TLDR: Affinia Therapeutics has successfully closed a $40 million Series C financing round, led by New Enterprise Associates (NEA) with new participation from Eli Lilly & Company. The funding will primarily fuel the development of its lead gene therapy program, AFTX-201, aimed at treating BAG3 dilated cardiomyopathy, and further advance its pipeline for other cardiovascular and neurological diseases. The company plans to submit an IND for AFTX-201 in Q4 2025, with a Phase 1/2 clinical trial anticipated in Q1 2026.
WALTHAM, MA – Affinia Therapeutics, a pioneering gene therapy company, has announced the successful closure of a $40 million Series C financing round. This significant capital infusion is set to accelerate the development of its innovative gene therapies targeting devastating cardiovascular and neurological diseases.
The financing round was spearheaded by New Enterprise Associates (NEA), a prominent venture capital firm, and saw the introduction of new investor Eli Lilly & Company. Existing investors, including Alexandria Venture Investments, LLC, Atlas Venture, Avidity Partners, F-Prime, GV (formerly Google Ventures), Mass General Brigham Ventures, and Perceptive Advisors, also demonstrated continued support by participating in the round.
The primary allocation of these funds will be directed towards advancing Affinia’s lead program, AFTX-201. This investigational genetic medicine is being developed as a potential first-in-class and best-in-class treatment for BAG3 dilated cardiomyopathy (DCM), a severe monogenic heart disease. BAG3 DCM affects over 70,000 patients across the U.S., Europe, and the U.K. alone, with a significant portion—nearly 25%—requiring heart transplants despite current standard care options.
AFTX-201 is engineered to deliver a fully human, full-length BAG3 transgene utilizing Affinia’s proprietary cardiotropic capsid. This novel capsid is designed for efficient and selective cardiac transduction at low doses, offering a targeted approach to treatment. The therapy is intended for a simple, one-time intravenous administration. Preclinical studies have yielded promising results, demonstrating that AFTX-201 improved BAG3 protein levels in the heart and completely restored cardiac function in animal disease models, a benefit not observed with conventional capsid approaches at the same dosage.
Looking ahead, Affinia Therapeutics anticipates submitting an Investigational New Drug (IND) application for AFTX-201 in the fourth quarter of 2025. Following potential acceptance by the U.S. Food and Drug Administration (FDA), the company aims to initiate the UPBEAT trial, a Phase 1/2 clinical trial for patients with BAG3 DCM, in the first quarter of 2026.
Beyond AFTX-201, the Series C funding will also bolster the advancement of Affinia’s broader gene therapy pipeline. The company’s approach leverages proprietary next-generation capsids, payloads, and manufacturing techniques. Notably, Affinia has applied its generative AI discovery platform to engineer novel myotropic capsids, specifically designed to target the heart and skeletal muscles while detargeting the liver, showcasing a cutting-edge application of artificial intelligence in drug discovery.
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Ed Mathers, General Partner at NEA, expressed his confidence in the company, stating, ‘We are pleased to be joined by this world-class syndicate of investors who share our enthusiasm about Affinia’s science and robust pipeline to treat devastating cardiovascular and neurological diseases.’ This sentiment underscores the strong investor belief in Affinia’s innovative platform and its potential to address critical unmet medical needs.
