Affinia Therapeutics, a biotechnology company pioneering engineered adeno-associated virus (AAV) gene therapies for severe cardiovascular and neurological conditions, has announced the closing of a $40 million Series C financing round. The funding was led by New Enterprise Associates (NEA), with participation from new investor Eli Lilly & Company, as well as existing investors Alexandria Venture Investments, Atlas Venture, Avidity Partners, F-Prime Capital, GV (formerly Google Ventures), Mass General Brigham Ventures, and Perceptive Advisors.
The new capital will accelerate the clinical development of Affinia’s lead program, AFTX-201, a potential first-in-class and best-in-class genetic medicine targeting BAG3 dilated cardiomyopathy (DCM)—a severe and inherited form of heart failure.
The company plans to submit an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) by the fourth quarter of 2025, and, pending approval, launch UPBEAT, a Phase 1/2 clinical trial, in early 2026.
Affinia’s approach represents a significant leap in the gene therapy field. Leveraging its generative AI-driven discovery platform, the company engineers novel myotropic capsids—AAV delivery systems optimized explicitly for cardiac and skeletal muscle targeting while minimizing liver exposure.
This platform enables highly selective gene delivery, enhanced efficacy, and reduced off-target risks, addressing one of the key challenges of traditional gene therapy.
The company’s investigational therapy, AFTX-201, is designed to deliver a fully human, full-length BAG3 transgene using a novel cardiotropic capsid for efficient and precise cardiac transduction at low doses. Administered as a one-time intravenous treatment, AFTX-201 has shown remarkable preclinical results: in animal models, it restored cardiac function and normalized BAG3 protein levels—outperforming conventional AAV constructs at equivalent doses.
The newly secured funding will also enable Affinia to advance its broader pipeline of next-generation gene therapies targeting other devastating diseases with significant unmet needs.
BAG3 DCM represents one of the most severe inherited heart diseases, affecting more than 70,000 people across the U.S., Europe, and the U.K.. Caused by mutations in the Bcl2-associated athanogene 3 (BAG3) gene, the disease leads to structural and functional deficiencies in heart muscle cells, resulting in progressive heart failure. Despite existing treatments, approximately 25% of patients ultimately require a heart transplant, highlighting the urgent need for transformative therapies like AFTX-201.
KEY QUOTES:
“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.”
Ed Mathers, General Partner at New Enterprise Associates (NEA) and Affinia Board Member
“We are grateful to this outstanding group of institutional and strategic investors who share our excitement about our novel, cardiotropic capsids and pipeline. This financing recognizes the potential of our novel capsids and the value of our lead program AFTX-201, bringing it one step closer to potentially become the first-in-class and best-in-class genetic medicine to treat BAG3 DCM.”
Rick Modi, Chief Executive Officer, Affinia Therapeutics
