US company Aegis Life has initiated dosing of the first participants in a Phase I/II clinical trial with parent company Entos Pharmaceuticals’ novel DNA Covid-19 vaccine, Covigenix VAX-001, to induce immunity against SARS-CoV-2.
Using new Fusogenix technology for delivery, Covigenix VAX-001 encodes the SARS-CoV-2 Spike (S) protein.
Aegis Life CEO John Lewis said: “We’re excited that the Phase I/II trials have begun with our Covid-19 DNA vaccine.
“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 carried out by the Canadian Center for Vaccinology and the IWK Health Centre in Nova Scotia, Canada.
Phase I will assess the safety and immunogenicity of the vaccine while the phase II trial design has a single-dose regimen as Covigenix VAX-001 had shown promising results on administering a single dose in preclinical studies.
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Furthermore, in preclinical animal studies, the vaccine had induced a strong humoral immunity and a balanced cell-mediated response against SARS-CoV-2.
Aegis focuses on developing, manufacturing and global marketing of novel DNA vaccines using Fusogenix technology.
This technology safely supplies nucleic acid cargo directly inside cells using innovative lipid formulations, making it the best platform for developing and producing numerous doses of safe, stable and efficient vaccines.
In addition, DNA vaccines are stable at room temperature for a month and 4 to 8°C for a year, which would aid in streamlining shipping, storage as well as vaccine distribution.
Aegis and Entos have also developed another DNA vaccine candidate called Covigenix VAX-002.
Covigenix VAX-002 is designed as a pan-coronavirus and emerging variant vaccine, which is currently in preclinical studies.
Aegis is actively pursuing investments from the US and international companies to progress its DNA-based vaccine candidates to late-stage clinical trials for evaluating safety and effectiveness.
On obtaining funds, the company also intends to scale up commercial manufacturing capacity to produce millions of vaccine doses and distribute them to the US and international markets.