Kintara and the Global Coalition for Adaptive Research Execute Agreement for VAL-083's Participation in the GBM AGILE Registrational Study
- Adaptive Clinical Trial Platform in Glioblastoma Multiforme -
- Expected to serve as basis for VAL-083's new drug application (NDA) submission and registration
- Expansion of clinical site involvement with 31 U.S. sites actively enrolling patients; international sites expected to come online in next 12 months
- Anticipated enrollment of 150-200 subjects into the VAL-083 arm of GBM AGILE
- Expected to accelerate time to pivotal trial completion and potential regulatory submission by up to 18 months
SAN DIEGO, Oct. 21, 2020 /PRNewswire/ -- Kintara Therapeutics, Inc. (Nasdaq: KTRA) ("Kintara" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, announced today 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," commented 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.
"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," commented 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.
ABOUT GLOBAL COALITION FOR ADAPTIVE RESEARCH
GCAR is a 501(c)(3) nonprofit organization, comprised of some of the world's foremost physicians, clinical researchers and investigators united in expediting the discovery and development of cures for patients with rare and deadly diseases. As its first priority, GCAR is sponsoring GBM AGILE, an adaptive platform trial for patients with GBM – the most common and deadliest of malignant primary brain tumors. Key strategic partners for the GBM AGILE study effort include the National Brain Tumor Society, National Foundation for Cancer Research, and Asian Fund for Cancer Research. These three nonprofit organizations are working together to provide philanthropic support as well as assistance in communicating with patients and families and inviting all others to join in supporting this innovative approach to brain tumor treatment development.
Located in San Diego, California, Kintara is dedicated to the development of novel cancer therapies for patients with unmet medical needs.
Kintara is developing two late-stage, Phase 3-ready therapeutics for clear unmet medical needs with reduced risk development programs. The two programs are VAL-083 for GBM and REM-001 for cutaneous metastatic breast cancer (CMBC).
VAL-083 is a "first-in-class", small-molecule chemotherapeutic with a novel mechanism of action that has demonstrated clinical activity against a range of cancers, including central nervous system, ovarian and other solid tumors (e.g. NSCLC, bladder cancer, head and neck) in U.S. clinical trials sponsored by the National Cancer Institute (NCI). Based on Kintara's internal research programs and these prior NCI-sponsored clinical studies, Kintara is currently conducting clinical trials to support the development and commercialization of VAL-083 in GBM.
Kintara is also advancing its proprietary, late-stage photodynamic therapy platform that holds promise as a localized cutaneous, or visceral, tumor treatment as well as in other potential indications. REM-001 therapy, has been previously studied in four Phase 2/3 clinical trials in patients with CMBC, who had previously received chemotherapy and/or failed radiation therapy. With clinical efficacy to date of 80% complete responses of CMBC evaluable lesions, and with an existing robust safety database of approximately 1,100 patients across multiple indications, Kintara is advancing the REM-001 CMBC program to late-stage pivotal testing.
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995, including statements regarding the status of the Company's clinical trials and the GBM AGILE Study. Any forward-looking statements contained herein are based on current expectations but are subject to a number of risks and uncertainties. The factors that could cause actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to the impact of the COVID-19 pandemic on the Company's operations and clinical trials; the Company's ability to develop, market and sell products based on its technology; the expected benefits and efficacy of the Company's products and technology; the availability of substantial additional funding for the Company to continue its operations and to conduct research and development, clinical studies and future product commercialization; and, the Company's business, research, product development, regulatory approval, marketing and distribution plans and strategies. These and other factors are identified and described in more detail in the Company's filings with the SEC, including the Company's Annual Report on Form 10-K for the year ended June 30, 2020, the Company's Quarterly Reports on Form 10-Q, and the Company's Current Reports on Form 8-K.
Director of Public Relations
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SOURCE Kintara Therapeutics
Released October 21, 2020