New Hope Research, Forge Biologics Enter cGMP Manufacturing Pact

The New Hope Research Foundation, a nonprofit organization dedicated to finding a genetic cure for GM2 gangliosidosis (including Tay-Sachs disease) and other lysosomal storage diseases, and Forge Biologics, a manufacturer of genetic medicines, entered into a development and cGMP manufacturing partnership to advance the Foundation’s novel gene therapy, NHR01, into Phase I/II clinical trials for patients with GM2 gangliosidosis.

Forge will provide adeno-associated virus (AAV) process development, analytical services, and cGMP manufacturing to New Hope Research Foundation. The Foundation will leverage Forge’s platform processes, including its proprietary HEK293 suspension Ignition Cells, to accelerate the initial production. All development and AAV manufacturing activities will occur at the Hearth, Forge’s 200,000 sq.-ft. gene therapy facility in Columbus, OH.

“We are proud to be the CDMO partner for New Hope Research Foundation, an organization that is significantly advancing a gene therapy approach to provide hope for patients suffering from Tay-Sachs disease,” said Timothy Miller, CEO, President, and Co-Founder of Forge Biologics. “At Forge, we are ready to partner with companies, nonprofit organizations, and gene therapy developers around the world, working towards the mission we share to bring potentially life-saving gene therapies to patients.”

Jack Keimel, co-founder and president of New Hope Research Foundation said, “Forge has proven to be a trusted partner to many gene therapy developers. We look forward to embarking on our manufacturing collaboration with their experienced team and tried and true platform process to help accelerate our therapy into clinical trials and deliver new hope for patients with GM2 gangliosidosis.”