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IDE161 is currently in the monotherapy expansion stage of a Phase 1 clinical trial, focusing on estrogen receptor-positive, human epidermal growth factor receptor 2 negative (ER+/Her2-) breast cancer with homologous recombination deficiency (HRD), as well as other solid tumors with HRD, including endometrial, colorectal, and prostate cancers. Early trial results have shown multiple partial responses and tumor shrinkage in these solid tumor types.
The U.S. Food & Drug Administration has granted IDE161 Fast-Track designation for the treatment of BRCA1/2 ovarian and breast cancers. This designation is intended to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need.
Under the terms of the collaboration, Merck will supply KEYTRUDA to IDEAYA, which will sponsor the Phase 1 combination trial. Both companies will retain commercial rights to their respective compounds, whether used alone or in combination. The trial aims to explore the therapeutic potential of combining IDE161 with KEYTRUDA, targeting two complementary mechanisms of the anti-tumor immune response in endometrial cancer.
This collaboration represents a strategic effort to extend the study of IDE161 beyond the HRD biomarker setting, as stated by IDEAYA’s Chief Medical Officer, Darrin Beaupre, M.D., Ph.D., and President and CEO, Yujiro S. Hata. Further details on the mechanistic rationale and preclinical data supporting the clinical combination will be provided in a future R&D update.
The announcement is based on a press release statement and comes with the usual disclaimer that forward-looking statements involve risks and uncertainties that could cause actual results to differ from those projected. The efficacy of IDE161 in combination with KEYTRUDA will be determined by the outcome of the clinical trials.
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