Kazia Therapeutics Limited develops clinical-stage oncology therapies through an Australian foreign-issuer structure whose American depositary shares trade under KZIA. Company news centers on paxalisib, a brain-penetrant dual PI3K/mTOR inhibitor being developed across brain cancer and advanced breast cancer indications, including triple-negative breast cancer studies that report clinical and translational findings.
Recurring updates also cover Kazia's broader oncology platform, including NDL2, a PD-L1 protein degrader platform, and MSETC, a SETDB1-targeted epigenetic program. Additional company developments include research leadership, licensing activity, financing and capital-structure actions, Nasdaq listing compliance, annual meeting matters, governance changes, and operating or financial results.
Kazia Therapeutics Limited (ASX: KZA; NASDAQ: KZIA) has received Rare Pediatric Disease Designation (RPDD) from the FDA for its drug paxalisib, aimed at treating Diffuse Intrinsic Pontine Glioma (DIPG), a rare childhood brain cancer. This designation may enable Kazia to obtain a priority review voucher, valued between US$68 million and US$350 million, if paxalisib receives approval for DIPG. Positive preclinical data has been reported, with initial efficacy results expected in the second half of 2020. Currently, there are no FDA-approved treatments for DIPG, with a typical survival time of around 9.5 months.
Kazia Therapeutics Limited (ASX: KZA; NASDAQ: KZIA) presented interim data at the AACR Annual Meeting, showcasing promising results for paxalisib in glioblastoma and Cantrixil in ovarian cancer. The phase II study of paxalisib, now with data on 30 patients, showed a progression-free survival (PFS) of 8.5 months and overall survival (OS) of 17.7 months. In the Cantrixil study, one complete response and two partial responses were noted, leading to an overall response rate of 19%. The company plans to commence pivotal studies for paxalisib in late 2020.