Candidate: bacTRL-Spike

Category: VAX

Type: Bifidobacteria monovalent SARS-CoV-2 DNA oral vaccine for prevention of COVID-19. The bacTRL-Spike platform technology is designed to deliver plasmid DNA, both orally and through IV application, enabling a patient’s own cells to produce therapeutic proteins.

Status: Symvivo said November 2 that it had enrolled and dosed the first healthy volunteer in the Phase I trial Evaluating the Safety, Tolerability and Immunogenicity of bacTRL-Spike™ Vaccine for Prevention of COVID-19 (NCT04334980), which the company is conducting in partnership with Nucleus Network in Brisbane, Australia. The Australian clinical trial is designed to evaluate safety and preliminary evidence of immunogenicity to SARS CoV-2 elicited by bacTRL-Spike among healthy volunteers.

Preliminary data are anticipated in early 2021, Symvivo said. Associate Professor Paul Griffin, infectious diseases physician and microbiologist at Nucleus Network, is the primary investigator.

In April, Symvivo disclosed on that it was recruiting up to 84 participants for the Phase I trial.

The vaccine is produced using Symvivo’s platform, in which 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.

COVID-19: 300 Candidates and Counting

To navigate through the >300 potential therapeutic and vaccine options for COVID-19, GEN has grouped the candidates into four broad categories based on their developmental and (where applicable) clinical progress:

FRONT RUNNER – the most promising therapeutics/vaccines based on clinical progress, favorable data or both.

DEFINITELY MAYBE – earlier phases with promising partners, or more advanced candidates in development that have generated uneven data

KEEPING AN EYE ON… – interesting technology, attracting notable partners, or both, but preliminary data.

TOO SOON TO TELL – longshots pending additional experimental and/or clinical data.

GEN has also tagged the most common treatment types:


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