Entos Pharmaceuticals (Entos), a clinical-stage biotechnology company developing genetic medicines with its Fusogenix proteolipid vehicle (PLV) nucleic acid delivery platform, is excited to announce the approval by the South African Health Products Regulatory Authority (SAHPRA) to start a Phase 2 clinical trial of its COVID-19 DNA vaccine candidate in South Africa. The approval is based on positive Phase 1 trial results showing that CovigenixVAX-001 met all safety endpoints with no serious adverse events reported.
Covigenix VAX-001 COVID-19, formulated using the Entos Fusogenix delivery platform, is a DNA vaccine encoding SARS-CoV-2 Spike protein and two genetic adjuvants engineered to stimulate the adaptive and innate immune systems. By stimulating both arms of the immune system, the single low dose vaccine is designed to provide effective and durable protection against COVID-19. Preclinical studies with Covigenix VAX-001demonstrate potent immunogenicity, conferring protection from infection withSARS-CoV-2 in animal models. The recently completed first-in-human Phase 1 clearly demonstrated that the Fusogenix platform is safe and well-tolerated for the intracellular delivery of DNA with the potential to promote positive immunological outcomes at low vaccine doses. Given the high stability of DNA, VAX-001 has the key advantage of stability for more than a year at normal refrigerated temperatures, making it more cost-effective to store, transport and deploy worldwide.
“We are excited to be moving forward with testing our COVID-19 DNA vaccine candidate in Phase 2 clinical trials after promising Phase 1 results,” said John Lewis, CEO of Entos. “Reaching this important milestone gets us one step closer towards helping end this pandemic by providing a potentially effective and safe fridge-stable, single dose vaccine against COVID-19 to under-vaccinated regions of the world.”
The Phase 2 clinical trial will be conducted at multiple sites in South Africa as a placebo-controlled, randomized, observer-blind trial to evaluate the safety, tolerability, and immunogenicity of Entos’ single-dose and double-dose arms, intramuscularly administered, CovigenixVAX-001 DNA vaccine candidate.