21 January 2021 - - US-based biopharmaceutical company VBI Vaccines Inc. (NASDAQ: VBIV) has provided an update on the progress of its coronavirus vaccine program, consisting of two vaccine candidates: VBI-2901, a trivalent pan-coronavirus vaccine candidate expressing the SARS-CoV-2 (COVID-19), SARS-CoV, and MERS-CoV spike proteins; and VBI-2902, a monovalent vaccine candidate expressing the SARS-CoV-2 spike protein.

The protective efficacy of VBI-2902, with two different adjuvant formulations, was assessed in hamsters where SARS-CoV-2 infection resembles features found in humans with moderate COVID-19 infection and is characterized by a rapid weight loss starting two days post infection.

These challenge study data reaffirm the high antibody binding and neutralizing antibody titer data seen in previously announced preclinical studies.

Additionally, VBI-2902, regardless of adjuvant formulation, was able to stop and reverse weight loss seen at two days post infection.

Where VBI-2902 led to animals regaining normal weight seven days post-infection, the animals who received placebo lost an average of 15% body weight in that same timeframe.

Additional observations in the vaccinated cohorts include prevention of peak viral replication in the lungs by approximately 10,000-fold and significantly reduced inflammation in the lungs compared to the placebo cohort.

These and other preclinical data are being targeted for publication.

VBI expects to initiate the first Phase 1/2 clinical study of VBI-2902 in Canada in Q1 2021. The clinical study protocol has previously been positively reviewed by Health Canada.

Though there have been unanticipated delays in receipt of release testing materials due to recent industry-wide supply chain issues, the company has been working closely with its partners and Health Canada to complete testing and release of clinical materials to enable clinical study initiation.

This study will use clinical material manufactured by our manufacturing partner, National Resilience, Inc., formerly Therapure Biomanufacturing.

Work is ongoing to further optimize and manufacture the company's pan-coronavirus vaccine candidate, VBI-2901, with the anticipation that a Phase 1/2 study will begin later in 2021.

To support the Phase 1/2 studies, VBI was awarded up to CADUSD56 m by the Strategic Innovation Fund of the government of Canada, to be paid as retrospective reimbursement for eligible expenses incurred.
About VBI Vaccines Inc.

VBI Vaccines is a commercial-stage biopharmaceutical company developing a next generation of vaccines to address unmet needs in infectious disease and immuno-oncology.