Forge Biologics Launches AAV Development, cGMP Manufacturing Partnership with Restore Vision

Editor’s Take: Broader implications of this partnership include advancement of clinical-stage gene therapy programs in the Asia-Pacific region.

Forge Biologics, part of Ajinomoto Bio-Pharma Services, is partnering with Restore Vision on an investigational gene therapy for retinitis pigmentosa.

Restore’s G protein-coupled receptor (GCPR) optogenetic adeno-associated virus (AAV) therapy, RV-001, is under evaluation in a Japan Phase I/II trial. RV-001 uses AAV vectors with a proprietary, gene-encoding “chimeric rhodopsin,” a protein-based optical sensor. According to Restore Vision, the trial in Japan is the first of its kind using chimeric rhodopsin. If successful, it may prove to restore vision in patients blinded by photoreceptor loss.

How Forge Will Contribute

The development and manufacturing partnership provides Restore Vision with Forge’s AAV process development and current good manufacturing practice (cGMP) capabilities. Forge will also lend analytical development, stability testing, and regulatory consultation services.

“Providing a new visual restoration treatment option for patients living with retinitis pigmentosa is central to our mission.”

Yusaku Katada, MD, PhD, Chief Executive Officer, Restore Vision

In short, Forge is performing AAV development and manufacturing at its 200,000-square-foot facility in Columbus, Ohio. Subsequently, drug product is transported to Japan for clinical supply.

Forge Biologics intends for the partnership to expand its support of clinical-stage gene therapy programs in the Asia-Pacific region.

CEO John Maslowski further commented on the collaboration with Restore.

“Forge is proud to support gene therapy developers around the world with integrated development, manufacturing, and regulatory expertise,” Maslowski said. “Our partnership with Restore Vision reflects our commitment to helping developers navigate the complexities of gene therapy manufacturing. [We have a] shared goal of enabling treatment options for patients.”

Restore Vision Opening New Pathways

Meanwhile, Restore Vision CEO Yusaku Katada, MD, PhD, said a new treatment option for patients with retinitis pigmentosa is crucial.

“We are pleased to collaborate with Forge Biologics,” Katada said. “[We] value their expertise in AAV development, manufacturing, and regulatory support as we advance RV-001 through Phase I/II clinical evaluation.”