Affinia Therapeutics Presents AFTX-201 Data and UPBEAT© Clinical Trial Design for BAG3-Associated Dilated Cardiomyopathy, Alongside Advances in BBB-Penetrant AAV Capsids and Proprietary Manufacturing, at the 29th ASGCT 2026 Annual Meeting

Excerpt from the Press Release:

WALTHAM, Mass.–(BUSINESS WIRE)–Affinia Therapeutics (“Affinia”), an innovative clinical-stage gene therapy company with a pipeline of first-in-class and/or best-in-class adeno-associated virus (AAV) gene therapies initially for devastating cardiovascular diseases, today announced the presentation of new preclinical and translational data on the company’s lead program AFTX-201, the design of the Phase 1/2 UPBEAT^© clinical trial investigating AFTX-201 in patients with BAG3-associated dilated cardiomyopathy (DCM), Affinia’s blood-brain-barrier (BBB)-penetrant AAV capsids, and Affinia’s proprietary high-yield manufacturing process. This research was presented in several oral and poster sessions at the 29^th American Society of Gene & Cell Therapy (ASGCT) 2026 Annual Meeting, being held May 11-15, 2026 in Boston, MA, and virtually.

AFTX-201 is a potential best-in-class investigational genetic medicine for the treatment of BAG3-associated DCM. AFTX-201 is designed to deliver a fully human, full-length BAG3 transgene using Affinia’s proprietary capsid engineered for efficient cardiac transduction at doses that are 5-10-fold lower than those associated with gene therapies using conventional capsids such as AAV9 or AAVrh74. The UPBEAT clinical trial is investigating the safety and efficacy of AFTX-201 as a treatment for people living with BAG3 DCM. AFTX-201 is given as a simple one-time intravenous administration. AFTX-201 increased BAG3 protein levels in the heart and fully restored cardiac function in an animal model of BAG3 DCM.

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