AFTX-201 / Affinia Therap - LARVOL DELTA

Process Development, Technology Transfer, Clinical Manufacturing and Process Characterization of AFTX-201, an Investigational New Medicine for the Treatment of BAG3-Associated Dilated Cardiomyopathy (ASGCT 2026) - No abstract available

Clinical • Cardiomyopathy • Cardiovascular

AFTX-201: A Novel Investigational AAV Gene Therapy for the Treatment of BAG3-Associated Dilated Cardiomyopathy (ASGCT 2026) - No abstract available

Gene therapy • Cardiomyopathy • Cardiovascular • Gene Therapies

Affinia Therapeutics Granted FDA Fast Track Designation for AFTX-201 as a Treatment for People Living with BAG3-Associated Dilated Cardiomyopathy (DCM) (Yahoo Finance)

Fast track • Cardiomyopathy

UPBEAT: An AAV Gene Therapy Trial of AFTX-201 in Adults With BAG3-Associated Dilated Cardiomyopathy (DCM) (clinicaltrials.gov) - P1/2 | N=22 | Not yet recruiting | Sponsor: Affinia Therapeutics

IO biomarker • New P1/2 trial • Cardiomyopathy • Cardiovascular • Gene Therapies • BAG3

Affinia Therapeutics Receives European Medicines Agency Orphan Drug Designation for AFTX-201 in BAG3-Associated Dilated Cardiomyopathy (DCM) (Businesswire)

Orphan drug • Cardiomyopathy

Development of a Flexible High Yielding, High Performing Process for Manufacturing of AFTX-201, a Novel Investigational AAV Gene Therapy for Treatment of BAG3 Dilated Cardiomyopathy (ASGCT 2025) - "Additionally, the high yields enabled a reduction in Toxicology and Clinical lot production scale from 250L to 50L, resulting in significant cost savings without compromising quality. Disease Focus of Abstract:Cardiovascular/Heart Disease"

Gene therapy • B Cell Lymphoma • Cardiomyopathy • Cardiovascular • Congestive Heart Failure • Gene Therapies • Heart Failure • Lymphoma • Oncology • BAG3 • BCL2

A Novel Investigational AAV Gene Therapy for Treatment of BAG3 Dilated Cardiomyopathy (ASGCT 2025) - "This trial aims to evaluate the safety, tolerability, and pharmacodynamics of AFTX-201, administered as a single intravenous dose to adult patients with symptomatic BAG3 mutation-associated dilated cardiomyopathy (DCM). Disease Focus of Abstract:Cardiovascular/Heart Disease"

Gene therapy • IO biomarker • B Cell Lymphoma • Cardiomyopathy • Cardiovascular • Congestive Heart Failure • Gene Therapies • Heart Failure • Lymphoma • Oncology • BAG3 • BCL2

Affinia Therapeutics to Present New Data on its AFTX-201 Program in BAG3 Dilated Cardiomyopathy, BBB-Penetrant AAV Capsids, and Proprietary Manufacturing Technology at the 28th Annual American Society of Gene & Cell Therapy 2025 Annual Meeting (Businesswire) - "Affinia Therapeutics...announced that new preclinical data on AFTX-201, its lead program for BAG3 dilated cardiomyopathy (DCM), as well as its novel AAV capsids for diseases of the central nervous system (CNS), and the company’s high-yield manufacturing process, will be presented in several oral and poster sessions at the 28th Annual American Society of Gene and Cell Therapy (ASGCT) 2025 Annual Meeting....Preclinical studies with AFTX-201 have shown correction of BAG-3 protein levels in the heart and complete restoration of cardiac function, whereas such benefits were not achieved with the same gene construct using a conventional capsid at the same dose....AFTX-201 in BAG3 dilated cardiomyopathy, on track for IND submission fourth quarter of 2025 with potential initial readouts of clinical trial safety and efficacy first half of 2026."

IND • Preclinical • Cardiomyopathy

Affinia Therapeutics Announces Development Candidate for BAG3 DCM and Completion of Pre-IND Meeting with the FDA (PRNewswire) - "Affinia Therapeutics...today announced the nomination of AFTX-201 as the company's development candidate for the treatment of BAG3 dilated cardiomyopathy (DCM)...Affinia completed a successful pre-IND meeting with the U.S. Food and Drug Administration (FDA) in late 2024 and plans to file an IND in the fourth quarter of 2025."

FDA event • IND • Cardiomyopathy