Kintara Therapeutics announced the execution of an agreement with the Global Coalition for Adaptive Research (GCAR) for VAL-083's participation in GCAR's Glioblastoma Adaptive Global Innovative Learning Environment (GBM AGILE) Study.
This study was conceived by an international consortium of major thought leaders in the glioblastoma (GBM) space and is designed to more efficiently identify effective therapies for GBM patients. Since the launch of the study in 2019, GBM AGILE continues to gain momentum among the GBM medical community and has recently expanded the number of participating trial sites in the U.S. from 24 to 31 centers. Kintara is currently advancing two ongoing Phase 2 clinical trials in GBM with VAL-083 in adjuvant and recurrent MGMT unmethylated GBM, and in combination with radiotherapy in newly-diagnosed MGMT unmethylated GBM. Kintara expects to provide an update on these Phase 2 studies at the Society of Neuro-Oncology SNO 2020 Virtual Conference, November 19-21, 2020.
"The consummation of a definitive agreement with GCAR for VAL-083's participation in GBM AGILE is a significant corporate and clinical milestone for the Company as it is expected to enable us to accelerate the facilitation of the final clinical stages and the regulatory process for our novel therapeutic candidate while enabling us to maximize financial and operational resources," said Saiid Zarrabian, Kintara's Chief Executive Officer. "The GCAR opportunity is a more robust, efficient, and cost-effective clinical trial solution than had we embarked on this effort independently and it provides multiple shots on goal via enrollment of three separate GBM patient subtypes enabled by GCAR's FDA-approved adaptive design protocol."
Under the terms of the agreement, Kintara will supply GCAR with VAL-083 drug along with funding to support the VAL-083 arm of the GBM AGILE registrational study. In turn, GCAR will manage all operational aspects of the study, including site activation and patient enrollment.
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"We are pleased to have reached this major milestone with Kintara and look forward to including VAL-083 into GBM AGILE in the very near future. We are delighted to have a total of 31 U.S. sites already enrolling in GBM AGILE, and expect up to 40 total sites by the end of 2020 in the U.S. and Canada. We have plans to expand to Europe in 2021," said Meredith Buxton, GCAR's Chief Executive Officer. "Having such a high number of sites simultaneously enrolling upon initiation of the Kintara trial arm should expedite the rate of patient enrollment."
The GBM AGILE Study is an international effort in newly-diagnosed and recurrent GBM, utilizing an FDA-approved master protocol with multiple drugs to be tested simultaneously and over time against a common control arm. As an approved registrational study, results from the VAL-083 arm of GBM AGILE Study are intended to be utilized to file for FDA approval. This study employs a cost-efficient, adaptive trial design with a Stage 1 (Phase 2) learning and adapting phase and a Stage 2 (Phase 3) expansion and confirmation phase. The totality of the data from the Stage 1 and Stage 2 expansion would be used for the regulatory filing of an NDA. The effort is led by top-tier key opinion leaders in the GBM field and has the collective support of an international group of more than 130 clinicians, researchers, biostatisticians, imagers, pathologists, leaders from government and industry, and patient advocates. GCAR functions as the GBM AGILE Study sponsor, and provides financial support for the program infrastructure, as well as general trial oversight. Comprising some of the world's foremost clinical, translational, and basic science investigators, GCAR strives to support the development of novel treatments to fight against rare and deadly diseases like GBM where patient prognosis is poor and treatment options are limited.