Serum Institute of India collaborates with Novavax to Develop, Commercialize Malaria Vaccine Candidate

Gaithersburg: Novavax, Inc., a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, and Serum Institute of India (SII) has announced a commercial license agreement for the use of Novavax' proprietary Matrix-M™ vaccine adjuvant with SII's malaria vaccine candidate. SII licensed the R21 malaria vaccine, which targets the most severe plasmodium falciparum-induced malaria disease, from the Jenner Institute at Oxford University in 2017.

Matrix-M is a key component in the malaria vaccine candidate, currently in a Phase 2b clinical trial sponsored by the Jenner Institute, with top-line data expected to be reported in the second quarter of 2020.

Under the terms of the agreement, SII is granted rights to use Matrix-M in the vaccine in regions where the disease is endemic and will pay Novavax royalties on its market sales of the vaccine. Matrix-M will be manufactured and supplied to SII by Novavax AB, a wholly-owned subsidiary of Novavax based in Uppsala, Sweden.

In addition, as part of the arrangement, Novavax has gained the rights to sell and distribute the SII-manufactured vaccine in high-income countries, primarily in the travellers and military vaccine markets.

Dr Adrian Hill, director of the Jenner Institute, is leading the clinical studies of the experimental vaccine, which was created using the R21 malaria antigen combined with Matrix-M. He commented, "It has proven very challenging to develop a vaccine against malaria and many different approaches have been tested. After a thorough evaluation of several adjuvants pre-clinically many years ago, we selected Matrix-M for this program based on the strong immune responses elicited in those preclinical studies. Multiple clinical trials sponsored by the Jenner Institute have now confirmed these immunogenicity results. The current Phase 2b efficacy trial represents an important opportunity to test the efficacy of a malaria vaccine using the potent Matrix-M adjuvant in infants in an endemic setting."

"Novavax' next-generation adjuvant, Matrix-M, is an impressive and critical component in this much-needed malaria vaccine," said Adar Poonawalla, Chief Executive Officer of Serum Institute of India. "This will be an important long-term partnership in advancing an innovative potential malaria vaccine and while we have much work to do, this marks a key step forward."

"As the world's largest vaccine producer in terms of doses delivered, Serum Institute of India is the ideal partner to ensure that an improved malaria vaccine ultimately reaches the many millions of individuals at risk in areas where malaria is endemic," said Stanley C. Erck, President and Chief Executive Officer of Novavax. "This agreement highlights our mutual confidence in Matrix-M's ability to induce a strong immune response that will ultimately increase vaccine effectiveness."

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