IDEAYA Announces Achievement of First Milestone in Ongoing Collaboration with GSK for Potential First-in-Class Pol Theta Helicase Inhibitor Development Candidate

Rhea-AI Summary

IDEAYA Biosciences has achieved a preclinical development milestone for its Pol Theta Helicase Inhibitor DC in collaboration with GSK, facilitating IND-enabling studies. The company anticipates potential preclinical and clinical milestone payments up to $20 million, including $10 million for IND effectiveness. Targeting first-in-human trials in H1 2023, IDEAYA aims for IND submission to advance this potential first-in-class therapy for patients with HR mutations. IDEAYA can benefit from up to $485 million in total milestones, plus commercial royalties.

Positive

• Achievement of preclinical development milestone supports ongoing IND-enabling studies.
• Potential to receive up to $20 million in milestone payments, including $10 million for IND effectiveness.
• Targeting first-in-human clinical evaluation in H1 2023 indicates progress towards commercialization.
• Eligible for total development and regulatory milestones up to $485 million, enhancing financial outlook.
• Collaboration with GSK positions IDEAYA for significant clinical and commercial opportunities.

Negative

• Dependence on GSK for clinical development and associated research costs raises potential risks.
• Forward-looking statements highlight substantial uncertainties in drug development and regulatory approval processes.

• Preclinical development milestone achieved in connection with ongoing IND-enabling studies to support evaluation of Pol Theta Helicase Inhibitor DC as combo with niraparib
• Potential to realize preclinical and clinical milestones up to $20 million total for preclinical to early Phase 1 clinical, including up to $10 million aggregate through IND effectiveness
• Targeting first-in-human clinical evaluation of Pol Theta Helicase Inhibitor DC in combination with niraparib in H1 2023 for patients having tumors with HRD

SOUTH SAN FRANCISCO, Calif. , Aug. 29, 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 that it has achieved a preclinical development milestone in connection with ongoing IND-enabling studies for its Pol Theta Helicase Development Candidate (DC).

"We are excited to advance our Pol Theta Helicase Inhibitor DC toward the clinic.  The achievement of this preclinical milestone supplements our balance sheet and reflects the continued progress IDEAYA and GSK are making to enable first-in-human studies with this development candidate in the first half of next year," said Michael White, Senior Vice President and Chief Scientific Officer of IDEAYA Biosciences. 

The Pol Theta Helicase Inhibitor DC is a potential first-in-class small molecule inhibitor of the helicase domain of DNA Polymerase Theta.  IDEAYA is collaborating with GSK on IND-enabling studies to support the evaluation of the Pol Theta Helicase DC in combination with niraparib, GSK's PARP inhibitor, for patients harboring tumors with BRCA or other homologous recombination (HR) mutations or homologous recombination deficiency (HRD). 

IDEAYA and GSK are targeting an IND submission for the Pol Theta Helicase DC, subject to satisfactory completion of ongoing IND-enabling studies, to enable first-in-human studies in the first half of 2023.  

GSK will lead clinical development for the Pol Theta program pursuant to its global, exclusive license to develop and commercialize the Pol Theta Helicase Inhibitor DC.  GSK is responsible for all research and development costs for the program. IDEAYA is eligible to receive total development and regulatory milestones of up to $485 million aggregate, inclusive of preclinical and clinical milestones of up to $20 million aggregate for advancing the Pol Theta Helicase DC through early Phase 1 clinical. 

Upon potential commercialization, IDEAYA will be eligible to receive up to $475 million of commercial milestones and tiered royalties on global net sales by GSK, its affiliates and their sublicensees ranging from high single digit to sub-teen double digit percentages, subject to certain customary reductions.

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 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 timing of IND submission and first-in-human clinical evaluation of Pol Theta Helicase DC combination with niraparib and (ii) the potential achievement of and/or receipt of future GSK milestone payments. Such forward-looking statements involve substantial risks and uncertainties that could cause IDEAYA's preclinical and clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the drug development process, including IDEAYA's programs' early stage of development, the process of designing and conducting preclinical and clinical trials, the regulatory approval processes, the timing of regulatory filings, the challenges associated with manufacturing drug products, IDEAYA's ability to successfully establish, protect and defend its intellectual property, the effects on IDEAYA's business of the worldwide COVID-19 pandemic, the ongoing military conflict between Russia and Ukraine, and other matters that could affect the sufficiency of existing cash to fund operations. 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 Quarterly Report on Form 10-Q filed on August 15, 2022 and any current and periodic reports filed with the U.S. Securities and Exchange Commission.

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SOURCE IDEAYA Biosciences, Inc.

FAQ

What milestone did IDEAYA achieve regarding its Pol Theta Helicase Inhibitor?

IDEAYA achieved a preclinical development milestone in connection with ongoing IND-enabling studies.

What is the financial potential related to IDEAYA's drug development?

IDEAYA is eligible to receive total milestone payments of up to $20 million for preclinical and clinical development.

When does IDEAYA plan to initiate first-in-human studies for its Pol Theta Helicase Inhibitor?

IDEAYA is targeting first-in-human clinical evaluation in the first half of 2023.

How much is the total potential milestone payment IDEAYA could receive from GSK?

IDEAYA could receive up to $485 million in total milestones from GSK.

What are the risks associated with IDEAYA's drug development process?

The risks include uncertainties in the drug development process, regulatory approval challenges, and reliance on GSK for clinical development.