Patrys Ltd (ASX:PAB) has confirmed that Good Manufacturing Practice (GMP) production of its drug PAT-DX1 is scheduled to begin in the first quarter of the 2024 calendar year.
This development is a result of Patrys' collaboration with a Contract Manufacturing and Development Organisation (CDMO) that has secured a manufacturing slot for PAT-DX1.
Drug pivotal in human trial
Patrys anticipates that the drug material produced in this run will be pivotal for initiating the first-in-human clinical trial of PAT-DX1 in the latter half of 2024, in keeping with the previously outlined timeline.
Patrys has also successfully completed GLP toxicology studies in both rats and non-human primates. The outcomes of these studies bolster the company’s confidence in the asset, with no significant safety or tolerability issues identified that might affect the upcoming Phase 1 clinical trial of PAT-DX1.
Positive preclinical results
CEO 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.”
About Patrys
Patrys is focused on the development of its unique deoxymab platform, which includes cell-penetrating antibodies, for the treatment of various cancers.
The deoxymab platform is based on the deoxymab 3E10 antibody, initially identified as an autoantibody in a mouse model of systemic lupus erythematosus (SLE).
Unlike typical antibodies that bind to cell surface markers, deoxymab 3E10 uniquely penetrates cell nuclei and binds directly to DNA, inhibiting DNA repair processes.
This mechanism is particularly effective against cancer cells, which often have high levels of mutations and underlying deficiencies in DNA repair mechanisms.
The humanised forms of deoxymab 3E10, including PAT-DX1 and PAT-DX3, have shown improved activity in pre-clinical studies.
PAT-DX1 has demonstrated significant potential in killing cancer cells across various models, including human tumour explants and xenograft and orthotopic models. Of particular note is its ability to cross the blood-brain barrier and reduce tumour size while increasing survival in multiple animal models of brain cancer and other cancers.
Patrys holds rights to develop and commercialise a portfolio of novel anti-DNA antibodies and antibody fragments, variants, and conjugates discovered at Yale University, targeting both cancer treatment and diagnostics.
This includes several granted patents in major markets worldwide, covering both the unconjugated form of deoxymab 3E10 and its nanoparticle conjugations.