Aperios COO and an oncology industry veteran herself, FDA expects to see over 200 INDs for cell and gene therapies in 2020, so it is imperative that our biotech clients have expertise like Jonathans to manage their trials. He has a strong understanding of the complexities of cell and gene therapy studies and can break down the components for ideal study set-up. We are so excited to have Jonathan help our immuno-oncology clients as they explore these groundbreaking treatments.

Cell and gene therapy trials are a logistical maze, and one missed endpoint can be catastrophic to the study, says Yusi. These programs allow me to utilize everything Ive learned about clinical research and oncology, and my medical and scientific background brings an understanding to the science behind the treatments. The bulk of my career has involved oncology trials, so as the treatments have evolved and become more personalized, my experience has evolved as well. These are life-saving breakthroughs, and Im happy to bring this experience to Aperio and our immune-based therapy clients.

About Aperio Clinical Outcomes

In a data driven industry, Aperio remains dedicated to transparency with clients and focused on the most important part of the process: people. Aperio provides full, customizable clinical research services across multiple therapeutic areas, as well as consulting services in Quality Assurance, Strategic Resourcing and Clinical Trial Technology. For more information: http://www.aperioclinical.com.

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Aperio Hires CAR-T Trials Expert Jonathan Yusi to Support Cell and Gene Therapy Studies - Business Wire

A novel conditioning regimen for hematopoietic stem cell transplantation (SCT) from haploidentical donors in patients with severe thalassemia appears to be safe and efficacious, yielding results similar to those for patients with fully matched donors, according to study results published in Biology of Blood and Marrow Transplantation.

Investigators initiated the program with high-risk thalassemia patients who had matched donors and found it to be safe and efficacious. They then hypothesized that they could expand the donor pool for SCT in patients with severe thalassemia to include haploidentical related donors using the same strategy.

The program consisted of a pharmacological pretransplant immune suppression phase (2 courses of dexamethasone and fludarabine) followed by pretransplant conditioning (fludarabine and intravenous busulfan), post-transplant graft-versus-host disease (GVHD) prophylaxis (cyclophosphamide, tacrolimus, and mycophenolate mofetil), and supportive care (penicillin V and ciprofloxacin as antibacterial prophylaxis and itraconazole as antifungal prophylaxis).

In total, 83 patients with transfusion-dependent thalassemia (median age, 12 years; range, 1-28) received transplants. Median follow-up was 15 months (range, 7-53). The 3-year overall and event-free survival rates were both 96% (95% CI, 85.7%-98.4%).

Among the first 31 patients, 2 primary graft failures occurred; the investigators noted that both occurred in patients who had high titers of antidonor-specific human leukocyte antigen antibodies (anti-DSA; > 1:3000). This prompted the team to adjust the first phase of the program to include bortezomib and rituximab for patients with high anti-DSA titers. No additional primary graft failures occurred, and no secondary graft failures occurred.

Adverse events included severe GVHD (6 patients), grade 1 to 2 mucositis (25 patients), grade 3 mucositis (10 patients), cytomegalovirus reactivation (15 patients), cytomegalovirus (2 patients), BK virus cystitis (23 patients), adenovirus cystitis (3 patients), herpes zoster reactivation (1 patient), gram-negative septicemia (5 patients), and gram-negative septicemia (2 patients). There were 4 patient deaths that resulted from pneumonia (2 patients), GVHD complications (1 patient), and bacterial sepsis (1 patient).

The present study demonstrated that outcomes after haplo[identical] SCT in patients with severe thalassemia are acceptable, and now very similar to whats expected with allo[geneic] SCT using matched donors, the investigators concluded.

Reference

1. Anurathapan U, Hongeng S, Pakakasama S, et al. Hematopoietic stem cell transplantation for severe thalassemia patients from haploidentical donors using novel conditioning regimen [published online January 10, 2020]. Biol Blood Marrow Transplant. doi:10.1016/j.bbmt.2020.01.002

The rest is here:
Novel Conditioning Regimen for Haploidentical HSCT in Severe Thalassemia - Hematology Advisor

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced financial results for the fourth quarter and full year of 2019.

"As evidenced by our results and our 2020 guidance, Merck had an extraordinary year and is in a position of operational and financial strength," said Kenneth C. Frazier, chairman and chief executive officer, Merck. "It is this position of strength, born of our focused execution, that gives us the confidence to spin off our Womens Health, trusted Legacy Brands and Biosimilar products into a new company, which will position us to deliver even greater value to patients and shareholders."

GAAP (generally accepted accounting principles) earnings per share assuming dilution (EPS) was $0.92 for the fourth quarter and $3.81 for the full year of 2019. GAAP EPS for the full year of 2019 reflects a $993 million charge for the acquisition of Peloton Therapeutics, Inc. (Peloton) and a $612 million pretax intangible asset impairment charge related to SIVEXTRO (tedizolid phosphate). Non-GAAP EPS of $1.16 for the fourth quarter and $5.19 for the full year of 2019 excludes acquisition- and divestiture-related costs, restructuring costs and certain other items. Non-GAAP EPS for the full year of 2019 also excludes the charge for the acquisition of Peloton and the SIVEXTRO impairment charge.

Merck continued to advance the development programs for KEYTRUDA (pembrolizumab), the companys anti-PD-1 therapy; Lynparza (olaparib), a PARP inhibitor being co-developed and co-commercialized with AstraZeneca; and Lenvima (lenvatinib mesylate), an orally available tyrosine kinase inhibitor being co-developed and co-commercialized with Eisai Co., Ltd. (Eisai).

The following table reflects sales of the companys top pharmaceutical products, as well as sales of animal health products.

Fourth-quarter pharmaceutical sales increased 7% to $10.5 billion, excluding the unfavorable effect from foreign exchange, sales grew 8%. The increase was driven primarily by growth in oncology, partially offset by the ongoing impacts of the loss of market exclusivity for several products. Additionally, fourth quarter 2019 sales were reduced by $120 million due to a previously disclosed borrowing of doses of GARDASIL 9 (Human Papillomavirus 9-valent Vaccine, Recombinant) from the U.S. Centers for Disease Control and Preventions (CDC) Pediatric Vaccine Stockpile. Sales in the fourth quarter of 2018 were increased by $125 million due to the replenishment of previously borrowed doses of GARDASIL 9.

Growth in oncology was largely driven by sales of KEYTRUDA, which were $3.1 billion for the quarter, reflecting strong momentum from the NSCLC indications as well as continued uptake in other indications, including the recently launched RCC and adjuvant melanoma indications. Additionally, oncology sales reflect alliance revenue of $132 million related to Lynparza and $124 million related to Lenvima, representing Mercks share of profits, which are product sales net of cost of sales and commercialization costs.

Performance in vaccines for the fourth quarter reflects the negative impact of borrowing doses of GARDASIL 9 from the CDC Pediatric Vaccine Stockpile as discussed above, partially offset by higher demand in Europe and China, as well as higher demand and pricing in the United States. Excluding the borrowing-related activity in both periods, GARDASIL [Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant] and GARDASIL 9 sales grew 15% in the quarter, including a 1% negative impact from foreign exchange.

Performance in hospital acute care reflects higher demand globally, particularly in the United States, for BRIDION (sugammadex) Injection 100 mg/mL, a medicine for the reversal of neuromuscular blockade induced by rocuronium bromide or vecuronium bromide in adults undergoing surgery; and the ongoing launch of PREVYMIS (letermovir), a medicine for prophylaxis (prevention) of cytomegalovirus (CMV) infection and disease in adult CMV-seropositive recipients of an allogeneic hematopoietic stem cell transplant.

Pharmaceutical sales growth for the quarter was partially offset by the ongoing impacts from the loss of market exclusivity, including for NOXAFIL (posaconazole), EMEND (aprepitant), ZETIA (ezetimibe) and VYTORIN (ezetimibe/simvastatin), CUBICIN (daptomycin) and REMICADE (infliximab). A generic entrant of NUVARING (etonogestrel/ethinyl estradiol vaginal ring) in the U.S. also negatively affected sales for the quarter and will continue to negatively affect sales in the future. In addition, the decline in sales of JANUVIA (sitagliptin) and JANUMET (sitagliptin and metformin HCI) reflects continued pricing pressure in the United States, which more than offset higher demand globally.

Full-year 2019 pharmaceutical sales increased 11% to $41.8 billion; excluding the unfavorable effect from foreign exchange, sales grew 14%, primarily reflecting growth in oncology and vaccines, partially offset by the ongoing effects from the loss of market exclusivity for several products and continued pricing pressure in diabetes.

Animal Health Revenue

Animal Health sales totaled $1.1 billion for the fourth quarter of 2019, an increase of 8% compared with the fourth quarter of 2018; excluding the unfavorable effect from foreign exchange, Animal Health sales grew 10%. Growth for the quarter was mainly driven by livestock products due to the Antelliq acquisition.

Worldwide sales for the full year of 2019 were $4.4 billion, an increase of 4%; excluding the unfavorable effect from foreign exchange, sales grew 9%. Full-year sales growth was mainly driven by livestock products due to the Antelliq acquisition, along with higher sales of companion animal products, primarily the BRAVECTO (fluralaner) line of products for parasitic control.

Animal Health segment profits were $366 million in the fourth quarter of 2019, a decrease of 5% compared with $387 million in the fourth quarter of 2018, primarily driven by unfavorable product mix and higher investments in selling and product development, partially offset by higher sales. Segment profits were $1.6 billion for the full year of 2019, a decrease of 3% compared with $1.7 billion in 2018, primarily driven by the unfavorable effects of foreign exchange.3

Fourth-Quarter and Full-Year Expense, EPS and Related Information

The tables below present selected expense information.

$ in millions

Fourth-Quarter 2019

GAAP

Acquisition- andDivestiture-Related Costs4

RestructuringCosts

Certain OtherItems

Non-GAAP2

Cost of sales

$3,669

$325

$90

$

$3,254

Selling, general and administrative

2,888

44

1

2,843

Research and development

2,548

166

11

2,371

Restructuring costs

194

194

Other (income) expense, net

(223)

(37)

7

(193)

Fourth-Quarter 2018

Cost of sales

$3,289

$525

$10

$3

$2,751

Selling, general and administrative

2,643

6

1

2,636

Research and development

2,214

91

1

2,122

Restructuring costs

138

138

Other (income) expense, net

110

179

(3)

(66)

$ in millions

Year Ended Dec. 31, 2019

Read more here:
Merck Announces Fourth-Quarter and Full-Year 2019 Financial Results - Yahoo Finance

ThermoGenesisHoldingsInc . (NASDAQ:THMO) was upgraded by equities research analysts at ValuEngine from a hold rating to a buy rating in a note issued to investors on Tuesday, January 14th, ValuEngine reports.

Separately, HC Wainwright restated a buy rating and issued a $7.50 price target on shares of ThermoGenesisHoldingsInc . in a research note on Thursday, November 21st.

THMO traded up $0.05 during trading on Tuesday, hitting $5.01. 6,800 shares of the stock were exchanged, compared to its average volume of 59,586. The company has a market cap of $14.25 million, a price-to-earnings ratio of -1.44 and a beta of 1.02. The company has a quick ratio of 1.36, a current ratio of 1.96 and a debt-to-equity ratio of 1.16. The companys fifty day simple moving average is $4.20. ThermoGenesisHoldingsInc . has a 1-year low of $2.35 and a 1-year high of $7.00.

ThermoGenesisHoldingsInc . (NASDAQ:THMO) last released its earnings results on Tuesday, November 19th. The company reported ($0.78) earnings per share (EPS) for the quarter, missing the Zacks consensus estimate of ($0.12) by ($0.66). ThermoGenesisHoldingsInc . had a negative net margin of 89.98% and a negative return on equity of 87.88%. The company had revenue of $4.06 million during the quarter, compared to analyst estimates of $4.80 million. On average, analysts forecast that ThermoGenesisHoldingsInc . will post -0.16 EPS for the current fiscal year.

ThermoGenesisHoldingsInc . Company Profile

ThermoGenesis Holdings, Inc develops, commercializes, and markets a range of automated technologies for cell-based therapies in the United States, China, rest of Asia, Europe, and internationally. The company operates through two segments, Clinical Development and Device. It offers AutoXpress System, an automated system for the isolation, collection and storage of hematopoietic stem cell concentrates derived from cord blood and peripheral blood; Point-of CareXpress System for the rapid, automated processing of autologous peripheral blood or bone marrow aspirate derived stem cells; CAR-TXpress System that addresses the critical unmet need for chemistry, manufacturing and controls improvement of the emerging CAR-T therapies for cancer patients; BioArchive Cryopreservation System, an automated, robotic, liquid nitrogen controlled-rate-freezing and cryogenic storage system for stem cell samples and clinical products; and manual disposables.

Further Reading: Price to Earnings Ratio (PE) Basics

To view ValuEngines full report, visit ValuEngines official website.

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ThermoGenesisHoldingsInc . (NASDAQ:THMO) Raised to Buy at ValuEngine - Riverton Roll

Biogen $BIIB just won one of the biggest fights its ever faced.

The big biotech beat Mylans challenge on the patents that guard their cash cow, Tecfidera, the multiple sclerosis drug that drove the companys comeback under George Scangos and sustains his successor Michel Vounatsos as they search for new drugs.

In the inter partes review ruling, the Patent Trial and Appeal Board or PTAB determined:Having considered all the evidence, petitioner has not demonstrated by a preponderance of the evidence the unpatentability of claims 1-20 of the 514 patent.The news, a closely watched catalyst that had analysts on high alert, immediately triggered a huge 29% spike in their share price. Tecfidera earned $3.3 billion in 2019, almost half its revenue for the year.

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Roche vet Sandra Horning jumps on biopharma board no. 3 what's that worth? - Endpoints News

(Bloomberg Opinion) -- The relatively new mantra of value-over-volume in the oil business is facing its first serious popularity contest.

ConocoPhillipss fourth-quarter earnings missed expectations. The company also trimmed production guidance for 2020. At the same time, Conoco boosted its share buyback program by two thirds to $25 billion, with $3 billion due this year, following a 38% dividend increase announced in October.

Investors seemed more focused on the former Tuesday morning, with Conoco one of only a few oil stocks in the red. Then again, down roughly 10% since year-end, it is also one of the better-performing oil stocks in what has been a dreadful start to 2020 for the sector. With that in mind, the cash-flow story should get more attention.

Conoco laid out a 10-year plan in November best described as embracing the darkness. In place of thebullishness typical of the sector was a long discussion of how to survive in a world where oil stocks arent popular and price cycles are fleeting. In short, it now reads like a premonition of the month just gone. Hence, Conoco emphasized paying out more cash to investors and paying its way at lower energy prices.

On that front, the latest results offer encouragement. Conoco covered capex, dividends and buybacks from operating cash flow in the fourth quarter. On a full-year basis, free cash flow was positive after dividends and only $532 million in the red after $3.5 billion of buybacks. Most importantly, Conoco managed to roughly balance all this, raising underlying productionand shareholder payouts as well as replacing reserves, despite a 9.5% drop in average realized prices for its oil and gas.

Underlying this is the reset in cash-flow priorities following early 2016s dividend cut, shifting away from capex toward payouts.

Conocos financial strategy doesnt render it impervious to black swans. Besides the viral ones, there are more prosaic upsets such as the Malaysian pipeline outage that forced the cut in production guidance. Still, if immunity is to be found anywhere in this business these days, it lies in a good balance sheet and prioritizing payouts.

To contact the author of this story: Liam Denning at ldenning1@bloomberg.net

To contact the editor responsible for this story: Mark Gongloff at mgongloff1@bloomberg.net

This column does not necessarily reflect the opinion of Bloomberg LP and its owners.

Liam Denning is a Bloomberg Opinion columnist covering energy, mining and commodities. He previously was editor of the Wall Street Journal's Heard on the Street column and wrote for the Financial Times' Lex column. He was also an investment banker.

For more articles like this, please visit us at bloomberg.com/opinion

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Originally posted here:
Conoco Works to Boost Its Immune System - Yahoo Finance

By Jessica Hamzelou

anandaBGD/Getty Images

The way a babys immune system works seems to influence whether they will develop temporary or persistent asthma later in life. The finding could help identify more targeted treatments for different types of asthma, say researchers behind the work.

By the time a child is 18 months old, they have already been exposed to plenty of bacteria, viruses and fungi. These early encounters with pathogens start to shape a childs immune system for later life.

To find out if such experiences might also predict a childs risk of developing disease, Susanne Brix at the Technical University of Denmark in Kongens Lyngby and her colleagues followed a group of infants in Denmark for the first six years of their lives.

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The team looked at how immune cells work in toddlers, and whether this is linked to the childrens risk of developing asthma by the time they were six years old. Asthma is pretty prevalent in the Nordic European countries, says Brix. We have a prevalence of around 20 per cent in early childhood.

Brix and her colleagues first took blood samples from 541 18-month-olds. Each blood sample was then presented with a range of compounds such as fragments of viruses or components of vaccines to see how the immune cells in the blood would respond.

The responses of a particular type of immune cell seem to be linked to a childs later risk of asthma, says Brix. This cell type, called a T helper cell, responds to potentially harmful pathogens by releasing a range of proteins.

The way these cells release two specific proteins seems to be linked to whether the child will later develop asthma or not babies whose immune cells produce more of these proteins are significantly more likely to have asthma when they are six years old, says Brix.

Her team also found differences between girls and boys. The immune cells in blood samples taken from boys responded more strongly to bacteria and fungi, while girls seem to mount stronger responses to viruses.

Brix doesnt know why this might be the case, but she suspects sex hormones like testosterone may be influencing the immune system. The difference may explain why boys are more likely to develop asthma early in life, says Brix.

It will be difficult to create a test that would be able to predict which babies will go on to develop asthma, but Brix says she hopes that her research might help to identify the best treatments for different types of asthma.

Some cases of asthma are temporary, and resolve in childhood, while others are persistent. The transient type is more common in boys, says Brix. It may be that one type of asthma is linked to the immune systems response to viruses, while another is linked to the response to bacteria. Better targeted treatments could potentially be developed to treat each type, she says.

Journal reference: Science Translational Medicine, DOI: 10.1126/scitranslmed.aaw0258

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Overactive immune cells in babies may lead to childhood asthma - New Scientist News

You cant listen to the news without hearing about the Coronavirus. While this deadly virus is scary, the plain old regular flu is much more common and can also be deadly.

Many people have already lost their lives during this current flu season (2019-20), and thousands more are sick or may soon be. Even if you got a flu shot, there is still a chance you can get the flu. Thankfully, there are things we can all do to try to stay healthy.

Keep reading for some ways you can build up your immune system and improve your overall health.

Most health experts sites having a healthy lifestyle as key when it comes to boosting your immune system and preventing illnesses. Some of the top things to incorporate into your life include regular exercise, eating a variety of healthy foods, maintain a healthy weight, drink alcohol in moderation, get enough sleep (we are talking seven to nine hours per night), wash your hands with soap and water frequently, minimize/manage your stress, and of course, dont smoke.

There are also lots of specific foods you can eat that taste great and pack powerful vitamins, minerals and antioxidants to boost your immune system and keep you healthy and strong.

Citrus

Loaded with vitamin C, citrus fruits increase your white blood cells which in turn, are key to fighting infections. Try squeezing lemons, limes, oranges and grapefruit into your water during the day for a citrus boost while you are staying hydrated.

Red bell peppers

While citrus is usually known for its vitamin C, did you know red bell peppers have twice as much vitamin C as citrus fruits do? They are also a good source of beta carotene.

Ginger

Used for centuries for medicinal purposes, ginger is thought to decrease inflammation and also may help lower your bad cholesterol. If you dont use fresh ginger in your cooking, you can still reap the benefits by making ginger tea.

Just peel a good bit of fresh ginger, cut into rounds and then pour boiling water over all.

Let steep for a few hours and then strain into a glass container. Refrigerate and add a cup or so to water, your morning health drink, or just straight up. I like to add the juice of a half of a lemon to mine every morning.

Garlic

A great way to add tons of flavor to your cooking, whether it is raw or cooked, garlic may also help lower your blood pressure in addition to boosting your immune system.

Broccoli

Loaded with lots of vitamins and minerals, broccoli also contain other antioxidants and fiber. Just be careful not to overcook broccoli and of course for the most benefits, eat it raw.

Spinach

Rich in vitamin C, and packed with antioxidants and beta carotene, spinach is super healthy. Like broccoli, avoid overcooking and for maximum benefits, consume spinach raw.

Yogurt

Look for yogurt that has live and active cultures on the label. Especially look for yogurt that is made from the milk from grass fed cows. These cultures stimulate your immune system and the yogurt just tastes so much better.

Avoid yogurt that has added sugar, which most do. If you need that sweet factor, serve yogurt with some fruit and a drizzle of honey preferably local honey.

Almonds

Vitamin E is a fat soluble vitamin, meaning it needs fat to be absorbed by the body. A mere half cup of almonds gives you 100% of what you need in a day of vitamin E.

Turmeric

This miracle spice has been used for centuries for medicinal purposes as well as for seasoning food. Besides being anti-inflammatory, it is also great for your bone health.

Green tea

Containing a powerful antioxidant called epigallocatechin gallate, or EGCG, green tea is also a good source of L-theanine, an important amino acid. I like to make a big pitcher of half green tea, half black tea and keep it in the refrigerator. I drink this iced tea all year long, even when it is cold outside.

Papaya

Loaded with vitamin C, papayas contain a digestive enzyme called papain which is anti-inflammatory. Papaya is also a terrific source for potassium, B vitamins and folate.

Kiwi

Every time I eat kiwi, I think, Why do I always forget about this delicious little fruit? Besides being yummy, kiwi are chock full of folate, potassium, vitamins K and C.

Poultry

When Im feeling under the weather, the only thing I want to eat is chicken noodle soup. It is soothing, delicious and healthy. Poultry is a great source of vitamin B-6, and is one of the most nourishing things you can eat when sick or anytime.

Sunflower seeds

I love snacking on these little seeds. They are also perfect as a salad topping. Loaded with phosphorous, magnesium, vitamins B-6 and E, sunflower seeds need to be in your diet.

So, now you know some of the top foods you need to be eating to help boost your immune system. Be sure to check out Fridays food column for some simple, yet delicious recipes utilizing some of these super foods.

South Forsyth resident Adlen Robinson is author of Home Matters: The Guide to Organizing Your Life and Home. Email her at adlen@adlenshomematters.com.

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Orgasms are a very common human phenomenon. The physical and mental health benefits have been researched frequently as a result, and yet, there is still so much to be learned about how our bodies and brains react to the chemicals and hormones released during and after experiencing this type of sexual release.

"The amount of speculation versus actual data on both the function and value of orgasm is remarkable" explains Julia Heiman, director of the Kinsey Institute for Research in Sex, Gender, and Reproduction.

Masturbation causes a rush of dopamine, which is a chemical that is associated with our ability to feel pleasure. Along with the rush of dopamine that is released during an orgasm, there is also a release of a hormone called oxytocin, which is commonly referred to as the "love hormone."

This concoction of chemicals does more than just boost our mood, it also can play a key role in decreasing stress and promoting relaxation. Oxytocin decreases cortisol, which is a stress hormone that is usually present (in high volumes) during times of anxiety, fear, panic, or distress.

According to BDSM and fetish researcher Dr. Gloria Brame, an orgasm is the biggest non-drug induced blast of dopamine that we can experience.

By boosting the oxytocin and dopamine levels and subsequently decreasing our cortisol levels, the brain is placed in a more relaxed, euphoric, and calm state.

Sexual arousal and orgasm increase the number of white blood cells in the body, making it easier to fight infection and illness.

Image by Yurchanka Siarhei on Shutterstock

How do those effects on the brain from reaching orgasm translate to boosting our immune system and making our body healthier?

The increase of oxytocin and dopamine that causes a decrease in cortisol levels can help boost our immune system because cortisol (well-known for being a stress-inducing hormone) actually helps maintain your immune system if released in small doses.

According to Dr. Jennifer Landa, a hormone-therapy specialist, masturbation can produce the right kind of environment for a strengthened immune system to thrive.

A study conducted by the Department of Medical Psychology at the University Clinic of Essen (in Germany) showed similar results. A group of 11 volunteers were asked to participate in a study that would look at the effects of orgasm through masturbation on the white blood cell count and immune system.

During this experiment, the white blood cell count of each participant was analyzed through measures that were taken 5 minutes before and 45 minutes after reaching a self-induced orgasm.

The results confirmed that sexual arousal and orgasm increased the number of white blood cells, particularly the natural killer cells that help fight off infections.

The findings confirm that our immune system is positively affected by sexual arousal and self-induced orgasm and promote even more research into the positive impacts of sexual arousal and orgasm.

Orgasms help minimize pain and promote relaxation which can help boost our immune system.

Photo by Marko Aliaksandr on Shutterstock

The benefits of masturbation have long been debated, but the more research that is done on the topic the more we understand that there are many positive reactions that happen in our bodies and brains when we orgasm.

Orgasms can help prevent or mitigate pain, which boosts the immune system, preventing cold and flu symptoms.

According to neurologist and headache specialist Stefan Evers, about one in three patients experience relief from migraine attacks by experiencing sexual activity or orgasm. Evers and his team conducted an experiment with 800 migraine patients and 200 patients who suffered from cluster-headaches to see how their experiences with sexual activity impacted their pain levels.

The study showed that 60% of migraine sufferers experienced pain relief after participating in sexual activity that resulted in orgasm. Of the cluster-headache sufferers, about 50% said their headaches actually worsened after sexual arousal and orgasm.

Evers suggested in his findings that the people who did not experience pain relief from migraines of headaches during their sexual activity did not release as large amounts of endorphins as those who did experience pain relief.

According to rheumatologist Dr. Harris McIlwain, people who suffer from chronic pain have immune systems that are simply not functioning at full capacity - therefore, alleviating pain (through orgasm, as an example) can help boost the immune system.

Orgasms can also promote relaxation and make it easier to fall asleep. Serotonin, oxytocin, and norepinephrine are all hormones that are released during sexual arousal and orgasm, and all three are known for counteracting stress hormones and promoting relaxation, which makes it much easier for you to fall asleep.

There are several studies showing that serotonin and norepinephrine help our body cycle through REM and deep non-REM sleeping cycles. During these sleep cycles, the immune system releases proteins called cytokines, which target infection and inflammation. This is a critical part of our immune response. Cytokines are both produced and released throughout our bodies while we sleep, which proves the importance of a good sleep schedule to a healthy immune system.

The immune system is a balanced network of cells and organs that work together to defend you against infections and diseases by stopped threats like bacteria and viruses from entering your system. While there are many things we need to do to keep our immune systems functioning at optimal levels, masturbation (or other means of achieving orgasm) has proven to have positive effects on the immune system as a whole.

Just as bad habits (such as an inconsistent sleep schedule or harmful chemicals in your body) can slow your immune system, positive habits (such as a healthy sleep schedule and active sex life) can help boost your immune system.

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Is masturbation the new cold and flu medicine? - Big Think

A retired Texan had endured 12 years of chemotherapy for blood cancer only to see the disease come back stronger and meaner each time.

It was long, hard and terrible, J.C. Cox, 66, said.

So when he was told that he could take part in a clinical trial of a newly modified form of immune therapy, he signed on.

In that small preliminary trial, the results of which were published Wednesday in the New England Journal of Medicine, nearly two-thirds of the patients, all of whom had cancer so advanced that just a decade ago there would have been no hope for them, went into complete remission. Cox was among that two-thirds.

The new treatment involves tweaking a type of therapy called CAR-T that helps the immune system home in on cancer cells. Those tweaks appear to have made it more effective than its predecessor while also leading to fewer side effects, the study found.

In CAR-T therapy, doctors equip a patients own T-cells with a sensor that essentially sniffs out a protein on cancer cells, allowing them to glom onto the protein and then destroy the diseased cells. CAR-T therapy has been approved by the U.S. Food and Drug Administration to treat several types of blood cancer.

The altered T cells end up working like a heat-seeking missile, said study co-author Dr. Katayoun Rezvani, a professor of stem cell transplantation and cellular therapy at The University of Texas MD Anderson Cancer Center.

There were several drawbacks to CAR-T, including the time it took to make the revved up T cells which needed to be harvested from patients and then sent to a lab, their cost, and most important, the possibility of life-threatening side effects.

To try to make a cheaper, safer therapy that would potentially work for all patients, Rezvani and her colleagues switched from T-cells to a different type of immune cell, called natural killer cells.

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Natural killer cells are the best killers of virally infected and abnormal cells, she said. They can continue to patrol and recognize abnormal cells.

There were several advantages to the natural killer cells, not the least of which was that, unlike T cells, they wouldnt make the patients sick by spewing out a flood of inflammatory proteins, leading to a severe condition called a cytokine storm. Another big advantage was that the natural killer cells from one patient could be given to another without any tissue matching. That meant that such cells from healthy donors or from donated umbilical cord blood could be banked and ready to use at any time.

Presumably, this would cut down on the wait time and the costs of the therapy, because the treatments werent being tailor-made for each individual patient.

Rezvani and her colleagues genetically modified the natural killer cells to have a receptor (the R in CAR) for a protein that is on the surface of the cancer cells they were targeting. The receptor would lock onto the protein and then the cell would do its work.

The researchers also tweaked the natural killer cells in two other ways. Unlike T cells which live for a long time, natural killer cells normally have a lifespan of just a couple of weeks, so the researchers added a growth factor that would keep them around for a lot longer. And as a precaution, they also inserted a switch that would allow the researchers to kill off the altered cells if they became too abundant.

Rezvani and her colleagues tested the new treatment in 11 blood cancer patients. When the patients were checked two months after treatment, seven had no signs of cancer while one other showed improvement but not complete remission. The other three had no response to the treatment.

Cox was the eighth patient to receive the new treatment, and initially had misgivings.

I didnt have any other options, Cox, who received the treatment for non-Hodgkin lymphoma, said. But it was scary knowing I would be No. 8 and would be getting the biggest dose.

The trial had been set up to start with a low dose, and then wait to see if there were any serious side effects. If not, the plan was to increase the dose in later patients.

Coxs years of chemotherapy made him worry about possible side effects. But it was probably the easiest thing Ive ever done, he said.

The researchers themselves werent sure what to expect. We were amazed at the safety, Rezvani said. And it didnt seem to matter what dose we gave. This truly is a living drug. It gets inside of the patients body and starts growing and attacking the cancer cells.

Larger studies are needed, but if the treatment which has been licensed to Takeda Pharmaceutical Co. lives up to its early promise, Rezvani hopes to try it on other cancers, such as ones that affect the brain and the breasts.

The response of the patients in the new study is impressive, said Dr. David Porter, the director of cell therapy and transplantation at the University of Pennsylvania Health System. I think this is a major advance in the field of targeted cellular therapy.

Moreover, the natural killer treatments dont seem to have the same life-threatening complications as the original CAR-T therapy, Porter said in an email. Porter was involved with previous CAR-T research, but was not involved with this trial.

But, Porter cautioned, the study included a very small number of patients.

Cox wasnt sure what to expect when he went to be checked two months after receiving his treatment. The news was better than he could have imagined: there was no sign of his cancer.

I did a lot of crying, but they were happy tears, he said. I still get emotional when I talk about it.

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