Forge Biologics Partners with Fractyl Health to Develop and Manufacture AAV for Gene Therapy Platform

Fractyl Health is working with Forge Biologics to advance its Rejuva pancreatic gene therapy platform, which aims to treat patients with obesity and type 2 diabetes. This partnership will leverage Forge's FUEL[TM] platform, a manufacturing solution designed to provide developers with efficient and scalable production capabilities. The agreement will enable Fractyl to utilize Forge's process development, cGMP manufacturing, and analytical development services.

Key Takeaways:

• Fractyl Health's Rejuva pancreatic gene therapy platform is in preclinical development for treating patients with obesity and type 2 diabetes.
• Forge Biologics will provide Fractyl with process development, cGMP manufacturing, and analytical development services.
• The partnership will utilize Forge's FUEL[TM] platform, including its proprietary HEK293 suspension Ignition Cells[TM] and pEMBR[TM] 2.0 adenovirus helper plasmid.
• The development and manufacturing activities will occur at Forge's 200,000 square foot gene therapy manufacturing facility, the Hearth.
• Harith Rajagopalan M.D., Ph.D., Co-Founder and Chief Executive Officer of Fractyl Health, stated that Forge's expertise in large-scale, efficient AAV manufacturing is invaluable in advancing their Rejuva platform.

Statistics:

• The Hearth, Forge's gene therapy manufacturing facility, has 20 custom-designed cGMP suites with 20,000L of bioreactor capacity.
• The Rejuva platform is currently in preclinical development and has not yet been evaluated by regulatory agencies for investigational or commercial use.

Sources:

• Forge Biologics press release, "Forge Biologics Announces Agreement to Advance Fractyl Health's Rejuva Gene Therapy Platform," May 14, Businesswire.com.