#USA #gene therapy #Lexington, Massachusetts #Genezen #Atsena Therapeutics

Genezen and Atsena Therapeutics Join Forces

In a groundbreaking announcement, Genezen, a premier contract development and manufacturing organization (CDMO) specializing in gene therapy, has established a strategic manufacturing partnership with Atsena Therapeutics. This collaboration is aimed at boosting the clinical development and commercial manufacturing of Atsena's innovative gene therapy pipeline.

Atsena Therapeutics is a clinical-stage company that focuses on leveraging genetic medicine to reverse or prevent blindness caused by inherited retinal conditions. The partnership centers on Atsena's lead program, ATSN-201, which is currently under evaluation in the pivotal LIGHTHOUSE study, targeting X-linked retinoschisis (XLRS). This condition, generally diagnosed in childhood, can lead to significant vision loss. Atsena is poised to file a Biologics License Application (BLA) as early as 2028, paving the way for potential new therapies in the field.

Strengthening Gene Therapy Development

Under the agreement, Genezen will utilize its advanced viral vector manufacturing capabilities to facilitate both clinical and commercial production of Atsena's therapies using their existing platform. This strategic partnership seeks to streamline the manufacturing process, making it more efficient and cost-effective. Genezen’s extensive experience in supporting late-stage programs lends itself well to ensuring regulatory compliance and validation readiness.

Steve Favaloro, CEO of Genezen, expressed enthusiasm about the collaboration, stating, "With this strategic partnership, we will leverage our deep technical capability and commercial capacity to support Atsena's pipeline programs. We are honored to support Atsena as they advance their critical gene therapies into pivotal clinical trials, moving closer to providing life-changing treatments for patients with vision loss."

Michael Kelly, Senior VP of Chemistry, Manufacturing, and Controls at Atsena Therapeutics, highlighted the advantages of working with Genezen, noting, "Genezen's demonstrated technical capabilities make them an ideal partner to support the commercial development and advancement of our pipeline. This collaboration brings us closer to our mission of improving the quality of life for patients affected by inherited retinal diseases through gene therapies that can prevent or reverse genetic blindness."

About Genezen

Genezen stands as a leader in the gene therapy manufacturing space, boasting over a decade of expertise and state-of-the-art facilities. They partner with innovators to deliver vital gene therapies on a global scale, from the conceptual stage right through to commercial production. You can learn more about Genezen at their website, genezen.com, or by following their updates on LinkedIn.

About Atsena Therapeutics

Atsena Therapeutics is dedicated to developing top-tier gene therapies aimed at reversing or preventing blindness due to inherited retinal disorders. Their lead program, ATSN-201, works against XLRS, with plans to commence enrollment in the pivotal Part C of the LIGHTHOUSE trial in early 2026. Other noteworthy initiatives from Atsena include therapies targeting Usher Syndrome Type 1B and Stargardt Disease, along with a unique gene therapy, ATSN-101, for Leber congenital amaurosis type 1 (LCA1). ATSN-101 has successfully completed a Phase I/II clinical trial and is expected to enter pivotal global clinical trials in the latter half of 2026 as part of a strategic collaboration with Nippon Shinyaku Co., Ltd.

Founded by pioneers in the ocular gene therapy arena, Atsena Therapeutics is committed to addressing the pressing needs of patients experiencing vision loss. For further information, visit their official site at atsenatx.com.