422nd Edition, September 9, 2020

Sally Allain, MSc., MBA, Head of JLABS @ Washington, D.C. joins Rich Bendis on BioTalk to discuss her career, the decision to open a BioHealth Capital Region location, and their new BLUE KNIGHT™ collaboration.

Listen now via Apple https://apple.co/35ivWc3, Google https://bit.ly/3k0vOlA, Spotify https://spoti.fi/2R84fuh, TuneIn https://bit.ly/2F0a0rN, and YouTube Audio https://www.youtube.com/watch?v=efHvb42ohtc.

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WASHINGTON — A group of prominent biotech CEOs are calling on their peers and the federal government to hold themselves to the highest standards when it comes to developing and reviewing Covid-19 treatments.

Among their demands: That biotech companies don’t simply release clinical trial data in press releases, and that federal regulators make it clear to the public that any vaccines or treatments will be approved strictly based on science.

Image: Colorized scanning electron micrograph of a cell (purple) infected with SARS-COV-2 virus particles (yellow), isolated from a patient sample. NIAID

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PASADENA, Calif., Sept. 4, 2020 /PRNewswire/ — Alexandria Venture Investments, the strategic venture capital platform of Alexandria Real Estate Equities, Inc. (NYSE: ARE), an urban office REIT and the first, longest-tenured and pioneering owner, operator and developer uniquely focused on collaborative life science, technology and agtech campuses in AAA innovation cluster locations, was recognized by Silicon Valley Bank in its “Mid-Year 2020 Healthcare Investments and Exits Report” as the #1 most active biopharma investor by new deal volume from 2019 to 1H20. As a testament to Alexandria’s position at the heart of the life science ecosystem, this marks the third consecutive year the company’s venture capital platform has earned this distinguished and impactful recognition. Since its founding in 1996, Alexandria Venture Investments has strategically invested in some of the most disruptive and promising seed-, early- and growth-stage technologies and companies, and it stands today as an integral component of the company’s uniquely differentiated and multifaceted business strategy.

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The 170,000-square-foot building would be located near Rye Street Tavern.

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Are you seeking an opportunity to engage your firm in a fun community-building activity?  Register one or more teams for the FRAXA Biotech Games.  The BioHealth Capital Region has been challenged by other clusters to demonstrate the greatest knowledge of biotech trivia. Proceeds benefit FRAXA Research Foundation, supporting Fragile X research projects at institutions around the world, including MIT, Harvard, Stanford and UCSD. Fragile X is the most common inherited cause of autism and intellectual disabilities.  BioHealth Innovation (BHI) is hosting the BioHealth Capital Region (Maryland, DC, and Virginia)’s participation in this exciting new event.   

Register one team or multiple teams this month to compete for the Cup in September!

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Pharmaceutical giants Sanofi and Glaxo Smith Kline (GSK) on Thursday started a clinical trial for their jointly developed COVID-19 vaccine candidate.

A total of 440 healthy adults are being enrolled in the trial across 11 investigational sites in the US, the two drugmakers said.

The vaccine candidate uses the same recombinant protein-based technology as one of Sanofi’s seasonal influenza vaccines with GSK’s pandemic adjuvant technology.

The Phase 1/2 clinical trial is a randomised, double blind and placebo-controlled trial designed to evaluate the safety, tolerability and immune response of the COVID-19 vaccine candidate.

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AstraZeneca said today it has launched a 30,000-patient Phase III trial in the U.S. of AZD1222, the COVID-19 vaccine it is co-developing with the University of Oxford and a spinout—a study that will account for most of the 50,000 participants on which the company intends to assess the vaccine.

The Phase III D8110C00001 trial (NCT04516746) is intended to evaluate the safety, efficacy, and immunogenicity of AZD1222 (formerly ChadOx1 nCoV-19) for the prevention of COVID-19. Participants will be randomized to receive two doses of either AZD1222 or a saline control, four weeks apart, with twice as many participants receiving the potential vaccine than the saline control.

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WASHINGTON, D.C., August 27, 2020 – Johnson & Johnson Innovation LLC today announced the first companies to be part of its medical countermeasure innovation collaboration called Blue Knight, a joint initiative dedicated to anticipating potential health security threats, activating the global innovation community, and amplifying scientific and technological advancements with the aim to prepare for and respond to our rapidly evolving global health environment. Blue Knight has been developed in collaboration with the Biomedical Advanced Research and Development Authority (BARDA), a component of the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services, and Johnson & Johnson Innovation – JLABS (JLABS), a global network of life science incubators empowering and enabling innovators to deliver potential life-enhancing health and wellness solutions to people around the globe.

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MANASSAS, Va. — September 2, 2020 — Ceres Nanosciences, a privately held company that makes innovative products to improve diagnostic testing, announced it has been awarded a contract from the National Institutes of Health (NIH) Rapid Acceleration of Diagnostics (RADxSM) initiative. The contract, for $6.5 million, will support an expansion to increase the manufacturing capacity of Ceres’ Nanotrap® Virus Particles for COVID-19 tests.

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Gaithersburg, MD, September 1, 2020 – Cartesian Therapeutics, a fully integrated, clinical-stage biopharmaceutical company developing cell and gene therapies for cancer, autoimmune diseases and respiratory diseases, today announced that it has initiated a Phase 1/2 clinical trial of its lead RNA-engineered mesenchymal stem cell (MSC) therapy, Descartes-30, in patients with moderate-to-severe ARDS, including that caused by COVID-19. Based upon the company’s research and analysis, this program is understood to be the first RNA-engineered cell therapy to enter clinical development for ARDS and COVID-19. It is also the first cell therapy to specifically degrade NETs, webs of extracellular DNA and histones that entrap inflammatory cells, block alveoli and vessels, and drive the pathogenesis of ARDS and COVID-19.

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CHARLOTTESVILLE, Va., Sept. 2, 2020 /PRNewswire/ — MicroGEM today announced it has been awarded up to $40.9 million by the National Institutes of Health (NIH), Rapid Acceleration of Diagnostics (RADxSM) initiative to expedite the launch of the company’s molecular diagnostic test that provides rapid, sensitive and specific identification of SARS-CoV-2 and influenza types A and B at the point-of-need.

MicroGEM’s COVID-19 saliva test provides laboratory-quality results in 15 minutes, allowing non-medical personnel to obtain rapid, on-site detection of COVID-19 without a laboratory. The system detects SARS-CoV-2 in saliva, simultaneously with influenza types A and B, using real-time reverse transcriptase RT-PCR. Based on patented enzymatic RNA extraction technology, the system is a simple approach to quickly detecting and managing infectious disease.

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HIV therapies, typically cocktails of antiviral drugs, have proven to be very successful in controlling HIV/AIDS. However, they are not a “cure,” which is a very lofty goal. American Gene Technologies (AGT), based in Rockville, Maryland, received the go-ahead from the U.S. Food and Drug Administration (FDA) to begin a Phase I clinical trial of AGT103-T, a gene therapy, to eliminate HIV from infected individuals.

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GAITHERSBURG, Md., Aug. 31, 2020 (GLOBE NEWSWIRE) — Emergent BioSolutions Inc. (NYSE: EBS) today announced that it is teaming up with the Boston Red Sox, Cincinnati Reds, Philadelphia Phillies, and Mothers Against Prescription Drug Abuse (MAPDA) to highlight the importance of potentially lifesaving overdose reversal medicines on International Overdose Awareness Day 2020. International Overdose Awareness Day is a global event held on August 31 each year that aims to raise awareness of overdose and reduce the stigma of drug-related deaths. Emergent, in collaboration with these teams and MAPDA, will address the importance of accessing overdose reversal medicines through special announcements, videos, and stadium presentations.

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As the world scrambles to develop diagnostics, treatments and vaccines for COVID-19, one big question looms: How will we face the next pandemic? Johnson & Johnson and the U.S. Biomedical Advanced Research and Development Authority (BARDA) are teaming up once again to answer that.

Through a joint effort dubbed Blue Knight, the duo aims to boost innovation and “amplify” scientific and technological advancements to prepare for potential health threats—starting with COVID-19. They’ve picked seven startups from J&J’s global JLABS network to participate. The startups will receive up to $500,000 in support, as well as mentorship from BARDA and J&J to help them navigate R&D challenges and regulatory pathways and get medicines and tools to patients and healthcare workers as soon as possible.

Image: Startups chosen for the program may participate at JLABS locations in Washington, D.C., New York, San Diego or Toronto. If they don’t need a physical location or lab space, they may participate virtually. (Johnson & Johnson)

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Microbiology Team Leader – https://jobs.gsk.com/en-gb/jobs/241125?lang=it-it (we also have a video of the line manager talking about the role, if you can add it to the newsletter)

New Product Development Director – Voltaren – https://jobs.gsk.com/en-gb/jobs/251039?lang=en-us&previousLocale=en-GB (we also have a line manager’s video)

Senior Process Engineer – https://jobs.gsk.com/en-gb/jobs/258078?lang=en-us&previousLocale=en-GB

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Vaccitech Ltd, a clinical-stage biopharmaceutical company developing immunotherapies to treat and prevent infectious diseases and cancer, announces that the development of AstraZeneca’s AZD1222 vaccine has expanded into a Phase III clinical trial in the US to assess its safety, efficacy and immunogenicity. AZD1222 was co-invented by Vaccitech and Oxford University’s Jenner Institute.

The US Phase III trial, called D8110C00001, is funded by the Biomedical Advanced Development Authority (BARDA), part of the office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services (HHS) and the National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. National Institutes of Health, and led by AstraZeneca. The NIAID-supported COVID-19 Prevention Network (CoVPN) will participate in the trial.

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Advances in science and technology can drive the next generation of skincare innovations. Today, cutting edge dermatological research and technologies hold the potential to revolutionize pore minimizing and anti-aging solutions.

To that end, Johnson & Johnson Innovation, Johnson & Johnson Consumer Inc., and Alibaba’s TMALL announce the Skincare of the Future QuickFire Challenge, calling on innovators to submit products, services and technologies aiming to help consumers tackle the world’s toughest skincare challenges, with a specific focus on pore minimizing and anti-aging solution.

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TruGenomix recently announced $1.8 million in financing in a seed round led by Sanford Health. The startup, a graduate of the Illumina Accelerator program and a Veteran Founder Initiative company, also announced matching funding from Viking Global, a partner of the Illumina Accelerator.

As a veteran-owned business, TruGenomix’s founding mission of improving the lives of U.S. military service members and veterans remains at its roots. With a vision of bringing behavioral health into the 21st century, TruGenomix is advancing the diagnosis of post-traumatic stress disorder (PTSD) through leveraging genomic and machine learning technologies.

Image: https://fi.co

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ROCKVILLE, Md. — Recognizing the benefits of proximity to leading U.S. researchers, regulators and advocacy groups, Nobelpharma America, LLC has chosen Montgomery County, Maryland as the location for its first overseas subsidiary of Nobelpharma Co. Ltd., a company headquartered in Tokyo, Japan. Nobelpharma’s company mission is to contribute to society by providing critical but neglected pharmaceuticals and medical devices.

Nobelpharma meets an essential patient need: it develops curative drugs and medical devices for diseases that often go overlooked because of the small number of patients. Examples include patients suffering from tuberous sclerosis complex (TSC) and adductor spasmodic dysphonia.

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Don’t miss your change to be named the BioHealth Startup with the Most Commectial Potential at the BHCR Forum, win $10,000 and more!

Applications due: 9/24

Finalists notified by: 10/2

Mandatory presenter coaching for finalists: 10/7

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Vaccitech officials say the company received a U.K. government grant to support research with its next-generation technology platform to protect against COVID-19. The grant is part of the UKRI-NIHR COVID-19 rapid response rolling call for proposals with potential to deliver public health impacts within 12 months.

Preclinical data indicate Vaccitech’s new platform induces antibody and cell-mediated immune responses when compared with the adenoviral platforms currently in vaccine trials for COVID-19, according to Bill Enright, Vaccitech CEO. The preclinical data informed the decision of UK Research and Innovation (UKRI) and the National Institute for Health Research (NIHR), and other funders, including the World Health Organization (WHO), to support Vaccitech’s research efforts, he added.

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ROCKVILLE, Md., Sept. 1, 2020 /PRNewswire/ — Emmes today announced that Jonathan DeCarlo has been promoted to chief financial officer. DeCarlo, who has served as vice president and controller, is replacing Brian Hochheimer, who is retiring after 15 years at Emmes.

Dr. Anne Lindblad, president and chief executive officer, said, “Jon has been a key player in Emmes’ growth and success. His technical skills, high levels of integrity and honesty, and vision, have earned the trust and respect from all those with whom he works. We are thrilled to have him as our new chief financial officer. I am extremely confident Emmes will be in excellent hands under Jon’s leadership.”

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ROCKVILLE, Md. & SAN DIEGO–(BUSINESS WIRE)–Immunomic Therapeutics, Inc., (“ITI”), a privately-held clinical-stage biotechnology company pioneering the study of nucleic acid immunotherapy platforms, announced today that results from multiple ATTAC clinical studies of dendritic cell vaccines have been published online by American Association for Cancer Research (AACR) in an article titled, “Once, Twice, Three Times a Finding: Reproducibility of Dendritic Cell Vaccine Trials Targeting Cytomegalovirus in Glioblastoma.”

ITI is developing several dendritic cell vaccines for the treatment of cancer, including ITI-1000 for glioblastoma (GBM), with leaders in cancer immunotherapy for brain tumors, John Sampson, M.D., Ph.D. from Duke University and Duane Mitchell, M.D., Ph.D. from the University of Florida. ITI’s dendritic cell vaccine is designed to target the pp65 viral antigen of Cytomegalovirus (CMV) that is expressed in GBM, but not in normal brain cells.

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BALTIMORE (WJZ) — As the fall semester begins, Johns Hopkins University wants to make sure its students are protected.

They are giving out wellness kits to undergraduates to help protect both students and the nearby community.

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