Kazia Therapeutics doses first patient in PNOC035 Phase 2 paxalisib-gemcitabine trial for recurrent pediatric AT/RT

• Kazia started dosing patients in PNOC035 Arm A, a Phase 2 study of paxalisib with gemcitabine in recurrent AT/RT.
• Trial targets patients ages 1 to 39, addressing a setting with no approved therapies, expanding paxalisib beyond diffuse midline glioma.
• Earlier preclinical findings supporting the combination were already presented at ISPNO, AACR, and Neuro-Oncology meetings.
• Preclinical work showed the regimen extended survival in models, supporting a potential improvement in outcomes if replicated clinically.
• Paxalisib holds FDA Orphan Drug status and Rare Pediatric Disease designation for AT/RT, positioning the program for a priority review voucher if approved.

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