Kazia Therapeutics Limited American Depositary Shares - KZIA STOCK NEWS

Kazia Therapeutics Limited (NASDAQ: KZIA) has revealed promising interim data from its phase I clinical trial of paxalisib in combination with radiotherapy for treating brain metastases. Conducted by Memorial Sloan Kettering Cancer Center, the trial showed a remarkable overall response rate of 100% in evaluable patients, compared to typical rates of 20-45% with standard radiotherapy. The data will be presented at the 2022 Annual Conference on CNS Clinical Trials and Brain Metastases in Toronto. Recruitment for the expansion stage of the trial is underway, aiming for an additional 12 patients.

Kazia Therapeutics Limited (NASDAQ: KZIA) has launched a new Scientific Advisory Board (SAB) to guide the development of its brain cancer treatment, paxalisib. The SAB includes four renowned experts in brain cancer research: Dr. Priscilla Brastianos, Dr. John de Groot, Dr. Alan Olivero, and Dr. Patrick Wen. Their expertise is crucial as paxalisib approaches the completion of the GBM AGILE clinical trial, anticipated in the second half of 2023. Kazia's CEO, Dr. James Garner, acknowledged the contributions of previous SAB members and emphasized the importance of this new team's guidance for the drug's potential commercialization.

Kazia Therapeutics Limited (NASDAQ: KZIA; ASX: KZA) announced that the FDA granted Rare Pediatric Disease Designation (RPDD) for its drug paxalisib, targeting atypical rhabdoid/teratoid tumors, a rare and aggressive childhood brain cancer. This designation may lead to a pediatric priority review voucher (pPRV), which can significantly shorten the FDA review process and has historically been valued over $100 million. The RPDD follows positive preclinical results presented at the AACR Annual Meeting in April 2022. Kazia is advancing clinical trials, including a phase II study of paxalisib.

Kazia Therapeutics Limited (NASDAQ: KZIA) has announced that the FDA has granted Orphan Drug Designation (ODD) for its drug, paxalisib, to treat atypical rhabdoid/teratoid tumors (AT/RT), a rare and aggressive childhood brain cancer. This designation provides advantages such as up to seven years of exclusivity and potential savings of over US$3 million in fees for regulatory filings. Paxalisib has previously received ODD for malignant glioma. The company continues its clinical studies to evaluate paxalisib’s efficacy in various brain cancers.

Kazia Therapeutics (NASDAQ: KZIA) announced promising new data on paxalisib at the 20th ISPNO in Hamburg. The research highlights paxalisib's effectiveness in treating childhood brain cancers with poor prognoses, specifically atypical teratoid/rhabdoid tumors and diffuse intrinsic pontine glioma (DIPG). Preclinical studies show that paxalisib, combined with ONC201, significantly extends survival in animal models. Two patients experienced dramatic tumor reduction with the combination therapy. A phase II clinical trial for this combination began recruitment in November 2021, with results anticipated in 1H CY2023.

Kazia Therapeutics Limited (NASDAQ: KZIA) announced that its phase II study of paxalisib for brain metastases treatment has progressed to an expansion stage specifically for breast cancer. The study, led by the Alliance for Clinical Trials in Oncology, began in 2019 and has successfully recruited the initial ten patients in the breast cancer cohort, achieving the response criteria needed for further patient enrollment. The study aims to evaluate the effectiveness of paxalisib based on the genetic profile of tumors, highlighting its role in precision medicine.

Kazia Therapeutics Limited (NASDAQ: KZIA) announced final data from its Phase II study of paxalisib for glioblastoma at ASCO 2022. The study involved 30 patients and found a median overall survival (OS) of 15.7 months, exceeding the 12.7 months reported for temozolomide. Median progression-free survival (PFS) was 8.6 months, significantly higher than the 5.3 months for the current standard of care. The maximum tolerated dose was determined to be 60mg once daily, with a safety profile consistent with previous studies. The company looks forward to further development based on these encouraging results.

Kazia Therapeutics Limited (NASDAQ: KZIA) announced the opening of recruitment for the paxalisib arm of the GBM AGILE study in Europe, specifically at University Hospital Zurich. This marks the first European clinical trial activity for paxalisib, which is part of a larger effort to find effective treatments for glioblastoma. Over 40 sites in the U.S. and Canada are already recruiting for this study, which aims to evaluate overall survival as a primary endpoint. The trial's duration is expected to be 30-36 months, with final data anticipated by the end of 2023.

Kazia Therapeutics is focusing on childhood brain cancer, leveraging its experience from adult brain cancer treatments. The company is addressing significant challenges in enrolling patients for clinical trials, creating a gap in treatment options. Despite limited data, Kazia is positioned to pioneer this niche market. Their current net present value is estimated at US$294m (US$22.28 per basic ADR). As of December 2021, Kazia reported net cash of US$11.0m and anticipates needing approximately US$51m in additional financing to support operations through 2024.