A Vancouver-based biotech company called Symvivo Corporation recently launched a Phase I clinical trial to asses the safety of a COVID-19 vaccine biological candidate known as bacTRL-Spike. A Bifidobacteria monovalent SARS-CoV-2 DNA oral vaccine candidate to prevent COVID-19, the company disclosed it was recruiting up to 84 participants for an observed-blinded Phase I clinical trial to evaluate the safety, tolerability and immunogenicity of the investigational candidate.
Called bacTRL-Spike, the vaccine was produced using Symvivo’s platform in which the Canadian venture administers genetically modified probiotic bacteria colonize the gut and bind directly to intestinal epithelial cells and constitutively replicate, secrete and deliver plasmid DNA molecules encoding antigenic transgenes and neutralizing antibodies.
This candidate originates from the sponsor’s platform. Known as the bacTRL platform, they posit that it is a good fit to rapidly respond to current and future outbreaks of emerging infectious diseases. The orally administered, genetically modified probiotic bacteria colonize the gut, bind directly to intestinal epithelial cells and constitutively replicate, secrete and deliver plasmid DNA molecules encoding antigenic transgenes and neutralizing nanobodies. They suggest it is akin to natural viral infection, transgenic antigens are translated into proteins that localize to their natural cellular extracellular locations in addition to being recycled and presented through MHC-class I activity. They are presently using this platform to manufacture and test the bacTRL-Spike to rapidly induce both cellular and humoral immunity against Spike protein to prevent COVID-19 infection. They are working on a couple other derivative candidates as well.
As published in Clinicaltrials.gov, Protocol bacTRL-Spike-1 will be the first-in-human study of bacTRL-Spike, and the first-in-human use of orally delivered bacTRL. Each oral dose of bacTRL-Spike contains bacterial medium with either 1 billion (Group 1A), 3 billion (Group 2A) or 10 billion (Group 3A) colony-forming-units of live Bifidobacterium longum, which has been engineered to deliver plasmids containing synthetic DNA encoding spike protein from SARS-CoV-2. Placebo will consist of bacterial medium without bacteria.
Total anticipated enrollment of 84 includes 63 planned to receive active vaccine in bacterial medium and 21 receiving placebo (bacterial in medium only). The study just recently commenced end of April and will run throughout the next year.
The Research Sites
The company has involved the Vaccine Evaluation Center, BC Children’s Hospital Research Institute, University of British Columbia and the Canadian Center for Vaccinology Dalhousie University, IWK Health Centre in Halifax, Nova Scotia.
Symvivo Corporation is a clinical state biotech company that has developed a live cell probiotic-based gene delivery platform. They have programs in the clinical and pre-clinical space in oncology, ischemic heart disease, vaccines and rare-diseases. Founded in 2013, the company is led by CEO and founder Alexander Graves. The company employs under 20.
According to one profile, the venture has raised $2 million from a local early state venture investor and $100K from a National Research Council. Founder Graves started the company, along with Mark Fox—a friend from undergrad—as he realized “he sucked” at research but desired to leverage his scientific degree in meaningful ways. Graves and Fox sought to develop a platform that could accelerate drug development by focusing on the discovery—developing patents for aspects of the drug delivery process that could be licensed to drug makers.
University of British Columbia
· Manish Sadarangani, BM, BCH, Dphil, Principal Investigator
· Soren Gantt, MD, PhD, Sub-investigator
· Mel Krajden, MD, PhD, Sub-investigator
· Muhammed Morshed, PhD, Sub-investigator
Dalhousie University/IWK Health Centre
· Joanne Langley, MD, MSc, FRCPC, Principal Investigator
· Scott Halperin, MD, Sub-investigator
· Shelly McNeil, MD, FRCPC Sub-investigator