Novavax Appoints Leadership Team to Advance NanoFlu through Regulatory Licensure
“The formation of this dedicated team enables
“Currently available flu vaccines provide inconsistent, inadequate protection against seasonal influenza,” said
The new NanoFlu leadership team includes several
Tim Hahn, Ph.D., Senior Vice President of CMC for NanoFlu, has led all CMC activities for NanoFlu since the beginning of the program. Most recently, Dr. Hahnled the establishment of a global supply chain for Novavax’ Matrix-M adjuvant. Matrix-M is a key component of both the NanoFlu and NVX-CoV2373 vaccines.
Vivek Shinde, M.D., Vice President of Clinical Development for NanoFlu, has served as the clinical lead for the NanoFlu program since its inception and through Phase 3. Dr. Shindealso recently led the initiation of the Phase 2b clinical trial in South Africafor NVX-CoV2373.
The new team will establish a separate NanoFlu development unit within Novavax, building on the company’s established knowledge base in the discovery and development of innovative vaccines to prevent serious infectious diseases. The team will also benefit from joint shared services with key cross-functional departments within
NanoFlu is a recombinant hemagglutinin (HA) protein nanoparticle influenza vaccine produced by Novavax in its SF9 insect cell baculovirus system. NanoFlu uses HA amino acid protein sequences that are the same as the recommended wild-type circulating virus HA sequences. NanoFlu contains Novavax’ patented saponin-based Matrix-M™ adjuvant.
NVX-CoV2373 is a vaccine candidate engineered from the genetic sequence of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax’ recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and contains Novavax’ patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and cannot replicate, nor can it cause COVID-19. In preclinical trials, NVX-CoV2373 demonstrated induction of antibodies that block binding of spike protein to receptors targeted by the virus, a critical aspect for effective vaccine protection. In the Phase 1 portion of its Phase 1/2 clinical trial, NVX-CoV2373 was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera. NVX-CoV2373 is also being evaluated in a Phase 3 trial in the
Novavax Forward-Looking Statements
Statements herein relating to the future of Novavax and the ongoing 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 by such statements. These risks and uncertainties include those identified under the heading “Risk Factors” in the Novavax Annual Report on Form 10-K for the year ended December 31, 2019, and Quarterly Report on Form 10-Q for the period ended June 30, 2020, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, 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 referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.