4 KEY MILESTONES HIGHLIGHTS – 2022/2023 The United States Food and Drug Administration (FDA) awards Rare Pediatric Disease Designation (RPDD) to paxalisib for the treatment of atypical teratoid/ rhabdoid tumours (AT/ RT), a rare and highly aggressive childhood brain cancer. Kazia announces launch of its new Scientific Advisory Board (SAB), consisting of four distinguished clinicians and scientists with expertise in the development of innovative therapies for brain cancer. The Global Coalition for Adaptive Research (GCAR) advises Kazia that the first stage of the paxalisib arm of the GBM AGILE pivotal study has completed recruitment. The treatment arm did not meet predefined criteria for continuing to a second stage, and patients enrolled in the first stage will continue on treatment as per protocol, and in follow-up, until completion of the final analysis. Promising new interim data released from an ongoing phase I clinical trial of paxalisib in combination with radiotherapy for the treatment of brain metastases, sponsored by Memorial Sloan Kettering Cancer Center in New York, NY. Final data from the completed phase II study of paxalisib monotherapy for newly diagnosed glioblastoma (GBM) patients with unmethylated MGMT promotor status was presented at the annual congress of the European Society for Medical Oncology (ESMO), held in Paris, France. The ongoing phase II study of paxalisib for the treatment of diffuse intrinsic pontine glioma (DIPG) and other diffuse midline gliomas (DMGs), sponsored by the Pacific Pediatric Neuro-Oncology Consortium (PNOC), opens in two Australian sites. Paxalisib demonstrates signals of activity as a monotherapy and in combination with MEK and BRAF inhibitors in preclinical models of melanoma according to new data from an ongoing research collaboration with the Huntsman Cancer Institute at the University of Utah in Salt Lake City, UT. Professor Matt Dun of the Hunter Medical Research Institute at the University of Newcastle gives an oral presentation at the Society for Neuro-Oncology annual meeting in Tampa, FL, on his research evaluating ONC201 with paxalisib to treat DMGs. Preclinical data for EVT801 published in Cancer Research Communications: “Targeting Tumor Angiogenesis with the Selective VEGFR-3 Inhibitor EVT801 in Combination with Cancer Immunotherapy”. Kazia enters a collaboration with QIMR Berghofer Medical Research Institute, one of Australia’s foremost cancer research centres, to explore novel uses of paxalisib in solid tumours. JUL 22 AUG 22 SEP 22 OCT 22 NOV 22 DEC 22
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