Therapeutic antibody development company Patrys Ltd (ASX:PAB) continued its progress in the quarter ended June 30, 2024, which featured the completion of a good manufacturing practice (GMP) standards manufacturing run of PAT-DX1.
PAT-DX1 is a drug substance that is likely to have clinical utility for treating primary and secondary brain cancers due to its ability to cross the blood brain barrier. It also may have utility for treating cancers with existing DDR deficiencies or in combination with other DNA-damaging agents such as radiation and many chemotherapy drugs.
Patrys CEO and managing director Dr James Campbell said: “The focus for Patrys for the April-June period was the GMP manufacturing run of PAT-DX1 which was completed during the quarter.
“Our contract manufacturing and development organisation advised that specification testing of the drug material from this production run is scheduled to be completed by the end of July — approximately one month later than the company was expecting.
“This specification testing must be successfully completed before the drug material can be released for use in clinical trials.
"We were also pleased to receive positive data from preclinical studies that further highlight the potential to use our deoxymabs for various autoimmune diseases.”
Quarterly highlights
During the quarter, Patrys completed large-scale fermentation for the production of its antibody product, PAT-DX1. The harvested antibody was purified using an optimised process, critical for specification testing to verify product quality under GMP standards before clinical trials. The specification testing, now delayed until the end of this month, is expected to impact development timelines.
Patrys announced new preclinical data for PAT-DX1 and PAT-DX3, presented by Dr Kim O’Sullivan from Monash University at the 21st International Vasculitis Workshop in Barcelona in April. The data demonstrated the potential of both antibodies in treating the autoimmune disease anti-neutrophil cytoplasmic antibody (ANCA) vasculitis. Key findings included:
- PAT-DX1 inhibits neutrophil extracellular trap (NET) formation from human blood neutrophils in vitro.
- In animal models of ANCA vasculitis, both PAT-DX1 and PAT-DX3 decreased NET formation and inflammation and reduced kidney injury and resultant protein in the urine.
Dr O’Sullivan also presented related findings at the annual meeting of the American Association of Immunologists in Chicago in May 2024.
Previous non-clinical studies by Patrys indicated that its deoxymabs suppress NET formation, which is linked to cancer cell maintenance, metastasis and inflammation regulation.
These results suggest that deoxymabs may offer a therapeutic option for vasculitis, reducing inflammation without immune suppression, potentially expanding the indications for Patrys’ deoxymab technology.
Patrys continues to manage a robust business development program, collaborating with global biotech and pharmaceutical companies and academics to explore applications for its deoxymab technology, including cancer therapies and treatments for inflammatory conditions.
During the quarter to June 30, Patrys experienced net cash outflows of $764,000, allocating A$527,000 to research and development (R&D) activities and payments to related parties and their associates of $147,000.
As at the quarter end, the company held $2.24 million in cash and cash equivalents.