Novavax Inc. (NVAX:NASDAQ), which focuses its efforts on developing next-generation vaccines to address infectious diseases, yesterday announced that it enrolled the first group of participants in a Phase 1/2 clinical trial of NVX‑CoV2373, its coronavirus vaccine candidate. The firm explained that NVX‑CoV2373 is a stable prefusion protein that is created utilizing its proprietary nanoparticle technology. The company further indicated that that "NVX‑CoV2373 includes Novavax' proprietary Matrix‑M™ adjuvant to enhance immune responses and stimulate high levels of neutralizing antibodies." The company added that it expects to receive the first initial Phase 1 immunogenicity and safety data in July 2020.
The company's President and CEO Stanley C. Erck commented, "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 firm advised that the Phase 1/2 clinical study, which is enrolling approximately 130 healthy participants 18 to 59 years of age at two locations in Australia, will be broken down into two parts. Phase 1 will be a randomized, placebo-controlled trial to test the immunogenicity and safety of NVX‑CoV2373. Phase 2 is then expected to expand to several other countries including the U.S. and will assess immunity, safety and COVID‑19 disease reduction in a broader age range of patients.
The company pointed out at "this Phase 1/2 approach allows for rapid advancement of NVX‑CoV2373 during the pandemic and that the trial is being supported by the recently announced funding arrangement with the Coalition for Epidemic Preparedness Innovations (CEPI)." The firm noted that CEPI will be providing up to $388 million in funding to advance clinical development of NVX‑CoV2373.
CEPI's CEO Dr. Richard Hatchett remarked, "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. ...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."
The company listed that "NVX‑CoV2373 is a vaccine candidate engineered from the genetic sequence of SARS‑CoV‑2, the virus that causes COVID-19 disease and that 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."
Novavax is a late-stage biotechnology company headquartered in Gaithersburg, Md., with additional facilities located in Rockville, Md., and Uppsala, Sweden. The firm is focused on improving global health through discovery, development and commercialization of novel vaccines to prevent serious infectious diseases. The company's product pipeline includes clinical vaccine candidates for respiratory syncytial virus, seasonal influenza and Ebola virus and other infectious diseases.
Novavax has a market capitalization of around $2.7 billion with approximately 57.96 million shares outstanding and a short interest of about 9.9%. NVAX shares opened 17% higher today at $54.00 (+$7.89, +17.11%) over Friday's $46.11 closing price. The stock has traded today between $49.57 and $54.50 per share and is currently trading at $50.15 (+$4.04, +8.76%).
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