IDEAYA Pronounces Constructive Interim Part 2 Monotherapy Growth Knowledge for IDE397 a Potential First-in-Class MAT2A Inhibitor in MTAP-Deletion Urothelial and Lung Most cancers

• ~39% Total Response Fee (ORR): 1 CR and 6 PRs (2 awaiting affirmation) by RECIST 1.1 out of 18 evaluable MTAP-deletion urothelial and NSCLC sufferers
• ~94% Illness Management Fee (DCR): 1 CR and 6 PRs and 10 SD by RECIST 1.1
• ~78% of Sufferers with Tumor Shrinkage: 14 sufferers noticed tumor shrinkage
• ~81% ctDNA Molecular Response Fee (MRR): 13 of 16 sufferers with > 50% ctDNA discount
• AE Profile: ~5.6% drug-related grade >3 AEs and no drug-related SAEs or discontinuations at 30 mg once-a-day enlargement dose
• IDE397 enlargement dose of 30 mg once-a-day achieved goal drug protection and plasma SAM pharmacodynamic discount related to preclinical tumor regressions
• ~48k U.S. annual incidence of MTAP-deletion urothelial most cancers and NSCLC, with excessive unmet want and no FDA-approved therapies for MTAP-deletion stable tumors
• Investor webcast scheduled for at this time, Monday, July 8, 2024, at 8:00 am ET

SOUTH SAN FRANCISCO, Calif., July 8, 2024 /PRNewswire/ — IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a precision medication oncology firm dedicated to the invention and improvement of focused therapeutics, at this time introduced optimistic medical information for the IDE397 Part 2 monotherapy enlargement dose in methylthioadenosine phosphorylase (MTAP)-deletion urothelial and non-small cell lung most cancers (NSCLC) sufferers. IDE397 is a potent and selective potential first-in-class methionine adenosyltransferase 2 alpha (MAT2A) inhibitor in Part 2 medical trials for the remedy of MTAP-deletion stable tumors.

“We’re extremely inspired by the preliminary medical efficacy and favorable security profile noticed with IDE397 on the 30mg once-a-day enlargement dose, together with a number of partial responses and one full response by RECIST 1.1 in MTAP-deletion urothelial and lung most cancers sufferers. As well as, at this enlargement dose we noticed a good hostile occasion profile with no drug-related severe hostile occasions and mid-single digit % grade 3 or larger drug-related hostile occasions, which we consider has the potential to allow longer period dosing in addition to combos,” stated Dr. Darrin Beaupre, M.D., Ph.D., Chief Medical Officer, IDEAYA Biosciences.

“IDE397 is a possible first-in-class MAT2A inhibitor, that’s being superior as a monotherapy agent in precedence MTAP-deletion stable tumor sorts and in excessive conviction rational combos, together with with Amgen’s investigational MTA-cooperative protein arginine methytranferase 5 inhibitor AMG 193 in NSCLC and with Gilead’s Trop-2 directed anti-body conjugate Trodelvy in urothelial most cancers. The IDE397 medical information replace demonstrates vital medical proof-of-concept in MTAP-deletion stable tumors to ship RECIST responses and inspiring preliminary sturdiness, with a handy 30mg once-a-day pill and favorable hostile occasion profile,” stated Yujiro S. Hata, Chief Government Officer and Founder, IDEAYA Biosciences.

There are presently no FDA-approved therapies for sufferers with MTAP-deletion stable tumors, highlighting the unmet medical want. The precedence MTAP-deletion stable tumor sorts for the IDE397 Part 2 monotherapy program are urothelial most cancers and NSCLC. MTAP-deletion prevalence has been reported at over 15% in NSCLC and over 25% in urothelial most cancers, primarily based on The Most cancers Genome Atlas (TCGA) database. We estimate that the MTAP-deletion annual incidence within the U.S. in NSCLC and urothelial most cancers is roughly 48,000 sufferers, primarily based on the 2024 Surveillance, Epidemiology, and Finish Outcomes (SEER) database. As well as, there are a number of potential enlargement MTAP-deletion stable tumor sorts which can be additionally being thought-about for monotherapy and mixture improvement, together with pancreatic, gastric, esophageal, and head and neck most cancers, amongst others. Based mostly on the TCGA database, MTAP-deletion prevalence in pancreatic most cancers has been reported at over 20%, representing a U.S. annual incidence of roughly 14,000 sufferers.

Scientific Knowledge Replace – IDE397 at 30mg QD Part 2 Growth Dose in MTAP-Deletion Urothelial Most cancers and NSCLC Sufferers

The corporate noticed encouraging medical exercise on the 30 mg enlargement dose in its Part 2 medical trial evaluating its potential first-in-class MAT2A inhibitor IDE397 in closely pre-treated MTAP-deletion urothelial most cancers and NSCLC sufferers. The sufferers evaluated had a median of two (2) prior traces of remedy, starting from one (1) to seven (7) prior traces of remedy. The reported Part 2 medical information are primarily based on eighteen (18) evaluable MTAP-deletion sufferers, together with seven (7) urothelial most cancers, 4 (4) adenocarcinoma NSCLC, and 7 (7) squamous NSCLC sufferers on the enlargement dose of 30 mg once-a-day of IDE397. 

Reported medical efficacy and tolerability information are preliminary and primarily based on investigator evaluation from an unlocked database as of the info evaluation cutoff date of June 21, 2024. 

The medical information replace within the eighteen (18) evaluable sufferers by RECIST 1.1 embrace:

• ~39% Total Response Fee (ORR). One (1) full response and 6 (6) partial responses by RECIST 1.1 analysis out of eighteen (18) evaluable sufferers. Two (2) partial responses are awaiting affirmation, together with one (1) urothelial most cancers affected person that had a 100% tumor discount within the goal lesion on the final CT-scan evaluation and one (1) adenocarcinoma NSCLC affected person. One (1) full response and two (2) partial responses had been urothelial most cancers sufferers. Amongst sufferers with lung most cancers, three (3) partial responses had been squamous NSCLC sufferers, and one (1) partial response was an adenocarcinoma NSCLC affected person. There was one (1) non-evaluable affected person who discontinued attributable to fast medical development of most cancers fatigue and drug-unrelated hostile occasions in cycle 1 of remedy
• 94% Illness Management Fee (DCR). One (1) full response, six (6) partial responses, and ten (10) secure illness by RECIST 1.1 analysis out of eighteen (18) evaluable sufferers
• 78% of sufferers with tumor shrinkage. Fourteen (14) out of eighteen (18) evaluable sufferers noticed tumor shrinkage
• Swim lane plot by CT-scan analysis and preliminary sturdiness evaluation: Eleven (11) of eighteen (18) sufferers nonetheless on remedy. 5 (5) of seven (7) RECIST 1.1 responses stay in response. Median period of remedy, median period of response, and median development free survival not but reached
• 81% ctDNA Molecular Response (MR) Fee. 13 (13) of sixteen (16) sufferers with 50% or larger ctDNA discount. There have been a number of high quality management failures of affected person samples that led to unavailability for MR evaluation
• Favorable hostile occasion (AE) profile. Roughly 5.6% grade 3 or larger drug-related AEs and no drug-related severe hostile occasions (SAEs) noticed at IDE397 30mg once-a-day enlargement dose. No drug-related AEs resulting in discontinuations noticed. We anticipate that the favorable AE profile and dosing comfort of a 30 mg once-a-day pill has the potential to allow long-term dosing and mixture improvement
• 30mg as soon as every day enlargement dose achieves goal drug protection and plasma S-adenosyl-l-methionine (SAM) pharmacodynamic discount related to preclinical tumor regressions

IDEAYA has activated over 35 medical trial websites globally within the U.S., Canada, Europe, and Asia Pacific to allow potential fast enrollment for the IDE397 Part 2 monotherapy enlargement in MTAP-deletion lung and bladder most cancers in its ongoing trial (NCT04794699). There’s additionally an Amgen-sponsored Part 1/2 trial of IDE397 and AMG 193 mixture in MTAP-Deletion NSCLC (NCT05975073) for which the businesses intend to develop a joint publication technique in 2024. As well as, IDEAYA has initiated enrollment in a Part 1 medical trial evaluating the protection, tolerability, pharmacokinetics, pharmacodynamics and efficacy of IDE397 together with Trodelvy (NCT04794699). IDEAYA can also be advancing a number of preclinical stage MTAP-deletion packages to allow wholly-owned combos with IDE397, together with a program concentrating on a improvement candidate nomination within the second half of 2024.

IDEAYA Investor Webcast and Convention Name

IDEAYA will host an investor webcast at this time, Monday, July 8, at 8:00 am Japanese Time (ET), to current the medical information replace for the IDE397 Part 2 monotherapy enlargement dose in MTAP-deletion urothelial most cancers and NSCLC sufferers.

Presenters on the investor webcast will embrace IDEAYA Biosciences administration, together with Yujiro S. Hata, Chief Government Officer, Darrin Beaupre, M.D., Ph.D., Chief Medical Officer, and Michael White, Ph.D., Chief Scientific Officer. 

The IDE397 investor webcast presentation, in addition to an up to date company presentation, which is able to incorporate the IDE397 Part 2 medical information replace on the 30mg enlargement dose in urothelial most cancers and NSCLC sufferers, will likely be obtainable on the corporate’s web site, at its Investor Relations portal at roughly 8:00 am ET on Monday, July 8, 2024.

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

Ahead-Wanting Statements
This press launch accommodates forward-looking statements, together with, however not restricted to, statements associated to (i) expectations concerning the medical exercise profile and potential benefits of IDEAYA’s medical packages, (ii) the timing for the event of a joint Amgen/IDEAYA publication technique for the Part 1/2 IDE397 and AMG 193 mixture, (iii) the timing of preclinical stage MTAP-deletion packages together with IDE397 and (iv) nomination of an IDE397 mixture improvement candidate within the second half of 2024. Such forward-looking statements contain substantial dangers and uncertainties that might trigger precise occasions and outcomes to vary from these expressed in these forward-looking statements, together with these associated to IDEAYA’s preclinical and medical improvement packages. Such dangers and uncertainties embrace, amongst others, the uncertainties inherent within the drug improvement course of, together with IDEAYA’s packages’ early stage of improvement, the method of designing and conducting preclinical and medical trials, severe hostile occasions, undesirable unintended effects or surprising traits of drug improvement packages, the regulatory approval processes, the timing of regulatory filings, the challenges related to manufacturing drug merchandise, IDEAYA’s skill to efficiently set up, shield and defend its mental property, the sufficiency of present money to fund operations, and different issues that might have an effect on the corporate’s enterprise, monetary situation, outcomes of operations and prospects. 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 occasions and outcomes to vary from these expressed in these forward-looking statements, in addition to dangers referring to the enterprise of IDEAYA generally, see IDEAYA’s Annual Report on Type 10-Okay filed on February 20, 2024, Quarterly Report on Type 10-Q filed on Could 7, 2024 and any further present and periodic studies filed with the U.S. Securities and Alternate Fee. 

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.