Latest news with #ForgeBiologics
Business Wire
14-05-2025
- Business
- Business Wire
Forge Biologics Announces AAV Development and cGMP Manufacturing Relationship with Fractyl Health to Advance Their Gene Therapy Platform for Patients with Metabolic Diseases
COLUMBUS, Ohio--(BUSINESS WIRE)--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 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
Yahoo
12-02-2025
- Health
- Yahoo
8-year-old in Stokes County fights rare brain disease
WALNUT COVE, N.C. (WGHP) — To know Bentley Shelton is to love him. 'He brings light to everybody that meets him,' said Brittany Shelton, Bentley's mom. 'He always smiles.' At 8 years old, Bentley faces more challenges than most kids his age. But it wasn't always that way. Parents of separated conjoined twin daughters rely on faith after son's pediatric cancer diagnosis 'He was born like a normal kid. He started walking at age one,' said Shelton. 'For a year, he climbed on top of things, he'd climb up on tables and everything. And then he just kind of started being clumsy and when I went back and looked at videos, and I knew what to look for I noticed signs; his knees would hyperextend, his ankles were not 90 degrees, and it was causing him to just not walk properly. Six weeks after those initial signs showed up, Bentley was diagnosed with Krabbe Leukodystrophy, a rare genetic disorder that causes progressive damage to the nervous system. Bentley is one of nearly 30 million Americans who live with a rare disease. 'He has to fight really hard to maintain what he has,' said Shelton. 'Every day is a constant struggle.' There is no cure for Krabbe, and treatment is limited to a stem cell transfer which Bentley underwent in Pittsburgh right after he was diagnosed. High Point teen undergoes special surgery with determination, a smile 'He has essentially lost his ability to walk. He loves to try so we help him, but he can't do it unassisted,' said Brittany. 'It did affect his vision. He was diagnosed with cortical visual impairment which I've kind of understood to be your eyes work fine, but your pathway doesn't. So, he looks at something and he can't process it… everything is just jumbled.' In late January, the Shelton family received another blow. A promising clinical trial involving gene therapy that Bentley was waitlisted for was abruptly canceled. Brittany turned to Facebook to share the devastating news. 'I think the more noise you make, the more people become aware,' said Brittany. 'That's really the only thing you can do.' Her post has been shared hundreds of times, and she's heard from people who work with pharmaceutical companies offering advice. 'I was just praying that someone would see it… that a pharmaceutical company would see it and take interest and see that these are real kids out there that have it and hopefully pick it back up and restart it.' It feels like a relentless race against time that Shelton is determined to help Bentley win. Micro-preemie twins born in Triad beat the odds, set to come home from hospital 'Science tells us you don't live a full life, but you know God tells us another thing, so we're hoping and praying for other treatments to become available,' said Shelton. 'It's a rare disease but it's one in 100-thousand and when you compare that to the whole population, that's a lot of kids. That's brothers, sisters, sons and daughters.' The Krabbe Disease clinical program by Forge Biologics was scheduled to run until November 2026. FOX8 reached out to Forge Biologics to find out what led to the program's cancellation, but we haven't heard back. Krabbe disease is not on the newborn screen in North Carolina. It is, however, part of newborn screenings in several other states including South Carolina and Tennessee. Copyright 2025 Nexstar Media, Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.
