IDEAYA Announces Clinical Collaboration to Evaluate IDE161 in Combination with KEYTRUDA® (pembrolizumab) in Patients with Endometrial Cancer

Rhea-AI Summary

IDEAYA Biosciences collaborates with Merck to evaluate IDE161 in combination with KEYTRUDA in endometrial cancer patients. IDE161 shows promising results in Phase 1 trials for various solid tumors.

Positive

• IDEAYA Biosciences partners with Merck to assess IDE161 with KEYTRUDA in MSI-high and MSS endometrial cancer patients.
• IDE161, a PARG inhibitor, combined with KEYTRUDA targets anti-tumor immune response mechanisms.
• Phase 1 trial focuses on HRD endometrial cancer and other solid tumors.
• IDE161 demonstrates partial responses and tumor shrinkage in priority solid tumor types.
• IDE161 receives Fast-Track designation for BRCA1/2 ovarian and breast cancers.
• Merck provides KEYTRUDA for the clinical trial collaboration with IDEAYA.
• Both companies retain commercial rights to their compounds for monotherapy or combination therapies.

Negative

• None.

Oncology Doctor

The combination of IDE161 and KEYTRUDA represents a promising approach in the treatment of endometrial cancer, particularly due to their complementary mechanisms targeting the immune response to tumors. In the context of MSI-high and MSS endometrial cancers, the use of an anti-PD-1 therapy like KEYTRUDA can enhance the immune system's ability to detect and destroy cancer cells. Adding a PARG inhibitor could potentially interrupt the cancer cell's repair processes, further sensitizing them to immune attack.

From a clinical perspective, the expansion of the trial to include both MSI-high and MSS populations is significant. MSI-high patients typically have a better response to immunotherapy compared to MSS patients due to a higher mutational burden that makes them more visible to the immune system. The investigation into whether PARG inhibitors can enhance responses in the MSS population, which is generally less responsive to immunotherapy, could lead to a new therapeutic option for this subgroup.

Medical Research Analyst

The Fast-Track designation by the FDA for IDE161 in BRCA1/2 ovarian and breast cancers underscores the potential significance of this drug in the oncology landscape. This status is granted to expedite the development and review of drugs which treat serious conditions and fill an unmet medical need. The early observations of partial responses and tumor shrinkage in the ongoing Phase 1 trial are indicative of IDE161's therapeutic potential, although these findings are preliminary and require validation in larger, controlled studies.

It's also important to note that the commercial rights retention by both IDEAYA and Merck allows for flexibility in future development and marketing strategies. This could lead to potential monotherapy or combination therapy applications, depending on the outcomes of the clinical trials. For stakeholders, this means there is a possibility of multiple revenue streams contingent upon successful trial outcomes and subsequent regulatory approvals.

Market Research Analyst

The strategic collaboration between IDEAYA Biosciences and Merck could have a notable impact on the market for cancer therapeutics, particularly in the area of precision medicine. The partnership leverages Merck's established presence in the immunotherapy space with KEYTRUDA and IDEAYA's focus on targeted therapeutics. The clinical trial's outcome could influence the competitive landscape of endometrial cancer treatments, potentially positioning the companies to capture a significant share of this market segment.

Furthermore, the successful development of a first-in-class PARG inhibitor could set a precedent in the industry, potentially opening the door to new treatment paradigms in other solid tumors with HRD. This would not only benefit patients but could also drive growth for IDEAYA Biosciences, reflected in its stock valuation and market position relative to its peers in the oncology sector.

• ­Trial will evaluate IDE161, IDEAYA's investigational PARG inhibitor, in combination with KEYTRUDA^® (pembrolizumab), Merck's anti-PD-1 therapy, in patients with MSI-high and MSS endometrial cancer
   
• Potential first-in-class PARG inhibitor, in combination with anti-PD-1 therapy, targets two complementary mechanisms of anti-tumor immune response in endometrial cancer
   
• IDEAYA will sponsor the clinical trial and Merck will provide KEYTRUDA 

SOUTH SAN FRANCISCO, Calif., March 12, 2024 /PRNewswire/ -- IDEAYA Biosciences, Inc. (Nasdaq:IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, today announced that it has entered into a clinical trial collaboration and supply agreement with Merck (known as MSD outside the US and Canada) to evaluate IDE161, the company's investigational, potential first-in-class, small molecule poly (ADP-ribose) glycohydrolase, or 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, in a Phase 1 clinical trial. 

"We are excited to enter this collaboration as it allows study within and beyond the homologous recombination deficient (HRD) setting in endometrial cancer," said Darrin Beaupre, M.D., Ph.D., Chief Medical Officer, IDEAYA Biosciences. "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," said Yujiro S. Hata, President and Chief Executive Officer, IDEAYA Biosciences. 

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. Of note, 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. IDE161 received the U.S. Food & Drug Administration Fast-Track designation for BRCA1/2 ovarian and breast cancers.

KEYTRUDA^® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

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. The mechanistic rationale and preclinical data to support the IDE161 and PD-1 clinical combination will be provided as part of a future R&D update.

About IDEAYA Biosciences

IDEAYA is a precision medicine oncology company committed to the discovery and development of targeted therapeutics for patient populations selected using molecular diagnostics. IDEAYA's approach integrates capabilities in identifying and validating translational biomarkers with drug discovery to select patient populations most likely to benefit from its targeted therapies. IDEAYA is applying its research and drug discovery capabilities to synthetic lethality – which represents an emerging class of precision medicine targets.

Forward-Looking Statements

This press release contains forward-looking statements, including, but not limited to, statements related the potential therapeutic benefits of IDE161 in combination with KEYTRUDA. IDEAYA undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of IDEAYA in general, see IDEAYA's recent Annual Report on Form 10-K filed on February 20, 2024 and any current and periodic reports filed with the U.S. Securities and Exchange Commission.

Investor and Media Contact
IDEAYA Biosciences
Andres Ruiz Briseno
SVP, Head of Finance and Investor Relations
investor@ideayabio.com

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SOURCE IDEAYA Biosciences, Inc.

What is IDEAYA Biosciences collaborating with Merck on?

IDEAYA Biosciences is collaborating with Merck to evaluate IDE161 with KEYTRUDA in patients with MSI-high and MSS endometrial cancer.

What is the focus of the Phase 1 clinical trial?

The Phase 1 trial is strategically focused on HRD endometrial cancer and other solid tumors using IDE161 and KEYTRUDA.

What designation did IDE161 receive?

IDE161 received Fast-Track designation for BRCA1/2 ovarian and breast cancers.

Who will provide KEYTRUDA for the clinical trial collaboration?

Merck will provide KEYTRUDA for the clinical trial collaboration with IDEAYA.

What rights do IDEAYA and Merck retain in the collaboration?

Both IDEAYA and Merck retain all commercial rights to their compounds for monotherapy or combination therapies.