Novavax Begins Enrollment in Phase II Coronavirus Vaccine Study

Novavax, Inc. NVAX announced that it has enrolled the first volunteer in the phase II portion of its ongoing phase I/II study, which is evaluating the immunogenicity and safety of its COVID-19 vaccine candidate NVX-CoV2373. The phase II portion will include adult patients aged between 60 years and 84 years, comprising almost 50% of the current patient population in the study. NVX-CoV2373 is a stable, prefusion protein made using Novavax’s proprietary nanoparticle technology and includes its proprietary Matrix M adjuvant.

The phase II portion of the study is looking for robust immune responses in older adults and is an expansion of the phase I study following encouraging safety and immunogenicity data on NVX-CoV2373 from the same. The study will enroll up to 1,500 healthy volunteers in the United States and Australia with approximately 50%between 60 and 84 years of age. It will assess two dose sizes (5 and 25 µg), each with 50 µg of Matrix M.

The primary objectives of the study are to evaluate the immunogenicity and safety in adults while the secondary objectives include preliminary evaluation of efficacy. Novavax plans to announce interim immunogenicity and safety data from the study in the fourth quarter of 2020.

The above-mentioned study is being supported by a funding from the Coalition for Epidemic Preparedness Innovations (CEPI).

Last week, Novavax initiated a phase IIb study to evaluate the efficacy of NVX-CoV2373 in South Africa. The mid-stage study is being conducted in collaboration with Professor Shabir Madhi, who is at the helm of the clinical analysis, and Wits University.

Shares of Novavax have skyrocketed 2896.4% so far this year compared with the industry’s increase of 1.3%.

Notably, earlier this month, Novavax released encouraging results from the phase I study of NVX-CoV2373. The clinical trial outcome showed that the vaccine was generally well-tolerated and elicited robust antibody responses, numerically superior to what was seen in human convalescent sera (antibodies derived from blood donated by people who recovered from the illness).

We remind investors that Novavax received a total of $2-billion funding, roughly divided into the U.S. Department of Defense’s aid of $60 million, the CEPI’s $388 million donation and the U.S. government’s OWS grant of $1.6 billion for developing NVX-CoV2373.

Significantly, all the above entities are financing several biotechs and large pharma companies including AstraZeneca AZN, Sanofi SNY, Moderna MRNA, Inovio Pharmaceuticals and many universities to accelerate the development of vaccines against COVID-19.

Zacks Rank

Novavax currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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