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IDEAYA Biosciences Announces Clearance of IND Application for Pol Theta Helicase Development Candidate GSK101 (IDE705)
GSK101 (IDE705) is being developed as a potential first-in-class Pol Theta Helicase Inhibitor in combination with niraparib in GSK-sponsored Phase 1/2
About this update from Ideaya Biosciences, Inc.
[{"type":"text","content":"GSK101 (IDE705) is being developed as a potential first-in-class Pol Theta Helicase Inhibitor in combination with niraparib in GSK-sponsored Phase 1/2 clinical trialGSK101 and niraparib combination development will focus on advanced solid tumors with HR mutations or HRD, pursuant to the clinical protocolIDEAYA to receive a $7 million milestone payment upon IND acceptance, and potential future aggregate milestones of up to $950 million related to GSK101 Pol Theta inhibitorsSOUTH SAN FRANCISCO, Calif., Aug. 21, 2023 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, announced the clearance of an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for initiation of a GSK-sponsored Phase 1/2 clinical trial to evaluate GSK101 (IDE705), a small molecule inhibitor of Pol Theta Helicase, in combination with niraparib, the GSK small molecule inhibitor of poly-(ADP-ribose) polymerase (PARP), for the treatment of patients having tumors with BRCA or other homologous recombination (HR) mutations or homologous recombination deficiency (HRD). \n\n \n \n \n \n \n \n\n \n\"There remains an unmet medical need for patients having tumors with homologous recombination mutations, such as BRCA1/2 mutations. Based on Pol Theta's critical role in microhomology-mediated end joining and BRCA reversions, a central mechanism of resistance to PARP inhibitors, we view the niraparib and GSK101 combination as having potential to improve depth and duration of tumor responses that could potentially impact longer-term outcomes for these cancer patients,\" said Dr. Ramon Kemp, Vice President, Global Head of Oncology Early Development, GSK.\n\"We are pleased to have our fourth potential first-in-class program advance into the clinic with GSK101, and we believe GSK is well-positioned to maximize the value of GSK101 by creating a potential best-in-class combination with niraparib to treat solid tumors. We are also targeting the Werner Helicase development candidate nomination later this year with GSK, which represents our fifth potential first-in-class program,\" said Yujiro S. Hata, Chief Executive Officer, IDEAYA Biosciences.\nGSK101 is a potential first-in-class small molecule inhibitor of the helicase domain of DN...