03.12.24
Ideaya Biosciences Inc., a precision medicine oncology company committed to the discovery and development of targeted therapeutics, has entered into a clinical trial collaboration and supply agreement with Merck to evaluate IDE161, the company's investigational small molecule poly (ADP-ribose) glycohydrolase, or PARG, inhibitor, in combination with KEYTRUDA (pembrolizumab), Merck's anti-PD-1 therapy, in patients with microsatellite instability-, or MSI-, high and microsatellite stable, or MSS, endometrial cancer, in a Phase 1 clinical trial.
"We are excited to enter this collaboration as it allows study within and beyond the homologous recombination deficient (HRD) setting in endometrial cancer," said Darrin Beaupre, M.D., Ph.D., Chief Medical Officer, Ideaya Biosciences.
"We are very pleased to collaborate with Merck on this trial evaluating IDE161 in combination with KEYTRUDA in patients with MSI-high and MSS endometrial cancer. Ideaya's IDE161 combination strategy is focused on advancing multiple high conviction rational combinations, including beyond the HRD biomarker setting," added Yujiro S. Hata, President and CEO, Ideaya Biosciences.
IDE161 is a small molecule inhibitor targeting PARG, that is being evaluated in a Phase 1 clinical trial, which is currently in its monotherapy expansion stage. The trial is strategically focused on estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (Her2-) breast cancer with HRD, as well as other solid tumors with HRD, such as endometrial cancer, colorectal cancer and prostate cancer. In parallel, Ideaya is continuing with a Phase 1 dose optimization. Of note, multiple partial responses by RECIST 1.1. and tumor shrinkage in priority solid tumor types were observed early in the Phase 1 dose escalation and dose expansion.
IDE161 received the U.S. Food & Drug Administration Fast-Track designation for BRCA1/2 ovarian and breast cancers.
Under the clinical trial collaboration and supply agreement, Merck will provide KEYTRUDA to Ideaya, which will be the sponsor of the Phase 1 clinical combination trial. Ideaya and Merck each retain all commercial rights to their respective compounds, including as monotherapy or as combination therapies.
"We are excited to enter this collaboration as it allows study within and beyond the homologous recombination deficient (HRD) setting in endometrial cancer," said Darrin Beaupre, M.D., Ph.D., Chief Medical Officer, Ideaya Biosciences.
"We are very pleased to collaborate with Merck on this trial evaluating IDE161 in combination with KEYTRUDA in patients with MSI-high and MSS endometrial cancer. Ideaya's IDE161 combination strategy is focused on advancing multiple high conviction rational combinations, including beyond the HRD biomarker setting," added Yujiro S. Hata, President and CEO, Ideaya Biosciences.
IDE161 is a small molecule inhibitor targeting PARG, that is being evaluated in a Phase 1 clinical trial, which is currently in its monotherapy expansion stage. The trial is strategically focused on estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (Her2-) breast cancer with HRD, as well as other solid tumors with HRD, such as endometrial cancer, colorectal cancer and prostate cancer. In parallel, Ideaya is continuing with a Phase 1 dose optimization. Of note, multiple partial responses by RECIST 1.1. and tumor shrinkage in priority solid tumor types were observed early in the Phase 1 dose escalation and dose expansion.
IDE161 received the U.S. Food & Drug Administration Fast-Track designation for BRCA1/2 ovarian and breast cancers.
Under the clinical trial collaboration and supply agreement, Merck will provide KEYTRUDA to Ideaya, which will be the sponsor of the Phase 1 clinical combination trial. Ideaya and Merck each retain all commercial rights to their respective compounds, including as monotherapy or as combination therapies.