Patrys Limited provides update on clinical development plans for deoxymab technology

Patrys Limited (ASX:PAB) has announced a strategic shift in its clinical development plans, prioritizing the development of PAT-DX3 over PAT-DX1. The decision comes after the Company's Contract Development and Manufacturing Organisation (CDMO) advised that the purified drug material from the recent good manufacturing practice (GMP) production run for PAT-DX1 did not meet the required specifications, leading to concerns about potential safety issues. As a result, Patrys has decided not to proceed with the planned first-in-human Phase 1 clinical trial of PAT-DX1 in cancer patients. Instead, the Company intends to focus on the development of therapeutic opportunities available for PAT-DX3 and establish co-development and licensing opportunities for PAT-DX1 with partners who have the requisite expertise and resources to optimize a robust manufacturing process for this challenging molecule.

Executive Commentary on Strategic Shift

While we continue to believe PAT-DX1 has great potential for a number of therapeutic applications, the specialized product optimization required to reliably manufacture this unique molecule is better aligned with the resources of larger industry players. This is a disappointment to both shareholders, the Board and management of Patrys. However, PAT-DX1 has proven to be a challenging molecule to produce and purify over multiple production runs. We believe it is in the best interest of the Company and its shareholders to focus our future development activities and investment on PAT-DX3 rather than PAT-DX1, as we further evaluate other opportunities to advance our deoxymab technology. - Patrys Chief Executive Officer and Managing Director, Dr. James Campbell

Summary of Strategic Update

Patrys Limited (ASX:PAB) has decided to prioritize the development of PAT-DX3 over PAT-DX1, following challenges with the GMP production run for PAT-DX1. The Company has opted not to proceed with the planned first-in-human Phase 1 clinical trial of PAT-DX1 in cancer patients due to concerns about potential safety issues. Instead, Patrys intends to focus on the development of therapeutic opportunities available for PAT-DX3 and establish co-development and licensing opportunities for PAT-DX1 with partners who have the requisite expertise and resources to optimize a robust manufacturing process for this challenging molecule. The decision reflects the Company's commitment to align its resources with the most promising opportunities and maximize the potential of its deoxymab platform. Patrys believes that PAT-DX3, with its advantages over PAT-DX1, holds significant promise for future R&D activities and partnering opportunities. The Company also aims to conduct additional preclinical studies to identify the most appropriate path for deoxymabs in the areas of inflammation and cancer, providing the greatest optionality for their future development and partnering activities.