Novavax (NASDAQ:NVAX) announced on Monday that it had begun enrolling participants in a phase 1/2 clinical trial of its coronavirus vaccine candidate NVX-CoV2373. The vaccine candidate demonstrated promising results in preclinical testing, including a significant immune system response and high levels of neutralizing antibodies, which bind to the novel coronavirus and block infection.
About the study
The clinical study will consist of two parts. The phase 1 part of the study will evaluate the immunogenicity and safety of Novavax's COVID-19 vaccine candidate and will be conducted at two sites in Australia. Around 130 healthy participants between the ages of 18 and 59 are expected to be enrolled in the clinical trial. Two doses of the vaccine of either 5 or 25 micrograms will be given to participants in two randomized groups.
Novavax plans to conduct the phase 2 part of the clinical study in multiple countries, including the U.S. This portion of the study will evaluate the immunity, safety, and disease reduction provided by NVX-CoV2373 in a broader age range of participants.
The clinical trial is being funded by the Coalition for Epidemic Preparedness Innovations (CEPI). Novavax recently announced that CEPI was investing up to $384 million to fund the clinical development of NVX-CoV2373 in addition to its initial $4 million investment.
Novavax anticipates sharing preliminary immunogenicity and safety results from the phase 1 part of the clinical trial in July 2020. It those results are promising, the biotech will quickly advance its vaccine candidate into the phase 2 portion of the study. CEPI's investment in Novavax will enable the manufacturing of NVX-CoV2373 to be done in parallel with clinical testing.