GAITHERSBURG, Md., Jan. 22, 2021 (GLOBE NEWSWIRE) — Novavax, Inc. (Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced the appointment of Madelyn ‘Lyn’ Caltabiano, Ph.D. to the position of Senior Vice President, Global Program Management. In this newly created role, Dr. Caltabiano will lead and expand the Global Program Management organization for the company’s pipeline and will develop appropriate strategies to assess the company’s operational performance, including areas related to portfolio valuation, milestone decision making and prioritization. She will report directly to Stanley C. Erck, President and Chief Executive Officer.
“Lyn’s deep experience in managing complex global programs will be critical as we work to simultaneously advance NVX-CoV2373 regulatory activities forward in multiple regions,” said Mr. Erck. “We welcome her invaluable project management experience as Novavax works to effectively deliver our vaccine candidate in the fight against the COVID-19 pandemic.”
Dr. Caltabiano joins Novavax from NexEos Diagnostics, Inc., where she was Development Lead and a core member of the management team. Previously, as Senior Vice President, Global Project and Alliance Management at Merck Research Laboratories, she rebuilt the R&D project and Alliance Management organizations and led the development of critical portfolio management and executive decision-making processes. Earlier, Dr. Caltabiano spent more than a decade at GlaxoSmithKline where she built the Alliance Management organization, headed project operations in Oncology R&D, and led the development of several new therapeutics.
Dr. Caltabiano graduated summa cum laude from Drexel University with a Bachelor of Science in biological sciences and earned a doctorate in pathology from the University of Pennsylvania.
NVX-CoV2373 is a protein-based 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. It is adjuvanted with Novavax’ patented saponin-based Matrix-M™ to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19. In preclinical studies, NVX-CoV2373 induced antibodies that block binding of spike protein to cellular receptors and provided protection from infection and disease. NVX-CoV2373 was generally well-tolerated and elicited robust antibody response numerically superior to that seen in human convalescent sera in Phase 1/2 clinical testing. NVX-CoV2373 is currently being evaluated in two pivotal Phase 3 trials: a trial in the U.K. that completed enrollment in November and the PREVENT-19 trial in the U.S. and Mexico that began in December. It is also being tested in two ongoing Phase 2 studies that began in August: a Phase 2b trial in South Africa, and a Phase 1/2 continuation in the U.S. and Australia.
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.
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. 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. Novavax is conducting late-stage clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults and will be advanced for regulatory submission. Both vaccine candidates incorporate Novavax’ proprietary saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.
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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 September 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.
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