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VBI Vaccines Announces Progress of Coronavirus Vaccine Program

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VBI Vaccines Inc. (Nasdaq: VBIV) announced progress on its coronavirus vaccine program, featuring two candidates: VBI-2901 (trivalent) and VBI-2902 (monovalent). Exciting preclinical results show VBI-2902 effectively prevents significant weight loss in infected hamsters and reduces lung inflammation. A Phase 1/2 clinical study for VBI-2902 is expected to start in Canada in Q1 2021, despite delays due to supply chain issues. The company received CAD$56 million from the Government of Canada to support these studies.

Positive
  • VBI-2902 demonstrated a significant ability to reverse weight loss in hamsters post-infection, indicating strong protective efficacy.
  • Phase 1/2 clinical study for VBI-2902 is anticipated to begin in Q1 2021, supported by Health Canada.
  • VBI received up to CAD$56 million from the Canadian government, aiding clinical study preparations.
Negative
  • Delays in clinical study initiation due to supply chain issues affecting the release of testing materials.

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.

About VBI Vaccines Inc.

VBI Vaccines Inc. (Nasdaq: VBIV) is a commercial-stage biopharmaceutical company developing a next generation of vaccines to address unmet needs in infectious disease and immuno-oncology. VBI is advancing the prevention and treatment of hepatitis B, with: (1) the only 3-antigen hepatitis B vaccine, Sci-B-Vac®, which is approved for use and commercially available in Israel and recently completed its Phase 3 program in the U.S., Europe, and Canada; and (2) an immunotherapeutic in development for a functional cure for chronic hepatitis B. VBI’s enveloped virus-like particle (eVLP) platform technology enables development of eVLPs that closely mimic the target virus to elicit a potent immune response. VBI’s lead eVLP programs include a vaccine immunotherapeutic candidate targeting glioblastoma (GBM), a prophylactic cytomegalovirus (CMV) vaccine candidate, and a prophylactic coronavirus vaccine program. VBI is headquartered in Cambridge, MA, with research operations in Ottawa, Canada, and research

FAQ

What progress has VBI Vaccines Inc. made with their coronavirus vaccine candidates VBI-2901 and VBI-2902?

VBI Vaccines Inc. is developing two coronavirus vaccine candidates, VBI-2901 and VBI-2902, with promising preclinical results showing effectiveness in preventing weight loss and lung inflammation in animal studies.

When is VBI-2902 expected to enter clinical trials?

The first Phase 1/2 clinical study for VBI-2902 is expected to begin in Canada in Q1 2021.

What financial support has VBI Vaccines received for its vaccine development?

VBI Vaccines Inc. was awarded up to CAD$56 million from the Strategic Innovation Fund of the Government of Canada to support its vaccine studies.

What were the results of the preclinical study for VBI-2902?

In preclinical studies, VBI-2902 prevented significant weight loss in infected hamsters and reduced lung inflammation compared to the placebo group.

What challenges has VBI faced in the clinical study process?

VBI has faced delays in the initiation of its clinical studies due to supply chain issues affecting the release of testing materials.

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