Novavax in Phase I/II Trial for COVID-19 Vaccine, To Expand Mfg

Novavax, a Gaithersburg, Maryland-based clinical-stage vaccine company, has acquired Praha Vaccines, part of the Cyrus Poonawalla Group, a Pune, Maharashtra, India-based business group, for approximately $167 million to expand manufacturing capacity for Novavax’s COVID-19 vaccine candidate.

The acquisition is expected to provide Novavax annual capacity of over 1 billion doses of antigen starting in 2021 for NVX‑CoV2373, Novavax’s COVID-19 vaccine candidate, a prefusion protein made using its proprietary nanoparticle technology. The company reported this week (May 25, 2020) that the vaccine candidate has entered into a Phase I/II clinical trial.

With the acquisition of Praha Vaccines, Novavax gains a 150,000-square-foot vaccine and biologics manufacturing facility in Bohumil, Czech Republic, other support buildings, and all related and required infrastructure. The facility is completing a renovation that includes Biosafety Level-3 (BSL-3) capabilities. As part of the transaction, approximately 150 employees with experience in vaccine manufacturing and support have joined Novavax.

The acquisition of Praha Vaccines is supported by Novavax’s funding arrangement with the Coalition for Epidemic Preparedness Innovations (CEPI), a public–private coalition that seeks to derail epidemics by speeding up the development of vaccines, to enable Novavax to expand its manufacturing capacity. Novavax will work with the Serum Institute of India, part of the Cyrus Poonawalla Group, to increase production levels at the Bohumil facility by the end of 2020.

In a related development, Novavax announced the enrollment of the first participants in a Phase I/II clinical trial of its COVID-19 vaccine candidate, NVX‑CoV2373. Preliminary immunogenicity and safety results from the Phase I portion of the trial are expected in July 2020.

The Phase I/II clinical trial is being conducted in two parts. The Phase I portion is a randomized, observer-blinded, placebo-controlled trial designed to evaluate the immunogenicity and safety of NVX‑CoV2373, both adjuvanted with Matrix‑M, the company’s proprietary adjuvant, and unadjuvanted. The trial is enrolling approximately 130 healthy participants at two sites in Australia.

The Phase II portion is expected to be conducted in multiple countries, including the US, and would assess immunity, safety and COVID‑19-disease reduction in a broader age range. The trial is being supported by a recently announced funding arrangement with CEPI.

Source: Novavax (acquisition) and Novavax (clinical trial)

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