Canada Funds COVID-19 Vaccine Development Study

USA-based VBI Vaccines Inc. announced the enrollment of its Phase 1/2 clinical study of VBI-2902, the Company’s monovalent enveloped virus-like particle (eVLP) COVID-19 vaccine candidate.

VBI-2900 consists of two enveloped virus-like particle (eVLP) vaccine candidates: VBI-2901, a trivalent pan-coronavirus vaccine expressing the SARS-CoV-2, SARS-CoV, and MERS-CoV spike proteins, and VBI-2902, a monovalent COVID-19-specific vaccine expressing the SARS-CoV-2 spike protein. 

The execution of this adaptive Phase 1/2 study will be conducted at nine clinical sites in Canada and is supported by funding from the Strategic Innovation Fund of the Government of Canada. 

François-Philippe Champagne, Canada’s Minister of Innovation, Science, and Industry, stated in a VBI press statement, “Today’s news is a welcome development, bringing VBI one step closer to delivering a safe and effective COVID-19 vaccine for Canadians. Through this investment, we continue to expand our toolbox to help fight this pandemic as well as future pandemics.”

The Phase 1 portion of the study will evaluate a one- and two-dose regimen of a 5µg dose of VBI-2902 and enroll up to 60 healthy adults age 18-54. Contingent upon enrollment rate, the initial data from Phase 1 of this study are expected by the end of Q2 2021.

The Phase 2 portion of the study is expected to be a dose-escalation extension study, assessing one- and two-dose regimens that will enroll an expanded adult population across three age cohorts: 18-54, 55-65, and 65+.

Mitch Davis, the President of the National Research Council (NRC), further commented, “The NCR of Canada and VBI Vaccines have a long-standing collaboration in research. Since March 2020, we have been working jointly with their research operations in Ottawa on pre-clinical evaluation, optimization, and manufacturing process development of this COVID-19 vaccine candidate. We are very pleased to see this candidate reach the important milestone of human clinical trials.”

VBI’s coronavirus vaccine program is being developed at the Company’s research facilities in Ottawa, Canada, and with the NRC, a recently expanded collaboration to include additional joint research and development activities for pre-clinical evaluation, optimization of clinical candidates, and manufacturing scale-up.