Affinia Therapeutics Inc.

Affinia Therapeutics is a clinical-stage biotechnology company headquartered in Waltham, Massachusetts, focused on developing transformative gene therapies. The company's core mission is to make a lasting positive impact on the lives of individuals affected by devastating rare and prevalent diseases by systematically engineering next-generation adeno-associated virus (AAV) vectors.

Leveraging its proprietary ART (Affinia Rationally-designed Therapies) platform, Affinia Therapeutics utilizes advanced tools such as artificial intelligence, structural modeling, and next-generation sequencing to re-engineer the fundamental components of gene therapy: capsids, payloads, and manufacturing processes. This approach aims to enhance tissue targeting, improve safety and efficacy, and optimize manufacturability. The company's pipeline includes product candidates for cardiovascular and neurological diseases, with its lead program, AFTX-201, targeting BAG3-associated dilated cardiomyopathy (DCM), a genetic heart disease.

In recent developments, Affinia Therapeutics announced a $40 million Series C financing round in October 2025. The company received FDA approval for an Investigational New Drug (IND) application for AFTX-201 and was granted Fast Track designation in the first quarter of 2026. Additionally, Health Canada approved a Clinical Trial Application for the UPBEAT trial for AFTX-201, and the European Medicines Agency granted Orphan Drug designation for the same program. Rick Modi serves as the Chief Executive Officer, leading the company's efforts to advance its gene therapy pipeline.