With growing tensions between Moderna and U.S. government scientists, Operation Warp Speed moved the investigational vaccine spotlight to NVX-CoV2373, the experimental vaccine from publicly traded Novavax Inc. (a late stage biotechnology company developing next-generation vaccines for serious infectious diseases). Not only did Novavax join the Operation Warp Speed Program, they became the largest funded vaccine developer to date with a $1.6 billion award by the federal government to complete late-stage clinical development, including a pivotal Phase 3 clinical trial as well as establish large-scale manufacturing and deliver 100 million doses of NVX-CoV2373 as early as late 2020. A small and not well known Australian clinical research organization (CRO) called Nucleus Network will be under the spotlight as they lead the Novavax Phase 1/2 clinical trial in that country.
Diversification so OWS has Highest Chance of Meeting Established Jan 2021 Deadline
The U.S. government has issued, via President Donald Trump and Operation Warp Speed, a target date for a safe and effective vaccine by January 2021. The challenge here is that vaccine development is known to take a considerable amount of time. Moderna was sought out as the favorite candidate but with recent insider trading chatter and, most lately, reports of a row between government scientists and the Cambridge biotech venture; it looks as though via Operation Warp Speed, they sought out another horse in the race so to speak. Thus Alex Azar, Secretary of U.S. Health and Human Services, declared, “Adding Novavax’ candidate to Operation Warp Speed’s diverse portfolio of vaccines increases the odds that we will have a safe, effective vaccine as soon as the end of this year.” Again this fits into President Trump’s bold claim and, come November, the stakes will be enormous in terms of clear evidence that this declaration (again the vaccine by January) is unfolding the way it was declared. Azar told the audience today that their target includes the manufacturing of up to 100 million doses for the American people.
What is NVX-CoV2373?
$1.6 billion is a lot of money for an investigational vaccine product that few know of. Back in late May, TrialSite News reported that the company enrolled the first patients for its Phase 1/2 clinical trial in Australia. It was noted that the company secured up to $388 million from the Coalition for Economic Preparedness Innovations (CEPI) at the time. Now the stakes got much bigger.
Novavax has developed a prefusion protein SARS-CoV-2 vaccine target produced via a proprietary nanoparticle platform technology called Matrix-M, which is an adjuvant to enhance immune responses and trigger high levels of neutralizing antibodies.
Apparently, the Matrix-M adjuvant evidences a strong and well-tolerated effect by stimulating the penetration of antigen-presenting cells into the vaccine administration site and enhancing antigen presentation in local lymph nodes, improving immune response and in effect augmenting the actual immunized person to produce sufficient antibodies in response to the virus.
Back in late May, TrialSite News reported on the Phase 1/2 clinical trial led by contract research organization (CRO) Nucleus Network. The Phase 1 was to prove preliminary immunogenicity and safety results and the results are expected in the month of July. The Phase 2 segment of the study assesses the immunity, safety and COVID-19 disease reduction is expected to commence shortly thereafter.
A Big Deal
Now this company few know of has a $1.6 billion infusion as the stakes get massive in the COVID-19 pandemic. As TrialSite News announced during its commencement, Operation Warp Speed (OWS) represents a serious use of federal resources, money and power to drive vaccine and therapy development targeting COVID-19.
Novavax Chief Executive Officer Stanley C. Erck reports, “The pandemic has caused an unprecedented public health crisis, making it more important than ever that industry, government and funding entities join forces to defeat the novel coronavirus together. We are honored to partner with Operation Warp Speed to move our vaccine candidate forward with extraordinary urgency in the quest to provide vital protection to our nation’s population.”
Based on the recent press release disclosure, deal terms include that Novavax must be able to demonstrate it has the ability to stand up large-scale manufacturing and transition into ongoing production, including the capability to stockpile and distribute large quantities of NVX-CoV-2373, including a pivotal Phase 3 clinical trial to determine the safety and efficacy of the experimental vaccine candidate. The Phase 3 study would include up to 30,000 subjects starting in the Fall of 2020. Note this is premised on their Phase 1/2 study producing solid results.
About Operation Warp Speed
Operation Warp Speed is facilitating, at an unprecedented pace, the development, manufacturing, and distribution of COVID-19 countermeasures, between components of Department of Health and Human Services (HHS), including the Centers for Disease Control and Prevention (CDC), FDA, the National Institutes of Health (NIH), and the Biomedical Advanced Research and Development Authority (BARDA, part of the HHS Office of the Assistant Secretary for Preparedness and Response); the Department of Defense. OWS is coordinate existing HHS-wide efforts, including the NIH’s ACTIV partnership for vaccine and therapeutic development, NIH’s RADx initiative for diagnostic development, and work by BARDA.
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 recently initiated development of NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19, with Phase 1 clinical trial results expected in July of 2020. 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.
The company was founded a few decades ago and is based in the Washington DC area. See their profile in a previous TrialSite News report. For value proposition, pipeline and more product information, see their presentation last January for the J.P. Morgan 38th Annual Healthcare Conference.