WALTHAM, Mass.– Affinia Therapeutics, a biotechnology company developing first-in-class and best-in-class adeno-associated virus (AAV) gene therapies for severe cardiovascular and neurological diseases, announced it has closed a $40 million Series C financing round. The round was led by New Enterprise Associates (NEA) with participation from new investor Eli Lilly & Company and existing investors including Alexandria Venture Investments, Atlas Venture, Avidity Partners, F-Prime, GV (formerly Google Ventures), Mass General Brigham Ventures, and Perceptive Advisors.
The proceeds will support clinical advancement of Affinia’s lead program, AFTX-201, a potential first- and best-in-class genetic medicine for BAG3 dilated cardiomyopathy (DCM). The company expects to submit an Investigational New Drug (IND) application to the U.S. Food and Drug Administration in the fourth quarter of 2025, followed by initiation of the Phase 1/2 UPBEAT clinical trial in early 2026. IND-enabling studies for AFTX-201 are currently underway after a successful pre-IND meeting with the FDA.
“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,” said Ed Mathers, General Partner at NEA and Affinia Board Member.
Affinia has applied its generative AI discovery platform to create novel myotropic capsids that specifically target cardiac and skeletal muscle tissue while detargeting the liver. AFTX-201 delivers a fully human, full-length BAG3 transgene through Affinia’s engineered cardiotropic capsid, achieving high-efficiency cardiac transduction at low doses. It is intended as a one-time intravenous infusion. Preclinical studies demonstrated that AFTX-201 restored normal cardiac function and increased BAG3 protein levels in animal models—results not seen with conventional capsids at equivalent doses.
“We are grateful to this outstanding group of institutional and strategic investors who share our excitement about our cardiotropic capsid technology and pipeline,” said Rick Modi, Chief Executive Officer of Affinia Therapeutics. “This financing brings us one step closer to advancing AFTX-201 toward the clinic and ultimately delivering the first-in-class, best-in-class genetic medicine for BAG3 DCM.”
BAG3 dilated cardiomyopathy is an inherited heart condition marked by mutations in the BAG3 gene, which lead to loss of critical protein function in cardiac cells. The disease affects more than 70,000 patients across the United States, Europe, and the United Kingdom and is associated with high mortality and early-onset heart failure. Despite standard-of-care treatments, up to 25 percent of patients eventually require heart transplantation.
