- Forge’s development and manufacturing services support RV-001, Restore Vision’s gene therapy for patients with retinitis pigmentosa, in Phase 1/2 clinical evaluation in Japan
TOKYO & COLUMBUS, Ohio--(BUSINESS WIRE)--Restore Vision, Inc. (“Restore Vision”), a clinical-stage biotechnology company advancing gene therapies for retinal disorders, and Forge Biologics (“Forge”), a leading manufacturer of gene therapies and member of Ajinomoto Bio-Pharma Services, today announced a development and manufacturing partnership to support RV-001, Restore Vision’s investigational GPCR-based optogenetic AAV gene therapy for patients with retinitis pigmentosa.
Through this collaboration, Forge is providing Restore Vision with AAV process development, current Good Manufacturing Practices (cGMP) manufacturing, analytical development, stability testing, and regulatory consultation services. The AAV development and manufacturing activities performed by Forge under this collaboration take place at the Hearth, Forge’s 200,000-square-foot facility in Columbus, Ohio, and the drug product is transported to Japan for clinical trial supply.
“Forge is proud to support gene therapy developers around the world with integrated development, manufacturing, and regulatory expertise,” said John Maslowski, Chief Executive Officer of Forge Biologics. “Our partnership with Restore Vision reflects our commitment to helping developers navigate the complexities of gene therapy manufacturing, with the shared goal of enabling treatment options for patients.”
Material manufactured at Forge for Restore Vision is being used to evaluate RV-001 in a Phase 1/2 clinical trial in Japan, further expanding Forge's experience supporting clinical-stage gene therapy programs in the Asia-Pacific (APAC) region.
“Providing a new visual restoration treatment option for patients living with retinitis pigmentosa is central to our mission,” said Yusaku Katada, M.D., Ph.D., Chief Executive Officer of Restore Vision. “We are pleased to collaborate with Forge Biologics and value their expertise in AAV development, manufacturing, and regulatory support as we advance RV-001 through Phase 1/2 clinical evaluation in Japan.”
About RV-001
RV-001 is Restore Vision’s lead investigational gene therapy product candidate, using adeno-associated virus (AAV) vectors with a proprietary gene encoding “Chimeric Rhodopsin,” which is a protein-based optical sensor. It is being developed as a treatment designed to restore vision in patients blinded by photoreceptor loss. Restore Vision takes a simple and minimally invasive intravitreal injection approach to deliver the therapeutic gene, which is intended to express Chimeric Rhodopsin in the remaining retinal interneurons and restore visual function. RV-001 is currently being evaluated in a Phase 1/2 clinical trial for gene-agnostic retinitis pigmentosa in Japan. This is the world’s first clinical trial of an optogenetic gene therapy using Chimeric Rhodopsin. RV-001 is an investigational product and has not been approved by any regulatory authority. Its safety and efficacy have not been established.
About Restore Vision Inc.
Restore Vision Inc., a clinical-stage gene therapy company, specializes in developing transformative gene therapies for inherited retinal disorders. By integrating academic excellence with entrepreneurial vision, the company is committed to pioneering treatments that address critical unmet medical needs and improve patient outcomes worldwide. To learn more, visit www.restore-vis.com.
About Forge Biologics
Forge Biologics, a member of Ajinomoto Bio-Pharma Services, is a gene therapy contract development and manufacturing organization (CDMO) 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.
Contacts
Media Inquiries
Restore Vision:
Hikaru Miyazaki
Chief Operating Officer
contact@restore-vis.com
Forge Biologics:
Media
Marina Corleto
Associate Director, Marketing & Communications
media@forgebiologics.com
Client Development
Taleen Barsoumian
Senior Vice President, Client Development
CD@forgebiologics.com
