Entos Pharmaceuticals has obtained approval from the South African Health Products Regulatory Authority (SAHPRA) to commence a Phase II clinical trial of its Covid-19 vaccine candidate, Covigenix VAX-001, in the country.
Made using the Entos’ Fusogenix proteolipid vehicle (PLV) nucleic acid delivery platform, the deoxyribonucleic acid (DNA) vaccine encodes the SARS-CoV-2 Spike protein.
It also includes two genetic adjuvants to induce the innate and adaptive immune systems, offering efficient and long-term protection from Covid-19.
The Fusogenix platform leverages a new mechanism of action to carry molecules directly into the cytosol of intended cells in an intact and unaltered manner.
The latest approval is based on positive Phase I data, which showed that Covigenix VAX-001 met all the safety goals without any serious adverse events noted in the trial.
Furthermore, the Fusogenix platform was found to be safe and well-tolerated for the intracellular delivery of DNA in the trial.
The platform also showed the potential to induce positive immunological outcomes at reduced dose levels of the vaccine.
The placebo-controlled, randomised, observer-blind Phase II trial will assess the safety, tolerability and immunogenicity of intramuscular doses of the vaccine in single-dose and double-dose groups.
To be carried out at various centres in South Africa, the trial will enrol healthy adults aged 18 years or above.
Entos Pharmaceuticals CEO John Lewis said: “We are excited to be moving forward with testing our Covid-19 DNA vaccine candidate in Phase II clinical trials after promising Phase I results.
“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.”
Due to the increased stability of DNA, VAX-001 could be stable for more than one year at standard refrigerated temperatures.
This makes the vaccine a more cost-efficient option for storing, transporting and deployment globally, the company noted.
Covigenix VAX-001 showed potent immunogenicity, offering protection from Covid-19 infection in animal models in preclinical studies.
In April, Aegis Life initiated dosing of the first participants in a Phase I/II clinical trial with Entos’ Covigenix VAX-001 to induce immunity against SARS-CoV-2.