Novavax announced on Tuesday that was awarded $1.6 billion for late-stage clinical trials and large-scale manufacturing to produce 100 million doses of its COVID-19 vaccine starting this year through President Donald Trump’s “Operation Warp Speed” program.
The funding, Novavax said, will enable it to complete late-stage clinical studies aimed at evaluating the safety and efficacy of its COVID-19 vaccine candidate NVX-CoV2373,
The planned late-stage studies include a pivotal Phase III clinical trial designed to assess NVX-CoV2373 in up to 30,000 participants, and set to start this fall.
“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,” Novavax president and CEO Stanley C. Erck said in a statement. “We are grateful to the U.S. government for its confidence in our technology platform, and are working tirelessly to develop and produce a vaccine for this global health crisis.”
Investors appeared to share that confidence, as shares of Novavax initially zoomed 36% on the news to $108.10 as of 9:50 a.m, before finishing the trading day at $104.56, a nearly 32% one-day gain. Novavax shares closed yesterday at $79.44.
NVX-CoV2373 consists of a stable, prefusion protein made using Novavax’ proprietary nanoparticle technology, and incorporating its proprietary saponin-based Matrix-M™ adjuvant. NVX-CoV2373 is among 18 “front runner” candidates among the more than 260 COVID-19 therapeutics tracked by GEN’s updated “COVID-19 DRUG & VACCINE TRACKER.”
NVX-CoV2373 is now under study in a Phase I/II clinical trial (NCT04368988), a two-part randomized, observer-blinded, placebo-controlled study designed to evaluate the immunogenicity and safety of the vaccine with or without Matrix-M adjuvant in 130 healthy participants ≥ 18 to 59 years of age. The trial—which began in Australia in May—is being funded by up-to $388 million in funding from the Coalition for Epidemic Preparedness Innovations (CEPI), which multiplied its initial $4 million investment in the vaccine candidate, made two months earlier.
First clinical results expected soon
Preliminary immunogenicity and safety results are expected by the end of this month. Soon after, Novavax plans to start the trial’s Phase II portion, designed to assess immunity, safety, and COVID-19 disease reduction.
Novavax’s award from Operation Warp Speed also allows for a follow-on agreement with the U.S. government for additional production and procurement to support the program’s vaccine production goal.
“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,” stated Alex Azar II, U.S. Secretary of Health and Human Services. “Today’s $1.6 billion investment supports the Novavax candidate, depending on success in clinical trials, all the way through to manufacturing 100 million doses for the American people.”
Novavax joins a cluster of companies whose vaccines, drugs, and/or diagnostics Washington has deemed promising enough against COVID-19 to warrant funding their development and/or manufacture through Operation Warp Speed.
Trump’s administration has committed the nation to delivering 300 million vaccine doses protecting against SARS-CoV-2 by January 2021 through Operation Warp Speed. The program funds and coordinates development of vaccines, drugs, and diagnostics across agencies of the Departments of Defense (DoD) and Health and Human Services (HHS)—the latter agency including the FDA, the NIH, the Centers for Disease Control and Prevention (CDC), and the Biomedical Advanced Research and Development Authority (BARDA).
Last month, the DoD awarded Novavax a $60 million contract for the manufacturing of NVX‑CoV2373. Through the Defense Health Program, the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense Enabling Biotechnologies (JPEO-CBRND-EB) agreed to support production of several vaccine components to be manufactured in the U.S.
Novavax plans to deliver for DoD this year 10 million doses of NVX‑CoV2373 that could be used in Phase II/III trials, or under an Emergency Use Authorization (EUA) if approved by the FDA.
Earlier this month, Vaxart and INOVIO announced their vaccine candidates were selected for a non-human primate (NHP) challenge study organized and funded by Operation Warp Speed. The study will assess Vaxart’s room temperature stable tablet vaccine, based on the company’s Vector-Adjuvant-Antigen Standardized Technology (VAAST™) Platform, and will also evaluate INOVIO’s DNA vaccine candidate INO-4800, which according to the company is on track for a Phase II/III trial this summer.
Fourteen of the 100+ vaccine candidates in development against COVID-19 were under study by Operation Warp Speed when it was announced in May, with former GlaxoSmithKline (GSK) vaccines chairman Moncef Slaoui, MD, as chief advisor and General Gustave F. Perna as chief operating officer. The New York Times later reported that Operation Warp Speed narrowed its focus to five vaccine candidates: Ad26.COV2-S by Johnson & Johnson (Janssen Pharmaceutical); AZD1222 by AstraZeneca, University of Oxford, and Vaccitech; BNT-162 by Pfizer and BioNTech; mRNA-1273 by Moderna; and an unnamed vaccine being developed by Merck & Co. and IAVI, a nonprofit scientific research organization dedicated to addressing urgent, unmet global health challenges.
BARDA awards Regeneron $450M
Novavax was one of two developers of COVID-19 therapeutics to announce funding from Washington today.
The other was Regeneron Pharmaceuticals, which said today it received $450 million from BARDA toward manufacturing and supplying REGN-COV2, the company’s double-antibody cocktail against COVID-19.
Just yesterday, Regeneron said REGN-COV2 was advancing into Phase III studies that include a 2,000-patient trial (NCT04452318) being conducted with the NIH’s National Institute of Allergy and Infectious Diseases (NIAID) to assess REGN-COV2’s ability to prevent infection among uninfected people who have had close exposure to a COVID-19 patient, such as a patient’s housemate.
Regeneron has also advanced REGN-COV2 into the Phase II/III portion of two adaptive Phase I/II/III trials designed to evaluate the antibody cocktail’s ability to treat hospitalized and non-hospitalized patients with COVID-19.
In its announcement today, Regeneron disclosed that initial doses of REGN-COV2 may be ready as early as the end of summer.
Regeneron’s funding agreement with BARDA covers a fixed number of bulk lots that are intended to be completed in the fall of 2020, as well as fill/finish and storage activities. Regeneron said today that should it win FDA emergency use authorization (EUA) or product approval, the U.S. government has committed to making doses from these lots available to Americans at no cost, and to overseeing their distribution.
The company also disclosed that its clinical program for REGN-COV2 is now assessing multiple dosages in order to establish the exact number of potential treatment doses (estimated range of 70,000 to 300,000) or prevention doses (estimated range of 420,000 to 1.3 million) available from these lots in total.