Aegis Life, Inc. announced today that the first participants have been dosed in a Phase 1/2 clinical trial with parent company Entos Pharmaceuticals’ Covigenix VAX-001, a novel DNA vaccine to stimulate immunity against SARS-CoV-2. Covigenix VAX-001 encodes the SARS-CoV-2 Spike (S) protein and uses novel Fusogenix technology for delivery. Using a next-generation gene delivery technology to the existing and approved mRNA vaccines, the VAX-001 DNA vaccine delivers the information needed inside cells to make the viral protein. In preclinical animal studies, VAX-001 induced a potent humoral immunity, and a balanced cell-mediated response against the novel coronavirus.
Fusogenix technology effectively and safely delivers nucleic acid cargo directly inside cells using advanced and proprietary lipid formulations, making it the ideal platform to develop and manufacture hundreds of millions of doses of safe, stable and effective vaccines. DNA vaccines also offer the advantage of stability at room temperature for one month and 4 to 8 °C for one year, which significantly simplifies shipping, storage and distribution. Aegis and Entos have also developed a second DNA vaccine candidate, in preclinical studies now, called Covigenix VAX-002, that is designed as a pan-coronavirus and emerging variant vaccine.
“We’re excited that the Phase 1/2 trials have begun with our COVID-19 DNA vaccine,” said John Lewis, CEO, Aegis Life. “This milestone brings us one step closer to providing this vaccine to people in the US and the rest of the world.”
The trial is being conducted by the Canadian Center for Vaccinology (CCfV) and the IWK Health Centre in Nova Scotia, Canada. Phase 1 will evaluate the safety and immunogenicity of the Covigenix VAX-001 DNA vaccine. Since preclinical studies demonstrated promising results for administering Covigenix VAX-001 in a single dose, the phase 2 trial design includes a single-dose regimen.