EDMONTON, Alberta & SAN DIEGO--(BUSINESS WIRE)--Entos® Pharmaceuticals (Entos or the Company), a clinical-stage biotechnology company developing genetic medicines with its proprietary Fusogenix™ PLV™ nucleic acid delivery platform, and its partner, Aegis Life, Inc. (Aegis), today announced the first participant has been dosed in the phase 1/2 clinical trial (NCT06436911) evaluating Covigenix VAX-002 as a COVID-19 booster vaccine.
The phase 1/2 trial is sponsored by Entos and managed by Calian. The trial is being conducted at 12 sites in Canada including sites planned in Alberta, Ontario, Quebec, and Nova Scotia. The phase 1 portion of the study is intended to determine the optimal dose of Covigenix VAX-002 for booster vaccination, with 50 participants. The phase 2 portion of the trial aims to evaluate the safety and immunogenicity response of the optimal dose, with 250 participants.
"We're excited to announce the first patient dosed in the phase 1/2 trial of our COVID-19 DNA vaccine booster candidate,” said John Lewis, CEO, Entos Pharmaceuticals. “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 is formulated using the Entos Fusogenix PLV delivery platform and plasmid DNA optimized to express key SARS-CoV-2 antigens to protect against the currently circulating omicron strains of SARS-CoV-2. The first patient was dosed at one of the Quebec sites, conducted by DIEX Recherche.
“COVID-19 will remain a public health issue, as evidenced in this summer’s surge of infections,” said Steve Chen, MD, CMO, Entos Pharmaceuticals. “Leveraging plasmid DNA cargo, Covigenix VAX-002 has the potential to offer a more durable alternative to what is currently available.”
“This phase 1/2 trial is important because it tests a new method of delivering protection against the virus that causes COVID-19,” said Jean-François Roussy, principal investigator at DIEX Recherche. “More than four years after the emergence of the pandemic, we still need new vaccine options that offer robust protection and easy administration. We are pleased to partner with Entos to conduct the trial and contribute to the understanding of the potential for Covigenix VAX-002 to positively impact global public health.”
Aegis has worldwide rights to the vaccine candidate outside of Canada and continues to support the vaccine trials as a global commercialization partner for the Entos Fusogenix PLV platform. Entos’ other genetic medicine programs include clinical candidates for partnered programs and future candidates in rare disease, eye and ophthalmic conditions, oncology, and infectious diseases.
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 acid 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. Entos® word mark and design logo, Fusogenix™ and PLV™ are registered trademarks of Entos Pharmaceuticals Inc. All other trademarks and registered trademarks are the property of their respective owners. For more information, visit www.entospharma.com, or follow Entos on LinkedIn.
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 for nucleic acid delivery, developed by parent company Entos Pharmaceuticals, 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.
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 Entos and its belief as to the mode of action and potential and benefits of the Fusogenix proteolipid vehicle 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 Entos 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.
