412th Edition – June 29, 2020

Alex Philippidis joins Rich Bendis on BioTalk to discuss the BioHealth Capital Region from a National viewpoint, other Hubs, and how the industry has adapted in the age of COVID-19.

Alex specializes in biopharma business news and industry issues for GEN. He joined GEN in 2011 after four years at GenomeWeb, where he covered research institutes and spent three years following biotech economic development as editor of the weekly newsletter BioRegion News. Alex reports a variety of news stories for GEN and Clinical OMICs and compiles the popular A-Lists series.

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Novavax Inc. plans to advance its Covid-19 vaccine candidate with new additions to the company and about $200 million in new funds from selling convertible preferred stock — the latest cash infusion for the Gaithersburg vaccine maker.

The preferred private placement with a Boston-based RA Capital Management investment fund, in a deal that closed June 16, came fewer than two weeks after Novavax (NASDAQ: NVAX) won a Department of Defense contract worth up to $60 million to help manufacture its coronavirus vaccine candidate. It also builds upon $388 million Novavax landed from the Norway-based Coalition for Epidemic Preparedness Innovations for the same program. And it follows the company’s preparations to sell up to $250 million in common stock, a move that sent its stock soaring toward the end of May.

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BALTIMORE, MD, June 24, 2020 – AsclepiX Therapeutics, Inc., a biopharmaceutical company that uses computational biology to identify potent peptide regulators of vascular homeostasis for the treatment of retinal and other important diseases, today announced that it has closed a $35 million Series A financing led by Perceptive Xontogeny Venture Fund (“PXV Fund”) with participation from the Perceptive Life Sciences Fund, both funds managed by Perceptive Advisors, and existing investors Rapha Capital Management and Barer & Son Capital.

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In response to medical data highlighting the serious impact of COVID-19 on children’s health, Children’s National is partnering with the National Capital Consortium for Pediatric Device Innovation (NCC-PDI) on a special pitch competition focused on COVID-19 related pediatric medical devices. “Make your Medical Device Pitch for Kids! – COVID-19 edition” is seeking devices that support home health monitoring and telehealth and improve sustainability, resiliency, and readiness in diagnosing and treating children during a pandemic.

Image: https://www.todaysmedicaldevelopments.com

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Charlottesville, Va., June 24, 2020 – HemoShear Therapeutics, a clinical stage company developing treatments for rare metabolic disorders, has received clearance from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application to conduct a phase 2 clinical trial of HST5040, an oral small molecule drug for the treatment of patients with methylmalonic acidemia (MMA) and propionic acidemia (PA). MMA and PA are rare genetic disorders caused by the deficiency of certain enzymes required to metabolize amino acids. The diseases result in the rapid buildup of life-threatening metabolites that can lead to severe organ damage, seizures, developmental deficits, and premature death.

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GAITHERSBURG, Md., June 29, 2020 (GLOBE NEWSWIRE) — Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced it was awarded $4.7 million from the U.S. Army Medical Research & Development Command (USAMRDC) to fund its Phase 1/2 clinical trial of T-COVID, an investigational intranasal immune modulator for the treatment of outpatients with early COVID-19. The competitive award was granted by USAMRDC in collaboration with the Medical Technology Enterprise Consortium (MTEC), a 501(c)(3) biomedical technology consortium working in partnership with the Department of Defense (DoD). The award is expected to provide Altimmune sufficient funding to cover the entire cost of conducting this clinical trial.

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The World Health Organization said on Friday that AstraZeneca’s experimental Covid-19 vaccine is the world’s leading candidate and reached the final stage in terms of development, Reuters reported.

AstraZeneca, a potential vaccine for coronavirus which is being developed by the researchers at the University of Oxford, has entered in large-scale, mid-stage human trials of the vaccine. This week, AstraZeneca signed its tenth supply-and-manufacturing deal.

Image: https://www.thehindubusinessline.com

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ROCKVILLE, Md. & SAN DIEGO–(BUSINESS WIRE)–Replicate Bioscience, Inc. (“Replicate”), a privately-held biopharmaceutical company creating novel treatments to prevent drug resistance in cancers, and Immunomic Therapeutics, Inc., (“ITI”), a privately-held clinical-stage biotechnology company pioneering the study of nucleic acid immunotherapy platforms, announced today that the companies have entered into a research and licensing option agreement to combine their platform technologies to combat infectious diseases and cancers.

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NEWARK, Del., June 24, 2020 /PRNewswire/ — Today, the National Institute for Innovation in Manufacturing Biopharmacueticals (NIIMBL) announces that they have identified nine projects to allocate approximately $8.9 million from the U.S. Department of Commerce’s National Institute of Standards and Technology (NIST) award received in May 2020 towards the support the nation’s response to the COVID-19 pandemic.

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George Petrocheilos and R. Jacob Vogelstein have left Camden Partners to continue to lead the newly independent fund as its managing partners.

Image: George Petrocheilos and R. Jacob Vogelstein are the managing partners of venture investment fund Catalio Capital Management LP. MARK DENNIS

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Johnson & Johnson Innovation is recruiting a Scientific Engagement Lead of Johnson & Johnson Innovation JLABS. The goal of Johnson & Johnson Innovation is to advance transformative healthcare solutions that improve the lives of people around the world and, in so doing, to deliver value to Johnson & Johnson (“J&J”). JJI accomplishes this by catalyzing new science and technology through collaboration and exchange of ideas. This growing team is looking for a colleague inspired to help build and innovate new ways of fostering a productive life-science ecosystem.

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Scott Plank’s latest investment is in a company that aims to solve logistical challenges within the organ transplant industry.

MediGO offers a hardware and software platform for organ transplantation logistics, designed to make it easier to track donated organs as they are delivered to their recipients.

Image: https://www.bizjournals.com – JONATHAN MUNSHAM

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Dear Innovator,

Happy Pride Month! It’s hard to believe it’s almost July. While we’re facing many challenges here in both Washington, DC and in the U.S., the team and I continued to stay busy while working from home over these past few months.

I wanted to take some time to update you on JLABS @ Washington, DC and our activity. Recently I visited the site and was encouraged to see the progress. The construction team has been hard at work even during these tough times and I am very thankful for those working on the front lines, to include our construction workers, during COVID.

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A drug company trying to save infants’ lives, a university center protecting hospitals from hackers, a tech company building extreme drones: three groups in the region are getting a cash boost from a fund that spurs innovation in Virginia.

Of the 26 tech companies and four universities receiving grants this year from the Center for Innovative Technology’s Commonwealth Research Commercialization Fund, three are from this region: ReAlta Life Sciences, Old Dominion University and Sentinel Robotic Solutions.

Image: https://www.pilotonline.com

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It’s not an understatement to say that the entire nation’s hopes are focused on what’s happening in a Maryland laboratory – step one in manufacturing a potential coronavirus vaccine.

Sean Kirk, executive vice president of Emergent BioSolutions, explained to correspondent Martha Teichner how a bioreactor is used to create the ingredients needed in the development and testing of a vaccine for clinical trials already underway in Australia. “This is where it begins, to produce the hundreds of millions of doses,” he said.

Image: https://www.cbsnews.com

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It has been a tumultuous 2020 for venture capital and mergers and acquisitions due to the market uncertainty sparked by the onset of the coronavirus pandemic. Companies seeking acquisitions and venture capital firms alike continue to find their footing, as do the life science companies progressing toward important milestones during a global public health crisis.

Image: https://biobuzz.io

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Cell and gene therapy has evolved into one of the biopharma industry’s hottest markets, with a major splash of investment and a run of approvals anticipated in the coming years. To meet what’s likely to be massive demand for manufacturing capacity, industry experts are calling for “forward-looking” investments—but as one pointed out, those checks aren’t easy to write.

Image: As many as 10 to 20 new cell and gene therapies could be approved each year through 2025. (Gilead)

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GAITHERSBURG, Md., June 29, 2020 (GLOBE NEWSWIRE) — Novavax, Inc. (NASDAQ: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced the appointment of Ben Machielse as Executive Vice President, CMC, with responsibility for overseeing Novavax’ manufacturing, process technology, quality and regulatory functions. The Company also announced several leadership promotions:

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Our newest Johnson & Johnson Innovation JLABS location, JLABS @ Washington, DC, continues to move closer to opening later this year. We recently caught up with Sally Allain, Regional Head of JLABS @ Washington, DC to get the latest updates on construction, how the team has adjusted in response to COVID measures, and what we can expect for the remainder of 2020.

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The U.S. Food and Drug Administration today launched Project Patient Voice, an initiative of the FDA’s Oncology Center of Excellence (OCE). Through a new website, Project Patient Voice creates a consistent source of publicly available information describing patient-reported symptoms from cancer trials for marketed treatments. While this patient-reported data has historically been analyzed by the FDA during the drug approval process, it is rarely included in product labeling and, therefore, is largely inaccessible to the public.

Image: https://www.linkedin.com/posts/astrazeneca_today-the-fdas-oncology-center-of-excellence-activity-6681307663625728000-S01t/

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In 2012, there were fewer than 1,400 maternal-fetal medicine specialists in the United States, and 98% resided inmetropolitan areas.

This left pregnant patients in rural areas without the ability to access care, especially if travel was not an option.

Today, telehealth can be used to fill that gap – but providers still may face challenges in ensuring patients get the services they need.

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Southeast Life Sciences, the organization behind 400 presentations, 790 funding transactions, and $5.2B in investments from 500 distinct investors is going virtual for a special edition of PitchRounds.

SE PitchRounds is Southeast Life Sciences presentation program. This special PitchRounds event is intended for companies in the southeast United States that are working on products, services, etc. that are addressing a need related to Covid-19. If you have any questions about eligibility, please contact Jason Rupp at jrupp@southeastlifesciences.org

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LOS ANGELES–(BUSINESS WIRE)–MedTech Innovator, the premier nonprofit accelerator in the medical technology industry, today announced the 50 companies selected to participate in the organization’s flagship four-month Showcase and Accelerator program, featuring the industry’s most transformative device, diagnostic, and digital health technologies from around the globe. These up and coming startups will receive unparalleled visibility and access to leading manufacturers, providers, investors, and other industry stakeholders. As part of its Accelerator program, MedTech Innovator will award up to $500,000 in cash and in-kind prizes during its final competition at The MedTech Conference, powered by AdvaMed.

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