VBI Vaccines Announces Initiation of Enrollment in Adaptive Phase 1/2 Study of Prophylactic COVID-19 Vaccine Candidate, VBI-2902

VBI Vaccines Inc. (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, announce the initiation of enrollment of its Phase 1/2 clinical study of VBI-2902, the Company’s monovalent enveloped virus-like particle (eVLP) COVID-19 vaccine candidate.

“We are excited to begin the clinical assessment of our eVLP approach to vaccination against coronaviruses with this first clinical study of VBI-2902,” said Jeff Baxter, President and CEO of VBI. “We are committed to bringing forward candidates that add meaningful clinical and medical benefit to those already approved – be it as a one-dose administration, more durable immune responses, and/or providing broader protection against known and emerging variants of COVID-19. We are grateful for the support of our Canadian partners at the Department of Innovation, Science and Economic Development, the National Research Council of Canada, and Resilience Biotechnologies. We look forward to sharing initial data from this study in the coming months.”

“Our Government is investing in a range of Made-in-Canada solutions to support our fight against COVID-19,” said François-Philippe Champagne, Canada’s Minister of Innovation, Science and Industry. “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.”

Mitch Davies, President, National Research Council Canada, further commented, “The National Research Council 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 activities for 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.”

The adaptive Phase 1/2 clinical study is randomized, observer-blind, placebo-controlled, and will evaluate the safety, tolerability, and immunogenicity of VBI-2902, adjuvanted with aluminum phosphate. The Phase 1 portion of the study will evaluate a one- and two-dose regimen of a 5µg dose of VBI-2902, and is planned to enroll up to 60 healthy adults age 18-54. Contingent upon rate of enrollment, 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+. The study will be conducted at nine clinical sites in Canada.

The execution of this adaptive Phase 1/2 study is supported by funding from the Strategic Innovation Fund of the Government of Canada. VBI’s coronavirus vaccine program is being developed at the Company’s research facilities in Ottawa, Canada, and with the National Research Council of Canada (NRC), a collaboration that was recently expanded to include additional joint research and development activities for pre-clinical evaluation, optimization of clinical candidates, and manufacturing scale-up.