On Mar. 9, 2021, VBI Vaccines announced 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.

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.