Affinia Therapeutics announced that it is partnering with Forge Biologics to manufacture clinical trial material under GMP standards. The parties will perform a tech transfer, enabling Forge to manufacture Affinia’s investigational medicine program AFTX-201. Forge will handle tech transfer, development, and manufacturing services at its 200,000 square foot gene-therapy manufacturing facility in Columbus, Ohio.
"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."
“Affinia’s proprietary plasmid design improves upstream yield 10x and also significantly improves other quality attributes,” May told BioProcess Insider. “These results have been seen across multiple natural and novel capsids and enable us to manufacture at a smaller scale than others. As such, the 50–250-L scale is expected to support our [investigational new drug] IND filing and phase I clinical trial material requirements.”
AFTX-201 is developed to treat monogenic dilated cardiomyopathy (DCM) caused by BLC2-associated athanogene 3 (BAG3) mutations. More than 70,000 people in Europe and the US suffer from BAG3 DCM, which is a disease that causes the heart’s left ventricle to become enlarged and weakened, which leads to difficulty in pumping enough blood.
Rami Daoud, chief business and financial officer at Affinia told us “the development of gene therapy programs can be quite rapid in devastating monogenic cardiac diseases where there is no disease-specific or disease-modifying treatment, such as is the case for BAG3 dilated cardiomyopathy. We hope for a successful program, and the parties would be pleased to look into expanding our collaboration to include supplying commercial product.”
He added that the company’s vision is to bring next-generation gene therapies for cardiovascular and neurological diseases to patients. “We anticipate that we would produce material for future pipeline candidates at Forge.”
"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."
Maslowski told BioProcess Insider that Forge is well situated to handle the challenges in adeno-associated virus (AAV) manufacturing, thanks to the firm’s strong leadership and experience working with more than 50 gene-therapy clients in many indications. “Our end-to-end manufacturing services–from in-house plasmid manufacturing to process and analytical development and robust tech transfer services–provide developers with a one-stop-shop experience, accelerating gene therapy program development.”
He added, “We are uniquely positioned to address these challenges by leveraging our in-house team of expert AAV manufacturing specialists and focusing on manufacturing innovations to deliver more efficient solutions for our clients.”
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