Genezen and Atsena Therapeutics Forge Strategic Gene Therapy Manufacturing Partnership

LEXINGTON, Mass and Durham, N.C., Jan. 20, 2026 /PRNewswire/ -- 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, today 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." About Genezen Genezen is a best-in-class gene therapy CDMO with over a decade of experience and state-of-the-art viral vector manufacturing facilities. From concept to commercial scale, Genezen partners with innovators to deliver life-saving gene and cell therapies worldwide. Learn more at genezen.com or follow Genezen on LinkedIn. About Atsena Therapeutics Atsena is a clinical-stage gene therapy company developing best-in-class treatments for the reversal or prevention of blindness from inherited retinal diseases. The company's lead program is evaluating ATSN-201 for X-linked retinoschisis (XLRS), a genetic condition that is typically diagnosed in childhood and leads to blindness later in life. Atsena plans to initiate enrollment in the pivotal Part C cohort of the ATSN-201 LIGHTHOUSE clinical trial in the first quarter of 2026. The company's proprietary pipeline also includes gene therapies in development for Usher Syndrome Type 1B and for Stargardt Disease. Atsena is also developing ATSN-101, a first-in-class, investigational gene therapy for Leber congenital amaurosis type 1 (LCA1), as part of its exclusive strategic collaboration with Nippon Shinyaku Co., Ltd. ATSN-101 has completed a Phase I/II trial with positive results (https://doi.org/10.1016/s0140-6736(24)01447-8), and Atsena expects to initiate a pivotal global clinical trial evaluating ATSN-101 in the second half of 2026. Founded by pioneers in ocular gene therapy, Atsena is led by an experienced team dedicated to addressing the needs of patients with vision loss. For more information, please visit https://atsenatx.com/. SOURCE Genezen