Genezen, Atsena Therapeutics Announce Strategic Gene Therapy Manufacturing Partnership

Genezen, a leading gene therapy contract development and manufacturing organization (CDMO), and Atsena Therapeutics ("Atsena"), a clinical-stage gene therapy company focused on using the life-changing power of genetic medicine to reverse or prevent blindness, announced a strategic manufacturing partnership to advance the clinical development and commercial manufacturing of Atsena's pipeline programs powered by novel adeno-associated virus (AAV) technology engineered to overcome the hurdles presented by inherited retinal diseases. Atsena's lead program is evaluating ATSN-201 in the pivotal LIGHTHOUSE study for the treatment of X-linked retinoschisis (XLRS) and is on track for a potential Biologics License Application filing in early 2028.

Under the collaboration, Genezen will leverage its viral vector manufacturing expertise to support clinical and commercial manufacturing using Atsena's existing platform. The partnership is designed to provide a streamlined and cost-efficient path to commercial manufacturing, reinforcing Genezen's track record of supporting late-stage programs through regulatory and validation readiness.

"With this strategic partnership, we will leverage our deep technical capability and commercial capacity to support Atsena's pipeline programs," said Steve Favaloro, Chairman and Chief Executive Officer of Genezen. "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," said Michael Kelly, Senior Vice President, Chemistry, Manufacturing and Controls of Atsena Therapeutics. "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."