On October 28, 2022 Patrys Limited (ASX: PAB, "Patrys" or the "Company"), a therapeutic antibody development company, reported its Quarterly Activities Report and Appendix 4C Quarterly Cash Flow report for the quarter ended 30 September 2022 (Press release, Patrys, OCT 28, 2022, View Source [SID1234623643]).
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Patrys Chief Executive Officer and Managing Director, Dr. James Campbell said: "We are delighted that the second engineering run has provided us with the material needed to complete the final studies that will allow us to initiate the first clinical trials of PAT-DX1 in the second half of next year. This is a very significant milestone for the company. The preclinical work on our deoxymabs continues to highlight the great potential these unique antibodies have to provide new therapeutic approaches for treating cancer. In addition to the exciting results reported from the Telethon Kids Cancer Centre, we are very pleased that additional grant funding has been secured to continue the research that is being conducted at the Olivia Newton John Cancer Research Institute looking at ways to use our deoxymabs to treat breast cancers."
Operations Update
At the beginning of the quarter, Patrys announced that its Contract Development Manufacturing Organisation (CDMO) had completed a second engineering run of PAT-DX1 which used an updated purification process to produce large-scale quantities of clinical grade PAT-DX1. In August, Patrys reported that the material produced in this engineering run had successfully completed specification testing. Specification testing is a necessary requirement to ensure that the activity and purity of the manufactured drug material falls within pre-defined tolerance levels. The PAT-DX1 drug material has also undergone microbiological and chemical testing to confirm the absence of contaminants. For personal use only 2 This GMP PAT-DX1 drug material will be used to complete the two remaining animal toxicology studies that are required before first-in-human studies can be initiated in 2H CY2023. Patrys has already successfully completed animal toxicology studies using non-GLP PAT-DX1 drug material and these showed that it is safe and well-tolerated. The GLP toxicology studies for PAT-DX1 are scheduled to commence in Q4 CY2022.
In August, Patrys reported new pre-clinical data for its lead asset, PAT-DX1 which supports the development of PAT-DX1 as a potential treatment for high grade glioma (HGG), a fast growing and clinically challenging form of brain cancer. The study was conducted in the laboratory of Professor Terrence Johns of the Telethon Kids Cancer Centre as part of the program of research being conducted under the $250,000 grant from the inaugural Clinical Accelerator fund of the Cure Brain Cancer Foundation awarded earlier this year.
In this study, the administration of PAT-DX1 increased the effectiveness of radiation therapy which resulted in a significant improvement in survival in an animal model of high-grade glioma Researchers at the Olivia Newton-John Cancer Research Institute (ONJCRI) have been awarded a $100,000 Victorian Medical Research Acceleration Fund (VMRAF) grant from the Victorian State Government to support research into the potential to incorporate PAT-DX1 and PAT-DX3 into new treatments for metastatic breast cancer. This research program will be led by Professor Robin Anderson, Head of ONJCRI’s Translational Breast Cancer Program and Metastasis Research Laboratory. Professor Anderson’s research is focused on understanding the genetic regulation of metastasis, primarily in breast cancer, and is aimed at identifying new targets for molecular based therapy for patients with progressive disease.
Corporate Update In August, John Read announced his intention to step down as Chair of Patrys having held the role since the company listed on the ASX approximately 15 years ago. Mr Read played a pivotal leadership role, most recently guiding the Company’s development of its unique deoxymab antibody technology platform. Current Director Mike Stork has been appointed as interim Chair while a search for a permanent Chair is completed. While this is being undertaken, Stefan Ross has been appointed as a Non-Executive Director and it is intended that he will step down from this position once a permanent Chair is appointed. In September Patrys and Hefei Co-Source mutually agreed to terminate the exclusive development and commercialisation program for China for the IgM asset PAT-SC1, which was the last of Patrys’ IgM legacy assets.
The termination of this program aligns with Patrys’ focus on advancing its deoxymab technology towards the clinic. During the quarter ended 30 September 2022, Patrys had net cash outflows from operating activities of A$2,584k, with A$2,151k invested in R&D activities. At 30 September 2022, Patrys held A$5.2M in cash and an additional A$2M in short-term investments. Payments to related parties and their associates during the quarter, which are outlined in Section 6 of the accompanying Appendix 4C to this For personal use only 3 quarterly activity report, were A$166k. These payments include non-executive director fees and consulting services as well as salary (including superannuation) for the CEO and Managing Director.