Novavax, Inc. - COVID-19

CEPI to provide up to an additional US$384 million funding for phase 1 and 2 clinical trials and large-scale manufacture of Novavax' NVX-CoV2373 vaccine candidate, taking total investment in NVX-COV2373 to US $388 million Phase 1 clinical trial expected to initiate in May with preliminary results in July May 11, 2020, Oslo'ÄîCEPI, the Coalition for Epidemic Preparedness Innovations, today announced that it will invest up to an additional US $384 million to accelerate the development and manufacture of Novavax Inc's. (NASDAQ: NVAX) NVX-CoV2373 vaccine candidate against COVID-19. Novavax is a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases. This brings CEPI's total investment in Novavax to up to US $388 million and its total investment in COVID-19 vaccine research & development to up to US $446 million. CEPI's expanded investment in Novavax will fund preclinical studies and phase 1 and phase 2 clinical trials. A phase 1 clinical trial will begin this month in Australia, followed by phase 2 clinical trials in multiple countries. If these are successful CEPI anticipates supporting any further clinical development needed to take NVX-CoV2373 through to licensure. CEPI's investment will also fund the transfer of NVX-CoV2373 technology to manufacturing partners in different geographical regions around the world, for large-scale production of vaccine. Additionally, funding will enable large-scale production of Novavax' saponin-based Matrix-M'Ñ¢ adjuvant in Novavax' manufacturing facility in Uppsala, Sweden, and a second production site to be determined. CEPI's additional funding will allow Novavax to begin manufacture of millions of doses by the end of 2020 with the goal of escalating large-scale production in 2021. CEPI and Novavax agree on the importance of global equitable access to vaccines produced out of our partnership. Under the terms of the agreement it is anticipated that vaccines will be procured and allocated through global mechanisms now under discussion as part of the Access to COVID-19 Tools (ACT) Accelerator, an international initiative launched by the WHO and global leaders last month. The NVX-CoV2373 vaccine candidate In March 2020, CEPI made an initial investment of $4 million in Novavax to use their recombinant protein nanoparticle technology to develop a vaccine candidate against COVID-19. In early April 2020, Novavax announced that they had identified a coronavirus vaccine candidate, NVX-CoV2373'Äîa stable, prefusion protein made using Novavax' proprietary nanoparticle technology. Novavax plans to use its proprietary Matrix-M'Ñ¢ adjuvant with NVX-CoV2373 to enhance immune responses. Preclinical studies have shown that NVX-CoV2373 induced robust neutralising antibody responses.