The Maryland-based company has enrolled and dosed its first patients in a Phase I/II study.
Two weeks after announcing it received $388 million from the Coalition for Epidemic Preparedness Innovations (CEPI) to advance its COVID-19 vaccine candidate, the Maryland-based company has enrolled and dosed its first patients in a Phase I/II study.
Preliminary immunogenicity and safety results from the Phase 1 portion of the trial are expected in July, the company said Monday. The trial will assess NVX‑CoV2373, a stable, prefusion protein made using its proprietary nanoparticle technology. NVX‑CoV2373 includes Novavax’s proprietary Matrix‑M adjuvant to enhance immune responses and stimulate high levels of neutralizing antibodies. The Phase I portion of the study will evaluate the immunogenicity and safety of the candidate based on two dosing levels.
If the Phase I data is promising, Novavax said it will quickly initiate the Phase II portion of the study. If it commences, the Phase II portion of the study will assess immunity, safety and COVID‑19 disease reduction in a broad age range.
“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,” Stanley C. Erck, president and chief executive officer of Novavax said in a statement.
Earlier this month, Novavax announced it received $384 million from CEPI, a Bill Gates-backed organization launched in 2017 to support the development of vaccines for a number of diseases. That funding was on top of a $4 million grant previously given to the company for vaccine development.
Richard Hatchett, CEO of CEPI, said the initiation of the Phase I study is an important step on the path of developing a safe and effective vaccine against COVID-19, which has infected more than 5.5 million people across the globe, including 1.6 million people in the United States.
“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’s 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,” Hatchett said in a statement. “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.”
In April, Novavax identified its vaccine candidate for COVID-19, NVX-CoV2373. The vaccine candidate has been developed from Novavax’s proprietary nanoparticle technology and includes the company’s proprietary Matrix-M adjuvant in order to enhance immune responses and stimulate high levels of neutralizing antibodies.
The Novavax vaccine is one of more than 100 candidates in development for COVID-19. Last week, China-based CanSino published Phase I data supporting development of its vaccine candidate. The company said its Ad5 vectored COVID-19 vaccine is tolerable and immunogenic at 28 days post-vaccination. CanSino has moved its vaccine candidate into Phase II. Massachusetts-based Moderna has also moved its mRNA vaccine candidate into Phase II development, which was granted Fast Track Designation by the U.S. Food and Drug Administration. Moderna announced preliminary Phase I data that shows both safety and efficacy for its mRNA vaccine. Pfizer and BioNTech partnered to develop a vaccine, with the first patient dosed in a Phase I/II study earlier this month. AstraZeneca partnered with Oxford University’s Jenner Institute on the development of a vaccine candidate in April. Johnson & Johnson has also invested heavily in its own vaccine research.
