Ray Therapeutics and Forge Biologics Expand Their Viral Vector cGMP Partnership to Encompass Plasmid DNA Manufacturing

• Building on AAV manufacturing partnership with new plasmid production, Forge’s end-to-end manufacturing services will help to advance Ray Therapeutics’ gene therapy for patients living with retinitis pigmentosa and other blinding diseases

SAN FRANCISCO & COLUMBUS, Ohio--(BUSINESS WIRE)--Ray Therapeutics, a biotechnology company developing optogenetic gene therapies for patients with retinal degenerative conditions, and Forge Biologics, a gene therapy-focused contract development and manufacturing organization, announced further collaboration for their manufacturing partnership to include clinical stage plasmid DNA production to support Ray Therapeutics’ lead optogenetics gene therapy program, RTx-015, in clinical trials for patients with retinitis pigmentosa.

Forge will provide research-grade and GMP-Pathway plasmid manufacturing services, in addition to adeno-associated viral vector (AAV) process development, scale-up engineering, and cGMP manufacturing services for Ray Therapeutics’ program, RTx-015. The program will continue to utilize Forge’s platform manufacturing processes, including its proprietary HEK 293 suspension Ignition Cells™ and pEMBR™ adenovirus helper plasmid. All development and cGMP manufacturing activities will occur at the Hearth, Forge’s 200,000 square foot gene therapy cGMP production facility in Columbus, Ohio.

“With the recent launch of research and clinical stage plasmid DNA manufacturing, we can better streamline the production of our clients’ AAV programs by vertically integrating plasmids into our manufacturing process,” said Timothy J. Miller, Ph.D., CEO, President, and Co-Founder of Forge. “Our partnership with Ray Therapeutics showcases how these new offerings can accelerate AAV gene therapies from idea into reality for patients in need, and we are excited to help Ray Therapeutics meet the needs of patients with retinitis pigmentosa.”

RTx-015 is intended for use in treating patients with retinitis pigmentosa (RP). Optogenetics is a promising approach that has the potential to restore useful vision to visually-impaired and blind individuals. Patients with RP have damaged photoreceptors, the primary cells required for vision, which are lost and cannot regenerate. However, inner retinal neurons downstream to photoreceptors, especially retinal ganglion cells (RGCs), persist in significant numbers through late-stage disease. Ray Therapeutics’ lead candidate RTx-015 uses intravitreal administration, from which the vector diffuses into the retina and transduces primarily the RGCs.

“By adding clinical grade plasmid production to their existing suite of AAV manufacturing capabilities, Forge is easing the scope of production and accelerating the development of our lead therapeutic,” said Paul Bresge, CEO of Ray Therapeutics. “Offering everything we need under one roof integrates our entire process so that we can focus on our mission to restore vision in patients losing their sight as fast as possible.”

About Retinitis Pigmentosa

Retinitis pigmentosa (RP), is a heterogeneous group of genetic diseases that cause retinal degeneration leading to near or complete blindness for most patients. The severe loss of photoreceptor cells that occurs in this genetic degenerative disease leads to partial or complete blindness. At present, no effective treatment is available to restore vision once the photoreceptor cells have been lost. Over 100 genetic mutations are known to cause RP and all types of inheritance patterns are recognized. Patients are typically diagnosed in their late teens, with symptoms including night blindness, reduced visual fields and eventual loss of visual acuity. As the disease progresses, retinal atrophy, and permanent loss of the light sensitive photoreceptors occur. The prevalence of RP is approximately 100,000 persons affected in the US.

About Ray Therapeutics

Ray Therapeutics is developing novel optogenetics gene therapies for patients with blinding diseases. The company is developing its lead candidate RTx-015 in retinitis pigmentosa, a degenerative retinal disease with significant unmet medical need. The company’s mission is to use optogenetics to restore vision, independent of genetic mutation for patients with inherited retinal diseases. Ray Therapeutics is based in San Francisco, CA. For additional information, please visit www.raytherapeutics.com.

About Forge Biologics

Forge Biologics is a hybrid gene therapy contract manufacturing and clinical-stage therapeutics development company. Forge’s mission is to enable access to life changing gene therapies and help bring them from idea to reality. Forge’s 200,000 square foot facility utilizes 20 cGMP suites in Columbus, Ohio, the Hearth, to serve as its headquarters. The Hearth is a custom-designed cGMP facility focused on AAV manufacturing and can host end-to-end manufacturing services to accelerate gene therapy programs from preclinical through clinical and commercial stage manufacturing. By taking a patients-first approach, Forge aims to accelerate the timelines of these transformative medicines for those who need them the most. To learn more, visit www.forgebiologics.com.

Media Inquiries—Forge Biologics
Marina Corleto
Senior Manager, Marketing and Communications
media@forgebiologics.com

Media Inquiries—Ray Therapeutics
Kimberly Ha
KKH Advisors
kimberly.ha@kkhadvisors.com

Client Development—Forge Biologics
John Maslowski
Chief Commercial Officer
CD@forgebiologics.com