VBI Vaccines Announces Initiation of Phase 1 Study of Multivalent Coronavirus Vaccine Candidate, VBI-2901

• Initiation of first clinical study of multivalent VBI-2901, designed to increase breadth of protection against COVID-19 and related coronaviruses
• Preclinical data support broadly reactive immunity of VBI-2901 against a panel of coronavirus variants in mice, which now also includes circulating BA.4 and BA.5
• The study is expected to enroll approximately 100 adults in Canada and is supported by the Government of Canada
• Interim data expected mid-year 2023, subject to speed of enrollment

Excerpt from the Press Release:

CAMBRIDGE, Mass.–(BUSINESS WIRE)–VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announced the initiation of enrollment in the Phase 1 clinical study of VBI-2901, a multivalent enveloped virus-like particle (eVLP) coronavirus vaccine candidate expressing the full-length spike proteins from the SARS-CoV-1 (SARS), SARS-CoV-2 (COVID-19), and MERS-CoV (MERS) viruses.

Jeff Baxter, VBI’s President and CEO commented, “We strive to contribute to the long-term solution in the fight against coronaviruses and remain committed to supporting our public health partners. As we work to develop a vaccine capable of providing broad protection against known, emerging, and as-yet-unknown COVID-19 and coronavirus strains, we believe this study initiation is a meaningful step toward that goal.”

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.

David Anderson, Ph.D., VBI’s Chief Scientific Officer added, “We are excited to kick-off the first human study of VBI-2901, a candidate that has consistently elicited a stronger response than our variant-specific candidates against a broad panel of coronavirus variants in mice. Our preclinical panels now include BA.4 and BA.5 as well as the ancestral strain, Delta, Beta, Lambda, Omicron, and pangolin and bat coronaviruses distantly related to circulating human strains. These data seen to date demonstrated that, generally, as the strains became more divergent from the ancestral strain, VBI-2901 elicited a greater increase in antibody responses compared to our other variant-specific COVID-19 vaccine candidates.”

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