• Preclinical hamster challenge study demonstrated robust immunogenicity and efficacy compared to placebo
  • First Phase 1/2 study of VBI-2902 expected to begin in Q1 2021

VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, today provided an update on the progress of its coronavirus vaccine program, consisting of two vaccine candidates: (1) VBI-2901, a trivalent pan-coronavirus vaccine candidate expressing the SARS-CoV-2 (COVID-19), SARS-CoV (SARS), and MERS-CoV (MERS) spike proteins; and (2) VBI-2902, a monovalent vaccine candidate expressing the SARS-CoV-2 spike protein.

“Over the last several months, the preclinical results achieved with our two coronavirus vaccine candidates continue to excite us, and we are working hard to get these candidates into the clinic in forms that are optimized both for clinical outcome and long-term commercial viability,” said Jeff Baxter, VBI’s president and CEO. “The COVID-19 challenge we face as an industry is two-fold: first, how do we get the ongoing pandemic under control, and second, how do we ensure long-term protection against known and emerging coronaviruses. We continue to progress our candidates as we work to optimize, assess, and manufacture them, with the goal of bringing forward candidates that add meaningful clinical and medical benefit to those vaccines already approved – be it as a one-dose administration and/or providing broader protection against known and mutated future strains of COVID-19.”

Preclinical Hamster Challenge Study

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.

Phase 1/2 Human Clinical Study

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 CAD$56 million by the Strategic Innovation Fund of the Government of Canada, to be paid as retrospective reimbursement for eligible expenses incurred.