Global Coalition for Adaptive Research, Kazia Therapeutics Limited and Kintara Therapeutics, Inc. The Global Coalition for Adaptive Research (GCAR) in collaboration with Kazia and Kintara, announced the activation of Kazia's paxalisib and Kintara's VAL-083 in GBM AGILE (Glioblastoma Adaptive Global Innovative Learning Environment). GBM AGILE is a revolutionary patient-centered, adaptive platform trial for registration that tests multiple therapies for patients with newly-diagnosed and recurrent glioblastoma (GBM) – the deadliest form of brain cancer. Kazia's paxalisib and Kintara's VAL-083 are entering the GBM AGILE trial, which initially opened in July 2019 and has screened over 370 patients to date.

Kazia's paxalisib will be enrolling in newly diagnosed unmethylated (NDUM) and recurrent GBM, and Dr. Ingo Mellinghoff, Chair of the Department of Neurology at Memorial Sloan Kettering Cancer Center and Dr. Eudocia Q Lee, Director of Clinical Research at the Center for Neuro-Oncology at Dana-Farber and an Assistant Professor of neurology at Harvard Medical School are serving as arm Principal Investigators for the paxalisib arm. Kintara's VAL-083 will be enrolling in NDUM and recurrent GBM, as well as be the first compound being evaluated for patients with newly diagnosed methylated MGMT. VAL-083 will be led by arm Principal Investigators, Dr. John de Groot, Professor, Department of Neuro-Oncology, MD Anderson Cancer Center, and Dr. James Perry, Professor of Neurology at the University of Toronto and Sunnybrook Research Institute.

GBM AGILE is an international, innovative platform trial designed to more rapidly identify and confirm effective therapies for patients with glioblastoma through response adaptive randomization and a seamless phase 2/3 design. The trial, conceived by over 130 key opinion leaders, is conducted under a master protocol, allowing multiple therapies or combinations of therapies from different pharmaceutical partners to be evaluated simultaneously. With its innovative design and efficient operational infrastructure, data from GBM AGILE can be used as the foundation for a new drug application (NDA) and biologics license application (BLA) submissions and registrations to the FDA and other health authorities.

The new interventions are opening first at Henry Ford Cancer Institute in Detroit under Henry Ford site Principal Investigator, Dr. Tom Mikkelsen, Medical Director, Henry Ford Precision Medicine Program & Clinical Trials, and will subsequently open at over 30 trial sites across the United States, with additional global sites in Canada, Europe, and China to follow.