Novavax, of Gaithersburg, Md., received the biggest slice of the Operation Warp Speed (OWS) pie as it will get $1.6 billion. Regeneron received $450 million for a large-scale COVID-19-related manufacturing demonstration project in the U.S., also from OWS.
Novavax and Regeneron are two of seven pharmaceutical companies receiving federal assistance from the CDC, the FDA, the Biomedical Advanced Research and Development Authority (BARDA), and the Department of Defense (DoD) to develop their coronavirus vaccines under the OWS banner. The other companies are Astrazeneca plc, Johnson & Johnson, Merck & Co. Inc., Moderna Inc. and Sanofi SA.
Novavax is now taxed with completing the late-stage clinical development, testing, manufacturing, stockpiling and delivery of 100 million doses of NVX-CoV2373, the company’s candidate engineered from the genetic sequence of SARS-CoV-2, by the end of this year. NVX‑CoV2373 is Novavax’s prefusion protein and includes the company’s Matrix‑M adjuvant. The testing specifically includes a pivotal phase III trial composed of 30,000 people that is set to begin this fall to determine NVX-CoV2373’s safety and efficacy.
Novavax stock (NASDAQ:NVAX) reacted well to the news as shares ratcheted solidly upward 31.62% July 7 to close at $104.56 per share.
Preclinical data showed NVX-CoV2373 demonstrated an indication of antibodies to block binding of spike protein to receptors that are targeted by the virus.
Novavax already has its phase I/II trial of NVX-CoV2373 going in Australia. The study of 130 healthy participants ages 18 to 59 began in May. Novavax expects preliminary immunogenicity and safety data by the end of July. The study is bolstered by an up-to $388 million funding agreement with the Coalition for Epidemic Preparedness Innovations.
The phase II Novavax study assessing immunity, safety and COVID-19 disease reduction is expected to begin soon after the phase I preliminary data arrive.
Tarrytown, N.Y.-based Regeneron’s $450 million comes through BARDA and the DoD to demonstrate commercial-scale manufacturing of the company’s REGN-CoV2. With the funding comes the commitment that the federal government will own the doses coming from the project. Regeneron expects anywhere from 70,000 to 300,000 doses from the project, with initial doses expected by this summer or fall.
REGN-CoV2, both a COVID-19 prophylaxis and treatment, is a double antibody cocktail targeting SARS-CoV-2. The phase III study of 2,000 uninfected people who have had close exposure to a COVID-19 patient has begun. The trial moved into phase III for the two adaptive phase I/II/III trials testing the cocktail in 1,850 hospitalized patients and 1,050 non-hospitalized patients with COVID-19.
The REGN-CoV2 cocktail is composed of two antibodies taken from genetically modified mice and humans who recovered from COVID-19. The treatment is designed to bind to the virus’ spike protein.
Regeneron’s stock (NASDAQ:REGN) rose 2.17% on July 7 to close at $640.88.
In April, Moderna was tabbed by OWS to receive up to $483 million to develop an mRNA vaccine (mRNA-1273) to treat COVID-19. An NIH-led phase I trial of mRNA-1273 completed its enrollment of three dose cohorts ((25 µg, 100 µg and 250 µg) and is expanding to another six cohorts of older adults and elderly adults. The company planned to hire 150 additional staffers to help with the program.
In late April, Moderna submitted its IND to the FDA for a phase II study of mRNA-1273 to treat COVID-19. In May, the company received FDA fast track designation as it finalized its protocol for mRNA-1273’s phase III trial. The 30,000 subject trial is expected to begin in July at the 100-µg dose level.
Astrazeneca’s AZD-1222 vaccine, formerly ChAdOx1, is on an accelerated path, supported with $1.2 billion through Operation Warp Speed. Already part of a phase I/II trial with the University of Oxford, it is set to enter a phase II/III at any time. The company signed an $87 million partnership with Emergent Biosolutions Inc. in June and agreed to supply the European Union with 400 million doses with deliveries starting by the end of 2020.
On March 30, OWS announced $456 million in funds for Johnson & Johnson’s candidate vaccine, with phase I trials set to begin sometime this summer.