Ideaya Biosciences, Inc. has just announced a clinical collaboration and supply agreement with Merck to evaluate ide161, the company's investigational small molecule poly (ADP-ribose) glycohydrolase (PARG) inhibitor, in combination with Keytruda® (pembrolizumab), Merck's anti-PD-1 therapy. This collaboration aims to examine the potential of this combination in treating patients with microsatellite instability-high (MSI-H) and microsatellite stable (MSS) endometrial cancer through a phase 1 clinical trial.
Ide161, the small molecule inhibitor targeting PARG, is currently undergoing evaluation in a phase 1 clinical trial, with a strategic focus on estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) breast cancer with homologous recombination deficiency (HRD), as well as other solid tumors with HRD, including endometrial cancer, colorectal cancer, and prostate cancer.
A key development is that 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. Notably, Ide161 has received fast-track designation from the U.S. Food & Drug Administration for BRCA1/2 ovarian and breast cancers.
Under the terms of the clinical trial collaboration and supply agreement, Merck will provide Keytruda to Ideaya, while Ideaya will sponsor the phase 1 clinical combination trial. Both companies will retain all commercial rights to their respective compounds, whether as monotherapy or as combination therapies.
Ideaya's President and Chief Executive Officer, Yujiro S. Hata, highlighted the significance of this collaboration, emphasizing the company's focus on advancing multiple high conviction rational combinations, including beyond the HRD biomarker setting.
This collaboration marks a significant step in the precision medicine oncology space, demonstrating Ideaya's commitment to leveraging translational biomarkers and drug discovery to develop targeted therapeutics for patient populations most likely to benefit from their treatments.
The market has reacted to these announcements by moving the company's shares 2.6% to a price of $44.7. For more information, read the company's full 8-K submission here.
