Health Canada Approves Entos Pharma's COVID-19 Booster Trial

Entos Pharmaceuticals and Aegis Life have announced that Entos has received approval from Health Canada to begin a phase 1/2 clinical trial for Covigenix VAX-002, a COVID-19 booster vaccine. This trial will evaluate the safety and immunogenic response of the vaccine, which is based on Entos' proprietary Fusogenix PLV nucleic acid delivery platform. The vaccine is designed to target key antigens of the SARS-CoV-2 virus, particularly focusing on the omicron variants currently in circulation.

The clinical trial, listed under NCT06436911, will start with a phase 1 segment, enrolling 50 participants. This initial phase aims to determine the optimal booster dose of Covigenix VAX-002, testing either 100 μg or 250 μg. Following this, phase 2 will involve 250 participants and will further assess the safety and immune response to the selected dose from phase 1. Insights gained from this study will be crucial for future intramuscular dosing and global development plans for the vaccine.

Steve Chen, M.D., Chief Medical Officer at Entos, emphasized the ongoing need for robust COVID-19 vaccines, particularly for elderly and immunocompromised individuals, and highlighted the importance of a fridge-stable vaccine for use in developing countries. Covigenix VAX-002 promises to be the first DNA vaccine offering prolonged protection and stability at refrigeration temperatures, setting it apart from other vaccines currently available.

The booster vaccine is produced at Entos' Good Manufacturing Practices (GMP) facility in Carlsbad, California. This facility was constructed to support the clinical development of Entos' genetic medicine programs, including Covigenix VAX-002, and to advance future candidates in various fields such as rare diseases, ophthalmic conditions, oncology, and infectious diseases.

Arun Raturi, Ph.D., Chief Scientific Officer at Entos, noted that Health Canada's approval marks a significant milestone for the company, as it allows Covigenix VAX-002 to be the first GMP clinical vaccine entirely manufactured in-house. The phase 1/2 trial will not only explore the vaccine's potential effectiveness in providing a COVID-19 booster but will also help validate the Fusogenix platform for future therapeutic developments.

Entos Pharmaceuticals, established in 2016, is focused on advancing genetic medicines through its Fusogenix PLV drug delivery system, which uses FAST proteins to facilitate direct fusion and delivery of nucleic acids to target cells. Entos has partnered with notable companies like Eli Lilly to broaden the impact of its platform. The company is headquartered in Edmonton, Canada, with subsidiaries in San Diego, California, and London, United Kingdom.

Aegis Life, a collaborator on this project, specializes in developing genetic vaccines and therapies targeting severe infectious diseases, utilizing the Fusogenix PLV platform created by Entos. This platform allows for the rapid development of RNA or DNA vaccines and therapeutics, promising significant advancements in the field of genetic medicine.