{"id":45327,"date":"2026-01-19T08:00:00","date_gmt":"2026-01-19T01:00:00","guid":{"rendered":"https:\/\/thaipropertynews.com\/feeds\/?p=45327"},"modified":"2026-01-19T08:00:00","modified_gmt":"2026-01-19T01:00:00","slug":"d3-bio-receives-u-s-fda-clearance-for-two-ind-applications-enabling-phase-1-trial-of-d3s-003-and-phase-2-combination-study-of-elisrasib-d3s-001-with-d3s-002","status":"publish","type":"post","link":"https:\/\/thaipropertynews.com\/feeds\/?p=45327","title":{"rendered":"D3 Bio Receives U.S. FDA Clearance for Two IND Applications, Enabling Phase 1 Trial of D3S\u2011003 and Phase 2 Combination Study of Elisrasib (D3S\u2011001) with D3S\u2011002"},"content":{"rendered":"<table border=\"0\" cellspacing=\"10\" cellpadding=\"5\" align=\"right\">\n<tbody>\n<tr>\n<td><img decoding=\"async\" src=\"https:\/\/mma.prnasia.com\/media2\/2758996\/D3_BIO_DeShengJi_Logo.jpg?p=medium600\" border=\"0\" alt=\"\" title=\"logo\" hspace=\"0\" vspace=\"0\" width=\"118\" \/><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p><span class=\"legendSpanClass\">SHANGHAI<\/span>, <span class=\"legendSpanClass\">Jan. 19, 2026<\/span> \/PRNewswire\/ &#8212; D3 Bio, a global clinical\u2011stage biotechnology company focused on developing transformative oncology therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has cleared two Investigational New Drug (IND) applications:<\/p>\n<div class=\"PRN_ImbeddedAssetReference\">\n<\/div>\n<ul type=\"disc\">\n<li>D3S\u2011003 \u2014 a\u00a0KRAS G12D inhibitor \u2014 enabling the start of a Phase 1 first\u2011in\u2011human clinical trial.<\/li>\n<li>A Phase 2 combination trial evaluating D3S\u2011001 (elisrasib), the Company&#8217;s next\u2011generation KRAS G12C inhibitor, in combination with D3S\u2011002, a selective oral ERK1\/2 inhibitor.<\/li>\n<\/ul>\n<p>D3S\u2011003 is an orally bioavailable, allele\u2011specific KRAS G12D inhibitor that targets both the GDP\u2011bound (OFF) and GTP\u2011bound (ON) conformations. Preclinical data demonstrate a differentiated, best\u2011in\u2011class profile with potent anti\u2011tumor activity, favorable drug\u2011like characteristics, and a promising safety margin. With FDA clearance received, D3 Bio will advance D3S\u2011003 into a Phase 1 first\u2011in\u2011human study in patients with advanced solid tumors harboring KRAS G12D mutations.<\/p>\n<p>The newly cleared Phase 2 study will evaluate the combination of D3S\u2011001 and D3S\u2011002 in patients with KRAS G12C\u2013mutant non\u2011small cell lung cancer (NSCLC) who have progressed on prior KRAS G12C\u2011targeted therapies. The trial, expected to begin in the first half of 2026, will investigate safety, pharmacokinetics, and early efficacy signals with the goal of establishing a rational combination strategy to address resistance and deliver more durable benefit in KRAS\u2011driven cancers.<\/p>\n<p>&#8220;We are excited to receive FDA IND clearance for D3S\u2011003 and to advance a Phase 2 combination clinical trial of elisrasib and D3S\u2011002,&#8221; said George Chen, Founder, Chairman and Chief Executive Officer of D3 Bio. &#8220;With D3S\u2011003, we are bringing a differentiated KRAS G12D inhibitor into the clinic to address one of the most prevalent and challenging KRAS mutations. In parallel, the combination study of elisrasib and D3S\u2011002 pushes forward our next\u2011generation KRAS G12C strategy, particularly for patients who have progressed on prior KRAS G12C\u2011targeted therapies. Together, these milestones underline the momentum of our KRAS franchise and reinforce our commitment to delivering transformative therapies for patients with KRAS\u2011mutant cancers who urgently need new options.&#8221;<\/p>\n<p><b>About Elisrasib (D3S-001)<\/b><\/p>\n<p>Elisrasib is a next\u2011generation KRAS G12C inhibitor designed for rapid, complete, and selective target engagement. It covalently binds the GDP\u2011bound (OFF) form of KRAS G12C, effectively blocking nucleotide cycling and suppressing oncogenic signaling. Preclinical studies show robust potency, complete KRAS G12C engagement at clinically relevant exposures, and CNS penetration capability. Elisrasib is currently being evaluated globally in a Phase 2 monotherapy and combination trial across KRAS G12C\u2013mutant solid tumors including NSCLC, CRC, and others.<\/p>\n<p>Key publications:<\/p>\n<ul type=\"disc\">\n<li><i>Cancer Discovery (2024) 14(9):1675\u20131698<\/i><\/li>\n<li><i>Nature Medicine (2025) 31(8):2768\u20132777<\/i><\/li>\n<\/ul>\n<p><b>About D3S\u2011002<\/b><\/p>\n<p>D3S\u2011002 is a selective ERK1\/2 inhibitor strategically designed for combination approaches, providing vertical MAPK\u2011pathway inhibition to enhance efficacy and overcome acquired resistance, particularly in tumors previously treated with KRAS G12C inhibitors.<\/p>\n<p>Key publication:<\/p>\n<ul type=\"disc\">\n<li><i>Cancer Res 1 April 2023; 83 (7_Supplement): 5501. <\/i><\/li>\n<\/ul>\n<p><b>About D3S\u2011003<\/b><\/p>\n<p>D3S\u2011003 is a differentiated KRAS G12D inhibitor targeting both OFF and ON conformations to address one of the most common KRAS mutations. The program aims to broaden D3 Bio&#8217;s multi\u2011allele KRAS franchise and deliver new solutions for the heterogeneous and evolving landscape of KRAS\u2011driven cancers.<\/p>\n<p><b>About D3 Bio<\/b><\/p>\n<p>D3 Bio is a global biotechnology company focused on the discovery, development, and registration of novel oncology and immunology therapies with first\u2011 or best\u2011in\u2011class potential. Guided by deep clinical insight and biomarker\u2011driven strategies, the Company is advancing a pipeline of programs targeting key oncogenic drivers and immune pathways. D3 Bio owns global rights to all its programs.<\/p>\n<p>For more information, please visit <b><a href=\"https:\/\/www.d3bio.com\/\" target=\"_blank\" rel=\"nofollow\">www.d3bio.com<\/a><\/b><\/p>","protected":false},"excerpt":{"rendered":"<p><!-- wp:html --><\/p>\n<table border=\"0\" cellspacing=\"10\" cellpadding=\"5\" align=\"right\">\n<tbody>\n<tr>\n<td><img decoding=\"async\" src=\"https:\/\/mma.prnasia.com\/media2\/2758996\/D3_BIO_DeShengJi_Logo.jpg?p=medium600\" border=\"0\" alt=\"\" title=\"logo\" hspace=\"0\" vspace=\"0\" width=\"118\" \/><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p><span class=\"legendSpanClass\">SHANGHAI<\/span>, <span class=\"legendSpanClass\">Jan. 19, 2026<\/span> \/PRNewswire\/ &#8212; D3 Bio, a global clinical\u2011stage biotechnology company focused on developing transformative oncology therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has cleared two Investigational New Drug (IND) applications:<\/p>\n<div class=\"PRN_ImbeddedAssetReference\">\n<\/div>\n<ul type=\"disc\">\n<li>D3S\u2011003 \u2014 a\u00a0KRAS G12D inhibitor \u2014 enabling the start of a Phase 1 first\u2011in\u2011human clinical trial.<\/li>\n<li>A Phase 2 combination trial evaluating D3S\u2011001 (elisrasib), the Company&#8217;s next\u2011generation KRAS G12C inhibitor, in combination with D3S\u2011002, a selective oral ERK1\/2 inhibitor.<\/li>\n<\/ul>\n<p>D3S\u2011003 is an orally bioavailable, allele\u2011specific KRAS G12D inhibitor that targets both the GDP\u2011bound (OFF) and GTP\u2011bound (ON) conformations. Preclinical data demonstrate a differentiated, best\u2011in\u2011class profile with potent anti\u2011tumor activity, favorable drug\u2011like characteristics, and a promising safety margin. With FDA clearance received, D3 Bio will advance D3S\u2011003 into a Phase 1 first\u2011in\u2011human study in patients with advanced solid tumors harboring KRAS G12D mutations.<\/p>\n<p>The newly cleared Phase 2 study will evaluate the combination of D3S\u2011001 and D3S\u2011002 in patients with KRAS G12C\u2013mutant non\u2011small cell lung cancer (NSCLC) who have progressed on prior KRAS G12C\u2011targeted therapies. The trial, expected to begin in the first half of 2026, will investigate safety, pharmacokinetics, and early efficacy signals with the goal of establishing a rational combination strategy to address resistance and deliver more durable benefit in KRAS\u2011driven cancers.<\/p>\n<p>&#8220;We are excited to receive FDA IND clearance for D3S\u2011003 and to advance a Phase 2 combination clinical trial of elisrasib and D3S\u2011002,&#8221; said George Chen, Founder, Chairman and Chief Executive Officer of D3 Bio. &#8220;With D3S\u2011003, we are bringing a differentiated KRAS G12D inhibitor into the clinic to address one of the most prevalent and challenging KRAS mutations. In parallel, the combination study of elisrasib and D3S\u2011002 pushes forward our next\u2011generation KRAS G12C strategy, particularly for patients who have progressed on prior KRAS G12C\u2011targeted therapies. Together, these milestones underline the momentum of our KRAS franchise and reinforce our commitment to delivering transformative therapies for patients with KRAS\u2011mutant cancers who urgently need new options.&#8221;<\/p>\n<p><b>About Elisrasib (D3S-001)<\/b><\/p>\n<p>Elisrasib is a next\u2011generation KRAS G12C inhibitor designed for rapid, complete, and selective target engagement. It covalently binds the GDP\u2011bound (OFF) form of KRAS G12C, effectively blocking nucleotide cycling and suppressing oncogenic signaling. Preclinical studies show robust potency, complete KRAS G12C engagement at clinically relevant exposures, and CNS penetration capability. Elisrasib is currently being evaluated globally in a Phase 2 monotherapy and combination trial across KRAS G12C\u2013mutant solid tumors including NSCLC, CRC, and others.<\/p>\n<p>Key publications:<\/p>\n<ul type=\"disc\">\n<li><i>Cancer Discovery (2024) 14(9):1675\u20131698<\/i><\/li>\n<li><i>Nature Medicine (2025) 31(8):2768\u20132777<\/i><\/li>\n<\/ul>\n<p><b>About D3S\u2011002<\/b><\/p>\n<p>D3S\u2011002 is a selective ERK1\/2 inhibitor strategically designed for combination approaches, providing vertical MAPK\u2011pathway inhibition to enhance efficacy and overcome acquired resistance, particularly in tumors previously treated with KRAS G12C inhibitors.<\/p>\n<p>Key publication:<\/p>\n<ul type=\"disc\">\n<li><i>Cancer Res 1 April 2023; 83 (7_Supplement): 5501. <\/i><\/li>\n<\/ul>\n<p><b>About D3S\u2011003<\/b><\/p>\n<p>D3S\u2011003 is a differentiated KRAS G12D inhibitor targeting both OFF and ON conformations to address one of the most common KRAS mutations. The program aims to broaden D3 Bio&#8217;s multi\u2011allele KRAS franchise and deliver new solutions for the heterogeneous and evolving landscape of KRAS\u2011driven cancers.<\/p>\n<p><b>About D3 Bio<\/b><\/p>\n<p>D3 Bio is a global biotechnology company focused on the discovery, development, and registration of novel oncology and immunology therapies with first\u2011 or best\u2011in\u2011class potential. Guided by deep clinical insight and biomarker\u2011driven strategies, the Company is advancing a pipeline of programs targeting key oncogenic drivers and immune pathways. D3 Bio owns global rights to all its programs.<\/p>\n<p>For more information, please visit <b><a href=\"https:\/\/www.d3bio.com\/\" target=\"_blank\" rel=\"nofollow\">www.d3bio.com<\/a><\/b><\/p>\n<p><!-- \/wp:html --><\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"rop_custom_images_group":[],"rop_custom_messages_group":[],"rop_publish_now":"initial","rop_publish_now_accounts":[],"rop_publish_now_history":[],"rop_publish_now_status":"pending","footnotes":""},"categories":[1],"tags":[],"class_list":["post-45327","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-uncategorized"],"_links":{"self":[{"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=\/wp\/v2\/posts\/45327","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=45327"}],"version-history":[{"count":0,"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=\/wp\/v2\/posts\/45327\/revisions"}],"wp:attachment":[{"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=45327"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=45327"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=45327"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}