Leveraging Northway Biotech's 20+ years of CDMO expertise, Diorasis Therapeutics is advancing AAV gene therapy for glaucoma treatment
VILNIUS, LT / ACCESS Newswire / July 29, 2025 / Diorasis Therapeutics ("DTx"), a preclinical-stage biotechnology company developing gene therapies for ophthalmic diseases, has entered into a strategic partnership 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.
Leveraging Northway Biotech's 20+ years of CDMO expertise, Diorasis Therapeutics is advancing DT003, a single-dose AAV gene therapy for glaucoma.
As part of the collaboration, Northway Biotech will leverage its 20 years of 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. Many patients face continued vision loss leading to irreversible blindness despite existing daily eye drops or surgery. We aim to change that trajectory by offering a durable, gene-independent solution that preserves vision and improves quality of life".
Prof. Vladas Algirdas Bumelis, CEO and Chairman of Northway Biotech, emphasized the shared commitment to high-quality execution and innovation: "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. This partnership built with DTx on mutual trust and honest communication allows us to move forward with clarity and make the right decisions together at every step."
About Diorasis Therapeutics
Diorasis Therapeutics is a late preclinical-stage biotech company pioneering gene therapies for ophthalmic diseases targeting intraocular pressure (IOP) lowering for glaucoma and neuroprotection. Its lead candidate DT003 targets the dysfunctional outflow of aqueous humor in glaucoma through a single, in office injection that enhances the eye's natural drainage system. By restoring physiological function at the source, DTx aims to deliver a long-term, gene-independent solution for lowering IOP in both juvenile and adult open-angle glaucoma patients. DT003 delivers directly to trabecular meshwork cells (via a single intracameral injection) a modified tissue plasminogen activator (tPA) gene, which is a master regulator for matrix metalloproteinases (enzymes that continuously remodel the outflow tissues). This approach is designed to restore physiological outflow of the aqueous humor by removing pathologically accumulated extracellular matrix material in the aqueous outflow system, thus reversing the root cause of elevated intraocular pressure (IOP) in glaucoma. In preclinical models of open angle glaucoma, including mice and sheep, DT003 demonstrated durable IOP reduction to normal levels.
Unlike gene therapies that target specific mutations, DT003 provides a gene-independent approach, taking advantage of gene therapy biofactory ultra-long duration characteristics, making it potentially applicable to a broad spectrum of patients with open-angle glaucoma - including both adult and juvenile forms of the disease.
For more information, visit: www.diorasistherapeutics.com
About Northway Biotech
Northway Biotech is a leading CDMO specializing in protein-based biologics and gene therapies, offering comprehensive, end-to-end development and manufacturing services. With deep expertise in cell line development, process optimization, and cGMP manufacturing, the company supports programs from early development through to commercial production. Northway Biotech delivers robust gene therapy capabilities, including plasmid DNA manufacturing, viral vector production, and fill-and-finish services, supported by BSL-2 and BSL-3 infrastructure. The company also offers viral clearance studies to ensure the quality, safety, and efficacy of biologics and advanced therapies. Founded in 2004, the privately held company operates state-of-the-art facilities in Lithuania and the United States, delivering high-quality, compliant solutions tailored to each client's unique needs.
For further information, visit www.northwaybiotech.com.
Northway Biotech Contact:
Prof. Vladas Algirdas Bumelis
CEO and Chairman of the Board
Diorasis Contact:
Remis Bistras
CEO
Contact Information
Vladas Bumelis
CEO and Chairman of the Board
vladas.bumelis@northwaybiotech.com
SOURCE: Northway Biotech
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