On May 25, 2020, Novavax, Inc. (NASDAQ: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, announced enrollment of the first participants in a Phase 1/2 clinical trial of its coronavirus vaccine candidate, NVX CoV2373, a stable, prefusion protein made using its proprietary nanoparticle technology. NVX CoV2373 includes Novavax’ proprietary Matrix M™ adjuvant to enhance immune responses and stimulate high levels of neutralizing antibodies. Preliminary immunogenicity and safety results from the Phase 1 portion of the trial are expected in July 2020. “Administering our vaccine in the first participants of this clinical trial is a significant achievement, bringing us one step closer toward addressing the fundamental need for a vaccine in the fight against the global COVID 19 pandemic,” said Stanley C. Erck, President and Chief Executive Officer of Novavax. “We look forward to sharing the clinical results in July and, if promising, quickly initiating the Phase 2 portion of the trial.” The Phase 1/2 clinical trial is being conducted in two parts. The Phase 1 portion is a randomized, observer-blinded, placebo-controlled trial designed to evaluate the immunogenicity and safety of NVX CoV2373, both adjuvanted with Matrix M and unadjuvanted. The trial is enrolling approximately 130 healthy participants 18 to 59 years of age at two sites in Australia. The protocol’s two-dose trial regimen assesses two dose sizes (5 and 25 micrograms) with Matrix M and without. The Phase 2 portion is expected to be conducted in multiple countries, including the United States, and would assess immunity, safety, and COVID 19 disease reduction in a broader age range. This Phase 1/2 approach allows for rapid advancement of NVX CoV2373 during the pandemic.
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