{"id":914430,"date":"2025-12-01T06:07:03","date_gmt":"2025-12-01T11:07:03","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/ideaya-biosciences-announces-ind-clearance-for-ide034-a-potential-first-in-class-bispecific-b7h3-ptk7-top1-adc-targeting-multiple-solid-tumor-types\/"},"modified":"2025-12-01T06:07:03","modified_gmt":"2025-12-01T11:07:03","slug":"ideaya-biosciences-announces-ind-clearance-for-ide034-a-potential-first-in-class-bispecific-b7h3-ptk7-top1-adc-targeting-multiple-solid-tumor-types","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/ideaya-biosciences-announces-ind-clearance-for-ide034-a-potential-first-in-class-bispecific-b7h3-ptk7-top1-adc-targeting-multiple-solid-tumor-types\/","title":{"rendered":"IDEAYA Biosciences Announces IND Clearance for IDE034, a Potential First-in-Class Bispecific B7H3\/PTK7 TOP1 ADC Targeting Multiple Solid Tumor Types"},"content":{"rendered":"<div class=\"xn-newslines\">\n<p class=\"xn-distributor\">PR Newswire<\/p>\n<\/p><\/div>\n<div class=\"xn-content\">\n<ul type=\"disc\">\n<li>B7H3 and PTK7 is co-expressed in multiple solid tumor types, including lung, colorectal, and head and neck cancers, at approximately 30%, 46%, and 27%, respectively<\/li>\n<li>Deep and durable regressions observed with IDE034\u00a0monotherapy in multiple preclinical in-vivo models with B7H3 and PTK7 co-expression<\/li>\n<li>Enhanced durability with IDE034 and IDE161\u00a0PARG inhibitor combination in preclinical <i>in vivo<\/i> models; targeting to share additional preclinical data supporting mechanistic rationale at a medical conference in H1 2026<\/li>\n<\/ul>\n<p>\n        <span class=\"legendSpanClass\">SOUTH SAN FRANCISCO, Calif.\u00a0and\u00a0SHANGHAI<\/span>, <span class=\"legendSpanClass\"><span class=\"xn-chron\">Dec. 1, 2025<\/span><\/span> \/PRNewswire\/ &#8212; IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, announced the clearance of an investigational new drug (IND) application with the U.S. Food and Drug Administration (FDA) for the initiation of a Phase 1 clinical trial to evaluate\u00a0IDE034, a potential first-in-class bispecific B7H3\/PTK7 TOP1 antibody-drug conjugate (ADC). \u00a0IDEAYA expects to begin enrolling the study in Q1 2026, initially evaluating patients with solid tumors known to express B7H3 and PTK7, including lung, colorectal, head and neck and ovarian\/gynecological cancers. \u00a0Based on the Human Protein Atlas database, B7H3\/PTK7 has been reported to be co-expressed in lung, colorectal, and head and neck cancers at approximately 30%, 46% and 27%, respectively.<\/p>\n<div class=\"PRN_ImbeddedAssetReference\" id=\"DivAssetPlaceHolder1\">\n<p>\n          <a href=\"https:\/\/mma.prnewswire.com\/media\/820568\/IDEAYA_Logo.html\" target=\"_blank\" rel=\"nofollow\"><br \/>\n            <img decoding=\"async\" src=\"https:\/\/mma.prnewswire.com\/media\/820568\/IDEAYA_Logo.jpg\" title=\"(PRNewsfoto\/IDEAYA Biosciences, Inc.)\" alt=\"(PRNewsfoto\/IDEAYA Biosciences, Inc.)\" \/><br \/>\n          <\/a>\n        <\/p>\n<\/p><\/div>\n<p>&#8220;IND clearance for IDE034 is an important step in expanding our potential first-in-class TOP1 ADC clinical pipeline into bispecific, precision-guided approaches,&#8221; said <span class=\"xn-person\">Darrin M. Beaupre<\/span>, M.D., Ph.D., Chief Medical Officer of IDEAYA Biosciences. &#8220;IDE034 has demonstrated robust antitumor activity and selective targeting of B7H3- and PTK7-expressing solid tumor models. The high prevalence of B7H3\/PTK7 co-expression in solid tumors such as lung, colorectal, and head and neck cancers underscores its broad indication potential.&#8221;<\/p>\n<p>&#8220;We are excited to advance our differentiated clinical strategy with now three potentially first-in-class clinical-stage programs focused on enhancing the efficacy of TOP1 ADCs through the PARG DDR combination mechanism.\u00a0 We believe this approach addresses a key unmet need by improving the durability of response to TOP1 payload-based ADC therapies.\u00a0 We are targeting to share additional preclinical data to support the PARG and TOP1 ADC combination rationale at a major medical conference in H1 2026,&#8221; said <span class=\"xn-person\">Yujiro S. Hata<\/span>, President and Chief Executive Officer of IDEAYA Biosciences.<\/p>\n<p>Preclinical studies have demonstrated strong anti-tumor activity in B7H3\/PTK7-positive tumor models, including deep and durable tumor regressions with IDE034 monotherapy, supporting advancement into clinical development. This co-expression pattern supports the potential for broad monotherapy activity, while the TOP1 payload provides a strong mechanistic rationale for combining IDE034 with IDEAYA&#8217;s PARG inhibitor, IDE161. \u00a0TOP1 inhibition induces replication stress and DNA damage, which can increase reliance on the PARG pathway; therefore, a IDE034 and IDE161 combination approach may enhance anti-tumor activity in patients with solid tumors that co-express B7H3 and PTK7, consistent with the results that were observed preclinically with this combination.<\/p>\n<p>\n        <b>About IDEAYA Biosciences<\/b>\n      <\/p>\n<p>IDEAYA is a precision medicine oncology company committed to the discovery, development, and commercialization of transformative therapies for cancer.\u00a0 Our approach integrates expertise in small-molecule drug discovery, structural biology and bioinformatics with robust internal capabilities in identifying and validating translational biomarkers to develop tailored, potentially first-in-class targeted therapies aligned to the genetic drivers of disease.\u00a0 We have built a deep pipeline of product candidates focused on synthetic lethality and antibody-drug conjugates, or ADCs, for molecularly defined solid tumor indications.\u00a0 Our mission is to bring forth the next wave of precision oncology therapies that are more selective, more effective, and deeply personalized with the goal of altering the course of disease and improving clinical outcomes for patients with cancer.<\/p>\n<p>\n        <b>Forward-Looking Statements<\/b>\n      <\/p>\n<p>This press release contains forward-looking statements, including, but not limited to, statements related to: (i) the timing of the initiation of and enrollment of subjects for\u00a0 the Phase 1 clinical trial to evaluate IDE034; (ii) the potential frequency of B7H3\/PTK7 co-expressed in solid tumors types, including lung, colorectal, and head and neck cancers; (iii) the potential therapeutic benefit of IDE034 as monotherapy and in combination with IDE161, a PARG inhibitor; and (iv) the timing of a data presentation related to the \u00a0IDE034 and IDE161, PARG inhibitor, combination at a medical conference. \u00a0Preclinical study results are not necessarily predictive of future clinical trial results and\/or approval.\u00a0 Such forward-looking statements involve substantial risks and uncertainties that could cause IDEAYA&#8217;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&#8217;s programs&#8217; 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&#8217;s ability to successfully establish, protect and defend its intellectual property, 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&#8217;s Annual Report on Form 10-K dated\u00a0February 18, 2025\u00a0and any current and periodic reports filed with the U.S. Securities and Exchange Commission.<\/p>\n<p>\n        <b>Investor and Media Contact<\/b><br \/>\n        <br \/>\n        <span class=\"xn-person\">Joshua Bleharski<\/span>, Ph.D.<br \/>Chief Financial Officer\u00a0<br \/><a href=\"mailto:investor@ideayabio.com\" target=\"_blank\" rel=\"nofollow\">investor@ideayabio.com<\/a><\/p>\n<p id=\"PURL\">\n        <img loading=\"lazy\" decoding=\"async\" title=\"Cision\" width=\"12\" height=\"12\" alt=\"Cision\" src=\"https:\/\/edge.prnewswire.com\/c\/img\/favicon.png?sn=SF35497&amp;sd=2025-12-01\" \/> View original content to download multimedia:<a id=\"PRNURL\" rel=\"nofollow\" href=\"https:\/\/www.prnewswire.com\/news-releases\/ideaya-biosciences-announces-ind-clearance-for-ide034-a-potential-first-in-class-bispecific-b7h3ptk7-top1-adc-targeting-multiple-solid-tumor-types-302628524.html\" target=\"_blank\">https:\/\/www.prnewswire.com\/news-releases\/ideaya-biosciences-announces-ind-clearance-for-ide034-a-potential-first-in-class-bispecific-b7h3ptk7-top1-adc-targeting-multiple-solid-tumor-types-302628524.html<\/a><\/p>\n<p>SOURCE  IDEAYA Biosciences, Inc.<\/p>\n<\/p><\/div>\n<p>    <img decoding=\"async\" alt=\"\" src=\"https:\/\/rt.prnewswire.com\/rt.gif?NewsItemId=SF35497&amp;Transmission_Id=202512010600PR_NEWS_USPR_____SF35497&amp;DateId=20251201\" style=\"border:0px;width:1px;height:1px\" \/><\/p>\n","protected":false},"excerpt":{"rendered":"<p>PR Newswire B7H3 and PTK7 is co-expressed in multiple solid tumor types, including lung, colorectal, and head and neck cancers, at approximately 30%, 46%, and 27%, respectively Deep and durable regressions observed with IDE034\u00a0monotherapy in multiple preclinical in-vivo models with B7H3 and PTK7 co-expression Enhanced durability with IDE034 and IDE161\u00a0PARG inhibitor combination in preclinical in vivo models; targeting to share additional preclinical data supporting mechanistic rationale at a medical conference in H1 2026 SOUTH SAN FRANCISCO, Calif.\u00a0and\u00a0SHANGHAI, Dec. 1, 2025 \/PRNewswire\/ &#8212; IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, announced the clearance of an investigational new drug (IND) application with the U.S. Food and Drug Administration (FDA) for &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/ideaya-biosciences-announces-ind-clearance-for-ide034-a-potential-first-in-class-bispecific-b7h3-ptk7-top1-adc-targeting-multiple-solid-tumor-types\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;IDEAYA Biosciences Announces IND Clearance for IDE034, a Potential First-in-Class Bispecific B7H3\/PTK7 TOP1 ADC Targeting Multiple Solid Tumor Types&#8221;<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-914430","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>IDEAYA Biosciences Announces IND Clearance for IDE034, a Potential First-in-Class Bispecific B7H3\/PTK7 TOP1 ADC Targeting Multiple Solid Tumor Types - Market Newsdesk<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.marketnewsdesk.com\/index.php\/ideaya-biosciences-announces-ind-clearance-for-ide034-a-potential-first-in-class-bispecific-b7h3-ptk7-top1-adc-targeting-multiple-solid-tumor-types\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"IDEAYA Biosciences Announces IND Clearance for IDE034, a Potential First-in-Class Bispecific B7H3\/PTK7 TOP1 ADC Targeting Multiple Solid Tumor Types - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"PR Newswire B7H3 and PTK7 is co-expressed in multiple solid tumor types, including lung, colorectal, and head and neck cancers, at approximately 30%, 46%, and 27%, respectively Deep and durable regressions observed with IDE034\u00a0monotherapy in multiple preclinical in-vivo models with B7H3 and PTK7 co-expression Enhanced durability with IDE034 and IDE161\u00a0PARG inhibitor combination in preclinical in vivo models; targeting to share additional preclinical data supporting mechanistic rationale at a medical conference in H1 2026 SOUTH SAN FRANCISCO, Calif.\u00a0and\u00a0SHANGHAI, Dec. 1, 2025 \/PRNewswire\/ &#8212; IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, announced the clearance of an investigational new drug (IND) application with the U.S. Food and Drug Administration (FDA) for &hellip; Continue reading &quot;IDEAYA Biosciences Announces IND Clearance for IDE034, a Potential First-in-Class Bispecific B7H3\/PTK7 TOP1 ADC Targeting Multiple Solid Tumor Types&quot;\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/ideaya-biosciences-announces-ind-clearance-for-ide034-a-potential-first-in-class-bispecific-b7h3-ptk7-top1-adc-targeting-multiple-solid-tumor-types\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2025-12-01T11:07:03+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/mma.prnewswire.com\/media\/820568\/IDEAYA_Logo.jpg\" \/>\n<meta name=\"author\" content=\"Newsdesk\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Newsdesk\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"5 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/ideaya-biosciences-announces-ind-clearance-for-ide034-a-potential-first-in-class-bispecific-b7h3-ptk7-top1-adc-targeting-multiple-solid-tumor-types\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/ideaya-biosciences-announces-ind-clearance-for-ide034-a-potential-first-in-class-bispecific-b7h3-ptk7-top1-adc-targeting-multiple-solid-tumor-types\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"IDEAYA Biosciences Announces IND Clearance for IDE034, a Potential First-in-Class Bispecific B7H3\\\/PTK7 TOP1 ADC Targeting Multiple Solid Tumor Types\",\"datePublished\":\"2025-12-01T11:07:03+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/ideaya-biosciences-announces-ind-clearance-for-ide034-a-potential-first-in-class-bispecific-b7h3-ptk7-top1-adc-targeting-multiple-solid-tumor-types\\\/\"},\"wordCount\":935,\"image\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/ideaya-biosciences-announces-ind-clearance-for-ide034-a-potential-first-in-class-bispecific-b7h3-ptk7-top1-adc-targeting-multiple-solid-tumor-types\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/mma.prnewswire.com\\\/media\\\/820568\\\/IDEAYA_Logo.jpg\",\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/ideaya-biosciences-announces-ind-clearance-for-ide034-a-potential-first-in-class-bispecific-b7h3-ptk7-top1-adc-targeting-multiple-solid-tumor-types\\\/\",\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/ideaya-biosciences-announces-ind-clearance-for-ide034-a-potential-first-in-class-bispecific-b7h3-ptk7-top1-adc-targeting-multiple-solid-tumor-types\\\/\",\"name\":\"IDEAYA Biosciences Announces IND Clearance for IDE034, a Potential First-in-Class Bispecific B7H3\\\/PTK7 TOP1 ADC Targeting Multiple Solid Tumor Types - 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Market Newsdesk","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/www.marketnewsdesk.com\/index.php\/ideaya-biosciences-announces-ind-clearance-for-ide034-a-potential-first-in-class-bispecific-b7h3-ptk7-top1-adc-targeting-multiple-solid-tumor-types\/","og_locale":"en_US","og_type":"article","og_title":"IDEAYA Biosciences Announces IND Clearance for IDE034, a Potential First-in-Class Bispecific B7H3\/PTK7 TOP1 ADC Targeting Multiple Solid Tumor Types - Market Newsdesk","og_description":"PR Newswire B7H3 and PTK7 is co-expressed in multiple solid tumor types, including lung, colorectal, and head and neck cancers, at approximately 30%, 46%, and 27%, respectively Deep and durable regressions observed with IDE034\u00a0monotherapy in multiple preclinical in-vivo models with B7H3 and PTK7 co-expression Enhanced durability with IDE034 and IDE161\u00a0PARG inhibitor combination in preclinical in vivo models; targeting to share additional preclinical data supporting mechanistic rationale at a medical conference in H1 2026 SOUTH SAN FRANCISCO, Calif.\u00a0and\u00a0SHANGHAI, Dec. 1, 2025 \/PRNewswire\/ &#8212; IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, announced the clearance of an investigational new drug (IND) application with the U.S. Food and Drug Administration (FDA) for &hellip; Continue reading \"IDEAYA Biosciences Announces IND Clearance for IDE034, a Potential First-in-Class Bispecific B7H3\/PTK7 TOP1 ADC Targeting Multiple Solid Tumor Types\"","og_url":"https:\/\/www.marketnewsdesk.com\/index.php\/ideaya-biosciences-announces-ind-clearance-for-ide034-a-potential-first-in-class-bispecific-b7h3-ptk7-top1-adc-targeting-multiple-solid-tumor-types\/","og_site_name":"Market Newsdesk","article_published_time":"2025-12-01T11:07:03+00:00","og_image":[{"url":"https:\/\/mma.prnewswire.com\/media\/820568\/IDEAYA_Logo.jpg","type":"","width":"","height":""}],"author":"Newsdesk","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Newsdesk","Est. reading time":"5 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/ideaya-biosciences-announces-ind-clearance-for-ide034-a-potential-first-in-class-bispecific-b7h3-ptk7-top1-adc-targeting-multiple-solid-tumor-types\/#article","isPartOf":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/ideaya-biosciences-announces-ind-clearance-for-ide034-a-potential-first-in-class-bispecific-b7h3-ptk7-top1-adc-targeting-multiple-solid-tumor-types\/"},"author":{"name":"Newsdesk","@id":"https:\/\/www.marketnewsdesk.com\/#\/schema\/person\/482f27a394d4fda80ecb5499e519d979"},"headline":"IDEAYA Biosciences Announces IND Clearance for IDE034, a Potential First-in-Class Bispecific B7H3\/PTK7 TOP1 ADC Targeting Multiple Solid Tumor Types","datePublished":"2025-12-01T11:07:03+00:00","mainEntityOfPage":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/ideaya-biosciences-announces-ind-clearance-for-ide034-a-potential-first-in-class-bispecific-b7h3-ptk7-top1-adc-targeting-multiple-solid-tumor-types\/"},"wordCount":935,"image":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/ideaya-biosciences-announces-ind-clearance-for-ide034-a-potential-first-in-class-bispecific-b7h3-ptk7-top1-adc-targeting-multiple-solid-tumor-types\/#primaryimage"},"thumbnailUrl":"https:\/\/mma.prnewswire.com\/media\/820568\/IDEAYA_Logo.jpg","inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/ideaya-biosciences-announces-ind-clearance-for-ide034-a-potential-first-in-class-bispecific-b7h3-ptk7-top1-adc-targeting-multiple-solid-tumor-types\/","url":"https:\/\/www.marketnewsdesk.com\/index.php\/ideaya-biosciences-announces-ind-clearance-for-ide034-a-potential-first-in-class-bispecific-b7h3-ptk7-top1-adc-targeting-multiple-solid-tumor-types\/","name":"IDEAYA Biosciences Announces IND Clearance for IDE034, a Potential First-in-Class Bispecific B7H3\/PTK7 TOP1 ADC Targeting Multiple Solid Tumor Types - 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