Affinia Therapeutics And Forge Biologics Partner To Advance Gene Therapies For Cardiovascular And Neurological Diseases

Affinia Therapeutics is a gene therapy company specialising in innovative AAV-based treatments for severe cardiovascular and neurological diseases. Today, it announced its partnership with Forge Biologics, a prominent gene therapy manufacturer and Ajinomoto Bio-Pharma Services group member. 

Through this agreement, Forge will support Affinia by providing tech transfer and manufacturing services for clinical trial materials under cGMP standards to advance Affinia’s therapeutic pipeline. The collaboration includes production for Affinia’s lead program, AFTX-201, which targets BAG3 dilated cardiomyopathy, a severe genetic heart condition affecting over 70,000 individuals across the U.S., Europe, and the U.K.

John Maslowski, President and CEO of Forge, said, “We’re proud to support Affinia’s vision of bringing hope to patients affected by cardiomyopathy through their innovative gene therapy. Forge’s comprehensive AAV development and manufacturing services, including our robust tech transfer capabilities, were designed to empower partners like Affinia as they work to deliver transformative therapies to patients worldwide.”

Affinia’s gene therapy pipeline utilises proprietary AAV capsids that have been validated in primate studies and a specialised plasmid design system. These technologies are designed to enhance tissue targeting, safety, and cost-effectiveness, aiming to deliver effective therapies for cardiovascular and neurological diseases.

“We are pleased to enter into this tech transfer and manufacturing partnership with an initial focus on AFTX-201 utilising our proprietary cardiac capsid and plasmid design. We are delighted with Forge’s expertise, strong collaboration, and industry-leading capabilities, evident during the tech transfer process. We look forward to advancing our innovative pipeline of rationally designed gene therapies toward the clinic jointly with Forge,” stated Rob May, Affinia’s Chief Technical Operations Officer.

Forge will handle the tech transfer, process and analytical development, toxicology, and cGMP manufacturing at its 200,000-square-foot Hearth facility in Columbus, Ohio. This partnership will facilitate Affinia’s progress toward clinical trials, with an initial focus on conditions that currently lack effective treatments.