GAITHERSBURG, Md. April 14, 2021 / PRNewswire / – Novavax, Inc. (Nasdaq: NVAX), a biotechnology company that develops next-generation vaccines for serious infectious diseases, announced today its participation in a Phase 2 clinical trial initiated by a recently expanded investigator named Comparison of COVID-19 Vaccine Program Combinations – Stage 2 (Com-COV2), to be carried out by the University of Oxford and with the support of the Vaccine Working Group of the UK. Novavax's candidate recombinant protein vaccine, NVX-CoV2373, is one of four COVID-19 vaccines that will be studied to assess the potential of combination regimens that combine vaccines from different manufacturers to achieve immune protection against COVID-19.
"The addition of Novavax to this important study reflects the urgency to find innovative ways to protect as many people as possible in a dynamic pandemic landscape," said Filip Dubovsky MD, Executive Vice President, Chief Medical Officer, Novavax. "The potential utility of pooling public health resources, including all available vaccines, could help us stay ahead of an evolving virus."
Com-COV2 will include 1,050 adults age 50 and older who received their first vaccination during the previous 8-12 weeks. Volunteer study participants will receive one of four different vaccines as a second dose, 350 of which will be given NVX-CoV2373. The investigation will compare the immune system responses of those receiving a heterologous regimen with those receiving a homologous regimen.
"The focus of these studies is to explore whether multiple COVID-19 vaccines can be used more flexibly, with different vaccines being used for the first and second doses," said Matthew Snape associate professor in Pediatrics and vaccination at Oxford University and lead investigator of the trial. "If we can show that these mixed schedules elicit an immune response that is as good as the standard schedules, this could allow more people to complete their COVID-19 immunization cycle more quickly."
According to the protocol, which is designed as a non-inferiority study, participants will be followed for reactogenicity (safety) and immune responses. The UK Medicines and Health Products Regulatory Agency (MHRA) and the Joint Committee on Vaccination and Immunization (JCVI) will formally evaluate the safety and efficacy of any new vaccination regimen before it is made available to the public.
NVX-CoV2373 is a protein-based candidate vaccine designed from the genetic sequence of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax's recombinant nanoparticle technology to generate antigen derived from coronavirus peak (S) protein and is complemented by Novavax's proprietary saponin-based Matrix-M ™ to enhance immune response and stimulate high levels neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and cannot replicate or cause COVID-19. In preclinical studies, NVX-CoV2373 induced antibodies that blocked the spike protein from binding to cell receptors and provided protection against infection and disease. Overall, it was well tolerated and elicited a robust antibody response in phase 1/2 clinical trials.
NVX-CoV2373 is being evaluated in two pivotal Phase 3 trials, a UK trial showing 96.4% efficacy against the parent virus strain and 89.7% overall, and the PREVENT-19 trial in the US and Mexico that started in December 2020 . It is also being tested in two ongoing phase 2 studies that began in August 2020 : a phase trial 2b in South Africa that demonstrated an efficacy of 48 , 6% against an emerging exhaust variant and a continuation of Phase 1/2 in the US and Australia .
NVX-CoV2373 is stored and stable at 2-8 ° C, allowing use of existing vaccine supply chain channels for distribution. It is packaged in a ready-to-use liquid formulation in 10-dose vials.
About Matrix-M ™
Novavax's proprietary saponin-based Matrix-M ™ adjuvant has demonstrated a potent and well-tolerated effect of stimulating entry of antigen-presenting cells at the site of injection and enhances antigen presentation in local lymph nodes, stimulating the immune response.
Novavax, Inc. (Nasdaq: NVAX) is a biotechnology company that promotes better health worldwide through the discovery, development, and commercialization of innovative vaccines to prevent infectious diseases serious. The company's proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles designed to address urgent global health needs. Novavaxis is conducting late-stage clinical trials for NVX-CoV2373, its candidate vaccine against SARS-CoV-2, the virus that causes COVID-19. NanoFlu ™, its quadrivalent nanoparticle flu vaccine, met all major goals in its pivotal Phase 3 clinical trial in older adults and will be advanced for regulatory submission. Both vaccine candidates incorporate Novavax's proprietary saponin-based adjuvant Matrix-M ™ to enhance the immune response and stimulate high levels of neutralizing antibodies.
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Forward-Looking Statements by Novavax
Statements in this document regarding the future of Novavax and the continued development of its vaccine and adjuvant products are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied in such statements. These risks and uncertainties include those identified under the heading "Risk Factors" in Novavax's Annual Report on Form 10-K for the year ended December 31, 2020 as filed with the Commission on Stock Market and Securities (SEC). . Investors are cautioned not to place significant reliance on the forward-looking statements contained in this press release. You are encouraged to read our SEC filings, available at sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those mentioned above. Investors, potential investors, and others should carefully consider these risks and uncertainties.
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SOURCE Novavax, Inc.