Serum Institute of India (SII) and the US-based biotechnology company, Novavax, Inc. have announced an agreement for a commercial license for the use of Novavax’s proprietary Matrix-M vaccine adjuvant with SII’s malaria vaccine candidate R21.
R21 is a malaria vaccine that targets Plasmodium falciparum which is known to cause one of the most severe form of the disease. SII had licensed the R21 vaccine from the Jenner Institute at Oxford University in 2017.
Matrix-M which is a key component in the malaria vaccine candidate currently is 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.
Matrix-M is a saponin-based adjuvant, charged by a novel formulation that provides a potent and well-tolerated adjuvant effect. Saponin-based adjuvants act in part by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in the local lymph nodes.
“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,” said Dr Adrian Hill, director of the Jenner Institute, in a statement.
“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.
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.
As part of the agreement, 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.