Forge Biologics Announces AAV Development and cGMP Manufacturing Relationship with Fractyl Health to Advance Their Gene Therapy Platform for Patients with Metabolic Diseases

• Fractyl Health will leverage Forge’s FUEL™ platform to manufacture AAV for Rejuva, Fractyl’s pancreatic gene therapy platform for patients with obesity and type 2 diabetes

Forge Biologics (“Forge”), a leading manufacturer of genetic medicines and member of the Ajinomoto Bio-Pharma Services group, today announced an AAV development and manufacturing agreement to help advance Fractyl Health’s Rejuva* pancreatic gene therapy platform for the treatment of patients with obesity and type 2 diabetes (T2D).

"We developed our FUEL™ platform to provide developers like Fractyl with a more efficient and scalable manufacturing solution to help reach broader patient populations,” said John Maslowski, President and CEO of Forge. “We are proud to support Fractyl in advancing a new class of metabolic disease therapies. Their mission to break the cycle of chronic disease management for patients is one we are honored and excited to help enable.”

“We are excited to collaborate with Forge in advancing our Rejuva pancreatic gene therapy platform. Forge’s expertise in large-scale, efficient AAV manufacturing is invaluable as we move forward in our mission to develop scalable treatments that aim to prevent and reverse obesity and metabolic disease,” said Harith Rajagopalan M.D., Ph.D., Co-Founder and Chief Executive Officer of Fractyl Health.

Through this relationship, Forge will provide Fractyl process development, cGMP manufacturing and analytical development services. Fractyl will also leverage Forge’s FUEL™ platform, including its proprietary HEK293 suspension Ignition Cells™ and pEMBR™ 2.0 adenovirus helper plasmid. All development and manufacturing activities will occur at the Hearth, Forge’s 200,000 square foot gene therapy manufacturing facility in Columbus, Ohio.

*The Rejuva platform is in preclinical development and has not yet been evaluated by regulatory agencies for investigational or commercial use.

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 www.forgebiologics.com.

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"We developed our FUEL™ platform to provide developers like Fractyl with a more efficient and scalable manufacturing solution to help reach broader patient populations,” said John Maslowski, President and CEO of Forge.