Novavax, Inc. (NASDAQ: NVAX), which released an update on its coronavirus vaccine program earlier this week, announced a manufacturing deal with a CDMO on Thursday night, while marking a slight delay in reading the Phase 1.
Novavax’s agreement with Fujifilm: Novavax, which is working on an investigational vaccine (codenamed NVX-CoV2373) against SARS-CoV2, said it reached a manufacturing agreement with Fujifim Diosynth Biotechnologies to manufacture a bulk pharmaceutical substance for the vaccine candidate. .
The companies said that Fujifilm’s Morrisville, North Carolina, site has begun production of the first batch of NVX-CoV2373.
The deal is based on the $ 1.6 billion funding award that Novavax was awarded under the federal government’s Operation Warp Speed project.
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The companies said the batches produced at the Fujifilm North Carolina site will be used in a future crucial Phase 3 clinical trial of up to 30,000 subjects, which will determine the safety and efficacy of NVX-CoV2373. The trial will begin in the fall.
“We are grateful to partner with the FUJIFILM Diosynth Biotechnologies team to ensure the large-scale manufacturing of our COVID-19 vaccine candidate,” said Stanley Erck, CEO of Novavax.
Delay of Novavax flags: Novavax said it plans to announce the Phase 1 data, consisting of immunogenicity and safety results, in the first week of August. The company had previously given a July deadline for launch.
The Phase 1 trial is part of the Phase 1/2 trial that the company started in 130 healthy participants, ages 18-59, in Australia in May.
Novavax said it now hopes that the Phase 2 part will assess the immunity, safety, and reduction of COVID-19 disease to begin shortly thereafter.
In premarket trading, Novavax shares fell 3.28% to $ 135.01, having gained more than 3,400% in the year-to-date period.
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