Patrys is pleased to announce that its Contract Manufacturing and Development Oganisation (CDMO) has confirmed that a manufacturing slot for the GMP (Good Manufacturing Practice) production of PAT-DX1 will be available in Q1 CY 2024.
Additionally, PAB’s GLP toxicology studies are complete, and no safety or tolerability issues were identified.
This news paves the way for Patrys to initiate its its first-in-human clinical trial of PAT-DX1 in the second half of CY 2024.
Dr James Campbell said:
“I am delighted to confirm that, based on the extensive and rigorous investigations by both our CDMO and external manufacturing consultants, we are now able to recommence our manufacturing program of PAT-DX1 in the upcoming quarter. This manufacturing run is expected to produce the drug material that Patrys will use in the Phase 1 clinical trial of PAT-DX1 that is scheduled for the second half of CY2024. With positive results from our final preclinical toxicology studies in hand, we look forward to reporting on the progress of manufacturing and other activities as we work towards initiating the clinical development of our deoxymab technology.”