Entos Pharmaceuticals Receives Approval from Health Canada to Begin Clinical Trial for COVID-19 Vaccine Booster

EDMONTON, Alberta & SAN DIEGO–()–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 that Entos has received approval from Health Canada to initiate a phase 1/2 clinical trial (NCT06436911) 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.”

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 FusogenixTM PLVTM drug delivery system. The Fusogenix PLV platform is formulated with FASTTM 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, FusogenixTM, PLVTM and FASTTM 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.

Source: http://www.businesswire.com/news/home/20240610041728/en/Entos-Pharmaceuticals-Receives-Approval-from-Health-Canada-to-Begin-Clinical-Trial-for-COVID-19-Vaccine-Booster/?feedref=JjAwJuNHiystnCoBq_hl-bQQCakZDujohEJegUyaJwquReQ0P23MrIoWkrUSV24ZevRMp3sIgu8q3wq1OF24lT93qbEzrwa15HGbLqMObxbNWfZlBntHS6jpH5ROLXsTFMkl05DM8ABqeyBleEmzJA==

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