Diorasis & Northway Biotech Partner for Glaucoma Gene Therapy Manufacturing

Diorasis Therapeutics (DTx), a preclinical-stage biotechnology company developing gene therapies for ophthalmic diseases, has partnered with Northway Biotech (NBT), a contract development and manufacturing organization (CDMO), to establish a scalable cGMP production process for DTx’s lead AAV-based gene therapy candidate for open angle glaucoma.

As part of the collaboration, Northway Biotech will leverage its experience in biologics manufacturing to develop a robust, compliant process for pre-clinical and clinical material production. The partnership includes AAV process development, analytical method development and qualification, pre-clinical manufacturing, as well as clinical manufacturing of cGMP drug substance and drug product for anticipated clinical trials.

Diorasis Therapeutics is focused on developing disease-modifying gene therapies in glaucoma with the goal of delivering extremely long-lasting efficacy from a single in-office dosing. Its lead program in open angle glaucoma is expected to enter clinical development following the completion of toxicology studies and regulatory submissions.

Remis Bistras, CEO of Diorasis Therapeutics, stated: “Partnering with Northway Biotech is a critical milestone as we advance our lead gene therapy candidate toward the clinic. Our mission is to transform glaucoma care with a single, long-lasting treatment that addresses the root cause of elevated intraocular pressure in open angle glaucoma.”

Prof. Vladas Algirdas Bumelis, CEO and Chairman of Northway Biotech, said: “We are very proud to support Diorasis Therapeutics in advancing their promising gene therapy program. Our dedicated team brings long-standing experience in cGMP manufacturing of complex biologics, and we are focused on delivering a reliable, scalable process to help ensure a confident and efficient transition into clinical trials.”