IDEAYA and Pfizer Enter Clinical Trial Collaboration and Supply Agreement to Evaluate Clinical Combination of IDE196 and Binimetinib in Solid Tumors Harboring GNAQ or GNA11 Hotspot Mutations
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Press Release[/caption]
SOUTH SAN FRANCISCO, Calif.,?March 18, 2020?/PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ:?IDYA), an oncology-focused precision medicine company committed to the discovery and development of targeted therapeutics to treat cancer, today announced that it has entered into a clinical trial collaboration and supply agreement with Pfizer Inc. (NYSE:?PFE) 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."
About IDEAYA Biosciences
IDEAYA is an oncology-focused precision medicine company committed to the discovery and development of targeted therapeutics for patient populations selected using molecular diagnostics.? IDEAYA's approach integrates capabilities in identifying and validating translational biomarkers with small molecule drug discovery to select patient populations most likely to benefit from the targeted therapies IDEAYA is developing.? IDEAYA is applying these capabilities across multiple classes of precision medicine, including direct targeting of oncogenic pathways and synthetic lethality ? which represents an emerging class of precision medicine targets.
Forward-Looking Statements
This press release contains forward-looking statements, including, but not limited to, statements related to (i) the clinical potential of binimetinib in combination with IDE196, including whether the combination will enhance the response rate, and the depth and durability of clinical benefit and (ii) the timing of initiation of the combination clinical trial of IDE196 ?plus binimetinib in mid-2020.? Such forward-looking statements involve substantial risks and uncertainties that could cause IDEAYA's preclinical and clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the drug development process, including IDEAYA's programs' early stage of development, the process of designing and conducting preclinical and clinical trials, the regulatory approval processes, the timing of regulatory filings, the challenges associated with manufacturing drug products, IDEAYA's ability to successfully establish, protect and defend its intellectual property and other matters that could affect the sufficiency of existing cash to fund operations. IDEAYA undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of IDEAYA in general, see IDEAYA's recent Quarterly Report on Form 10-Q filed on?November 13, 2019?and any current and periodic reports filed with the U.S. Securities and Exchange Commission.
SOURCE IDEAYA Biosciences, Inc.
Press Release[/caption]
SOUTH SAN FRANCISCO, Calif.,?March 18, 2020?/PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ:?IDYA), an oncology-focused precision medicine company committed to the discovery and development of targeted therapeutics to treat cancer, today announced that it has entered into a clinical trial collaboration and supply agreement with Pfizer Inc. (NYSE:?PFE) 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."
About IDEAYA Biosciences
IDEAYA is an oncology-focused precision medicine company committed to the discovery and development of targeted therapeutics for patient populations selected using molecular diagnostics.? IDEAYA's approach integrates capabilities in identifying and validating translational biomarkers with small molecule drug discovery to select patient populations most likely to benefit from the targeted therapies IDEAYA is developing.? IDEAYA is applying these capabilities across multiple classes of precision medicine, including direct targeting of oncogenic pathways and synthetic lethality ? which represents an emerging class of precision medicine targets.
Forward-Looking Statements
This press release contains forward-looking statements, including, but not limited to, statements related to (i) the clinical potential of binimetinib in combination with IDE196, including whether the combination will enhance the response rate, and the depth and durability of clinical benefit and (ii) the timing of initiation of the combination clinical trial of IDE196 ?plus binimetinib in mid-2020.? Such forward-looking statements involve substantial risks and uncertainties that could cause IDEAYA's preclinical and clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the drug development process, including IDEAYA's programs' early stage of development, the process of designing and conducting preclinical and clinical trials, the regulatory approval processes, the timing of regulatory filings, the challenges associated with manufacturing drug products, IDEAYA's ability to successfully establish, protect and defend its intellectual property and other matters that could affect the sufficiency of existing cash to fund operations. IDEAYA undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of IDEAYA in general, see IDEAYA's recent Quarterly Report on Form 10-Q filed on?November 13, 2019?and any current and periodic reports filed with the U.S. Securities and Exchange Commission.
SOURCE IDEAYA Biosciences, Inc.
