Maryland-based biotechnology company Novavax (NASDAQ: NVAX) has announced the advancement of its COVID-19 vaccine candidate NVX-CoV2373 to phase 1/2 human trials, with patients already enrolling in the study. The company anticipates that preliminary data on the immunogenicity and safety of the vaccine from the phase 1 portion of the trial will be available in July of 2020.
President and Chief Executive Officer of Novavax Stanley C Erck stated, “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. 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 will consist of two parts: a randomized, observer-blinded, placebo-controlled phase 1 study of the vaccine in 130 healthy adults between the ages of 18 and 59 at two sites in Australia, and a phase 2 trial of the vaccine in “a broader age range” of patients in multiple countries including the United States. If the phase 1 trial is successful, the phase 2 study will begin “promptly” afterwards.
The phase 1 study will evaluate NVX-CoV2373 with and without Novavax’s proprietary Matrix-M adjuvant and at two doses, 5 and 25 micrograms. Both studies will be supported with funding that Novavax has received from the Coalition for Epidemic Preparedness Innovations (CEPI), the “single largest investment” that the organization has made to-date.
CEPI CEO Dr. Richard Hatchett stated, “Entering clinical trials is an important step on the path to delivering a safe, effective and globally accessible vaccine against COVID-19. Vaccines provide our best hope of permanently defeating this pandemic, so it is encouraging to see rapid progress being made in the development of Novavax’ vaccine candidate.”
“CEPI’s priority in building our portfolio has been to focus on vaccine candidates with the potential to be developed at speed and scale and made globally accessible. Our investment in Novavax allows us to focus 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,” Dr. Hatchett continued.
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The vaccine candidate NVX‑CoV2373 was chosen by Novavax for advancement to human phase 1/2 trials based on evidence of immunogenicity in pre-clinical animal models, including the induction of neutralizing antibody against SARS-CoV-2, the virus that causes COVID-19.
According to Novavax’s press release, the pre-clinical data “provide strong evidence that the vaccine candidate will be highly immunogenic in humans, potentially leading to protection from COVID‑19 and thus helping to control the spread of this disease.”