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HOOKIPA Announces Positive Phase 2 Interim Safety, Immunogenicity, and Efficacy Data for its Cytomegalovirus Vaccine Candidate HB-101

November 30th, 2020 7:57 am

NEW YORK and VIENNA, Austria, Nov. 30, 2020 (GLOBE NEWSWIRE) -- HOOKIPA Pharma Inc. (NASDAQ: HOOK, ‘HOOKIPA’), a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, today announced positive interim efficacy results, as well as additional safety and immunogenicity data, for its prophylactic Cytomegalovirus (CMV) vaccine candidate HB-101. HB-101, a non-replicating arenavirus vaccine, is being investigated in a double-blind Phase 2 clinical trial (NCT03629080) to assess safety, immunogenicity and efficacy in individuals receiving a kidney transplant from a living donor. HOOKIPA will host a conference call and live audio webcast today at 8:30am EST.

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HOOKIPA Announces Positive Phase 2 Interim Safety, Immunogenicity, and Efficacy Data for its Cytomegalovirus Vaccine Candidate HB-101

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Novavax Announces COVID-19 Vaccine Clinical Development Progress

November 30th, 2020 7:57 am

GAITHERSBURG, Md., Nov. 30, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today provided an update on its COVID-19 vaccine program. NVX?CoV2373 is a stable, prefusion protein antigen derived from the genetic sequence of the SARS-CoV-2 coronavirus spike (S) protein and adjuvanted with Novavax’ proprietary Matrix?M™.

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Autolus Therapeutics announces publication of new AUTO6 Phase 1 data in childhood neuroblastoma in Science Translational Medicine

November 30th, 2020 7:57 am

- Findings from the Phase 1 study provide evidence that AUTO6 induces clinical activity in this solid tumor setting without inducing on-target off-tumor toxicity

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Allergy Publishes Results from BioCryst’s APeX-J Trial of Oral, Once-Daily Berotralstat for the Prevention of HAE Attacks

November 30th, 2020 7:57 am

RESEARCH TRIANGLE PARK, N.C., Nov. 30, 2020 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced the journal Allergy has published data from the APeX-J trial, a randomized, placebo-controlled trial conducted in Japan evaluating oral, once-daily berotralstat for the prophylactic treatment of hereditary angioedema (HAE).

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Agios Launches Anemia ID, a No-Cost Genetic Testing Program for Hereditary Anemias

November 30th, 2020 7:57 am

CAMBRIDGE, Mass., Nov. 30, 2020 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (NASDAQ:AGIO), a leader in the field of cellular metabolism to treat cancer and rare genetic diseases, today announced the launch of Anemia ID, a program providing no-cost genetic testing for patients with suspected hereditary anemias. The next-generation sequencing panel consists of more than 50 genes and disorders that are known to cause hereditary anemias, including pyruvate kinase deficiency. Patients with hereditary anemia can face a difficult path to a proper diagnosis, and access to comprehensive diagnostic testing is a common barrier to diagnosis. Receiving an accurate diagnosis enables patients and their physicians to better understand their condition and informs disease management decisions.

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Prevail Therapeutics Receives European Commission Orphan Designation for PR006 for the Treatment of Frontotemporal Dementia

November 30th, 2020 7:57 am

NEW YORK, Nov. 30, 2020 (GLOBE NEWSWIRE) -- Prevail Therapeutics Inc. (Nasdaq: PRVL), a biotechnology company developing potentially disease-modifying AAV-based gene therapies for patients with neurodegenerative diseases, today announced that the European Commission has granted orphan designation for PR006 for the treatment of frontotemporal dementia (FTD). PR006 is an investigational AAV9 gene therapy delivering the GRN gene and is being developed as a potential therapy for patients with frontotemporal dementia with GRN mutations (FTD-GRN).

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Prevail Therapeutics Receives European Commission Orphan Designation for PR006 for the Treatment of Frontotemporal Dementia

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IGM Biosciences to Host Conference Call and Webcast to Review IGM-2323 Data Presented at the 62nd Annual ASH Meeting

November 30th, 2020 7:57 am

MOUNTAIN VIEW, Calif., Nov. 30, 2020 (GLOBE NEWSWIRE) -- IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage biotechnology company focused on creating and developing engineered IgM antibodies, today announced that the Company will host a conference call and live audio webcast on Saturday, December 5, 2020, at 2:00 p.m. ET. The event will take place following a poster presentation featuring the first clinical data from the Company’s Phase 1 trial evaluating IGM-2323 at the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition.

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IGM Biosciences to Host Conference Call and Webcast to Review IGM-2323 Data Presented at the 62nd Annual ASH Meeting

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Apellis Pharmaceuticals to Present at the 2020 Evercore ISI HealthCONx Conference

November 30th, 2020 7:57 am

WALTHAM, Mass., Nov. 30, 2020 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS), a global biopharmaceutical company and leader in targeted C3 therapies, today announced that the company will present at the 2020 Evercore ISI HealthCONx Conference on Thursday, December 3, 2020 at 1:25 p.m. ET. The conference will be held in a virtual meeting format.

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Imara to Present Clinical Data on IMR-687 as Monotherapy and in Combination with Hydroxyurea in Patients with Sickle Cell Disease at the 62nd ASH…

November 30th, 2020 7:57 am

BOSTON, Nov. 30, 2020 (GLOBE NEWSWIRE) -- Imara Inc. (Nasdaq: IMRA), a clinical-stage biopharmaceutical company dedicated to developing and commercializing novel therapeutics to treat patients suffering from rare inherited genetic disorders of hemoglobin, today announced that clinical data from the ongoing IMR-687 Phase 2a open label extension (OLE) clinical trial in adult patients with sickle cell disease (SCD) will be presented at the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition to be held virtually December 5-8, 2020.

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Imara to Present Clinical Data on IMR-687 as Monotherapy and in Combination with Hydroxyurea in Patients with Sickle Cell Disease at the 62nd ASH...

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TG Therapeutics to Participate in the 3rd Annual Evercore ISI HealthCONx Conference

November 30th, 2020 7:57 am

Fireside chat scheduled for Tuesday, December 1, 2020 at 10:05 AM ET Fireside chat scheduled for Tuesday, December 1, 2020 at 10:05 AM ET

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Auxly Reports Third Quarter 2020 Financial Results

November 30th, 2020 7:57 am

Strong Sequential Revenue Growth Strong Sequential Revenue Growth

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Iovance Biotherapeutics to Present at Upcoming Conferences in December

November 30th, 2020 7:57 am

SAN CARLOS, Calif., Nov. 30, 2020 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel T cell-based cancer immunotherapies, today announced that the company plans to present at the following conferences in November:

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Otonomy Provides Update on OTIVIDEX® and OTO-313 Programs

November 30th, 2020 7:57 am

SAN DIEGO, Nov. 30, 2020 (GLOBE NEWSWIRE) -- Otonomy, Inc. (Nasdaq: OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today provided updates regarding the statistical analysis plan for the ongoing Phase 3 trial of OTIVIDEX in Ménière’s disease, and outlined plans for a Phase 2 trial of OTO-313 in tinnitus.

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MacroGenics Announces Achievement of $25 Million in Milestones Related to Retifanlimab Collaboration with Incyte

November 30th, 2020 7:57 am

ROCKVILLE, MD, Nov. 30, 2020 (GLOBE NEWSWIRE) --  MacroGenics, Inc. (Nasdaq: MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced that $25 million in milestones have been achieved under its exclusive global collaboration and license agreement with Incyte for retifanlimab, an investigational anti-PD-1 monoclonal antibody designed by MacroGenics and licensed to Incyte (as INCMGA0012). The milestones were triggered by clinical and regulatory activities related to the further advancement of the molecule, including the recent initiation of POD1UM-303, Incyte’s Phase 3 global study in patients with metastatic squamous cell anal carcinoma (SCAC).

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MacroGenics Announces Achievement of $25 Million in Milestones Related to Retifanlimab Collaboration with Incyte

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Sunesis Pharmaceuticals and Viracta Therapeutics Announce Definitive Merger Agreement

November 30th, 2020 7:57 am

Merger to create Nasdaq-listed company focused on developing Viracta’s precision oncology pipeline targeting virus-associated malignancies

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GW Pharmaceuticals to Present at the Evercore ISI 2020 Healthcare Conference

November 30th, 2020 7:57 am

LONDON and CARLSBAD, Calif., Nov. 30, 2020 (GLOBE NEWSWIRE) -- GW Pharmaceuticals plc (NASDAQ: GWPH, GW, the Company or the Group), a world leader in the science, development, and commercialization of cannabinoid prescription medicines, today announced that the Company will present at the Evercore ISI HealthCONx Conference on Wednesday, December 2, 2020 at 1:50 pm EST.

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Future Meat is cutting costs on mass production with an unlikely cellular approach – The Spoon

November 30th, 2020 7:57 am

Founded in 2018, Future Meat stayed under the radar until last fall when their Series A funding round raised $14 millionincluding a sizable investment from Tyson Ventures. Now, just two years in, theIsraeli start-up is expecting a major scale up in early 2021 and is optimistic about being among the first to gain FDA approval thanks to an uncommon cellular approach.

Commercial scale has been Future Meats priority from the start. We know we can [culture meat]. The question is how much will it cost, said Yaakov Nahmias, Future Meat Chief Scientific Officer told me in an interview earlier this month. Do you really want to make a $25,000 steak?

Key to its plan to ramp up biomass and cut costs, is a unique choice of starter cells. While most cultured meat start-ups rely on some form of stem or muscle cell, the basic building block of Future Meats products is the cell-type that makes up your connective tissue: fibroblasts.

These are the cells that every time you get cut, they close that cut very fast, according to Nahmias, who developed the fibroblast technology in his university lab.

Stem cells are a popular candidate for cell culture because they can become any type of cell, but growing and maintaining them is very expensive, Nahimas said. Theyre what we call phenotypically unstable. Meaning, stem cells dont stay stem cells for long. In nature, theyre meant to be stem cells for a day or less before transforming into another cell type. To harness their potential or stabilize stem cells, many start-ups rely on gene editing, a method that Future Meat is avoiding.

Fibroblasts, on the other hand, are phenotypically stable making them less volatile and easier to grow in mass quantities. And Future Meat has an extensive patent portfolio protecting the way they growand direct these fibroblasts. They can accelerate a natural process called spontaneous immortalization where the cells DNA rearranges so that it can divide forever. And by adding some food grade molecules to the cellular medium they can pressure the fibroblast to become fat cells or muscle cells, Nahmias said.

Another key advantage of these connective tissue cells is that Future Meat can grow them in suspension, they dont require surfaces to cling to. Many other mammalian cells, like muscle cells (myocytes), need something to hold on to, a sort of scaffolding, when cultured. Culturing in suspension means no need for scaffolding and it significantly increases the biomass that can be cultivated in a single bioreactor.According to Kate Krueger, alternative protein consultant at Helikon Consulting, Suspension cell culture has a lot of promise in reducing cost of manufacture.

Today, Future Meat bioreactor systems can reach yields of 33 percent, converting a third of their volume to mass every two weeks. Its possible to grow the mass of 100 chickens every two weeks in a bioreactor the size of a standard refrigerator, Nahmias said. Theyre also working on a hybrid product, a combination of plant protein and bioreactor-grown fat cells that they can produce at two tons per week. By the second quarter of next year they expect peak capacity to increase to half a ton every two weeks and for that to triple again by the end of 2021.

For now Future Meat is all about getting to scale, market and a reasonable price point to validate their process and prove their tech. But the end-game for Future Meat is about developing a platformthink of it as the AWS of cultured meat. And the target customer isnt just a new meat industry, its the old one.

The idea is to integrate their technology into the existing supply chain. Even individual farmers looking to diversify could include a bioreactor as part of their operations, Nahmias said. But he expects involvement from meat and ingredient giants like Tyson and Cargill will be what finally catapults cultured meat into the mainstream. Future Meats game plan is to have the approved and affordable tech ready and waiting. Because once it happens, he said, its going to move quickly.

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Mutations of the coronavirus do not appear to make the virus more infectious, study says | TheHill – The Hill

November 30th, 2020 7:54 am

None of the mutations observed in the coronavirus that causes COVID-19 appear to increase the viruss transmissibility, a new study says.

The study led by researchers from University College London published Wednesday in Nature Communications analyzed a global dataset of virus genomes from more than 46,000 people with COVID-19 from 99 countries.

Our country is in a historic fight against the Coronavirus. Add Changing America to your Facebook or Twitter feed to stay on top of the news.

Researchers so far have identified more than 12,700 mutations in the SARS-CoV-2 virus.

Coronaviruses like SARS-CoV-2 mutate all the time and most are neutral. But some can be advantageous or detrimental to the virus, potentially with troublesome consequences, such as making the virus more contagious and a vaccine less effective.

But so far, researchers say they have yet to find any evidence common mutations are increasing the viruss transmissibility.

We realised early on in the pandemic that we needed new approaches to analyze enormous amounts of data in close to real time to flag new mutations in the virus that could affect its transmission or symptom severity, Lucy van Dorp, a professor at University College Londons Genetics Institute and a lead researcher of the study, said in a statement.

Fortunately, we found that none of these mutations are making COVID-19 spread more rapidly, but we need to remain vigilant and continue monitoring new mutations, particularly as vaccines get rolled out, she said.

Researchers found most of the viruss mutations occurred as a result of the human immune system response, rather than the result of the virus adapting to its human host.

Over the course of the pandemic, one mutation in the virus spike protein called D614Gwas reported as being a mutation that could make the virus more contagious than earlier strains that emerged out of Wuhan, China.

The study published Wednesday found the mutation is in fact not associated with a greater increase in transmission.

Francois Balloux, a UCL professor who worked on the research, said the virus posed no threat to COVID-19 vaccine efficacy at this time but warned the introduction of vaccines could exert new selective pressures on the virus to mutate to escape recognition by the humane immune system.

The news on the vaccine front looks great. The virus may well acquire vaccine-escape mutations in the future, but were confident well be able to flag them up promptly, which would allow updating the vaccines in time if required, Balloux said.

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Spaceflight does some weird things to astronauts bodies – MIT Technology Review

November 30th, 2020 7:54 am

The Twins Study gave us a first sketch of the human bodys molecular responses to spaceflight, but these outlines needed to be filled in, says Christopher Mason, an associate professor of physiology and biophysics at Weill Cornell Medicine. The changes we saw needed more context and replication. We needed additional studies to map out the frequency of the changes we observed in other astronauts, and other organisms, that go into space, and also to see if the degree of change was similar for shorter missions.

That brings us to a new package of research that builds on the Twins Study, reanalyzing some of the original data with new techniques and providing comparisons with other astronauts. In a set of 19 studies published today in a slew of different journals (along with 10 preprints still under peer review), researchers like Mason (a senior author on 14 of the papers) studied the physiological, biochemical, and genetic changes that occurred in 56 astronauts (including Kelly) who have spent time in spacethe largest study of its kind ever conducted.

The new papers, which incorporate results from cell-profiling and gene-sequencing techniques that have become easier to run only recently, reveal that there are some features of spaceflight that consistently appear in humans, mice, and other animals when they go to space, says Mason. There appears to be a core mammalian set of adaptations and responses to the rigors of spaceflight.

The researchers highlightsix biological changesthat occur in all astronauts during spaceflight: oxidative stress (an excessive accumulation of free radicals in the bodys cells), DNA damage, dysfunction of the mitochondria, changes in gene regulation, alterations in the length of telomeres (the ends of chromosomes, which shorten with age), and changes in the gut microbiome.

Of these six changes, the biggest and most surprising one for scientists wasmitochondrial dysfunction. Mitochondria play a critical role in producing the chemical energy necessary to keep cellsand by extension, tissue and organsfunctional. Researchers found irregular mitochondrial performance in dozens of astronauts and were able to broadly characterize these changes thanks to new genomics and proteomics techniques. Afshin Beheshti, a bioinformatician at NASA and senior author of one study, says mitochondrial suppression helps explain how many of the problems astronauts experienced (like immune system deficiencies, disrupted circadian rhythm, and organ complications) are actually holistically related to each other, since they all rely on the same metabolic pathways.

When youre in space, its not just one are or organ thats affected, its the whole body thats affected, says Beheshti. "We started connecting the dots."

Other research homed in on problems observed at the genetic level. The Twins Study showed that Kellys telomeres got longer in space before shrinking back to normal or even shorter lengths soon after he returned to Earth. Telomeres are supposed to shorten with age, so lengthening makes little sense, and the Twins Study didnt provide enough data to prompt any real conclusions as to why it happened and what the effects were.

Susan Bailey, a Colorado State University expert on telomere research and a senior author for several of the papers, says the new research found that 10 other astronautsexperienced the same telomere lengthening Kelly did irrespective of mission durationas well as the same telomere shrinking once they came back to Earth.

Notably, one of the papers in the new package found that longer telomeres were also associated with climbers of Mount Everest. For Bailey and her colleagues, this suggests that telomere lengthening isaffected by oxidative stresssomething that climbers and astronauts both experience, and that disrupts proper telomere maintenance.

NASA

They are still trying to pinpoint how these pathways work and exactly what the consequences could be (its probably not a secret to longevity), but we now have a foundation to build onwe know what to look for and be aware of in future astronauts on long-duration [and deep space] exploration missions, she says.

Though some of the changes are unexpected, many are no cause for concern. What is amazing to me is how well we adapt to space, says Jeffrey Sutton, director of the Baylor College of Medicines Center for Space Medicine, who was not involved with the new research.Blood cell mutations decreased in Kelly while he was in space(a total surprise for Mason). Astronauts also exhibiteddecreased levels of biomarkers associated with agingandincreased levels of microRNAsthat regulate the vascular systems response to radiation damage and microgravity. One of the strangest findings was that astronauts gut microbiomes managed to bring space microbes found on the ISS back to Earth.

The studies individually and collectively are truly impressive, says Sutton. We have entered a new era of space biomedical research, where the approaches and tools of precision and translational medicine are being applied to advance our understanding of human adaptation to space.

Ultimately, however, the data highlights just how much havoc and stress even the healthiest bodies face during space missionswhich should have an impact on planning for longer missions. I dont think were close to sending untrained people into space for really long periods of time, says Scott Kelly.

Physiologically, he thinks its probably safe to send people to Mars and back. In the distant future, however, instead of going to Mars, were going to be going to the moons of Jupiter or Saturn, he says. Youre going to be in space for years. And at that point, well have to take a closer look at artificial gravity as a mitigation. I wouldnt want to be arriving on the surface of another planetary body and not be able to function. A year or so is workable. Several years probably isnt.

NASA

Were still far away from having to evaluate those kinds of risks. Mason and his colleagues suggest that there should be pharmacological strategies for reducing the impact of gravity on the bodies of returning astronauts.

Sutton believesprecision medicinecould play a huge role in tailoring those drugs to protect astronauts against the effects of microgravity and radiation. And the shared biological responses between astronauts and Mount Everest climbers suggest that some interventions used to protect extreme sports athletes from oxidative stress could be applied to astronauts too.

What we need is more dataand more populations to use for comparison. Mason, Bailey, and their colleagues are starting to collect cell and gene profiles of more astronauts, especially those going on future year-long missions. They also want to study people whove experienced other conditions similar in some way to spaceflight, such as radiotherapy patients, pilots, and flight attendants.

The more we know about the health effects of long-duration spaceflight, the better able we will be to help maintain the health and performance of astronauts during and after spaceflight, says Bailey. Such knowledge benefits those of us on Earth as wellwe are all concerned about getting older, and being in poor health.

This post has been updated with comments from Afshin Beheshti.

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Precision Medicine Software Market 2020: Potential growth, attractive valuation make it is a long-term investment | Know the COVID19 Impact | Top…

November 30th, 2020 7:54 am

Precision Medicine Software Marketis anticipated to discover Robust Growth by 2026. This report focuses on the leading key players with global perspective with a professional and in-depth study on the current state of Precision Medicine SoftwareIndustry. Precision Medicine Softwaremarket research report provides important market strategies and Latest trends with discussion of market consumption, major drivers, restraints and market share forecasted to 2026.

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Top Key Players in Precision Medicine Softwaremarket: Syapse, , Allscripts, , Qiagen, , Roper Technologies, , Fabric Genomics, , Foundation Medicine, , Sophia Genetics, , PierianDx, , Human Longevity, , Translational Software, , Gene42, Inc, , Lifeomic Health

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The outbreak of COVID-19 has brought effects on many aspects, like flight cancellations; travel bans and quarantines; restaurants closed; all indoor events restricted; emergency declared in many countries; massive slowing of the supply chain; stock market unpredictability; falling business assurance, growing panic among the population, and uncertainty about future.

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