Entos Pharmaceuticals, a clinical-stage biotechnology company developing genetic medicines with its proprietary Fusogenix PLV nucleic acid delivery platform, and its partner, Aegis Life, today announced that Entos has received approval from Health Canada to initiate a phase 1/2 clinical trial evaluating Covigenix VAX-002, an investigational COVID-19 booster vaccine.
Formulated using the Entos Fusogenix PLV delivery platform, Covigenix VAX-002 is a plasmid DNA vaccine that has been optimized to express key SARS-CoV-2 antigens, focusing on the currently circulating omicron strains. Aegis has worldwide rights to the vaccine outside of Canada and will collaborate with Entos on its clinical development.
The Covigenix VAX-002 COVID-19 vaccine booster clinical study is a phase 1/2 design. The phase 1 component of the trial has a target enrollment of 50 participants and is intended to determine the optimal dose of Covigenix VAX-002 for booster vaccination (100 μg or 250 μg). The phase 2 portion of the study is expected to enroll 250 participants and will evaluate the safety and immunogenicity response of the optimal dose identified in phase 1. Results from the trial will guide future intramuscular dosing of Covigenix formulations and support future global development plans.
“COVID-19 remains a serious public health issue,” said Steve Chen, M.D., Chief Medical Officer at Entos. “Elderly and immunocompromised patients are still in need of a COVID-19 vaccine that can provide durable and robust protection. Developing countries are also still in need of a fridge-stable vaccine that can be deployed rapidly. Covigenix VAX-002 has the potential to be the first DNA fridge-stable vaccine offering longer-lasting protection than any other vaccine currently on the market.”
The vaccine booster is being produced in the Company’s Good Manufacturing Practices (GMP) manufacturing facility in Carlsbad, California. This new facility was built by Entos to support the clinical development of their genetic medicine programs, including Covigenix VAX-002, clinical candidates for partnered programs, as well as future candidates in rare disease, eye and ophthalmic conditions, oncology, and infectious diseases.
“The approval by Health Canada to move Covigenix VAX-002 into the clinic represents a major milestone for Entos,” said Arun Raturi, Ph.D., Chief Scientific Officer at Entos. “This will be the first GMP clinical vaccine manufactured completely in-house at Entos. The phase 1/2 study will not only provide important insights into the potential utility of Covigenix VAX-002 in patients who require a COVID-19 booster, but will also serve as an opportunity to further validate the Fusogenix platform as a foundation for future vaccine and therapeutic development.”
