Affinia Therapeutics Partners with Forge Biologics for cGMP Manufacturing of Gene Therapies

• Affinia Therapeutics collaborates with Forge Biologics to manufacture gene therapies for clinical trials.

• The initial focus includes Affinia’s AFTX-201 for BAG3 dilated cardiomyopathy, affecting 70,000 patients across the U.S. and Europe.

Affinia Therapeutics and Forge Biologics have announced a partnership to transfer technology and produce clinical trial material for Affinia’s gene therapy programs under Current Good Manufacturing Practice (cGMP) standards. The agreement covers Affinia’s investigational treatment AFTX-201, developed to target BAG3 dilated cardiomyopathy, a rare genetic heart disease affecting more than 70,000 people across the U.S., Europe, and the U.K.

Forge, a member of the Ajinomoto Bio-Pharma Services group, will support Affinia with cGMP manufacturing services at the Hearth, its 200,000-square-foot facility in Columbus, Ohio. Services include process and analytical development, toxicology, and clinical-grade manufacturing. “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,” said John Maslowski, President and CEO of Forge.

Affinia’s approach involves rationally designed adeno-associated virus (AAV) gene therapies aimed at cardiovascular and neurological diseases. The company’s novel tissue-targeting capsids, along with its proprietary plasmid design, are intended to improve therapeutic efficacy and reduce manufacturing costs.

Rob May, Affinia’s Chief Technical Operations Officer, stated, “We are pleased to enter into this tech transfer and manufacturing partnership with an initial focus on AFTX-201 utilizing our proprietary cardiac capsid and plasmid design.”