Patrys Ltd (ASX:PAB) has pushed its Phase 1 clinical trial of PAT-DX1 into 2024, based on the recent updates from its contract development manufacturing organisation (CDMO) regarding the timing of availability of clinical-grade PAT-DX1.
PAT-DX1 is a deoxymab that can be used to target nanoparticles carrying a payload of anti-cancer drugs specifically to tumours.
Preparations for the study are well underway and the company remains focused on advancing PAT-DX1 to the clinic.
However, despite prior successful manufacturing test runs, Patrys’ CDMO has reported a sporadic issue relating to the cell line used to produce good manufacturing practice (GMP) PAT-DX1.
While this issue is actively being investigated and resolved, it will result in a delay in the availability of investigational drug material to be used for Patrys’ Phase 1 clinical trial of PAT-DX1.
In the meantime, the final, non-clinical GLP toxicology studies of PAT-DX1 remain on track with initial results expected in May 2023.
GMP production resolved
Patrys managing director and CEO Dr James Campbell said: “We are disappointed that the delay in availability of clinical grade material is going to push our Phase 1 clinical trial of PAT-DX1 into the calendar year 2024.
“Once the sporadic issue affecting GMP production is resolved, we are confident the manufacturing and purification process developed and tested for PAT-DX1 can provide the material required to initiate the first human clinical trial of a deoxymab antibody.
“In the meantime, we look forward to completing the remaining, non-clinical GLP toxicology studies of PAT-DX1 in May as scheduled.
“Furthermore, work on our full-sized IgG deoxymab, PAT-DX3, is progressing well and we expect to provide an update on this program in the coming weeks.”
Mouse model
Patrys’ deoxymab platform is based on the deoxymab 3E10 antibody that was first identified as an autoantibody in a mouse model of the human disease systemic lupus erythematosus (SLE).
Deoxymabs, such as PAT-DX1 and PAT-DX3, can be used to target nanoparticles carrying a payload of anti-cancer drugs specifically to tumours.
This allows specific delivery of cancer drugs to multiple types of cancer while having minimal impact on normal, healthy cells.
Patrys believes that PAT-DX1 may have application across a wide range of cancers including gliomas, melanomas, prostate, breast, pancreatic and ovarian cancers.