Genezen, Atsena Therapeutics team on AAV gene therapy manufacturing

Genezen, a gene therapy contract development and manufacturing organization (CDMO) headquartered in Indianapolis, and Atsena Therapeutics, a clinical-stage gene therapy company based in Durham, North Carolina, announced a manufacturing partnership to support the clinical development and potential commercialization of Atsena’s adeno-associated virus gene therapy programs.

Under the agreement, Genezen will provide viral vector manufacturing services to support Atsena’s existing AAV platform for both clinical and commercial supply, according to the companies. The collaboration is intended to support late-stage development activities, including regulatory and validation readiness.

Atsena’s lead program, ATSN-201, is being evaluated for the treatment of X-linked retinoschisis. The company said the program is on track for a potential biologics license application filing in early 2028.

“With this strategic partnership, we will leverage our deep technical capability and commercial capacity to support Atsena’s pipeline programs,” Genezen CEO Steve Favaloro said in a statement. “We are honored to support Atsena as they advance their critical gene therapies into pivotal clinical trials and move closer to providing life-changing treatments for patients with vision loss.”

“Genezen’s demonstrated technical capabilities make them an ideal partner to support the commercial development and advancement of our pipeline,” Michael Kelly, senior vice president of chemistry, manufacturing and controls of Atsena Therapeutics, said in a statement. “This collaboration brings us closer to our mission of improving the quality of life of patients with inherited retinal disease with gene therapies that prevent or reverse genetic blindness.”