Entos Pharmaceuticals, Inc.

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, Fusogenix TM and PLV TM are registered trademarks of Entos Pharmaceuticals Inc. All other trademarks and registered trademarks are the property of their respective owners.

SEATTLE--( BUSINESS WIRE )-- Oisín Biotechnologies (Oisín), a privately held biotechnology company focused on mitigating the effects of age-related diseases, today announced the publication of preclinical data from its follistatin (FST) gene therapy program to mitigate muscle loss in an article titled “Safe and Effective Delivery of DNA and RNA Using Proteolipid Vehicles” in Cell. Scientists at Oisín, OncoSenX , the University of Alberta , Dalhousie University , and Aegis Life, Inc. , contributed to the published research led by Entos ® Pharmaceuticals , inventor of the FAST-PLV™ platform. The article is available from Cell online today and in print on September 19th. “When we set out to build cutting-edge genetic medicines to address age-related diseases, we knew the ability to deliver nucleic acids safely and effectively to a broad array of cell types would be essential to our success,” said Matthew Scholz, chief executive officer, Oisín Biotechnologies. “We placed an early bet on the Entos FAST-PLV system because it has the potential to overcome the biodistribution, tolerability, and repeat-dosing limitations of other commonly used delivery systems. The data published today in Cell validate that choice and provide important proof-of-principle for our follistatin gene therapy program. As we utilize the FAST-PLV system in our other ongoing development programs, the remarkable flexibility of the platform continues to support the broader potential of our genetic medicine approach to addressing age-related diseases.” The published data include results from studies conducted by Oisín scientists evaluating the impact of administering a single dose of FAST-PLV FST gene therapy in mice, over time. After 15 weeks, the mice administered with FST gene therapy had significantly greater grip strength and body weight increases than the control group. At 34 weeks, the FST gene therapy mice showed significant increases in muscle size, especially in the hind limbs and throughout the torso, that correlated with a significant increase in cross-sectional muscle fiber area compared with the control group. “Muscle loss is associated with age-related frailty, which affects the mobility and quality of life for millions of elderly people,” said Henry Garcia, Ph.D., head of Aging R&D at Oisín. “With an aging population and the increasing use of GLP-1 class agonists to treat diabetes and obesity, there is a growing need for a therapy that can safely and effectively mitigate the side effect of muscle loss and, ideally, rebuild muscle.” FAST-PLVs form the basis of the Entos Fusogenix™ PLV delivery platform. This technology is licensed to Oisin for the development of age-related disease applications. In July 2024 , Oisín announced the first close of a $15 million Series A financing round, to advance its age-related disease therapy portfolio. About Oisín Biotechnologies Oisín is a privately held biotechnology company developing genetic medicines to address age-related diseases. Headquartered in Seattle, Washington, Oisín utilizes the Entos ® Fusogenix™ PLV™ delivery platform to deliver DNA directly to cells throughout the body, addressing the damage and detrimental effects caused by the aging process itself. The company’s first therapies focus on eliminating unwanted fat cells and building muscle mass. For more information, visit www.oisinbio.com or follow Oisín on X and 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 TM PLV TM 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. For more information, visit www.entospharma.com , or follow Entos on LinkedIn . Entos ® word mark and design logo, Fusogenix TM and PLV TM are registered trademarks of Entos Pharmaceuticals Inc. All other trademarks and registered trademarks are the property of their respective owners.

EDMONTON, Alberta--( BUSINESS WIRE )-- Entos ® Pharmaceuticals (Entos), a clinical-stage genetic medicines company committed to using its Fusogenix™ PLV™ technology to develop cures and improve the lives of patients and their families, today announced the publication of a research article in Cell. The article, titled “ Safe and Effective Delivery of DNA and RNA Using Proteolipid Vehicles ,” details the development of a novel delivery platform for nucleic acid medicines that overcomes the limitations of current delivery systems. Incorporating fusion associated small transmembrane (FAST) proteins into a proteo-lipid vehicle (PLV), or FAST-PLV, this new platform can effectively deliver mRNA or plasmid DNA into a wide variety of cells and tissues with low immunogenicity and broad distribution throughout the body. Entos led research that involved collaborators from the University of Alberta , Dalhousie University , Oisín Biotechnologies and Aegis Life, Inc. , to develop the platform and conduct studies demonstrating its advantages over lipid nanoparticle (LNP) delivery systems. The research findings were published by Cell online this morning and will appear in the journal’s September 19 th print issue. “Currently AAV and LNPs are the main delivery platforms for genetic medicine. Both platforms have significantly advanced the field with approved therapies and vaccines for a variety of serious and often life-threatening diseases,” said John Lewis, Ph.D., senior author of the study and Bird Dogs Chair of Translational Oncology at the University of Alberta and CEO of Entos Pharmaceuticals. “Despite these advancements, gaps remain in the ability of current technologies to fully realize the potential of genetic medicines. We designed the FAST-PLV platform to bridge these gaps and deliver on the promise of genetic medicines that patients urgently need.” The FAST-PLV platform is a fusion-powered delivery system for genetic medicines that combines aspects of viral and non-viral approaches to leverage a completely new mechanism for intracellular delivery of RNA and DNA. While AAV and LNP rely on endocytosis, the FAST protein enables direct fusion of the PLV to the plasma membrane of target cells. This substantially improves the potency and tolerability of genetic medicines, while enabling the development of formulations that are inherently non-liver tropic, enabling the delivery of therapeutic doses of nucleic acid therapies to cells and tissues throughout the body. In this work, the platform was evaluated for safety, efficacy, and biodistribution in various animal models, as well as demonstrating that the FAST-PLV platform is non-immunogenic, which allows for repeat dosing of genetic medicines. “I am incredibly proud of the strides we've made in genetic medicine with our FAST-PLV platform. This breakthrough not only underscores the potential of our technology to overcome current limitations in gene delivery but also reinforces our commitment to developing safer, more effective, and re-dosable therapies for patients. The publication of our work in Cell is a significant milestone, and we believe it marks the beginning of a new era in the field of genetic medicine,” said Arun Raturi PhD., senior author and CSO of Entos Pharmaceuticals. FAST-PLVs form the basis of Entos’ Fusogenix™ PLV™ delivery platform, which is being utilized by Entos Pharmaceuticals to develop novel therapies for congenital generalized lipodystrophy, obesity, Stargardt disease and cystic fibrosis in addition to its clinical VAX-002 vaccine program. Entos and its valued partners are developing applications in the central and peripheral nervous systems, oncology, longevity and more. 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 TM PLV TM 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. 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 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. Entos ® word mark and design logo, Fusogenix TM and PLV TM are registered trademarks of Entos Pharmaceuticals Inc. All other trademarks and registered trademarks are the property of their respective owners.