ASX Health Stocks: Patrys to commence Phase 1 trial as drug production process put in motion
Health & Biotech
Health & Biotech
Therapeutic antibody development biotech, Patrys (ASX:PAB), announced 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 of 2024.
Patrys says it’s confident that the drug material from this manufacturing run will enable the company to initiate its first-in-human clinical trial of PAT-DX1 in the second half of 2024 as previously guided.
In addition, Patrys confirmed that its GLP toxicology studies in both rats and non-human primates are complete, and that reports from these studies did not identify any safety or tolerability issues that might affect the proposed Phase 1 clinical trial of PAT-DX1.
“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 calendar year 2024,” said Patrys’ CEO, Dr James Campbell.
“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.”
Patrys’ PAT-DX1 is a form of deoxymab, a chemical compound that is attracted to, and binds to, strands of DNA.
All tumours, regardless of what type of cancer or where it is located, release DNA into the bloodstream. Deoxymabs are attracted to this DNA, and consequently are able to locate both primary and secondary cancers (metastases) throughout the body.
This opens up the potential to use deoxymabs as pan-cancer seeking agents for the targeted delivery of cancer therapies.
Patrys’ PAT-DX1 has been shown to reduce tumour size and cross the brain barrier. What this means is that the drug is able to penetrate the semi-permeable membrane between the blood and the interstitium of the brain, making it more effective.
PAT-DX1 is also tumour-agnostic, meaning that it can target many different tumour types in the body, regardless of specific tumour antigens.
The US Patent and Trademark Organisation (US PTO) has granted two patents that provide further intellectual property protection for Patrys’ deoxymab antibody technology until 2039.
There are now six granted patents covering the unconjugated form of deoxymab 3E10 (and derivatives thereof) in Europe, Japan, China, and three granted in the US.