SAN DIEGO, Calif. & EDMONTON, Alberta--(BUSINESS WIRE)--Aegis Life, Inc. (Aegis) and its partner Entos® Pharmaceuticals (Entos), announced today that the Phase 1 portion of a Phase 1/2 clinical trial of Covigenix VAX-002 (NCT06436911) evaluating it as a COVID-19 booster vaccine is fully enrolled. Covigenix VAX-002 is formulated using the Entos Fusogenix™ PLV™ technology and plasmid DNA expressing key SARS-CoV-2 antigens to protect against the current circulating omicron strains of SARS-CoV-2. Enrollment in the phase 1 portion of the study was initiated in August 2024. The development of the Fusogenix platform for DNA delivery is detailed in a publication released today in print in Cell.
The phase 1/2 trial is being conducted at 12 sites in Canada. The phase 1 portion is intended to determine the safety and the optimal dose of Covigenix VAX-002 as a COVID-19 booster vaccine. The trial design includes an interim analysis of the phase 1 cohort, the results of which will inform the dosing schedule for phase 2. The phase 2 portion of the trial aims to evaluate the safety and immunogenicity response of the optimal dose.
“We’d like to thank the sites for their efforts and most importantly the individuals who have participated in the trial in the spirit of advancing our science. Our ability to enroll the phase 1 portion of this study in just a few weeks reflects the excitement in the clinical community about the potential of Covigenix VAX-002 to stimulate potent immunity against the current SARS-CoV-2 strains,” said Steve Chen, M.D., Chief Medical Officer at Aegis. “We believe that leveraging the DNA cargo capacity of the Fusogenix PLV platform in Covigenix VAX-002 could provide a more durable and effective vaccine booster than what is available today.”
Data from studies validating the safety and efficacy of the Fusogenix platform as a novel approach for delivering DNA to cells were recently published in Cell. Results of these studies demonstrate that proteolipid vehicles using FAST protein overcome the limitations of current viral and non-viral genetic medicine delivery systems. Benefits of the FAST-PLV system include improved delivery to tissues other than the liver, the ability to re-dose, and enhanced expression of genetic medicines in tissues beyond the liver.
About Aegis Life, Inc.
At Aegis Life, we develop next generation genetic vaccines and therapies for the world’s most dangerous infectious diseases. Leveraging the Fusogenix PLV platform developed by Entos® Pharmaceuticals, for nucleic acid delivery, this breakthrough non-viral gene delivery platform allows us to rapidly develop and advance safe and effective RNA or DNA vaccines and therapeutics. For more information, visit www.aegis.life or follow Aegis on LinkedIn.
About Entos Pharmaceuticals Inc.
A new reality in genetic medicine lies ahead, one that will be ushered in with the advent of safe, effective, and re-dosable nucleic acid delivery technologies. Since its inception in 2016, Entos® has been dedicated to advancing next-generation genetic medicines using our proprietary Fusogenix™ PLV™ drug delivery system. The Fusogenix PLV platform is formulated with FAST proteins to enable the delivery of nucleic acids to target cells through direct fusion. Entos is pioneering the development of life-changing medicines for patients and has partnered with global companies, such as Eli Lilly, to accelerate and expand the impact of our platform. Entos Pharmaceuticals Inc. is headquartered in Edmonton, Canada, with its wholly owned U.S. and U.K. subsidiaries based in San Diego, California and London, United Kingdom, respectively. For more information, visit www.entospharma.com, or follow Entos on LinkedIn.
Forward Looking Statements
This press release contains forward-looking statements, within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements contained in this press release include statements regarding Aegis and their belief as to the mode of action and potential and benefits of the Entos Fusogenix-PLV platform and the mode of action and potential and benefits of Covigenix VAX-002 for the treatment of COVID-19; and other statements related to anticipated developments in the Company’s business and technologies. In any forward-looking statement in which Aegis expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation, or belief will be achieved. Such forward-looking statements involve known and unknown risks and uncertainties, which could cause the Company’s actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of Fusogenix as a nucleic acid delivery vehicle, the efficacy of Covigenix VAX-002, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. We may incur expenses or delays relating to such events outside of our control, which could have a material adverse impact on our business, operating results, and financial condition. Investors should consult with the U.S. Securities Commission for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake any obligation to update these forward-looking statements except as required by applicable laws.
Entos® word mark and design logo, FusogenixTM and PLVTM are registered trademarks of Entos Pharmaceuticals Inc. All other trademarks and registered trademarks are the property of their respective owners.
