IDEAYA Biosciences Announces Development Candidate Nomination of a Werner Helicase Inhibitor in Collaboration with GSK and Investor R&D Day
- IDEAYA Biosciences selects a Werner Helicase Inhibitor Development Candidate with potential for clinical evaluation in MSI-High solid tumors
- IDEAYA earns $3 million milestone from GSK for IND-enabling studies with potential for additional $17 million milestones through early Phase 1
- IDEAYA plans to host an Investor R&D Day in Q4 2023 with participation of GSK
- None.
- Selected a Werner Helicase Inhibitor Development Candidate in collaboration with GSK
- Observed monotherapy complete responses preclinically in multiple in vivo xenograft MSI-High models and pharmacological sensitivity in therapy-refractory CRC organoid models
- Earned
$3 million $17 million - Targeting an IND in 2024 to enable first-in-human clinical evaluation of Werner Helicase Inhibitor Development Candidate for patients having tumors with MSI-High
- Subject to IND submission and clearance, GSK will lead clinical development and the global research and development costs will be shared between GSK (
80% ) and IDEAYA (20% ) - IDEAYA will be eligible to receive additional development milestones of up to
$465.0 million $475.0 million 50% ofU.S. net profits - IDEAYA is hosting an Investor R&D Day in Q4 2023, with participation of GSK
The Werner Helicase Inhibitor DC is a potent, selective, small molecule inhibitor of the helicase domain of Werner protein. IDEAYA is collaborating with GSK on IND-enabling studies to support the clinical evaluation of the Werner Helicase Inhibitor DC for patients having tumors characterized by high microsatellite instability (MSI-High). There is high prevalence of MSI-High across multiple solid tumor indications, including endometrial, colorectal, and gastric cancers (approximately
"Our Werner Helicase Inhibitor DC has demonstrated robust in vivo efficacy in multiple MSI-High cancer models. We are excited to advance the Werner Helicase Inhibitor DC into IND-enabling studies to support potential clinical evaluation in MSI-High solid tumors with monotherapy and potentially also with combination therapies," said Benjamin Schwartz, Ph.D., Vice President, Head of Oncology Synthetic Lethality Research Unit at GSK.
"Werner Helicase is one of the most well-validated synthetic lethality targets in the cancer genome. Werner protein is required for the survival of cancer cells with microsatellite instability. Inhibition of the helicase domain of Werner protein results in catastrophic double-strand DNA fragmentation in these MSI-High tumors, with exquisite selectivity relative to microsatellite stable (MSS) normal cells," said Michael White, Senior Vice President and Chief Scientific Officer of IDEAYA Biosciences.
"IDEAYA was one of the first groups to publish on the Werner Helicase and MSI-High synthetic lethal interaction. Werner Helicase was one of the earliest drug discovery programs we launched since the founding of IDEAYA, and it is extremely exciting to achieve the development candidate nomination milestone for this program with GSK, which represents our fifth potential first-in-class program," said Yujiro S. Hata, CEO at IDEAYA Biosciences.
IDEAYA and GSK are targeting an Investigational New Drug (IND) submission to the
IDEAYA and GSK are collaborating on the ongoing IND-enabling studies and GSK will lead clinical development for the Werner Helicase program. GSK is responsible for
IDEAYA plans to host an Investor R&D Day in the fourth quarter of 2023, with participation of GSK. The company will provide an outline of agenda topics and participating key opinion leaders for the Investor R&D Day in advance of the event.
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 to (i) the potential receipt and amount of development and commercial milestones, (ii) the timing of submission of an IND for the Werner Helicase Inhibitor DC, (iii) the timing and content of an Investor R&D Day, (iv) the prevalence of tumors with MSI-High, and (v) the potential combination strategy for the Werner Helicase Inhibitor DC. 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 Quarterly Report on Form 10-Q filed on August 10, 2023 and any current and periodic reports filed with the
Investor and Media Contact
IDEAYA Biosciences
Andres Ruiz Briseno
Senior Vice President, Head of Finance and Investor Relations
investor@ideayabio.com
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SOURCE IDEAYA Biosciences, Inc.
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