Aegis Life and Entos Complete Phase 1 COVID-19 Booster Trial Enrollment

Aegis Life, Inc. (Aegis) and its partner Entos Pharmaceuticals (Entos) have announced the completion of participant enrollment for the Phase 1 portion of their Phase 1/2 clinical trial of Covigenix VAX-002 (NCT06436911). This clinical trial aims to evaluate Covigenix VAX-002 as a booster vaccine for COVID-19. The Covigenix VAX-002 vaccine is formulated using the Entos Fusogenix™ PLV™ technology, which employs plasmid DNA to express key antigens of SARS-CoV-2, specifically targeting the currently circulating omicron strains of the virus. The Phase 1 portion of the trial began enrollment in August 2024, and the results of this phase are expected to help determine the optimal dose for the Phase 2 portion of the study. The development of the Fusogenix platform is elaborated in a recent publication in the journal Cell.

The clinical trial is being conducted at 12 different sites across Canada. The primary goal of Phase 1 is to assess the safety and determine the optimal dosage of Covigenix VAX-002 as a COVID-19 booster vaccine. An interim analysis of the Phase 1 cohort will be used to guide the dosing schedule for Phase 2. During the second phase, the emphasis will be on evaluating the vaccine's safety and the immune response elicited by the optimal dose.

Dr. Steve Chen, the Chief Medical Officer at Aegis, expressed his gratitude to the clinical sites and participants involved in the trial, emphasizing the enthusiasm within the clinical community regarding Covigenix VAX-002's potential to generate strong immunity against the current SARS-CoV-2 strains. He remarked that the rapid enrollment in the Phase 1 portion of the study reflects the excitement surrounding the vaccine's potential. Dr. Chen also believes that utilizing the DNA cargo capability of the Fusogenix PLV platform in Covigenix VAX-002 could result in a more durable and effective booster vaccine compared to current options.

Recent studies validating the safety and efficacy of the Fusogenix platform for DNA delivery were published in Cell. These studies indicate that the proteolipid vehicles using FAST protein can overcome the limitations associated with current viral and non-viral genetic medicine delivery systems. Benefits of the FAST-PLV system include enhanced delivery to tissues outside of the liver, the ability to re-dose, and improved expression of genetic medicines in various tissues.

Aegis Life, Inc. is focused on developing next-generation genetic vaccines and therapies for the world's most dangerous infectious diseases. The company leverages the Fusogenix PLV platform created by Entos Pharmaceuticals for rapid development of safe and effective RNA or DNA vaccines and therapeutics.

Entos Pharmaceuticals Inc. is at the forefront of genetic medicine, aiming to revolutionize the field with its innovative nucleic acid delivery technologies. Since its establishment in 2016, Entos has been committed to advancing genetic medicines using its proprietary Fusogenix™ PLV™ drug delivery system. This platform, formulated with FAST proteins, facilitates the delivery of nucleic acids to target cells through direct fusion. Entos is pioneering the development of transformative medicines and has established partnerships with global companies such as Eli Lilly to expand the capabilities and impact of their platform. Entos Pharmaceuticals Inc. is headquartered in Edmonton, Canada, with subsidiaries in San Diego, California, and London, United Kingdom.