KAZIA EXECUTES LICENSING AGREEMENT WITH QIMR BERGHOFER

Rhea-AI Summary

Kazia Therapeutics (NASDAQ: KZIA) has executed an exclusive licensing agreement with QIMR Berghofer Medical Research Institute for intellectual property rights related to PI3K inhibitor combination therapies. The agreement covers the development of PI3K inhibitors combined with immunotherapy or PARP inhibitors, including Kazia's lead candidate, paxalisib. This follows a collaboration that began in December 2022, resulting in supportive patents for paxalisib as an immune modulator in diseases like breast cancer.

The license includes standard provisions for fees and milestones. Kazia's CEO, Dr. John Friend, emphasized the significance of this agreement for paxalisib's development and the company's commercial portfolio. Preclinical studies have shown promising results for paxalisib in combination with immunotherapy in solid tumors, particularly breast cancer. Further data is expected to be presented at scientific meetings in 2025.

Positive

• Exclusive worldwide license for PI3K inhibitor combination therapies
• Potential expansion of paxalisib's applications beyond brain cancer
• Promising preclinical results for paxalisib in combination with immunotherapy for solid tumors
• Multiple regulatory designations for paxalisib, including Orphan Drug and Fast Track

Negative

• Financial terms of the license agreement not disclosed
• No immediate revenue impact from the licensing deal
• Clinical efficacy of paxalisib combinations yet to be proven in human trials

Oncology Research Analyst

This licensing agreement marks a significant milestone for Kazia Therapeutics. The exclusive rights to develop PI3K inhibitors in combination with immunotherapy or PARP inhibitors could potentially expand Kazia's oncology portfolio beyond brain cancer. Preclinical data showing paxalisib's ability to enhance immunotherapy efficacy in breast cancer is particularly promising.

The agreement's structure, including upfront fees and milestone payments, is standard for the industry. However, the real value lies in the potential for new patent protections and expanded indications for paxalisib. This could significantly extend the drug's commercial lifespan and market potential.

Investors should note that while promising, these are still early-stage developments. The true impact on Kazia's valuation will depend on future clinical trial results, particularly in solid tumors outside the brain. This agreement positions Kazia well for future growth but doesn't guarantee immediate financial returns.

Immunology Expert

The combination of PI3K inhibitors with immunotherapy represents a cutting-edge approach in cancer treatment. Paxalisib's observed ability to "reinvigorate the immune system" in preclinical studies is particularly intriguing. This could potentially address a major challenge in immunotherapy: overcoming immune suppression within the tumor microenvironment.

The research focusing on Triple Negative Breast Cancer (TNBC) is noteworthy. TNBC is notoriously difficult to treat and new combination approaches are desperately needed. If clinical trials can replicate the preclinical results showing reduced tumor volume and metastases, it could represent a significant advance in TNBC treatment.

However, it's important to remember that many promising preclinical results fail to translate to human trials. Investors should watch closely for the upcoming data presentations in 2025 to gauge the potential of this approach.

Financial Analyst

While the financial terms of the agreement aren't fully disclosed, the structure aligns with industry standards. The milestone-based payments help Kazia manage cash flow, only paying out as the research progresses. This is a prudent approach for a small biotech company.

The real financial potential lies in the expanded market opportunities. If successful, this could allow Kazia to target the much larger solid tumor market, significantly increasing the potential revenue from paxalisib. The breast cancer market alone is valued at over $20 billion globally.

However, investors should be cautious. Drug development is risky and Kazia will likely need additional funding to support expanded clinical trials. The company's cash position and burn rate should be closely monitored. While this agreement enhances Kazia's long-term prospects, it doesn't immediately solve any near-term financial challenges the company may face.

SYDNEY, Sept. 12, 2024 /PRNewswire/ -- Kazia Therapeutics Limited (NASDAQ: KZIA), an oncology-focused drug development company, is pleased to announce 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).

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."

About Kazia Therapeutics Limited

Kazia Therapeutics Limited (NASDAQ: KZIA) is an oncology-focused drug development company, based in Sydney, Australia.

Our lead program is paxalisib, an investigational brain-penetrant inhibitor of the PI3K / Akt / mTOR pathway, which is being developed to treat multiple forms of brain cancer. Licensed from Genentech in late 2016, paxalisib is or has been the subject of ten clinical trials in this disease. A completed Phase 2 study in glioblastoma reported early signals of clinical activity in 2021, and a pivotal study in glioblastoma, GBM AGILE, has been completed with presentation of paxalisib arm data expected later in 2024 at a major medical conference. Other clinical trials involving paxalisib are ongoing in brain metastases, diffuse midline gliomas, and primary CNS lymphoma, with several of these trials having reported encouraging interim data.

Paxalisib was granted Orphan Drug Designation for glioblastoma by the FDA in February 2018, and Fast Track Designation (FTD) for glioblastoma by the FDA in August 2020. Paxalisib was also granted FTD in July 2023 for the treatment of solid tumour brain metastases harboring PI3K pathway mutations in combination with radiation therapy. In addition, paxalisib was granted Rare Pediatric Disease Designation and Orphan Drug Designation by the FDA for diffuse intrinsic pontine glioma in August 2020, and for atypical teratoid / rhabdoid tumours in June 2022 and July 2022, respectively.

Kazia is also developing EVT801, a small-molecule inhibitor of VEGFR3, which was licensed from Evotec SE in April 2021. Preclinical data has shown EVT801 to be active against a broad range of tumour types and has provided evidence of synergy with immuno-oncology agents. A Phase I study has been completed and presentation of preliminary data at a medical conference is anticipated in CY2024.

For more information, please visit www.kaziatherapeutics.com or follow us on X @KaziaTx.

Forward-Looking Statements
This announcement may contain forward-looking statements, which can generally be identified as such by the use of words such as "may," "will," "estimate," "future," "forward," "anticipate," or other similar words. Any statement describing Kazia's future plans, strategies, intentions, expectations, objectives, goals or prospects, and other statements that are not historical facts, are also forward-looking statements, including, but not limited to, statements regarding: the timing for results and data related to Kazia's clinical and preclinical trials and investigator-initiated trials of Kazia's product candidates, the potential benefits of Kazia's product candidates, including paxalisib, and Kazia's strategy and plans with respect to its programs, including paxalisib and EVT801. Such statements are based on Kazia's current expectations and projections about future events and future trends affecting its business and are subject to certain risks and uncertainties that could cause actual results to differ materially from those anticipated in the forward-looking statements, including risks and uncertainties: associated with clinical and preclinical trials and product development, related to regulatory approvals, risks related to collaborations with third parties, and related to the impact of global economic conditions. These and other risks and uncertainties are described more fully in Kazia's Annual Report, filed on form 20-F with the United States Securities and Exchange Commission (SEC), and in subsequent filings with the SEC. Kazia undertakes no obligation to publicly update any forward- looking statement, whether as a result of new information, future events, or otherwise, except as required under applicable law. You should not place undue reliance on these forward-looking statements, which apply only as of the date of this announcement.

This announcement was authorized for release by Dr John Friend, CEO.

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SOURCE Kazia Therapeutics Limited

FAQ

What is the significance of Kazia's licensing agreement with QIMR Berghofer for KZIA stock?

The agreement gives Kazia exclusive rights to develop PI3K inhibitor combinations, potentially expanding the applications of their lead drug paxalisib beyond brain cancer to solid tumors like breast cancer, which could increase the drug's market potential and impact KZIA's stock positively.

How might the preclinical results of paxalisib combinations affect KZIA's future prospects?

Preclinical studies showing paxalisib's efficacy in combination with immunotherapy for solid tumors, especially breast cancer, suggest potential for expanded indications. If confirmed in clinical trials, this could significantly increase the drug's market value and KZIA's revenue prospects.

What are the key regulatory designations for paxalisib that could benefit KZIA?

Paxalisib has received several FDA designations, including Orphan Drug and Fast Track for glioblastoma, and Rare Pediatric Disease and Orphan Drug designations for certain rare pediatric cancers. These designations can expedite development and provide market exclusivity, potentially benefiting KZIA.

When can investors expect new clinical data for KZIA's paxalisib?

Investors can expect presentation of paxalisib arm data from the pivotal GBM AGILE study in glioblastoma later in 2024 at a major medical conference. Additionally, further data on paxalisib combinations is expected to be presented at scientific meetings in 2025.