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Novavax and Serum Institute of India to develop and commercialize Malaria Vaccine Candidate

Novavax IncandSerum Institute of India(SII) have announced a commercial license agreement for the use of Novavax’ proprietary Matrix-M vaccine adjuvant with SII’s malaria vaccine candidate.

SII had licensed the R21 malaria vaccine, which targets the most severePlasmodium falciparum-induced malaria disease, from theJenner InstituteatOxford Universityin 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 payNovavaxroyalties on its market sales of the vaccine. Matrix-M will be manufactured and supplied to SII byNovavax AB, a wholly-owned subsidiary ofNovavaxbased in Uppsala, Sweden.

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

DrAdrian 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. Hecommented, “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 theJenner Institutehave 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,” saidAdar 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 Indiais 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,” saidStanley C. Erck, President and Chief Executive Officer ofNovavax. “This agreement highlights our mutual confidence in Matrix-M’s ability to induce a strong immune response that will ultimately increase vaccine effectiveness.”

Novavax and Serum Institute of India signed a commercial license agreement for the use of Novavax’ proprietary Matrix-M vaccine adjuvant with SII’s malaria vaccine candidate.