IDEAYA Biosciences, Inc. (IDYA), a precision medicine oncology company, announced Tuesday that it has entered into a clinical trial collaboration and supply agreement with drug major Merck & Co Inc. (MRK).
The Phase 1 clinical trial will evaluate IDE161, IDEAYA's investigational 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.
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.
IDE161 is IDEAYA's investigational, potential first-in-class, small molecule poly (ADP-ribose) glycohydrolase, or PARG, inhibitor.
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.
IDE161 received the U.S. Food & Drug Administration Fast-Track designation for BRCA1/2 ovarian and breast cancers.
Yujiro Hata, President and Chief Executive Officer, IDEAYA Biosciences, said, "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."
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