Forge Biologics, a leading manufacturer of genetic medicines, has entered into an agreement with Fractyl Health to provide AAV development and cGMP manufacturing services for Fractyl's Rejuva pancreatic gene therapy platform. The collaboration aims to advance potential treatments for patients suffering from obesity and type 2 diabetes (T2D).
The manufacturing partnership, announced on May 14, 2025, will utilize Forge's proprietary FUEL™ platform to produce adeno-associated virus (AAV) vectors for Fractyl's gene therapy approach. This collaboration represents a significant step forward in developing novel therapeutic options for metabolic diseases that affect millions worldwide.
"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."
Innovative Approach to Metabolic Disease
Metabolic diseases, particularly obesity and type 2 diabetes, represent a growing global health crisis. According to the World Health Organization, over 650 million adults worldwide are obese, while diabetes affects approximately 422 million people globally. Current treatments often focus on symptom management rather than addressing underlying causes.
Fractyl Health's Rejuva platform takes a different approach by targeting the pancreas directly with gene therapy. The platform is designed to potentially prevent and reverse obesity and metabolic disease, rather than simply managing symptoms.
"We are excited to collaborate with Forge in advancing our Rejuva pancreatic gene therapy platform," said Harith Rajagopalan M.D., Ph.D., Co-Founder and Chief Executive Officer of Fractyl Health. "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."
Manufacturing Capabilities and Technology
Under the agreement, Forge will provide Fractyl with comprehensive services including process development, cGMP manufacturing, and analytical development. Fractyl will leverage several key components of Forge's technology platform:
- FUEL™ platform for AAV manufacturing
- Proprietary HEK293 suspension Ignition Cells™
- pEMBR™ 2.0 adenovirus helper plasmid
All development and manufacturing activities will take place at Forge's facility known as the Hearth, a 200,000 square foot gene therapy manufacturing facility located in Columbus, Ohio. The facility houses 20 custom-designed cGMP suites with 20,000L of bioreactor capacity.
Current Development Status
It's important to note that the Rejuva platform is currently in preclinical development and has not yet been evaluated by regulatory agencies for investigational or commercial use. The partnership with Forge represents an important step in advancing the technology toward potential clinical trials.
The collaboration highlights the growing importance of specialized manufacturing capabilities in the gene therapy sector, particularly for complex conditions like metabolic diseases that affect large patient populations and require scalable production solutions.
About the Companies
Forge Biologics, a member of Ajinomoto Bio-Pharma Services, is a hybrid gene therapy contract manufacturing and clinical-stage therapeutics development company. The company aims to enable access to gene therapies by providing end-to-end manufacturing services, from research-grade production to cGMP manufacturing and fill-finish capabilities.
Fractyl Health is focused on developing novel therapeutic approaches for metabolic diseases, with a particular emphasis on obesity and type 2 diabetes. Their Rejuva platform represents an innovative approach to addressing these conditions through pancreatic gene therapy.
As this collaboration progresses, it could potentially open new avenues for treating metabolic diseases that have traditionally been difficult to address with conventional pharmaceutical approaches.
