• Government of Canada will support advancement of VBI’s coronavirus program through Phase 2 clinical development
  • Pre-clinical data are expected to enable selection of clinical candidates in Q3 2020 and the initiation of clinical studies by the end of 2020

Variation Biotechnologies Inc., an Ottawa-based wholly-owned Canadian subsidiary of VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, today announced that it has been awarded up to a CAD$56 million contribution from the Strategic Innovation Fund of the Government of Canada to support the development of the company’s coronavirus program, VBI-2900, through Phase 2 clinical studies.Coronaviruses are enveloped viruses by nature, which make them prime targets for VBI’s flexible enveloped virus-like particle (eVLP) platform technology. A multivalent eVLP vaccine candidate, co-expressing SARS-CoV-2, SARS-CoV, and MERS-CoV spike proteins, may enable the immune system’s production of broadly reactive antibodies, potentially offering protection from emerging strains of COVID-19 that evolve over time.

“We are grateful for the support of the Government of Canada and we share their public health commitment to providing an effective response to the ongoing COVID-19 pandemic,” said Jeff Baxter, VBI’s President and CEO. “VBI’s coronavirus program is a differentiated approach, using a proven, scalable, and cost-effective technology to potentially broaden the immune response to SARS-CoV-2 and potentially other coronaviruses. This funding will help accelerate our vaccine candidates into and through clinical development, the first clinical studies for which are expected to initiate by the end of 2020.”

“This investment with VBI is part of Canada’s plan to mobilize science to fight COVID-19,” said Navdeep Bains, Canada’s Minister of Innovation, Science, and Industry. “An effective vaccine will be critical as we work to contain the COVID-19 virus and prevent future infections, and we recognize VBI’s potential to be part of the solution.”

As part of the previously-announced collaboration with the National Research Council of Canada (NRC), a series of three pre-clinical mouse studies initiated in the second quarter of 2020 to evaluate: (1) trivalent vs. monovalent vaccine constructs, (2) multiple different adjuvants, and (3) pre-fusion vs. post-fusion spike proteins. Based on the results of these studies, which are being conducted at both the NRC core facilities and VBI’s research facility in Ottawa, Canada, VBI expects to select the optimal vaccine candidates in the third quarter of 2020 to enable the start of clinical studies by the end of 2020.

In addition to progressing the VBI-2900 program through Phase 2 clinical development, VBI expects to use this funding to finalize all manufacturing process development and to expand the workforce at its research and development facility in Ottawa. Further discussions with the Government of Canada may explore additional federal funding to support late-stage development.

The Government of Canada issued a news release this morning announcing VBI’s funding award and additional steps the Government is taking to combat COVID-19.

About Coronaviruses

Coronaviruses are a large family of enveloped viruses that usually cause respiratory illness of varying severities, including the common cold and pneumonia. Only seven coronaviruses are known to cause disease in humans, four of which most frequently cause symptoms of the common cold. Three of the seven coronaviruses, however, have more serious outcomes in people: (1) SARS-CoV-2, a novel coronavirus identified as the cause of coronavirus disease 2019 (COVID-19); (2) MERS-CoV, identified in 2012 as the cause of Middle East respiratory syndrome (MERS); and (3) SARS-CoV, identified in 2002 as the cause of an outbreak of severe acute respiratory syndrome (SARS).1,2

  1. “Coronavirus.” World Health Organization, https://www.who.int/health-topics/coronavirus.
  2. “Coronaviruses.” National Institute of Allergy and Infectious Diseases, https://www.niaid.nih.gov/diseases-conditions/coronaviruses