As the coronavirus COVID-19 continues to spread across the U.S.  — there are currently 150 confirmed cases with 11 total deaths as of this writing — several BioHealth Capital Region (BHCR) life science companies are urgently pushing to develop and deploy a COVID-19 vaccine.

In another encouraging sign, Altimmune, which is located in Gaithersburg, Maryland announced that it had made progress on a potential vaccine. The company has advanced a potential single-dose, recombinant intranasal vaccine using its proprietary technology. Altimmune’s research scientists have completed the design and synthesis of the vaccine and it is now moving into animal testing. Altimmune projects that clinical testing of the coronavirus vaccine could begin as early as August 2020.

The potential new COVID-19 vaccine has been developed using the same technology that was deployed to create NasoVAX™, Altimmune’s recombinant intranasal vaccine for influenza, which is currently Phase 2A trials. NasoVAX, according to Altimmune’s recent press release, has shown “…the ability of intranasal vaccine delivery to stimulate a durable and broad immune response against the influenza virus.” The company believes that a COVID-19 vaccine delivered intranasally provides a more direct immune response to the likely point of the initial viral attack.

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• Vaccine candidate derived from coronavirus spike (S) protein
• Matrix-M™ adjuvant expected to boost immune responses
• Phase 1 clinical trial planned for late spring

GAITHERSBURG, Md., Feb. 26, 2020 (GLOBE NEWSWIRE) — Novavax, Inc. (NASDAQ: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced progress in its efforts to develop a novel vaccine to protect against coronavirus disease COVID-19. Novavax has produced and is currently assessing multiple nanoparticle vaccine candidates in animal models prior to identifying an optimal candidate for human testing, which is expected to begin by the end of spring 2020.

Novavax created the COVID-19 vaccine candidates using its proprietary recombinant protein nanoparticle technology platform to generate antigens derived from the coronavirus spike (S) protein. Novavax expects to utilize its proprietary Matrix-M™ adjuvant with its COVID-19 vaccine candidate to enhance  immune responses.

“Our previous experience working with other corona  viruses, including both MERS and SARS, allowed us to mobilize quickly against COVID-19 and successfully complete the critical preliminary steps to engineer viable vaccine candidates,” said Stanley C. Erck, President and Chief Executive Officer of Novavax. “Now that the protein has been expressed stably in our baculovirus system, we aim to identify the optimal candidate and scale up production of sufficient vaccine for preliminary clinical trials. We are now well-positioned to advance the COVID-19 vaccine candidate to Phase I clinical testing in May or June.”

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Part 1: This article is the first in a new series where we will explore the impact that the booming biotech market is having on hiring and talent strategies for companies and for biotech clusters.

Life science industry growth projections for the next decade mean the battle to acquire and retain the best talent will continue in 2020 and beyond, both here in the U.S. and globally.  The many top biotech clusters across the U.S., including the BioHealth Capital Region (BHCR), will experience a new set of challenges as competition for talent becomes more fierce.

According to a recent CBRE report entitled “Markets Positioned for ‘Century of Biology’,” 2019 was a year of explosive growth for the biotech industry, fueled in part by the rapid emergence and proliferation of personalized medicine, including the burgeoning cell and gene therapy industries. The CBRE report calculates the life sciences sector is growing at its fastest pace since 2000, expanding 3.2% year-over-year

Rent for lab space in the Boston-Cambridge cluster, according to this same report, increased by double digits in 2019 and 1.9M square feet of lab space is currently under construction there. Another recent report by MassBio showed “…that the Massachusetts biopharma industry experienced the highest year-over-year employment growth in over a decade, adding over 4,300 new jobs from 2017 to 2018 for 6.4% growth.” More specifically,  the report cites that biotech research & development (R&D) employment growth was nearly 50% over the past 10 years. Additionally, New York currently has 1.5M square feet of lab space under construction; Seattle, Houston, Austin and Denver were tagged by CBRE as emerging clusters. The next decade is ripe for disruption and more explosive change and growth.

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Vigene Biosciences officially opened its new, state-of-the-art 51,000 square foot cell and gene therapy manufacturing facility in Rockville, Maryland at a ribbon-cutting ceremony on January 29th.

The grand opening marked a major milestone for the company, which has grown from three employees to approximately 100 team members since launching in 2012. The $20M project has increased Vigene’s footprint to 71,000 total square feet, amplifying its capacity to serve its clients and achieve the company’s ultimate mission: Making gene therapy treatments more affordable for people and families battling cancer and genetic disorders.

The ribbon-cutting ceremony was a vibrant, joyful celebration of Vigene’s remarkable achievements. It was also a moment of real hope for families seeking better, more affordable gene and cell therapies for loved ones stricken with cancer and rare diseases.

Gina Hann, the founder of the non-profit organization Batten Hope, was Vigene Biosciences’ grand opening special guest. Her seven-year-old son, Joseph, known as JoJo, was diagnosed with a rare form of Batten disease at age five. Batten disease is a terminal, genetic, neural-degenerative disease. Hann spoke to the rapt crowd about her family’s experiences and her son’s courageous battle with Batten disease.

“I want everyone in this building to understand why the work that you are doing is so, so important. This is a great day for the rare disease community, and in case you’re wondering who this community is I want to give you a sense of it: one in ten. Look around this room and how many people are here. One in ten are impacted directly by rare disease,” stated Hann.

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Why You Should Consider Workplace Culture Before Taking the Leap

The startup mythology has its origins in the tales of geniuses like Walt Disney, Bill Gates and Jeff Bezos’ going from small California garages to world domination. And the startup mystique became part of popular culture with Silicon Valley companies like Google and others creating workplace cultures where employees skateboarded down hallways, enjoyed yoga and meditation sessions onsite, and blew off steam with breaks at the company-provided vintage arcade and craft coffee bar.

These startup stereotypes bely a stark reality, however: Most startups are risky and operate on tighter budgets until they survive long enough to mature and raise ample funding.

If you get in at the right inflection point, the spoils of joining a startup can be life-changing. Regardless, leaving an established life science company for a bioscience startup is a tough decision defined by the high-risk, high-reward nature of these fledgling companies fighting to win funding and bring its product to the market.

For those in the early stages of their life science career, joining a bioscience startup could be a no brainer—there’s likely a lot less risk and so much more to gain. For the less experienced, stock options are not the only potential windfall; startup culture will likely furnish development opportunities to less-experienced workers not readily available to them in larger, established biotech or big pharma organizations.

Click here to read more via BioBuzz.

SAN FRANCISCO, Jan. 17, 2020 /PRNewswire/ — AMPEL BioSolutions’ Co-Founder and COO/CSO Dr. Amrie Grammer today at the Biotech Showcase at JP Morgan Healthcare announces the kickoff of a Series A $12.5M raise to commercialize LuGENE^TM, a gene-based diagnostic.  AMPEL’s initial focus is Lupus, but the test can be used for many autoimmune or inflammatory diseases.  AMPEL’S goal is to have its test available for routine use by physicians within the next few years.

GAITHERSBURG, Md., Jan. 15, 2020 (GLOBE NEWSWIRE) — Novavax, Inc. (NASDAQ: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for NanoFlu™, its recombinant quadrivalent seasonal influenza vaccine candidate, adjuvanted with Matrix-M™, in adults 65 years of age and older.

“The FDA’s decision to grant Fast Track Designation for NanoFlu reflects the urgent unmet medical need for a more effective vaccine against influenza, particularly in the older adult population which often experiences serious and sometimes life-threatening complications, of the disease” said Stanley C. Erck, President and Chief Executive Officer of Novavax. “We believe that NanoFlu will offer an innovative improvement compared to traditional egg-based vaccines, which frequently result in mismatch and poor effectiveness. We look forward to working closely with the FDA through the expedited review process, accelerating the access to this vaccine for the most vulnerable populations.”

The ongoing Phase 3 clinical trial is intended to evaluate the immunogenicity and safety of NanoFlu compared to the quadrivalent formulation of Fluzone. The trial’s primary objectives are to demonstrate non-inferior immunogenicity as measured by hemagglutination inhibition (HAI) titers of vaccine homologous influenza strains compared to Fluzone, and to describe its safety profile. Top-line clinical data from the trial is expected by the end of the first quarter of 2020 and could support a U.S. biologics license application (BLA) and future licensure of NanoFlu using the FDA’s accelerated approval pathway.

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