Entos Pharmaceuticals, Inc.

Welcome to Endpoints News’ manufacturing briefs, where we bring you essential news on new builds, collaborations, recalls and more. The Government of Canada is contributing $62 million to Entos Pharmaceuticals to build a 103,000 square-foot manufacturing and R&D facility in Edmonton, Alberta. The build will cost a total of $198.5 million and will hire 90 new employees, according to a Tuesday release. CDMO Vetter is investing over €150 million ($163 million) to expand its warehouse in Ravensburg, Germany. The move will increase its cool storage services, according to a Tuesday release. The European Commission has launched a new regulation called the Critical Medicines Act to improve the continent’s pharma supply chains. The act will increase or improve EU manufacturing capacity for raw materials and drug products, among others. Some member states will or have received financial support to improve manufacturing, according to a Monday release. The Noramco Group is investing $25 million into its factory in Whippany, NJ, to expand manufacturing of sterile injectables, syringes and vials, the company said Monday. Scimplify has secured $40 million in a Series B raise, which will be used to scale up its chemical manufacturing platform, the company announced Wednesday. LGM Pharma is investing over $6 million to expand its Rosenberg, TX, manufacturing site for making liquid, semi-solid and suppository drug products, the company said Wednesday. WuXi XDC has signed a memorandum of understanding with the South Korean biotech AbTis, the company said Tuesday. WuXi will provide its ADC discovery services and manufacturing platform and AbTis will bring its conjugation tech. Emergent BioSolutions and Swiss vaccine company Rocketvax have entered into a new partnership . Emergent will manufacture and commercialize four of Rocketvax’s clinical stage assets, the companies said Wednesday. RoslinCT and Ayrmid Pharma announced their intent to partner on the production of the cell therapy Omisirge for blood cancer, the companies announced Tuesday. RoslinCT will tech transfer and commercially make the drug at its site in Hopkinton, MA.

Entos Pharmaceuticals, a spinout of the University of Alberta, linked up with Eli Lilly in a research collaboration and licensing agreement in 2022. With grant funding from governments at multiple levels in Canada, Entos Pharmaceuticals is looking to plant roots at a CAD $198.5 million ($137.2 million) R&D and manufacturing hub in Edmonton.The 103,000-square-foot R&D center and biomanufacturing plant will be used to develop and produce the company’s Fusogenix proteolipid vehicles (PLVs). The space will support the University of Alberta spin-off's continued evolution, building on its partnership with Eli Lilly centered on the PLV drug delivery technology. In 2022, Lilly shelled out $50 million upfront for exclusive rights to use the tech for nucleic acid-based products targeting the central and peripheral nervous systems.Besides aiding Entos' industry collaborations, the new digs will help to build out Canada’s capacity for domestic drug manufacturing, the company noted in a press release. The Government of Canada agreed to chip in $62 million CAD ($42.8 million) for the site, while the Government of Alberta committed $15.5 million CAD ($10.7 million).Entos was born from the University of Alberta’s Faculty of Medicine & Dentistry and formed as its own entity in 2016.“Our government is protecting the Canadians of tomorrow by making the necessary investments today,” Canada’s Minister of Innovation, Science and Industry, François-Philippe Champagne, said in the release. “By supporting the construction of this state-of-the-art facility in Edmonton, we are strengthening our capacity to produce cutting-edge therapeutics and vaccines, which will better equip Canada in responding to future health emergencies.” Canada has been home to a few new facilities in life sciences lately as the country looks to increase its domestic supply, including a cell and gene manufacturing plant from CDMO OmniaBio and the country’s largest vaccine manufacturing site courtesy of Sanofi.Entos, meanwhile, is “thrilled to receive this investment,” CEO John Lewis said in a statement. “It will help us develop, scale up, produce, and commercialize Fusogenix PLV therapeutics to address critical health needs and fill gaps in Canada’s domestic manufacturing capacity," he added.The company, which also operates in San Diego, California and London, England, uses its proprietary fusogenic fusion associated small transmembrane (FAST) proteins to enable the delivery of mRNA or DNA into target cells. Before Lilly hopped on board, Entos and BioMarin entered into a collaboration in 2021, although that partnership is no longer listed on the company’s website.Separately, Entos is working on drug candidates in cystic fibrosis, Stargardt disease and obesity, including a GLP-1 gene therapy program.

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.