29 September 2022 - - US-based biopharmaceutical company VBI Vaccines Inc. (NASDAQ: VBIV) has started enrollment in the Phase 1 clinical study of VBI-2901, a multivalent enveloped virus-like particle coronavirus vaccine candidate expressing the full-length spike proteins from the SARS-CoV-1, SARS-CoV-2 (COVID-19), and MERS-CoV viruses, the company said.

Coronaviruses are enveloped viruses by nature, making them prime targets for VBI's flexible eVLP technology, which in a Phase 1a/1b study of two monovalent, variant-specific vaccine candidates generated human proof-of-concept data demonstrating the safety, tolerability, and immunogenicity of the eVLP platform against coronaviruses.

The Phase 1 randomized, open-label study will enroll three cohorts of subjects, randomized 1: 1: 1, to compare either two intramuscular doses of VBI-2901 at a low- or high- dose level, or one dose of VBI-2901 at the high-dose level in approximately 100 healthy adults age 18-64 who have previously received two or more immunizations with COVID-19 vaccines licensed by Health Canada.

Each participant must have received their previous dose of a licensed COVID-19 vaccine at least six months prior to study enrollment.

This study is supported by funding from the government of Canada's Innovation, Science and Economic Development through the Strategic Innovation Fund.

VBI-2900 consists of three enveloped virus-like particle vaccine candidates: VBI-2901, a multivalent coronavirus vaccine expressing the SARS-CoV-2, SARS-CoV, and MERS-CoV spike proteins, VBI-2902, a monovalent COVID-19 vaccine expressing a modified prefusion form of the SARS-CoV-2 ancestral spike protein, and VBI-2905, a monovalent COVID-19 vaccine expressing a modified prefusion form of the spike protein from the Beta variant (also known as B.1.351).

The vaccine program has been developed through collaborations with the National Research Council of Canada, the Coalition for Epidemic Preparedness Innovations, and the government of Canada, through their Strategic Innovation Fund.

VBI Vaccines Inc. is a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease.

Through its innovative approach to virus-like particles, including a proprietary enveloped VLP platform technology, VBI develops vaccine candidates that mimic the natural presentation of viruses, designed to elicit the innate power of the human immune system.

VBI is focused on targeting and overcoming significant infectious diseases, including hepatitis B, coronaviruses, and cytomegalovirus, as well as aggressive cancers including glioblastoma. VBI is headquartered in Cambridge, Massachusetts, with research operations in Ottawa, Canada, and a research and manufacturing site in Rehovot, Israel.