Olaparib

Debiopharm will pay $10 million upfront for the rights to lunresertib.\n Seven months after pressing pause on its plans for its PKMYT1 inhibitor, Repare Therapeutics has found a partner to take the cancer drug forward.Back in January, Repare abandoned phase 3 plans to evaluate the candidate, called lunresertib, in combination with its ATR inhibitor camonsertib for platinum-resistant ovarian cancer. While the biotech continued to assess lunresertib in combination with Debiopharm’s WEE1 inhibitor as part of a collaboration, Repare said at the time that it would halt other plans to develop lunresertib unless a partner can be found.That partner has finally appeared in the form of Debiopharm, which will pay $10 million upfront for the rights to lunresertib. Under the deal, Repare will also be in line for a further $5 million in near-term payments, as well as up to $257 million in potential clinical, regulatory, commercial and sales milestones, and single-digit royalties on sales.Debiopharm will also take over the ongoing study of lunresertib with its WEE1 inhibitor, dubbed Debio 0123.“Based on very promising phase 1/1b clinical data, we believe the combination of lunresertib and Debio 0123 is highly synergistic and could potentially drive rapid and deep tumor regressions,” Debiopharm CEO Bertrand Ducrey said in a July 15 post-market release. “We believe the synthetic lethality approach of lunresertib in combination with Debio 0123 will allow us to bring this innovative precision therapy to patients with difficult-to-treat cancers.”Following two rounds of pipeline prioritizations in a year, Repare reaffirmed this morning that it is focused on a pair of phase 1 trials for its PLK4 inhibitor RP-1664 and the Polθ ATPase inhibitor RP-3467. RP-1664 is currently being evaluated as a monotherapy in adult and adolescent patients with TRIM37-high solid tumors. Meanwhile, Repare is assessing RP-3467 alone and in combination with Lynparza in patients with ovarian cancer, breast cancer, castration-resistant prostate cancer and pancreatic adenocarcinoma, with a readout penciled in for the third quarter.“This agreement builds upon the success of Repare and Debiopharm’s existing collaboration studying the combination of lunresertib and Debio 0123,” Repare’s CEO Steve Forte said in the same release.“Our recent business development efforts have continued to enable Repare to focus on the advancement of our clinical priorities and sustained value creation,” Forte added. “We remain focused on two ongoing phase 1 clinical trials with readouts expected in the second half of 2025: the LIONS trial evaluating our RP-1664 PLK4 inhibitor and the POLAR trial evaluating our RP-3467 Polθ ATPase inhibitor.”

SYDNEY, July 9, 2025 /PRNewswire/ -- Kazia Therapeutics (NASDAQ: KZIA) is pleased to announce preliminary results from the first patient in its Phase 1b trial evaluating a combination regimen of Paxalisib, pembrolizumab (Keytruda®), and standard chemotherapy after completing Cycle 1 (21 days) of dosing. The patient, a 61-year-old woman with metastatic triple-negative breast cancer localized to the left upper lobe of the lung, has shown highly encouraging preliminary results at 21 days, with a >50% reduction in circulating tumor cells (CTCs) and a notable decrease in CTC clusters. The early data in this first patient closely mirror the mechanistic preclinical findings published in Molecular Cancer Therapeutics (), which highlight that Paxalisib, when combined with immunotherapy, significantly disrupted both single CTCs and multicellular clusters in preclinical models. Key Highlights - Patient Profile: 61-year-old female, metastatic triple-negative breast cancer (lung metastasis). - Investigational Regimen: Paxalisib, pembrolizumab, and chemotherapy. - Results at Day 21 (End-of-Cycle 1): >50% reduction in total CTC count. Comparable reduction in CTC clusters—these aggregates are associated with heightened metastatic potential. Reduction in the mesenchymal phenotype of the remaining CTCs; this phenotype is one of the hallmarks of aggressive metastatic seeding cancer cells. First-in-human data support potential for potent CTC mobilization suppression by this combination. Clinical Significance of Patient Data CTC clusters have long been recognized as critical mediators of metastasis and markers of poor prognosis. They are known to resist apoptosis, evade immune detection, and seed new tumor sites with exceptional efficiency. Notably, standard chemotherapy has been shown in some studies to transiently increase CTC and cluster counts within the first cycle, with levels sometimes doubling before normalizing after cycle two. In contrast, immunotherapy alone has demonstrated variable impact, often showing delayed or modest effects on CTCs, likely due to immune-mediated mechanisms over weeks to months. In this case, the combination regimen of Paxalisib and immunotherapy achieved a rapid reduction in both CTC numbers and clusters as well as a reduction in the mesenchymal phenotype—an outcome not typically seen with chemotherapy or immunotherapy alone after only 21 days of treatment. This early clinical data reflects mechanistic synergy consistent with the preclinical data described in the MCT manuscript. Dr. John Friend, MD, Chief Executive Officer of Kazia Therapeutics, said "It is very exciting to see our extensive preclinical research translate into such positive early data in this first patient receiving a combination of Paxalisib and immunotherapy. The degree of reduction in tumor cell dissemination markers in just 21 days gives us strong reason for optimism as we continue this clinical trial." Dr. Friend continued "CTC clusters are emerging as key drivers of metastatic spread—they're 20–100X more efficient at seeding than single CTCs—and the sharp decline we're seeing is truly encouraging. We believe this combination may offer a meaningful early intervention against systemic disease progression." Next Steps - Explore potential relationship between CTC kinetics and radiographic responses - Enrollment continues in the Phase Ib study, expanding cohort size to assess safety, tolerability, and pharmacodynamics - Planned comprehensive analysis of immune microenvironment and CTC kinetics across all patients through serial monitoring - Longer-term follow-up will include imaging, progression-free survival, and assessment of correlation with molecular biomarkers For investor and media, please contact Alex Star, Managing Director LifeSci Advisors LLC, [email protected], +1-201-786-8795. 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 cancer. Licensed from Genentech in late 2016, paxalisib is or has been the subject of ten clinical trials in this disease. A completed Phase 2/3 study in glioblastoma (GBM-Agile) was reported in 2024 and discussions are ongoing for designing and executing a pivotal registrational study in pursuit of a standard approval. Other clinical trials involving paxalisib are ongoing in advanced breast cancer, 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 preliminary data was presented at 15th Biennial Ovarian Cancer Research Symposium in September 2024. For more information, please visit 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, Kazia's strategy and plans with respect to its paxalisib program, the potential results of its Phase 1b clinical trial evaluating paxalisib in combination with olaparib or pembrolizumab for patients with advanced breast cancer, the potential benefits of paxalisib as an investigational PI3K/mTOR inhibitor, timing for any regulatory submissions or discussions with regulatory agencies, the potential market opportunity for paxalisib and Kazia's intent and efforts to regain and/or maintain compliance with the applicable Nasdaq continued listing requirements and standards. 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, including the risk that interim or early data may not be consistent with final data, risks related to regulatory approvals, risks related to the impact of global economic conditions, and risks related to Kazia's ability to regain and/or maintain compliance with the applicable Nasdaq continued listing requirements and standards. These and other risks and uncertainties are described more fully in Kazia's Annual Report, filed on form 20-F with the SEC, and in subsequent filings with the United States Securities and Exchange Commission. 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 SOURCE Kazia Therapeutics Limited WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED