{"id":40782,"date":"2025-09-05T13:27:30","date_gmt":"2025-09-05T05:27:30","guid":{"rendered":"https:\/\/flcube.com\/?p=40782"},"modified":"2025-09-05T13:27:31","modified_gmt":"2025-09-05T05:27:31","slug":"transthera-begins-phase-ii-tinengotinib-trial-with-akeso-bispecifics-for-advanced-hcc","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=40782","title":{"rendered":"TransThera Begins Phase II Tinengotinib Trial with Akeso Bispecifics for Advanced HCC"},"content":{"rendered":"\n<p><strong>TransThera Sciences (Nanjing) Inc.<\/strong> (<a href=\"https:\/\/www.google.com\/finance\/quote\/2617:HKG\">HKG: 2617<\/a>) announced the first patient dose in an open\u2011label, multi\u2011center Phase\u202fII clinical trial evaluating its flagship product <strong>Tinengotinib (TT\u201100420)<\/strong> in combination with Akeso Bio\u2019s bispecific antibodies <strong>AK\u2011112 (cadonilimab)<\/strong> and <strong>AK\u2011102 (ivonescimab)<\/strong> for advanced hepatocellular carcinoma (HCC).<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-study-design\">Study Design<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Population<\/strong> \u2013 Patients with advanced, therapy\u2011refractory HCC.<\/li>\n\n\n\n<li><strong>Intervention<\/strong> \u2013 Oral Tinengotinib plus either AK\u2011112 (PD\u20111\/CTLA\u20114) or AK\u2011102 (PD\u20111\/VEGF).<\/li>\n\n\n\n<li><strong>Endpoints<\/strong> \u2013 Objective response rate, progression\u2011free survival, overall survival, and safety.<\/li>\n\n\n\n<li><strong>Phase<\/strong> \u2013 Open\u2011label, multi\u2011center, global enrollment.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-tinengotinib-a-multi-kinase-inhibitor\">Tinengotinib \u2013 A Multi\u2011Kinase Inhibitor<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Target<\/th><th>Therapeutic Rationale<\/th><\/tr><\/thead><tbody><tr><td><strong>FGFR \/ VEGFR<\/strong><\/td><td>Inhibits angiogenesis and tumor proliferation.<\/td><\/tr><tr><td><strong>JAK<\/strong><\/td><td>Modulates cytokine signaling and immune evasion.<\/td><\/tr><tr><td><strong>Aurora kinases<\/strong><\/td><td>Suppresses mitotic progression in cancer cells.<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Clinical Status<\/strong> \u2013 In global Phase\u202fIII registration studies for solid tumors.<\/li>\n\n\n\n<li><strong>Regulatory Designations<\/strong> \u2013 FDA: Orphan Drug &amp; Breakthrough Therapy; EMA: Orphan Drug.<\/li>\n\n\n\n<li><strong>Efficacy Portfolio<\/strong> \u2013 Demonstrated activity in cholangiocarcinoma, metastatic castration\u2011resistant prostate cancer (mCRPC), and other solid tumors.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-strategic-rationale\">Strategic Rationale<\/h2>\n\n\n\n<ol class=\"wp-block-list\">\n<li><strong>Synergy with Bispecifics<\/strong> \u2013 Combining kinase inhibition with dual checkpoint\/angiogenesis blockade may overcome resistance mechanisms in HCC.<\/li>\n\n\n\n<li><strong>Accelerated Pathway<\/strong> \u2013 Phase\u202fII data will inform dosing and safety for the upcoming Phase\u202fIII program.<\/li>\n\n\n\n<li><strong>Portfolio Expansion<\/strong> \u2013 Positions TransThera as a leader in oncology drug combinations, enhancing its valuation and investor appeal.<\/li>\n<\/ol>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-market-implications\">Market Implications<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>HCC Landscape<\/strong> \u2013 Rising incidence and limited effective options; combination therapies are a focus of regulatory agencies and payers.<\/li>\n\n\n\n<li><strong>Competitive Edge<\/strong> \u2013 Tinengotinib\u2019s broad kinase inhibition combined with Akeso\u2019s bispecific platform offers a unique mechanism profile versus existing TKIs and immunotherapies.<\/li>\n\n\n\n<li><strong>Commercial Potential<\/strong> \u2013 Successful trial outcomes could unlock significant revenue streams in the >$3\u202fB HCC market.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/li>\n<\/ul>\n\n\n\n<div data-wp-interactive=\"core\/file\" class=\"wp-block-file\"><object data-wp-bind--hidden=\"!state.hasPdfPreview\" hidden class=\"wp-block-file__embed\" data=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/09\/2025090402172_c.pdf\" type=\"application\/pdf\" style=\"width:100%;height:600px\" aria-label=\"Embed of 2025090402172_c.\"><\/object><a id=\"wp-block-file--media-a791d4c9-b5d3-48f9-b868-0b3bedca3451\" href=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/09\/2025090402172_c.pdf\">2025090402172_c<\/a><a href=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/09\/2025090402172_c.pdf\" class=\"wp-block-file__button wp-element-button\" download aria-describedby=\"wp-block-file--media-a791d4c9-b5d3-48f9-b868-0b3bedca3451\">Download<\/a><\/div>\n","protected":false},"excerpt":{"rendered":"<p>TransThera Sciences (Nanjing) Inc. (HKG: 2617) announced the first patient dose in an open\u2011label, multi\u2011center&#8230;<\/p>\n","protected":false},"author":1,"featured_media":40784,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"googlesitekit_rrm_CAownpewDA:productID":"","_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":true,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[7,11],"tags":[16,62,4181,601],"class_list":["post-40782","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-cancer","tag-clinical-trial-approval-initiation","tag-hkg-2617","tag-transthera-sciences"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v23.6 (Yoast SEO v27.5) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>TransThera Begins Phase II Tinengotinib Trial with Akeso Bispecifics for Advanced HCC - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"China\u2011headquartered TransThera Sciences (HKG: 2617) has dosed the first patient in an open\u2011label Phase\u202fII study combining its oral kinase inhibitor **Tinengotinib** with Akeso\u2019s bispecific antibodies AK\u2011112 and AK\u2011102 for advanced hepatocellular carcinoma.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/flcube.com\/?p=40782\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"TransThera Begins Phase II Tinengotinib Trial with Akeso Bispecifics for Advanced HCC\" \/>\n<meta property=\"og:description\" content=\"China\u2011headquartered TransThera Sciences (HKG: 2617) has dosed the first patient in an open\u2011label Phase\u202fII study combining its oral kinase inhibitor **Tinengotinib** with Akeso\u2019s bispecific antibodies AK\u2011112 and AK\u2011102 for advanced hepatocellular carcinoma.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/flcube.com\/?p=40782\" \/>\n<meta property=\"og:site_name\" content=\"Insight, China&#039;s Pharmaceutical Industry\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/profile.php?id=61566606313834\" \/>\n<meta property=\"article:published_time\" content=\"2025-09-05T05:27:30+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2025-09-05T05:27:31+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/09\/0504.webp\" \/>\n\t<meta property=\"og:image:width\" content=\"1080\" \/>\n\t<meta property=\"og:image:height\" content=\"608\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"Fineline Cube\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:description\" content=\"Navigate the complexities of China\u2019s pharmaceutical industry with precision and clarity. 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