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KZIA 资讯
KZIA 事件
Kazia Therapeutics Receives $2M Milestone Payment from Sovargen
Kazia Therapeutics announced that Sovargen, a biotechnology company specializing in central nervous system diseases that has exclusively licensed paxalisib from Kazia for the development and commercialization of paxalisib as a potential treatment for mTORopathy-related epilepsies, has dosed the first patient in a Phase 1b/2a clinical trial evaluating paxalisib for the treatment of intractable epilepsy associated with focal cortical dysplasia type 2, or FCD T2, and tuberous sclerosis complex, or TSC. The dosing triggers a $2M development milestone payment to Kazia under the companies' exclusive licensing agreement. Sovargen is responsible for developing, manufacturing and commercializing paxalisib as a potential treatment for the mTORopathy-related epilepsies in all countries worldwide, excluding mainland China, Hong Kong, Macao and Taiwan. Under the agreement, Kazia is eligible to receive additional milestone payments of up to $17M upon the achievement of further development and regulatory milestones, plus a percentage of sub-licensing revenues and royalties on net sales of any products incorporating paxalisib. FCD T2 and TSC are rare, genetically driven neurological disorders. There are currently no approved therapies for FCD T2.
Kazia Therapeutics Begins PNOC035 Clinical Trial
Kazia Therapeutics announced that the first patient has been dosed in Arm A of PNOC035, a Phase 2 platform study evaluating paxalisib in combination with gemcitabine for patients ages 1 to 39 with recurrent or progressive atypical teratoid/rhabdoid tumor, or AT/RT. AT/RT is widely recognized as one of the most aggressive forms of pediatric brain cancer. PNOC035 is conducted by the Pediatric Neuro-Oncology Consortium, or PNOC, an open-label, multi-center platform study. In Arm A, patients receive oral, once-daily paxalisib in combination with intravenous gemcitabine on Days 1, 8 and 15 of each 28-day treatment cycle. The combination increased median survival nearly four-fold in an orthotopic AT/RT preclinical model and demonstrated complementary anti-tumor activity across multiple AT/RT cell lines. These preclinical findings provided the rationale for advancement into the multicenter PNOC035 clinical study evaluating paxalisib plus gemcitabine in children and young adults with recurrent or progressive AT/RT. These findings, previously presented at ISPNO, AACR and Neuro-Oncology meetings, provided the scientific rationale for PNOC035 and extend paxalisib's pediatric neuro-oncology development beyond diffuse midline glioma into another area of significant unmet need. Paxalisib has been granted both Orphan Drug Designation and Rare Pediatric Disease Designation by the FDA for AT/RT.
Kazia Therapeutics Reports Paxalisib Significantly Reduces Tumor Burden
Kazia Therapeutics announced new preclinical and translational data showing that its lead asset, paxalisib, reduced tumor burden, the total amount of cancer in the body, by 52% in microsatellite stable / proficient mismatch repair colorectal cancer. In a separate study, adding paxalisib to an existing immunotherapy drug reduced tumor volume by an additional 50%, compared with the immunotherapy alone. Across both studies, treatment was well tolerated, with no evidence of treatment-related toxicity. The Company plans to launch a five-arm Phase 2 clinical trial evaluating paxalisib as a monotherapy in combination with pembrolizumab versus standard of care in pre-treated MSS/pMMR metastatic colorectal cancer. The primary endpoint is safety and tolerability, with progression-free survival, overall response rate and overall survival as secondary endpoints. Enrollment is expected to begin in the first quarter of 2027, with full enrollment of all five arms anticipated by the end of 2027.
Kazia Therapeutics Releases New Data Showing Paxalisib's Anti-Tumor Activity in HR+/HER2- Breast Cancer
Kazia Therapeutics announced new preclinical data demonstrating the safety and anti-tumor activity of paxalisib in HR+/HER2- breast cancer, including evidence that paxalisib resensitized CDK4/6 inhibitor-resistant tumors to standard-of-care therapy. Based on these findings, the Company is moving rapidly to expand its ongoing TNBC clinical trial into hormone receptor-positive, HER2-negative advanced breast cancer to evaluate this effect directly and filed a related provisional patent application. In addition to these findings, paxalisib in combination with fulvestrant, and paxalisib in combination with fulvestrant and palbociclib, showed consistent safety and resulted in statistically significant reductions in tumor volume across preclinical models. Kazia has filed a patent that is supported by the Company's preclinical findings and has identified a high-risk subset of metastatic HR+/HER2- breast cancer defined by a novel PI3K/mTOR biomarker, with tissue- and blood-based tests associated with poor survival.
Kazia Therapeutics Announces $40 Million Public Offering Pricing
Kazia Therapeutics announced the pricing of its previously announced tranched registered public offering of (i) 2,580,000 American Depositary Shares, each representing five hundred ordinary shares of the company, no par value per share, or in lieu of ADSs to certain investors, pre-funded warrants to purchase ADSs, (ii) accompanying Series A Warrants to purchase up to 2,243,478 ADSs, which are exercisable immediately at a purchase price of $17.825 per ADS and will expire upon the earlier of 30 days following the company's Stage IV triple-negative breast cancer (TNBC) data readout, expected in the second half of 2027, or the five-year anniversary of issuance, and (iii) accompanying Series B Warrants to purchase up to 2,064,000 ADSs, which are exercisable immediately at a purchase price of $19.375 per ADS and will expire upon the earlier of 30 days following the company's HR+/HER2- data readout, expected in the first half of 2028, or the five-year anniversary of issuance. All of the securities in the Offering are being sold by Kazia. The combined public offering price for each ADS and accompanying warrants is $15.50, and the combined public offering price for each pre-funded warrant and accompanying warrants is $15.4999, for expected gross proceeds to Kazia of approximately $40M, before deducting underwriting discounts and commissions and offering expenses. If all of the Series A Warrants and Series B Warrants are exercised in full, the company would receive additional gross proceeds of approximately $80M, before deducting applicable expenses. Leerink Partners and Guggenheim Securities are acting as joint bookrunning managers for the Offering. BTIG and Needham & Company are acting as lead managers for the Offering. Laidlaw & Company Ltd. is acting as co-manager for the Offering. The Offering is expected to close on or about August 31.
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