Melbourne-based oncology biotech Patrys Ltd (ASX:PAB) says specification testing for the drug substance produced in the recent manufacturing run of PAT-DX1 is still in progress.
Material needed for clinical trials
The company’s contract development manufacturing organisation (CDMO) has advised that its specification testing for the drug substance produced in the recent manufacturing run of PAT-DX1 is now expected to be completed by the end of this month – one month later than was anticipated.
Patrys is developing cancer therapies through its deoxymab platform of cell-penetrating antibodies.
The specification testing must be successfully completed for the drug material to be released for use in clinical trials.
As the availability of Good Manufacturing Practice (GMP) drug material is on the critical path for initiating the clinical development process, this delay will directly impact on the commencement of clinical development activities for PAT-DX1.
The company says the specification testing will be wrapped up in the next four weeks and will advise if there are any further amendments to this revised timeline.
About the platform
The company's efforts are focused on harnessing the unique properties of these antibodies to treat various types of cancer.
The deoxymab platform is anchored in the deoxymab 3E10 antibody, initially identified as an autoantibody in a mouse model of systemic lupus erythematosus (SLE).
Unlike most antibodies that bind to cell surface markers, deoxymab 3E10 penetrates cell nuclei and binds directly to DNA, inhibiting DNA repair processes.
This mechanism is particularly effective against cancer cells, which often exhibit high levels of mutations and deficiencies in DNA repair mechanisms.
This means that deoxymab 3E10 is able to kill cancer cells selectively, with minimal impact on normal cells.
As a single agent, deoxymab 3E10 has demonstrated the ability to enhance the efficacy of both chemotherapy and radiotherapy considerably.
Additionally, it can be conjugated to nanoparticles to facilitate the targeted delivery of chemotherapeutics and imaging agents to tumours.
Pre-clinical studies have shown PAT-DX1's significant ability to kill cancer cells across various models, including cell models, human tumour explants, and xenograft and orthotopic models.
Notably, it has been shown to cross the blood-brain barrier, reduce tumour size, and increase survival rates in multiple animal models of brain cancer and other cancers, as well as metastases.
Patrys believes PAT-DX1 could be applicable to a wide range of cancers, including gliomas, melanomas, prostate, breast, pancreatic, and ovarian cancers.