The Phase I segment of the trial aims to identify the optimal dose of the vaccine for booster vaccination, involving 50 participants. Credit: Hakan Nural on Unsplash.

Entos Pharmaceuticals and its partner Aegis Life have announced the first subject dosing in the Phase I/II clinical trial of Covigenix VAX-002 as a booster vaccine for Covid-19.

The first subject was dosed at a Quebec site.

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The trial is sponsored by Entos and overseen by Calian. It is conducted by DIEX Recherche.

It is underway at 12 locations across Canada, including sites in Ontario, Alberta, Quebec and Nova Scotia.

The Phase I segment of the trial aims to identify the optimal dose of Covigenix VAX-002 for booster vaccination, involving 50 participants.

The Phase II portion will assess the safety and immune response of the chosen dose in 250 participants.

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Entos Pharmaceuticals CEO John Lewis said: “We’re excited to announce the first patient dosed in the Phase I/II trial of our Covid-19 DNA vaccine booster candidate.

“This milestone brings us closer to providing protection against the still-emerging SARS-CoV-2 omicron variants to people in North America, as well as developing countries in need of fridge-stable vaccines.”

Covigenix VAX-002 uses the Entos’ Fusogenix PLV delivery system and plasmid DNA designed to produce key SARS-CoV-2 antigens, targeting the current omicron variants.

Aegis holds the global rights to the vaccine outside Canada and continues to support the trials as a commercialisation partner for the Entos Fusogenix PLV platform.

Entos is also advancing other genetic medicine programmes, including candidates for partnered initiatives and future therapies for rare diseases, eye and ophthalmic conditions, cancer, and infectious diseases.

Entos Pharmaceuticals CMO Steve Chen said: “Covid-19 will remain a public health issue, as evidenced in this summer’s surge of infections.

“Leveraging plasmid DNA cargo, Covigenix VAX-002 has the potential to offer a more durable alternative to what is currently available.”

In June this year, Health Canada granted approval to Entos Pharmaceuticals for launching a Phase I/II trial of its investigational Covid-19 vaccine booster, Covigenix VAX-002.