Entered into Clinical Study Collaboration and Supply Agreement with Gilead to evaluate IDE397, IDEAYA's MAT2A inhibitor, in combination with sacituzumab-govitecan-hziy ('Trodelvy') Gilead's Trop-2 directed ADC, in MTAP-deletion bladder cancer

与Gilead进入临床研究合作并提供协议，以评估IDE397，IDEAYA的MAT2A抑制剂，与sacituzumab govitecan hziy（'Trodelvy'）Gilead的Trop-2定向ADC联合用于MTAP缺失性膀胱癌

Potential first-in-class MAT2A-Trop2 ADC clinical combination targets two distinct, mechanistically complementary, nodes of MTAP-deletion bladder cancer pathway

潜在的一流MAT2A-Trop2 ADC临床组合针对MTAP缺失膀胱癌途径的两个不同的，机制上互补的节点

MTAP-deletion prevalence in bladder cancer is estimated to be approximately 26%

MTAP在膀胱癌中的缺失率估计约为26%

IDEAYA will sponsor the clinical trial and Gilead will provide Trodelvy

IDEAYA将赞助临床试验，Gilead将提供Trodelvy

SOUTH SAN FRANCISCO, Dec. 4, 2023 /PRNewswire/ -- IDEAYA Biosciences, Inc. (Nasdaq:IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, announced it has entered into a clinical study collaboration and supply agreement with Gilead Sciences, Inc.

南旧金山，2023年12月4日/PRNewswire/-IDEAYA Biosciences，Inc。（纳斯达克股票代码：IDYA），一家致力于发现和开发靶向治疗药物的精准肿瘤公司，宣布已进入临床研究合作并与Gilead Sciences，Inc。签订供应协议。

(Gilead) to evaluate the efficacy and safety of IDE397, its investigational, potential first-in-class, small molecule MAT2A inhibitor, in combination with Gilead's sacituzumab-govitecan-hziy ('Trodelvy'), a Trop-2 directed antibody-drug conjugate (ADC), in a Phase 1 clinical trial. .

（Gilead）评估IDE397（其研究中潜在的一流小分子MAT2A抑制剂）与Gilead的sacituzumab govitecan hziy（'Trodelvy'）（一种Trop-2定向抗体-药物偶联物）联合使用的有效性和安全性。（ADC），在1期临床试验中。 .

'We are pleased to collaborate with Gilead to evaluate this potential first-in-class Trop-2 directed ADC and MAT2A clinical combination in MTAP-deletion bladder cancer. MTAP-deletion prevalence in bladder cancer is approximately 26% and this patient population represents a high unmet medical need, as there are no approved therapies for MTAP-deletion bladder cancer,' said Darrin Beaupre, M.D., Ph.D., Chief Medical Officer, IDEAYA Biosciences..

'我们很高兴与Gilead合作评估这种潜在的一流Trop-2定向ADC和MAT2A临床组合在MTAP缺失膀胱癌中的应用。膀胱癌中MTAP缺失的患病率约为26%，并且该患者群体代表了高度未满足的医疗需求，因为没有批准的MTAP缺失膀胱癌疗法，“IDEAYA Biosciences首席医疗官Darrin Beaupre博士说。。

'We are delighted to enter into this clinical collaboration with Gilead that advances our multi-pronged strategy designed to deliver maximal benefit to MTAP-deletion solid tumor patients. We believe the strong mechanistic rationale of this combination, and the monotherapy efficacy observed by both agents in MTAP-deletion bladder cancer, may enable this combination to be differentiated and studied in an earlier-line clinical setting,' said Yujiro Hata, President and Chief Executive Officer, IDEAYA Biosciences. .

“我们很高兴与Gilead进行这项临床合作，推动我们的多管齐下的策略，旨在为MTAP缺失实体瘤患者提供最大的益处。我们相信这种组合的强大机制基础以及两种药物在MTAP缺失膀胱癌中观察到的单一疗法疗效可能使这种组合能够在早期的临床环境中进行区分和研究，“总裁兼首席执行官Yujiro Hata说。，IDEAYA Biosciences。 .

IDE397 is a potent and selective small molecule inhibitor targeting methionine adenosyltransferase 2a (MAT2A), in patients having solid tumors with methylthioadenosine phosphorylase (MTAP) deletion. The MTAP deletion patient population is estimated to represent approximately 15% of solid tumors, including approximately 19% of squamous NSCLC and 26% of bladder cancer. Sacituzumab govitecan, commercialized under the brand name Trodelvy, is a Trop-2 directed antibody-drug conjugate currently approved in the U.S.

IDE397是一种有效的选择性小分子抑制剂，靶向甲硫氨酸腺苷转移酶2a（MAT2A），用于患有甲硫腺苷磷酸化酶（MTAP）缺失的实体瘤患者。估计MTAP缺失患者群体约占实体瘤的15%，包括约19%的鳞状NSCLC和26%的膀胱癌。Sacituzumab govitecan以商品名Trodelvy商业化，是目前在美国批准的Trop-2定向抗体-药物偶联物。

for the treatment of HR+/HER2- metastatic breast cancer, metastatic triple-negative breast cancer and metastatic urothelial cancer..

用于治疗HR+/HER2-转移性乳腺癌，转移性三阴性乳腺癌和转移性尿路上皮癌。。

IDEAYA is evaluating IDE397 in an ongoing Phase 1/2 clinical trial. The company has initiated and is actively enrolling patients into monotherapy expansion in squamous NSCLC and bladder cancer and collaborating with Amgen in a Phase 1 combination study with AMG 193, Amgen's MTA-Cooperative PRMT5 inhibitor. .

IDEAYA正在进行的1/2期临床试验中评估IDE397。该公司已启动并积极招募患者参与鳞状NSCLC和膀胱癌的单药治疗扩展，并与Amgen合作开展Amgen公司的MTA合作PRMT5抑制剂AMG 193的1期联合研究。 .

Under the clinical study collaboration and supply agreement, Gilead will provide drug supply to IDEAYA, which will be the sponsor of the Phase 1 clinical combination trial. IDEAYA and Gilead each retain all commercial rights to their respective compounds, including as monotherapy or as combination therapies.    .

根据临床研究合作和供应协议，Gilead将向IDEAYA提供药物供应，IDEAYA将成为1期临床联合试验的赞助商。IDEAYA和Gilead各自保留其各自化合物的所有商业权利，包括作为单一疗法或联合疗法。    .

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About IDEAYA Biosciences

关于IDEAYA生物科学

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是一家精准医学肿瘤学公司，致力于为使用分子诊断选择的患者群体发现和开发靶向治疗药物。IDEAYA的方法将识别和验证转化生物标志物的能力与药物发现相结合，以选择最有可能从其靶向治疗中受益的患者群体。

IDEAYA is applying its research and drug discovery capabilities to synthetic lethality – which represents an emerging class of precision medicine targets.  .

IDEAYA正在将其研究和药物发现能力应用于合成致死率-这代表了一类新兴的精准医学目标。  .

Forward-Looking Statements

前瞻性声明

This press release contains forward-looking statements, including, but not limited to, statements related (i) the prevalence of MTAP-deletion and (ii) the potential therapeutic benefits of the combination of IDE397 and Trodelvy. IDEAYA undertakes no obligation to update or revise any forward-looking statements.

本新闻稿包含前瞻性声明，包括但不限于与（i）MTAP删除的普遍性和（ii）IDE397和Trodelvy组合的潜在治疗益处相关的声明。IDEAYA不承担更新或修改任何前瞻性声明的义务。

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 November 7, 2023 and any current and periodic reports filed with the U.S.

有关可能导致实际结果与这些前瞻性声明中所表达的结果不同的风险和不确定性的进一步描述，以及与IDEAYA业务相关的风险，请参阅IDEAYA最近提交的关于表格10-Q的季度报告2023年11月7日提交的以及向美国提交的任何当前和定期报告。

Securities and Exchange Commission..

证券交易委员会。。

Investor and Media ContactIDEAYA BiosciencesAndres Ruiz BrisenoSVP, Head of Finance and Investor Relations  [email protected]

投资者和媒体联系方式Aya BiosciencesAndres Ruiz BrisenoSVP，金融和投资者关系负责人[电子邮件保护]

SOURCE IDEAYA Biosciences, Inc.

来源IDEAYA Biosciences，Inc。