New Enterprise Associates led the round with support from new investor, Eli Lilly & Company, and existing investors

Financing supports IND submission and clinical activities for Affinia’s lead program AFTX-201, a potential first-in-class and best-in-class genetic medicine for BAG3 dilated cardiomyopathy

WALTHAM, Mass.: Affinia Therapeutics (“Affinia”), an innovative gene therapy company with a pipeline of first-in-class and/or best-in-class adeno-associated virus (AAV) gene therapies for devastating cardiovascular and neurological diseases, today announced it has closed a $40 million Series C financing. The financing was led by New Enterprise Associates (NEA) with participation from new investor, Eli Lilly & Company, and existing investors Alexandria Venture Investments, LLC, Atlas Venture, Avidity Partners, F-Prime, GV (formerly Google Ventures), Mass General Brigham Ventures, and Perceptive Advisors.

The proceeds from the financing will fund development of Affinia’s lead program, AFTX-201, a potential first-in-class and best-in-class investigational genetic medicine for the treatment of BAG3 dilated cardiomyopathy (DCM). Affinia expects to submit an Investigational New Drug (IND) application in the fourth quarter of 2025 and if accepted by the U.S. Food and Drug Administration (FDA), initiate the UPBEAT trial, a Phase 1/2 clinical trial for patients affected by BAG3 DCM, in the first quarter of 2026. Currently, AFTX-201 is undergoing IND-enabling studies which were initiated after Affinia’s completion of a successful pre-IND meeting with the FDA. In addition, the financing will support the advancement of Affinia’s gene therapy pipeline of novel product candidates in additional devastating diseases.

“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 engineer novel myotropic capsids, targeting the heart and skeletal muscles, with liver detargeting. AFTX-201 is designed to deliver a fully human, full-length BAG3 transgene using Affinia’s novel cardiotropic capsid engineered for efficient and selective cardiac transduction at low doses. AFTX-201 is intended to be given as a simple one-time intravenous administration. Preclinical studies in an animal disease model demonstrated that AFTX-201 improved BAG3 protein levels in the heart and completely restored cardiac function, whereas such benefits were not achieved with the same gene construct using a conventional capsid at the same dose.

“We are grateful to this outstanding group of institutional and strategic investors who share our excitement about our novel, cardiotropic capsids and pipeline,” said Rick Modi, Affinia’s Chief Executive Officer. “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.”

BAG3 DCM is a serious, inherited heart condition with a high mortality and a significant unmet medical need. The disease affects more than 70,000 patients in the U.S., Europe, and U.K. regions alone. The BAG3, or Bcl2-associated athanogene 3, gene encodes for a protein that is critical to the normal structure and function of heart cells. Patients with BAG3 DCM have a mutation in the BAG3 gene and a deficiency in functional BAG3 protein, resulting in early onset heart failure that progresses rapidly. Despite current standard of care, almost 25% of patients require a heart transplant.

About Affinia Therapeutics

Affinia Therapeutics is pioneering a shift to a new class of rationally designed gene therapies that treat rare and prevalent diseases. Affinia Therapeutics’ pipeline of first-in-class or best-in-class product candidates in cardiovascular and neurological diseases leverages its proprietary next-generation capsids, payloads, or manufacturing approaches and have shown efficacy, safety, and differentiation in relevant animal models. For more information, visit https://www.affiniatx.com.

Fonte: Business Wire