Vaxart falls on mixed Phase I readout for COVID-19 vaccine; plus BMS-Rockefeller mAb cocktail deal and vaccine updates for Sputnik V, Novavax, Bharat-Ocugen and Sinovac
Vaxart Inc. (NASDAQ:VXRT) lost $13.81 (59%) to $9.52 Wednesday on preliminary Phase I data for VXA-CoV2-1. The data showed the vaccine did evoke CD8+ T cell and IgA responses but no detectable serum neutralizing antibodies. Most subjects also did not have detectable IgG responses. The trial of the oral COVID-19 vaccine, and adenoviral vector encoding the spike and nucleocapsid proteins, evaluate single and prime-boost regimens.
Sinovac seeking conditional authorization of vaccine in China
Sinovac Biotech Ltd. (NASDAQ:SVA) submitted an application to China’s National Medical Products Administration (NMPA) for conditional marketing authorization of CoronaVac. In Phase III trials conducted in Brazil, Indonesia and Turkey, the inactivated SARS-CoV-2 vaccine posted efficacy of 50.4%, 65.3% and 91.3%, respectively. In the Brazilian study, the COVID-19 vaccine completely prevented severe disease and was 78.3% effective against mild cases requiring medical treatment. Similar breakdowns by COVID-19 severity have not been disclosed for the other trials.
EMA begins Novavax vaccine review
EMA said Wednesday has begun a rolling review of NVX-CoV2373 based on preclinical and early clinical data. Novavax Inc. (NASDAQ:NVAX) reported a week ago that the COVID-19 vaccine had an 89.3% efficacy in a U.K. Phase III study. A Novavax spokesperson told BioCentury the company is considering discussing with FDA an emergency use authorization request for vaccine based on the U.K. data. The company is also conducting a U.S. Phase III trial of NVX-CoV2373.
Novavax also said it has a memorandum of understanding with Canada to produce the vaccine in the country. In August, Novavax agreed to provide Canada with up to 76 million COVID-19 vaccine doses.
BMS licenses Rockefeller’s mAb cocktail
Bristol Myers Squibb Co. (NYSE:BMY) gained exclusive rights to develop, manufacture and commercialize a neutralizing mAb duo from The Rockefeller University to treat or prevent COVID-19. Rockefeller, which is eligible for royalties, began Phase I testing of IV subcutaneous formulations of the cocktail in January. Preclinical data suggests low subcutaneous doses for the mAbs, which were engineered to have an extended half-life, could be effective against multiple SARS-CoV-2 variants.
Mexico, Nicaragua bring Sputnik V to 18 authorizations
N.F. Gamaleya Scientific Research Institute of Epidemiology and Microbiology and the Russian Direct Investment Fund said Mexico and Nicaragua authorized Sputnik V, bringing the total number of countries that registered the heterologous adenoviral vector vaccine to 18. The new authorizations were announced a day after The Lancet published detailed Phase III data showing Sputnik V has efficacy on par with other leading vaccines across several groups.
Bharat, Ocugen in U.S. vaccine deal
Bharat Biotech International Ltd. granted Ocugen Inc. (NASDAQ:OCGN) exclusive U.S. rights to Covaxin. The Indian company, which will receive 55% of U.S. profits, will provide Ocugen with initial doses of the inactivated SARS-CoV-2 vaccine after FDA has granted an emergency use authorization and will support technology transfer for manufacturing in the U.S. Covaxin gained emergency approval from the Drugs Controller General of India (DCGI) in January.