Brisbane, Australia October 19, 2020 – Nucleus Networks announced today that Symvivo Corporation has received regulatory approval to initiate a Phase 1, first-in-human trial of bacTRL-Spike™, an orally-delivered, room temperature stable DNA vaccine candidate for the prevention of COVID-19.
Symvivo has partnered with Nucleus Network, Australia’s largest Phase 1 clinical trials specialist, to initiate a Phase 1 trial evaluating the safety, tolerability, and immunogenicity of bacTRL-Spike™ in healthy adult volunteers.
“This unique approach delivers genetic material directly to the lining of the lower gastrointestinal tract, enabling both systemic and mucosal anti-SARS-CoV2 immune responses,” said Alexander Graves, president and CEO of Symvivo Corporation. “Results from this trial will provide valuable insight enabling the development of a room-temperature stable oral formulation, with the ultimate goal of delivering a COVID-19 vaccine directly into people’s homes throughout the world for self-administration and bypassing cold-chain supply logistics.”
The Phase 1 study of this vaccine will be conducted at the Nucleus Network Brisbane Clinic, under the supervision of Associate Professor Paul Griffin, infectious diseases physician and microbiologist at Nucleus Network, and principal investigator of the Phase 1 trial.
“The global pandemic has become the most visible example of the medical research sector for this generation,” said Assoc. Professor Griffin. “It’s inspiring to see the level of innovation and application that has gone into developing a safe and protective vaccine. The potential of this orally-delivered vaccine is particularly exciting, and we are enthusiastic about conducting this trial so that we may better understand this DNA vaccine.”
DNA vaccines work by introducing the immune system to a modified version or component of the infectious agent that has been altered to provoke an immune response without creating an infection.
Anyone interested in participating in the trial in Australia can register their details via the Nucleus Network website: https://www.nucleusnetwork.com/participate-in-a-trial or call 1800 243 733.
For more information on the Symvivo clinical trial, see NCT04334980 study information on Clinicaltrials.gov.
Nucleus Network is the only multi-site Phase 1 clinical trials provider located in Australia and the USA. We provide high-quality, first-in-human and early-phase trials for biotechnology and pharmaceutical companies across the USA, Europe and Asia. Located within cutting-edge health precincts, our cost-effective, accelerated clinical development solutions are supported by advanced technology, clinical excellence and research expertise.
Symvivo is a clinical stage biotechnology company advancing a proprietary platform for the site-specific delivery of genes for the treatment and prevention of disease. Symvivo’s bacTRL platform technology delivers plasmid DNA, both orally and through IV application, that enables a patient’s own cells to produce therapeutic proteins. Symvivo is advancing therapeutics in the area of oral DNA vaccines, oncology, immunology and protein therapy. Symvivo is headquartered in Burnaby, BC. For more information please visit www.Symvivo.com.