IDEAYA Biosciences Selects IDE397 Phase 2 Monotherapy Expansion Dose For Global Enrollment Targeting High Priority MTAP-Deletion Solid Tumor Types

IDEAYA Biosciences, Inc. (NASDAQ:), a precision drugs oncology firm dedicated to the invention and improvement of focused therapeutics, introduced collection of a monotherapy enlargement dose for the Part 2 medical trial evaluating IDE397 in sufferers having strong tumors with MTAP deletion.

“We now have chosen a IDE397 Part 2 monotherapy enlargement dose for analysis in our high-priority strong tumor sorts with MTAP deletion, together with NSCLC, bladder most cancers and gastroesophageal most cancers. We’re within the early phases of enrollment into our world Part 2 medical trial monotherapy enlargement and have medical targets to additional outline IDE397’s monotherapy efficacy in our excessive precedence strong tumor sorts and to handle contribution of parts for medical mixtures,” mentioned Dr. Darrin M. Beaupre, M.D., Ph.D., Chief Medical Officer, IDEAYA Biosciences.

IDE397 is a potent and selective small molecule inhibitor concentrating on methionine adenosyltransferase 2a (MAT2A). IDEAYA is clinically evaluating IDE397 as monotherapy in a Part 1/2 medical trial in sufferers having strong tumors with methylthioadenosine phosphorylase (MTAP) deletion, with ongoing enrollment into the worldwide Part 2 medical trial.

IDEAYA is focusing monotherapy enlargement cohorts in high-priority tumor sorts with MTAP deletion, together with NSCLC, bladder most cancers and gastricesophageal most cancers. MTAP deletion is estimated to happen in ~16% of non-small cell lung most cancers (NSCLC), ~30% of bladder most cancers and ~15% to ~25% of gastricesophageal most cancers. These monotherapy indications are being prioritized primarily based on preliminary medical efficacy and preclinical information demonstrating in vivo efficacy in related patient- and/or cell-derived xenograft fashions and noticed endogenous pathway suppression in MTAP deleted tumors. These information have been introduced on the 2023 Annual Assembly of the American Affiliation of Most cancers Analysis (AACR 2023).

The corporate noticed tumor shrinkage in a number of sufferers handled with IDE397 monotherapy in IDEAYA’s high-priority MTAP-deletion strong tumor sorts, together with a pre-treated affected person that had an noticed partial response (PR) by RECIST 1.1 (~40% tumor discount) on the first post-baseline scan.

IDEAYA is collaborating with Amgen to clinically consider IDE397 together with AMG 193 in sufferers having strong tumors with MTAP deletion. AMG 193 is the Amgen investigational MTA- cooperative protein arginine methyltransferase 5 (PRMT5) inhibitor. The medical analysis of IDE397 with AMG 193 represents a novel and potential first-in-class artificial lethality mixture. Concentrating on two mechanistically distinct nodes of the MTAP methylation pathway – MAT2A and PRMT5 gives a synergistic strategy for concentrating on MTAP-null tumors.

In Might 2023, IDEAYA reported clearance of the Amgen-sponsored Investigational New Drug (IND) utility and U.S. FDA authorization to proceed with the IDE397 / AMG 193 Part 1/2 medical trial. The Part 1/2 medical trial will consider the protection, tolerability, pharmacokinetics, pharmacodynamics and efficacy of IDE397 together with AMG 193.

IDEAYA and Amgen co-presented preclinical information at AACR 2023 demonstrating deep and sturdy anti-tumor efficacy for the IDE397 and AMG 193 mixture in a NSCLC MTAP-null CDX mannequin. These information confirmed full responses following roughly 30 days of mixture remedy at doses under the maximally efficacious preclinical dose for every compound, which have been sturdy from roughly study-day 40 to study-day 100. The IDE397 and AMG 193 mixture was nicely tolerated, with no noticed physique weight reduction by means of the approximate 30 days of mixture remedy in these fashions. Moreover, the outcomes of gene expression evaluation of hallmark pathways, different splicing evaluation and retained intron evaluation collectively demonstrated that mixed pharmacological inhibition of MAT2A and PRMT5 deepens the organic response by means of maximal pathway suppression. The improved mixture impact was noticed selectively in MTAP-deleted fashions.

Pursuant to the mutually non-exclusive CTCSA, Amgen is the sponsor of the IDE397 and AMG 193 mixture medical trial and every of IDEAYA and Amgen will provide their respective compounds, IDE397 and AMG 193. Every celebration pays fifty % (50%) of the exterior third-party prices for conducting the medical trial and be wholly liable for their respective personal inner prices and bills in assist of the medical trial. The businesses will collectively personal medical information and all mental property, if any, regarding the mixed use of IDE397 and AMG 193 from the medical trial. Every celebration retains business rights to its respective compounds, together with with respect to make use of as a monotherapy or mixture agent. The businesses have shaped a joint oversight committee liable for coordinating all regulatory and different actions in assist of the medical trial.

About IDEAYA Biosciences

IDEAYA is a precision drugs oncology firm dedicated to the invention and improvement of focused therapeutics for affected person populations chosen utilizing molecular diagnostics. IDEAYA’s strategy integrates capabilities in figuring out and validating translational biomarkers with drug discovery to pick out affected person populations most definitely to learn from its focused therapies. IDEAYA is making use of its early analysis and drug discovery capabilities to precision drugs targets, together with artificial lethality – which represents an rising class of precision drugs targets.

Ahead-Wanting Statements

This press launch comprises forward-looking statements, together with, however not restricted to, statements associated to medical targets for the IDE397 Part 2 medical trial. IDEAYA undertakes no obligation to replace or revise any forward-looking statements. For an additional description of the dangers and uncertainties that might trigger precise outcomes to vary from these expressed in these forward-looking statements, in addition to dangers regarding the enterprise of IDEAYA normally, see IDEAYA’s Quarterly Report on Type 10-Q filed on Might 9, 2023 and any present and periodic experiences filed with the U.S. Securities and Alternate Fee.

Investor and Media Contact
IDEAYA BiosciencesPaul A. StoneChief Monetary Officer
investor@ideayabio.com

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SOURCE IDEAYA Biosciences, Inc.