IDEAYA Advances First-in-Class PARG Development Candidate, IDE161, into IND-Enabling Studies and Exercises Option with Cancer Research UK and University of Manchester for Exclusive Worldwide License
IDEAYA Biosciences, Inc. (NASDAQ: IDYA) announced the initiation of IND-enabling studies for IDE161, a potential first-in-class PARG inhibitor. The company has exercised its option for an exclusive worldwide license from Cancer Research UK and the University of Manchester. IDE161 targets tumors with homologous recombination deficiencies, including those with BRCA1 and BRCA2 mutations. IDEAYA plans to submit an IND application for IDE161 in Q4 2022, following successful preclinical studies. The company holds comprehensive rights to IDE161 under its licensing agreement.
- Initiation of IND-enabling studies for IDE161, a potential first-in-class PARG inhibitor.
- Exclusive worldwide license obtained from Cancer Research UK and University of Manchester.
- Targeting tumors with homologous recombination deficiencies, enhancing potential market reach.
- Clinical efficacy observed in various cancer models, including those resistant to PARP inhibitors.
- The timeline for IND submission is subject to the completion of ongoing preclinical studies, creating uncertainty.
- Forward-looking statements regarding clinical evaluation and impact are subject to risks and uncertainties that may affect outcomes.
SOUTH SAN FRANCISCO, Calif., Jan. 31, 2022 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a synthetic lethality focused precision medicine oncology company committed to the discovery and development of targeted therapeutics, announced initiation of IND-enabling studies for IDE161, a potential first-in-class PARG inhibitor development candidate. The company also exercised its option for an exclusive worldwide license from Cancer Research Technology Ltd., dba Cancer Research UK (CRUK), and University of Manchester.
IDE161 is a potential first-in-class small molecule inhibitor of poly (ADP-ribose) glycohydrolase, or PARG, a novel target in the same clinically validated pathway as poly (ADP-ribose) polymerase, or PARP. IDEAYA plans to evaluate IDE161 in patients having tumors with homologous recombination deficiencies (HRD), including BRCA1 and BRCA2, and potentially other genetic alterations identified through IDEAYA's biomarker discovery platform.
"We are very excited about potential development opportunities for IDE161. We have shown dose-dependent in vivo efficacy of PARG inhibitors as monotherapy with tumor regression or stasis in multiple CDX models and PDX models, including in ovarian cancer, gastric cancer and breast cancer models. Significantly, we have observed in vivo efficacy of PARG inhibitors in BRCA1 and BRCA2 models which are refractory to or have acquired resistance to PARP inhibitors, suggesting an opportunity for clinical differentiation," said Dr. Michael White, Senior Vice President and Chief Scientific Officer of IDEAYA.
"We identified IDE161 through our internal drug-discovery platform, and in parallel, we have invested significantly in translational biology and biomarker discovery. We believe PARG inhibitors could be substantially impactful for BRCA1 and BRCA2 patients non-responsive to PARP inhibitors. We are excited to advance IDE161 as a first-in-class development candidate toward the clinic," said Yujiro Hata, President and Chief Executive Officer of IDEAYA.
IDEAYA is targeting an IND submission for IDE161 in the fourth quarter of 2022, subject to satisfactory completion of ongoing preclinical and IND-enabling studies.
Following the option exercise with Cancer Research UK and University of Manchester, IDEAYA holds exclusive worldwide license rights covering a broad class of PARG inhibitors. IDEAYA owns or controls all commercial rights in IDE161, subject to certain economic obligations pursuant to its exclusive, worldwide license with Cancer Research UK and University of Manchester.
About IDEAYA Biosciences
IDEAYA is a synthetic lethality-focused 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 early 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 clinical evaluation of IDE161, (ii) the impact of IDE161 on patients, and (iii) the timing of IND submission for IDE161. 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 November 15, 2021 and any current and periodic reports filed with the U.S. Securities and Exchange Commission.
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SOURCE IDEAYA Biosciences, Inc.
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