CEPI extends collaboration with Novavax to advance development and manufacture of COVID-19 vaccine
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—CEPI, 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™ 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—a stable, prefusion protein made using Novavax' proprietary nanoparticle technology. Novavax plans to use its proprietary Matrix-M™ adjuvant with NVX-CoV2373 to enhance immune responses. Preclinical studies have shown that NVX-CoV2373 induced robust neutralising antibody responses.
The expansion of our partnership with Novavax represents CEPI's single biggest investment to date. Our vaccine R&D programmes are starting to show progress, so it is vital that we invest now to boost manufacturing capacity, so that our partners have the ability to produce vaccines at a global scale.
In response to this global pandemic we're having to be innovative in the way we approach vaccine development and manufacturing. We need to make progress on manufacturing in parallel with the clinical development of the vaccine, so that if the vaccine is proven to be safe and effective, we can make doses available to those who need them without delay.
We still have a long way to go, but we're making important steps forward to deliver a safe, effective, and globally accessible vaccine as quickly as possible.
CEPI's investment in Novavax is critical to our ability to move quickly to advance this promising vaccine candidate as well as to prepare for the delivery of the millions of doses needed globally. We are humbled by their confidence in our science and committed to deliver on behalf of the global community.
About CEPI
CEPI is an innovative partnership between public, private, philanthropic, and civil organisations, launched at Davos in 2017, to develop vaccines to stop future epidemics. CEPI has moved with great urgency and in coordination with WHO in response to the emergence of COVID-19. CEPI has initiated 9 partnerships to develop vaccines against the novel coronavirus. The programmes will leverage rapid response platforms already supported by CEPI as well as new partnerships. The aim is to advance COVID-19 vaccine candidates into clinical testing as quickly as possible.
Before the emergence of COVID-19 CEPI's priority diseases included Ebola virus, Lassa virus, Middle East Respiratory Syndrome coronavirus, Nipah virus, Rift Valley Fever and Chikungunya virus. CEPI also invested in platform technologies that can be used for rapid vaccine and immunoprophylactic development against unknown pathogens (Disease X).
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About Novavax, Inc.
Novavax, Inc. (Nasdaq:NVAX), is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases and address urgent, global health needs. Novavax recently initiated development of a vaccine program against COVID-19, with human results expected in July of 2020. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial. ResVax™, its RSV vaccine for infants via maternal immunization, is the only vaccine to demonstrate efficacy in a Phase 3 clinical trial. Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce a new class of highly immunogenic nanoparticles addressing urgent global health needs.
For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.
About Matrix-M™
Novavax' patented saponin-based Matrix-M adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.
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Image Caption: Scientist looking at ampoule with new medication, vaccination development/ iStock.
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