IDEAYA Biosciences has entered into a clinical trial collaboration and supply agreement with Pfizer for an IDEAYA-sponsored clinical combination study of IDE196, a Protein Kinase C (PKC) inhibitor, and binimetinib, a MEK inhibitor that Pfizer has exclusive rights to in the U.S. and Canada, in GNAQ or GNA11 hotspot mutated solid tumors, including Metastatic Uveal Melanoma (MUM), Cutaneous Melanoma, and Colorectal Cancer (CRC).
IDEAYA and Pfizer will form a Joint Development Committee (JDC), and there will be joint decision making and data sharing of the clinical trial results between the parties. IDEAYA will sponsor the study and Pfizer will supply binimetinib for the study. The clinical combination trial is targeted to initiate in mid-2020.
"The prevalence of GNAQ or GNA11 hotspot mutations in MUM, Cutaneous Melanoma, CRC, and other solid tumors represents approximately 6,000 patients in the U.S. and the five major European countries, and there are no approved targeted therapies for MUM or GNAQ/GNA11 hotspot mutation solid tumors," said Yujiro S. Hata, Chief Executive Officer and President, IDEAYA Biosciences. "We look forward to testing the clinical potential of binimetinib in combination with IDE196 in this genetically distinct patient population."
The clinical combination study will evaluate whether inhibition of the MAP-Kinase pathway at two nodes, through upstream PKC and downstream MEK, will enhance the response rate and depth and durability of clinical benefit in patients whose solid tumors harbor GNAQ or GNA11 hotspot mutations. The clinical trial will also study pharmacokinetics of each agent and tolerability of the combination.
"We are thrilled to work with Pfizer to evaluate the clinical combination of IDE196 and binimetinib in MUM and other solid tumors with GNAQ or GNA11 mutations," said Julie Hambleton, M.D., Chief Medical Officer, IDEAYA Biosciences. "There is supportive preclinical data and clinical precedence in oncology for targeting multiple nodes in the MAP-Kinase pathway, and we look forward to testing this hypothesis clinically."