Therapeutic antibody development company Patrys Ltd (ASX:PAB) has provided an update on the recently completed GMP manufacturing run of PAT-DX1.
Patrys’ contract development manufacturing organisation (CDMO) has advised the company that the quality assurance and quality control approvals for the revised specification testing protocols are pending ahead of final product testing.
Accordingly, Patrys has been advised that specification testing for the drug substance produced in the recent manufacturing run of PAT-DX1 is now expected to be complete in the first half of October 2024.
This specification testing must be successfully completed for the drug material to be released for use in clinical trials. Any delays with specification testing and drug release directly impact on the commencement of clinical development activities for PAT-DX1.
PAT-DX1 antibody fragment
PAT-DX1 is a dimer of a small antibody fragment derived from a humanised version of the binding domain from the original mouse deoxymab antibody 3E10. Patrys is manufacturing a large scale GMP batch of PAT-DX1 that will be suitable for use in clinical studies.
PAT-DX1 is likely to have clinical utility for treating primary and secondary brain cancers due to its ability to cross the blood brain barrier.
It may also have utility for treating cancers and/or metastases that are associated with NETosis, or in combination with DNA damaging agents such as radiation and many chemotherapy drugs.