On September 12, 2024 Kazia Therapeutics Limited (NASDAQ: KZIA), an oncology-focused drug development company, reported that an agreement has been executed with QIMR Berghofer Medical Research Institute, one of Australia’s foremost cancer research centres, to obtain an exclusive license to certain intellectual property rights in relation to combination therapies consisting of PI3K inhibitor drugs, and one or more immunotherapy or PARP inhibitor drugs (PI3K combination) (Press release, Kazia Therapeutics, SEP 12, 2024, View Source [SID1234646545]).
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Under the license agreement, Kazia receives an exclusive, worldwide, sub-licensable and royalty-bearing licence to certain intellectual property for the development of any drugs or product candidates within the PI3K inhibitor class in combination with immunotherapy or PARP inhibitors. Paxalisib, Kazia’s lead product candidate, is a member of the PI3K inhibitor class.
The exclusive license agreement follows a collaboration between Kazia and QIMR Berghofer which began in December 2022 and has already led to the filing of supportive patents which include the use of paxalisib as an immune modulator in the treatment of diseases such as breast cancer.
The terms of the license include standard provisions for an upfront license fee and development milestones related to the initiation of Phase 1, Phase 2 trial, first Phase 3 trial, first product approval.
Commenting on the new license agreement, Kazia CEO, Dr John Friend said: "This is an exciting evolution in our partnership with QIMR Berghofer and an important milestone for not only Kazia’s development of paxalisib, but also the company’s commercial portfolio as we secure the licence of a significant cancer immunotherapy pathway. We are very pleased to have obtained the potential intellectual property rights around PI3K inhibitors, which is a significant step forward as we continue to explore cancer treatments beyond the brain, including novel therapeutics in solid tumours such as breast cancer."
Professor Fabienne Mackay, Director and CEO of QIMR Berghofer said: "We are pleased to enter this exclusive licence agreement with Kazia following what has been a successful research collaboration over the past two years. We look forward to progressing the clinical development pathway for PI3K inhibitor drugs such as paxalisib under this partnership in the hope of delivering tangible, life-changing benefits to patients."
Kazia’s preclinical research collaboration with QIMR Berghofer Medical Research Institute is investigating the use of paxalisib in solid tumours. The ongoing research project is led by Professor Sudha Rao, a leading expert in transcriptional biology, particularly as it applies to the function of the immune system in cancer. Prof Rao is the principal investigator of preclinical studies where paxalisib and KEYTRUDA combination is used in Triple Negative Breast Cancer, and paxalisib and LYNPARZA (Olaparib) combination in advanced breast cancer.
Professor Rao’s team has demonstrated in preclinical studies that the combination of paxalisib with checkpoint inhibitor blockade resulted in highly consistent and statistically significant signals of efficacy including overall tumour volume, metastases, and inflammatory markers. Furthermore, the addition of paxalisib to immunotherapy was observed to reinvigorate the immune cells within the tumour microenvironment by restoring immune killing function while inhibiting "pro-tumour" immune cells. Further data is expected to be presented at future scientific meetings in 2025.
Commenting on the research, Prof Rao said: "The immune system plays a critical role in fighting against cancer. We urgently need treatments that can make cancer cells visible, and at the same time increase the utility of immunotherapy for metastatic breast cancers. In that sense, paxalisib is an exciting PI3K inhibitor because it not only has been observed to inhibit primary tumour burden but was also observed to reinvigorate the immune system of cancer patients. We look forward to providing a preliminary update in the near future on our findings of using paxalisib in breast cancer."