Kazia Therapeutics lands key manufacturing patents for paxalisib in US and India

Kazia Therapeutics Ltd (ASX:KZA) (NASDAQ:KZIA) has secured manufacturing patents for its paxalisib cancer treatment candidate in key territories, extending its patent protection out until 2036. The oncology-focused drug development company has been awarded manufacturing patents in the US and India, while a similar patent has progressed in Australia and is on track to be granted in the coming quarter. Further patents remain pending in the European Union, China, Canada and other strategic territories. These are expected to be approved in due course. “Exceptionally robust protection” Kazia CEO Dr James Garner said: “As we move towards commercialisation, we have worked closely with our intellectual property counsel to ensure we achieve the maximum possible degree and duration of protection for the intellectual property embodied in paxalisib. “The original patents for paxalisib protect its chemical structure and have been granted in almost all relevant territories. “The new suite of patents additionally covers the process by which paxalisib is manufactured and, together with the original composition of matter patents, provide exceptionally robust protection. “The manufacturing patents are now granted in the US and India, and are also expected to be granted in other key territories after review by the respective patent agencies.” Shares have been as much as 3.5% higher to A$1.345 while the company's market cap pre-open was approximately A$172.3 million. New patents Crucially, these newly granted manufacturing patents, which expire in 2036, provide an additional layer of protection by covering the process by which paxalisib is manufactured. According to Kazia, any generic competitor would now need to develop an alternative method of chemical synthesis, which is technically challenging and hence a costly exercise. Interestingly, existing ‘composition of matter’ patents for the chemical structure of paxalisib generally expire in 2031 but are likely to be eligible for a five-year patent term extension in key territories. GBM AGILE and paxalisib trials While it continues to acquire patents in key markets, Kazia is focused on conducting studies with paxalisib, particularly against glioblastoma — the most common and aggressive form of primary brain cancer in adults. GBM AGILE, a pivotal glioblastoma study for paxalisib’s registration, is currently underway in the United States. The trial is expected to open in Europe during 2021’s second half. Meanwhile, eight additional studies are active in various forms of brain cancer at leading research hospitals across the US. Current studies evaluating paxalisib in brain cancer. These studies are designed and largely funded by the institutions that run them, with input and support from Kazia. Potentially, the data they generate may provide a path to substantially expand the commercial use of paxalisib.