On September 1, 2021, Entos Pharmaceuticals, a clinical-stage biotechnology company developing genetic medicines with its Fusogenix proteolipid vehicle (PLV) nucleic acid delivery platform, announced the approval by SAHPRA to start a Phase 2 clinical trial of Entos’s COVID-19 DNA vaccine candidate (Covigenix VAX-001) in South Africa. The approval is based on positive Phase 1 trial results showing that Covigenix VAX-001 met all safety endpoints with no serious adverse events reported. The Covigenix VAX-001 COVID-19 vaccine, formulated using the Entos Fusogenix delivery platform, is a DNA vaccine encoding the 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-001 demonstrate potent immunogenicity, conferring protection from infection with SARS-CoV-2 in animal models.
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