Partnership will include cGMP manufacturing services for AFTX-201, Affinia's investigational gene therapy medicine for BAG3 dilated cardiomyopathy

WALTHAM, Mass. and COLUMBUS, Ohio, Nov. 13, 2024 /PRNewswire/ -- Affinia Therapeutics ("Affinia"), an innovative gene therapy company with a pipeline of rationally designed adeno-associated virus (AAV) gene therapies for devastating cardiovascular and neurological diseases, and Forge Biologics ("Forge"), a leading manufacturer of genetic medicines and member of the Ajinomoto Bio-Pharma Services group, today announced an agreement to tech transfer and manufacture clinical trial material under Current Good Manufacturing Practice (cGMP) standards to help advance Affinia's pipeline of development candidates into clinical trials. The scope includes Affinia's investigational medicine program, AFTX-201 for BAG3 dilated cardiomyopathy, a devastating monogenic heart disease affecting more than 70,000 patients in the U.S., Europe, and U.K. regions.

"We're proud to support Affinia's vision of bringing hope to patients affected by cardiomyopathy through their innovative gene therapy," said John Maslowski, President and CEO of Forge. "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 pipeline of rationally designed gene therapies incorporate the company's novel tissue-tropic AAV capsids validated in single-clonal nonhuman primate studies and the company's proprietary plasmid design system validated across a range of novel and conventional capsids and payloads. These innovations confer unique properties that enable the targeted delivery of genetic payloads to tissues of interest, improving efficacy, safety, and cost of goods, as well as the potential treatment of prevalent diseases with first-in-class or best-in-class therapies. The company's initial programs are intended to help patients affected by devastating cardiovascular or neurological diseases.

"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," said Rob May, Affinia's Chief Technical Operations Officer. "We are delighted with Forge's expertise, strong collaboration, and industry-leading capabilities that were 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."

Through this partnership, Forge will provide tech transfer services, process and analytical development, toxicology, and cGMP manufacturing services to Affinia. All tech transfer, development, and manufacturing activities will occur at the Hearth, Forge's 200,000 square foot gene therapy manufacturing facility in Columbus, Ohio.

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 .

About Forge Biologics

Forge Biologics, a member of Ajinomoto Bio-Pharma Services, is a hybrid gene therapy contract manufacturing and clinical-stage therapeutics development company, enabling access to life-changing gene therapies by bringing them from concept to reality. Forge's 200,000 square foot facility, the Hearth, is headquartered in Columbus, Ohio, and houses 20 custom-designed cGMP suites with 20,000L of bioreactor capacity. Forge's end-to-end, scalable plasmid and AAV manufacturing services include research-grade manufacturing, process and analytical development, cGMP manufacturing, fill and finish, and integrated regulatory support to help accelerate the timelines of transformative medicines for patients with genetic diseases. To learn more, visit .

SOURCE Affinia Therapeutics