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

Novavax, Inc. 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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