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WaPo: D.C. region leaders pitch plan to build stronger post-pandemic economy

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More than 50 local leaders have mapped out an economic recovery strategy for the Washington area that they say would leave it more unified, resilient and prosperous than before the novel coronavirus upended the region.

Connected DMV — a group representing the local academic, nonprofit, public and private sectors — initially came together in March 2019 to drive economic growth in the D.C. area. When the pandemic struck a year later, the group pivoted to creating what it calls a “strategic renewal” task force, which issued a report this month with 12 initiatives to remedy the region’s social and economic challenges.

They range from a coordinated regional contact-tracing system to the creation of a pandemic biodefense facility. One effort calls for an economic development plan that permeates the jurisdictional barriers that have previously caused Maryland, Virginia and the District to operate in silos.

Click here to read more via the Washington Post.

BioBuzz: Maryland Company Poised to Produce Millions of Point-of-Care COVID-19 Tests that Deliver Accurate Results in 15 Minutes

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Rockville, Maryland’s Maxim Biomedical (MaximBio) is on the cusp of bringing 3 million of its new and effective point-of-care COVID-19 tests to the fight against the coronavirus pandemic in early 2021, with a scale up to 15 million tests per month expected by Q2 2021.

The company’s brand new point-of-care (POC), ready out-of-the-box antigen test is based on a Lateral Flow Assay technology (LFA) that produces visually interpreted results within 15 minutes.

MaximBio is a family-owned business that was founded in 2005; it is part of the Maxim family of businesses. The company operates out of its 26,000 square foot fully FDA-registered, cGMP compliant, and ISO13485 certified facility in Rockville that houses 13 labs. MaximBio offers a suite of FDA and CDC approved products, as well as customizable CDMO services.

Click here to read more via BioBuzz

Merck acquires OncoImmune to ramp supply of promising Covid drug

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Pharmaceutical giant Merck said it plans to acquire privately held OncoImmune for $425 million in cash, gaining rights to an under-the-radar drug that has shown striking results in hospitalized patients with Covid-19.

The medicine, CD24Fc, was shown in a late-stage clinical study in September to reduce the risk of respiratory failure or death by more than 50% in patients hospitalized with Covid-19 and requiring oxygen, Merck said Monday.

The drug was given as an intravenous infusion in addition to standard-of-care, which could include remdesivir and dexamethasone, and was compared to standard-of-care alone. The data, in 203 patients, also showed that patients receiving CD24Fc had a 60% higher probability of seeing improved clinical status.

“The results are remarkable,” Merck’s research chief, Dr. Roger Perlmutter, said in a telephone interview.

Click here to read more via CNBC

6th Annual “Virtual” BioHealth Capital Region Forum Recap

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Recordings of Keynotes, Panels and the Fireside Chat Available Online

The 6th Annual BioHealth Capital Region (BHCR) Forum like many events in 2020, went virtual this year with over 1,200 online registrants and 59 speakers coming together. The Forum, which has been held at AstraZeneca (Formerly MedImmune) since 2014 in Gaithersburg, MD, brought together the BioHealth Industry with a full slate featuring leaders of industry, academia, and government. The common message throughout the entire agenda was how this region has continued to operate and innovate while working to help the world solve the COVID-19 Pandemic.

The 2020 Crab Trap Competition, typically held during the Forum, will take place at Noon on October 21st. The Crab Trap focuses on companies in therapeutics, diagnostics, medical devices, healthcare services, e-health, mobile health, electronic medical records, health informatics, and BioHealth cyber security. This years’ finalists include BrainScope, CARRTECH, Creative Bio-Peptides, innara HEALTH, and KaloCyte.

The entire 6th Annual BioHealth Capital Region is currently available by visiting https://eventmobi.com/biohealth2020.

NOTE: If you haven’t already registered, please enter your information for immediate access. Click on the “Agenda” line to browser all the videos now available.

Head of JLABS @ Washington, D.C., Sally Allain, MSc., MBA, Guests on BioTalk

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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.

As Head of JLABS @ Washington, DC, Sally sets the strategic direction and oversees all operational activities for JLABS in the greater Washington metro region, including Maryland and Virginia. In this role, Sally is responsible for the process of evaluating and selecting a strong portfolio of innovators for JLABS @ Washington, DC, and building strategic partnerships with corporate, academic, government and industry organizations that aim to strengthen the region’s life sciences innovation network.

Sally joined JLABS after serving as Senior Director, Strategy & Operations on the Global External Innovation team at Johnson & Johnson, where she supported portfolio management and reporting and strategic business development efforts across the organization. Prior, Sally was with Janssen R&D, Immunology, where she managed a team in research operations and alliance management for the early discovery to early development portfolio. Sally understands well the needs of healthcare entrepreneurs, having launched her research career at a San-Diego based biotech startup and then working internationally for a UK-based governmental economic development agency creating early-stage biotech and academic collaborative programs aimed at accelerating the development of products to address the needs of patients and consumers.

Sally received her MBA from the University of California Berkeley, Haas School of Business, where she was recognized by ‘Poets and Quants’ as one of the ‘Top 50’ EMBA students across US & International Programs in 2016; a Master of Science Degree in Microbiology / Immunology from Virginia Tech; and a Bachelor of Science Degree in Biology from Virginia Tech.

Click here to download the transcript.

Novavax and Canada Reach Agreement in Principle to Acquire Novavax’ COVID-19 Vaccine

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Novavax and Canada Reach Agreement in Principle to Acquire Novavax’ COVID-19 Vaccine
Aug 31, 2020 at 8:55 AM EDT

•  Canadian government to purchase up to 76 million doses of NVX-CoV2373

GAITHERSBURG, Md., Aug. 31, 2020 (GLOBE NEWSWIRE) — Novavax, Inc. (Nasdaq: NVAX), a late stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced it has reached an agreement in principle with the Government of Canada to supply up to 76 million doses of NVX-CoV2373, Novavax’ COVID-19 vaccine.

“We are pleased to work with the Canadian government on supply of our COVID-19 vaccine, an essential step to ensure broad access of our vaccine candidate,” said Stanley C. Erck, President and Chief Executive Officer of Novavax. “We are moving forward with clinical development of NVX-CoV2373 with a strong sense of urgency in our quest to deliver a vaccine to protect the world.”

“We are pleased to announce this agreement with Novavax, which will give Canadians access to a promising COVID-19 vaccine candidate. This is an important step in our government’s efforts to secure a vaccine to keep Canadians safe and healthy, as the global pandemic evolves,” said The Honourable Anita Anand, Minister of Public Services and Procurement, Government of Canada.

Novavax and Canada expect to finalize an advance purchase agreement under which Novavax will supply doses of NVX-CoV2373 to Canada beginning as early as the second quarter of 2021. This purchase arrangement will be subject to licensure of the Novavax vaccine by Health Canada.

NVX-CoV2373 is currently in multiple Phase 2 clinical trials. The Phase 2 portion of the Phase 1/2 clinical trial to evaluate the safety and immunogenicity of NVX-CoV2373 began in August in the United States and Australia, and expands on the age range of the Phase 1 portion by including older adults 60-84 years of age as approximately 50 percent of the trial population. Secondary objectives include preliminary evaluation of efficacy. In addition, a Phase 2b clinical trial to assess efficacy began in South Africa in August.

About NVX-CoV2373

NVX‑CoV2373 is a vaccine candidate engineered from the genetic sequence of SARS‑CoV‑2, the virus that causes COVID-19 disease. NVX‑CoV2373 was created using Novavax’ recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and contains Novavax’ patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. In preclinical trials, NVX‑CoV2373 demonstrated indication of antibodies that block binding of spike protein to receptors targeted by the virus, a critical aspect for effective vaccine protection. In its Phase 1 data of the Phase 1/2 clinical trial, NVX‑CoV2373 was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera. Phase 2 clinical trials began in August. Novavax has secured $2 billion in funding for its global coronavirus vaccine program, including up to $388 million in funding from the Coalition for Epidemic Preparedness Innovations (CEPI).

About Matrix-M™

Novavax’ patented saponin-based Matrix-M™ adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.

About Novavax

Novavax, Inc. (Nasdaq:NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. Novavax is undergoing clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both vaccine candidates incorporate Novavax’ proprietary saponin-based Matrix-M™ adjuvant in order to enhance the immune response and stimulate high levels of neutralizing antibodies. Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.

For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

Novavax Forward-Looking Statements

Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading “Risk Factors” in the Novavax Annual Report on Form 10-K for the year ended December 31, 2019, and Quarterly Report on Form 10-Q for the period ended June 30, 2020, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

Contacts:

Novavax

Investors
Silvia Taylor and Erika Trahan
ir@novavax.com
240-268-2022

Media
Brandzone/Speak Life Science
Amy Speak
amy@speaklifescience.com
617-420-2461

Join BHI and Represent the BioHealth Capital Region in the FRAXA Biotech Games™ for Research

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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!

GEN: NIH Invests $248.7 Million to Ramp up COVID-19 Testing

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Six months into the COVID-19 pandemic, the question of why tests that detect the presence of the SARS-CoV-2 virus are not faster, better, and cheaper in this country still remains. Despite an incredibly complicated answer, the National Institutes of Health (NIH) has announced that they are going to help some companies work to develop their technologies, with the hope of getting over this roadblock. The program will give $248.7 million to seven biomedical diagnostic companies. The money is intended to support a range of new lab-based and point-of-care tests that, they hope, could significantly increase the number, type, and availability of tests by millions per week as early as September 2020.

The initiative is called NIH’s Rapid Acceleration of Diagnostics (RADx). “The RADx initiative has enabled some of the nation’s most creative biomedical device inventors to ramp up development of their testing technologies at unprecedented speed,” said NIH director Francis S. Collins, MD, PhD. “The innovations selected to date represent the diverse types of promising technologies that will serve the nation’s testing needs.”

The seven companies range in scope from small start-ups to large publicly-held organizations and their corresponding technologies use different methods and formats and can be performed in a variety of settings to meet diverse needs.

Click here to read the entire article from GEN

BARDA upgrades Emergent pact with $258M option for anthrax vaccine stores

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Drugmakers around the world are scrambling to develop a COVID-19 shot, and Emergent BioSolutions has already signed on to help produce doses for some major players. Now, the Gaithersburg, Maryland-based biopharma has scored a contract update to deploy future vaccine doses for a wholly different kind of health crisis.

On Monday, Emergent BioSolutions said it received a contract modification from the Office of the Assistant Secretary for Preparedness and Response—part of the U.S. Department of Health and Human Services—to exercise an option valued at $258 million for extra doses of the company’s up-and-coming anthrax vaccine, NuThrax.

Emergent’s anthrax vaccine absorbed with adjuvant first scored a procurement contract from the Biomedical Advanced Research and Development Authority (BARDA) back in late 2016. The Monday update marks the first time BARDA has leveraged one of its options to lock down additional doses of the vaccine.

Click here to read more via FiecePharma

Emergent BioSolutions Receives EMA Agreement for Proposed Development Path of Investigational Chikungunya VLP Vaccine Candidate

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GAITHERSBURG, Md., Jan. 13, 2020 (GLOBE NEWSWIRE) — Emergent BioSolutions Inc. (NYSE:EBS) announced that it has received agreement from the European Medicines Agency (EMA) to pursue its proposed development plan for its chikungunya virus virus-like particle (CHIKV VLP) vaccine candidate. The company has proposed conducting a safety and immunogenicity Phase 3 trial using Serum Neutralizing Antibodies (SNA) as an immune correlate of protection to predict clinical benefit of the vaccine candidate.

“Emergent is encouraged by the concurrence we have received from EMA in paving the path for chikungunya vaccine development based on SNA as the surrogate endpoint,” said Abbey Jenkins, senior vice president and vaccines business unit head at Emergent BioSolutions. “As a leading provider of travel health vaccines, Emergent seeks to address the threat posed by this highly debilitating virus by defining a realistic and optimal path to bring to market a much-needed chikungunya vaccine that could potentially serve patients worldwide. We look forward to continuing to work with regulators, including the U.S. Food and Drug Administration (FDA) with whom we had our End-of-Phase 2 meeting last December, as we plan to initiate a pivotal Phase 3 trial this year and define the approach for a post-approval confirmatory efficacy trial.”

Click here to read the entire press release.

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