Ideaya Biosciences has entered a clinical trial collaboration and supply agreement with Merck to evaluate the combination of IDE161 and KEYTRUDA in a trial for the treatment of endometrial cancer.
IDE161 is an investigational, potential first-in-class, small molecule poly glycohydrolase, or PARG inhibitor of IDEAYA while Keytruda is an anti-PD-1 therapy of Merck.
The Phase I clinical trial will enrol patients with microsatellite instability-high (MSI-H) and microsatellite stable (MSS) endometrial cancer.
The deal will see Merck supply KEYTRUDA to IDEAYA for the trial conduct while IDEAYA will sponsor the Phase I combination trial.
Both companies will hold all the commercial rights to their respective compounds, as monotherapy or in combination therapies.
IDE161 is currently in the monotherapy expansion stage of a Phase I clinical trial.
The trial is assessing estrogen receptor-positive, human epidermal growth factor receptor 2 negative breast cancer with homologous recombination deficiency (HRD), and various other solid tumours with HRD, including endometrial, colorectal, and prostate cancers.
In parallel, IDEAYA is carrying out the Phase I dose optimisation.
Early observations from the Phase I dose escalation and expansion stages have shown multiple partial responses according to RECIST 1.1 criteria and tumour shrinkage in priority solid tumour types.
IDE161 obtained fast-track designation from the US Food and Drug Administration (FDA) for the treatment of breast cancer gene 1/2 ovarian and breast cancers.
IDEAYA Biosciences president and CEO Yujiro Hata 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.”
In May last year, the company received clearance for an investigational new drug application from the US FDA to begin a Phase I/II clinical trial of IDE397 alongside AMG 193 for solid tumours.
