SOUTH SAN FRANCISCO – IDEAYA Biosciences, Inc. (NASDAQ:IDYA), a precision medicine oncology company valued at $2.4 billion, has initiated a Phase 1 clinical trial to evaluate the safety and efficacy of its investigational drug, IDE161, in combination with KEYTRUDA, Merck (NS:PROR)'s anti-PD-1 therapy. The trial will focus on patients with high microsatellite instability (MSI-high) and microsatellite stable (MSS) endometrial cancer. According to InvestingPro data, the company maintains a strong financial position with more cash than debt on its balance sheet, supporting its research initiatives.
The first patient has been dosed in the trial, which is part of IDEAYA's strategy to explore high conviction rational combinations of therapies. While analysts tracked by InvestingPro maintain a strong buy consensus with a price target ranging from $27 to $65, they anticipate some near-term challenges with sales expected to decline in the current year. The company's Chief Medical (TASE:PMCN) Officer, Dr. Darrin M. Beaupre, expressed enthusiasm about the progress of the IDE161 program and the potential benefits of the drug combination for endometrial cancer patients.
Dr. Panos Konstantinopoulos, Director of Translational Research at Dana-Farber Cancer Institute and an Associate Professor of Medicine at Harvard Medical School, also highlighted the promise of PARG inhibition in precision oncology for these patients. Preclinical models have shown robust anti-tumor activity of IDE161, and the trial aims to assess its impact in a clinical setting.
IDE161 is a potential first-in-class inhibitor targeting poly(ADP-ribose) glycohydrolase (PARG), which is part of the same biological pathway as the clinically validated poly(ADP-ribose) polymerase (PARP). The U.S. Food and Drug Administration has granted IDE161 two Fast Track designations for certain ovarian and breast cancer conditions.
Merck will supply KEYTRUDA under a clinical trial collaboration and supply agreement, and both IDEAYA and Merck retain commercial rights to their respective compounds. The trial, known as IDE161-001 (NCT05787587), will also determine the optimal dose of IDE161 monotherapy in a priority solid tumor type based on its safety profile and preliminary efficacy.
This news is based on a press release statement and includes no endorsement of the claims. The potential therapeutic benefits of IDE161 in combination with KEYTRUDA are subject to ongoing evaluation and regulatory review. For deeper insights into IDEAYA's financial health, market position, and detailed analysis, investors can access the comprehensive Pro Research Report available on InvestingPro, which offers exclusive metrics and expert analysis for over 1,400 US stocks.
In other recent news, Ideaya Biosciences has experienced a series of significant events. Leerink Partners downgraded Ideaya's stock from Outperform to Market Perform due to uncertainties in key programs. The firm cited concerns about the progress of the darovasertib program and the efficacy of the neoadjuvant program in larger patient groups.
Despite these concerns, Ideaya Biosciences presented promising interim Phase 1 expansion data for its investigational drug IDE397, which targets MTAP-deletion urothelial cancer and non-small cell lung cancer. The results demonstrated a high disease control rate of 93% with no drug-related serious adverse events. The company plans to expand the Phase 1/2 study of IDE397 in collaboration with Gilead (NASDAQ:GILD).
Analysts from UBS, Cantor Fitzgerald, and Goldman Sachs have expressed optimism about the company's drug candidates. UBS initiated coverage on Ideaya Biosciences with a Buy rating, highlighting the potential of its leading drug candidate, darovasertib. Goldman Sachs reaffirmed their Buy rating on Ideaya Biosciences, estimating peak sales for darovasertib to reach $3.0 billion. Cantor Fitzgerald initiated coverage on Ideaya Biosciences with an Overweight rating, underscoring the potential of the company's leading drug candidates in targeted oncology. These are recent developments in Ideaya Biosciences.
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