Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Diorasis Therapeutics (DTx’s), a preclinical-stage biotechnology firm specialising in gene therapies for ophthalmic conditions, has joined forces with Northway Biotech (NBT), a contract development and manufacturing organisation (CDMO).
The lead programme in open-angle glaucoma is anticipated to enter clinical development following the completion of toxicology studies and the necessary regulatory submissions. Credit: Nappy/Unsplash.
Subscribe to our email newsletter
This collaboration is said to result in a “scalable” cGMP production process for DTx’s AAV-based gene therapy candidate targeting open angle glaucoma.
As part of this partnership, Northway Biotech will utilise its 20 years of experience in biologics manufacturing to offer a “compliant” process to produce pre-clinical and clinical materials.
The collaboration covers various stages of AAV process development, analytical method development and qualification, as well as the pre-clinical and clinical manufacturing of cGMP drug substances and drug products in preparation for upcoming clinical trials.
Diorasis Therapeutics CEO Remis Bistras said: “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”.
Diorasis Therapeutics is dedicated to developing disease-modifying gene therapies for glaucoma to achieve long-lasting efficacy from a single in-office administration.
Its lead programme in open-angle glaucoma is anticipated to enter clinical development after the completion of toxicology studies and regulatory submissions.
Northway Biotech CEO chairman Vladas Algirdas Bumelis said: “We are very proud to support Diorasis Therapeutics in advancing their promising gene therapy programme.
“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.”
