Forge Biologics and Oculogenex Announce AAV Contract Development and Manufacturing Partnership

Forge to provide manufacturing and development services for Oculogenex’s novel AAV gene therapy to improve vision in patients with macular degeneration

LA HABRA, Calif. & COLUMBUS, Ohio--(BUSINESS WIRE)--Oculogenex, a biotech company developing a novel adeno-associated viral (AAV) gene therapy treatment to stop the degeneration of central vision in patients, and Forge Biologics, a gene therapy-focused contract development and manufacturing organization, today announced a manufacturing partnership to help support the advancement of Oculogenex’s gene therapy program for dry age-related macular degeneration (AMD) toward clinical trials.

Forge will provide AAV process and analytical development, and manufacturing services for Oculogenex. The program will utilize Forge’s platform process, including its proprietary HEK 293 suspension Ignition™ cell line and pEMBR™ adenovirus helper plasmid. All AAV development and manufacturing activities will occur at the Hearth, Forge’s 200,000 square foot gene therapy cGMP production facility in Columbus, Ohio.

“We are excited to announce our partnership supporting Oculogenex’s efforts in developing a gene therapy that has the potential to dramatically change and improve the quality of life for patients suffering from dry AMD,” said John Maslowski, Chief Commercial Officer of Forge Biologics. “Their work is incredibly important to patients, and we look forward to delivering the resources and scale as their preferred AAV manufacturing partner on this endeavor.”

Oculogenex’s investigational approach is a novel ocular regenerative AAV gene therapy that is delivered as a one-time injection into the eye. Preclinical data demonstrate that this approach makes retinal cells more resistant to stress, helps cells repair damage, and increases the cells’ lifespans. The approach has the potential to activate dormant stem cells in the retina to replace lost tissue. Post-administration benefits have been demonstrated in preclinical research, and the company is completing additional preclinical research to prepare for entry into Phase I clinical trials.

“We started this company because there were no treatments available for patients with dry age-related macular degeneration,” said Hema Ramkumar, M.D., CEO and Founder of Oculogenex. “I am thrilled to be partnering with Forge to be able to offer better options to these patients, with promise for other patients living with degenerative blinding retinal diseases.”

About Age-Related Macular Degeneration

Age-related macular degeneration (AMD) is the leading cause of irreversible vision loss in patients over 60 in the United States and a leading cause of vision loss in the world. Patients with early forms of the disease may see wavy lines or distorted vision and have difficulty seeing and reading. Those affected by advanced disease have loss of central vision and cannot see the object they are trying to focus on. For elderly patients, the inability to read correlates with loss of independence, disability, depression, increased risk of falls, and mortality. Advanced age-related macular degeneration is either geographic atrophy (the dry type) or wet macular degeneration, which is treated with frequent injection therapy. There are no current treatments for dry age-related macular degeneration.

About Oculogenex

Oculogenex is a biotech company utilizing gene therapy to improve vision in patients with degenerative retinal diseases. The California-based company is developing a gene therapy treatment to stop the degeneration of central vision in patients with age-related macular degeneration. The therapy has the potential to dramatically improve the quality of life of patients living with blinding retinal diseases and no treatment options. To learn more, visit www.oculogenex.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 dedicated to AAV manufacturing and hosts scalable, end-to-end manufacturing services. Offerings include process and analytical development, plasmid DNA manufacturing, viral vector manufacturing, final fill, as well as regulatory consulting support 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.