Novavax's Coronavirus Vaccine Candidate Protects Against Viral Replication In Animal Studies

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Novavax, Inc. (NASDAQ: NVAX) reported results from animal challenge studies of its coronavirus vaccine candidate Tuesday that reinforce the positive interim Phase 1 data the company released in early August.

What Happened: Novavax's NVX-CoV2373, produced from the full-length SARS-CoV-2 spike glycoprotein stabilized in the perfusion confirmation, with the saponin-based Matrix-M adjuvant induced hACE2 receptor blocking and neutralizing antibodies in macaques, investigators at the company said in a preprint.

SARS-CoV-2 GMT antibody titers in immunized macaques were 7.9-10.1-fold higher than in convalescent sera, the preprint said.

Among the other key findings were that the vaccine offered protection against SARS-CoV-2 replication in the nose and lungs; and the absence of pulmonary pathology in vaccinated macaques, according to the investigators.

"These results support ongoing Phase 1/2 clinical studies of the safety and 42 immunogenicity of NVX-CoV2327 vaccine," Novavax said.

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What's Next? Novavax recently initiated a Phase 2b efficacy trial in South Africa even as the Phase 1 portion of its Phase 1/2 trial is ongoing. The company said it plans to initiate Phase 2 trials in Australia and the U.S. in the near future.

The company's coronavirus vaccine program has been funded by federal agencies and private organizations such as the Bill & Melinda Gates Foundation.

Novavax has also struck deals to supply a coronavirus vaccine, contingent on approval or emergency use authorization, to countries such as the U.S., U.K., South Korea and low- and middle-income countries. It has also secured manufacturing partnership with CDMOs to help scale up manufacturing.

NVAX Price Action: Novavax shares were trading 0.51% higher at $147.81 at last check Thursday.

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