VBI Vaccines to begin Phase 1/2 study of coronavirus vaccine candidate
The Cambridge, Massachusetts headquartered company is working on two candidates. The most advanced, VBI-2902, is a monovalent vaccine candidate expressing the SARS-CoV-2 spike protein.
VBI-2901, meanwhile, is a trivalent pan-coronavirus vaccine candidate expressing the SARS-CoV-2 (COVID-19), SARS-CoV (SARS), and MERS-CoV (MERS) spike proteins.
Both candidates set for clinical trials in 2021
VBI-2902 is due to proceed into a Phase 1/2 study in Canada in Q1 2021, with the study protocol having been positively reviewed by Health Canada.
The vaccine - using two different adjuvant formulations - has been 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," reports the company.
“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.”
The pan-coronavirus vaccine candidate, VBI-2901, is anticipated to start a Phase 1/2 study later in the year.
Jeff Baxter, VBI’s president and CEO, said: “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.”
The coronavirus vaccines have been developed with the company's existing eVLP (enveloped virus-like particle) platform. "Enveloped virus-like particle (eVLP) vaccines closely mimic the structure of viruses found in nature, but without the viral genome, potentially yielding safer and more potent vaccine candidates. Coronaviruses are enveloped viruses by nature, which may make them prime targets for this eVLP vaccine technology," explains the company.
VBI has been awarded up to CAD$56m (USD $44m) by the Strategic Innovation Fund of the Government of Canada to support the vaccines’ development.
VBI Vaccines develops infectious disease and immuno-oncology vaccines. Its Sci-B-Vac hepatitis B vaccine is approved for use in Israel, and recently completed Phase 3 studies in the US, Europe and Canada. Lead programs for its eVLP platform include a vaccine immunotherapeutic candidate targeting glioblastoma (GBM), a prophylactic cytomegalovirus (CMV) vaccine candidate, and a prophylactic coronavirus vaccine program.
