{"id":43859,"date":"2025-10-20T19:01:36","date_gmt":"2025-10-20T11:01:36","guid":{"rendered":"https:\/\/flcube.com\/?p=43859"},"modified":"2025-10-20T19:01:37","modified_gmt":"2025-10-20T11:01:37","slug":"multitude-therapeutics-announces-early%e2%80%91stage-efficacy-signals-for-amt%e2%80%91116-a-first%e2%80%91in%e2%80%91class-cd44v9%e2%80%91targeting-adc","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=43859","title":{"rendered":"Multitude\u202fTherapeutics Announces Early\u2011Stage Efficacy Signals for AMT\u2011116, a First\u2011In\u2011Class CD44v9\u2011Targeting ADC"},"content":{"rendered":"\n

Multitude Therapeutics, Inc.<\/strong> today released preliminary data from its ongoing Phase\u202fI\/II, open\u2011label, multicenter, dose\u2011escalation and expansion study of AMT\u2011116<\/strong>, a novel antibody\u2011drug conjugate (ADC) that targets the CD44v9 onco\u2011antigen. The data were presented at the European Society for Medical Oncology (ESMO) Congress 2025<\/strong> in Berlin, Germany.<\/p>\n\n\n\n

Study Design & Patient Population<\/h2>\n\n\n\n
    \n
  • Phase<\/strong> \u2013 I\/II, open\u2011label, multicenter, dose\u2011escalation + expansion<\/li>\n\n\n\n
  • Enrollment<\/strong> \u2013 164 subjects (as of\u202fJuly\u202f17\u202f2025)<\/li>\n\n\n\n
  • Dosing<\/strong> \u2013 1.5\u202f\u2013\u202f5.0\u202fmg\/kg Q2W (once every two weeks)<\/li>\n\n\n\n
  • Cancer Types<\/strong> \u2013 EGFR\u2011wild\u2011type NSCLC, nasopharyngeal carcinoma, anal squamous cell carcinoma, salivary gland carcinoma<\/li>\n\n\n\n
  • Line of Therapy<\/strong> \u2013 1\u20135 prior lines for EGFR\u2011wild\u2011type NSCLC patients<\/li>\n<\/ul>\n\n\n\n

    Key Efficacy Findings<\/h2>\n\n\n\n
    Sub\u2011cohort<\/th>Dose<\/th>Objective Response Rate (ORR)<\/th>Disease\u2011Control Rate (DCR)<\/th><\/tr><\/thead>
    EGFR\u2011wild\u2011type NSCLC (\u2265\u202f3.0\u202fmg\/kg)<\/td>3.0\u202f\u2013\u202f5.0\u202fmg\/kg<\/td>40\u202f%<\/strong> (6\/15)<\/td>93\u202f%<\/strong> (14\/15)<\/td><\/tr>
    EGFR\u2011wild\u2011type NSCLC (5.0\u202fmg\/kg)<\/td>5.0\u202fmg\/kg<\/td>80\u202f%<\/strong> (4\/5)<\/td>100\u202f%<\/strong> (5\/5)<\/td><\/tr>
    Nasopharyngeal carcinoma (\u2265\u202f3.0\u202fmg\/kg)<\/td>3.0\u202f\u2013\u202f5.0\u202fmg\/kg<\/td>50\u202f%<\/strong> (3\/6)<\/td>\u2014<\/td><\/tr>
    Anal squamous cell carcinoma (\u2265\u202f3.0\u202fmg\/kg)<\/td>3.0\u202f\u2013\u202f5.0\u202fmg\/kg<\/td>60\u202f%<\/strong> (3\/5)<\/td>\u2014<\/td><\/tr>
    Salivary gland carcinoma (\u2265\u202f3.0\u202fmg\/kg)<\/td>3.0\u202f\u2013\u202f5.0\u202fmg\/kg<\/td>33\u202f%<\/strong> (2\/6)<\/td>\u2014<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n
      \n
    • CD44v9 Expression<\/strong> \u2013 Anti\u2011tumor activity observed regardless of baseline CD44v9 levels.<\/li>\n\n\n\n
    • Long\u2011Term Outlook<\/strong> \u2013 Early data suggest durable responses; ongoing follow\u2011up will clarify survival benefits.<\/li>\n<\/ul>\n\n\n\n

      Safety Profile<\/h2>\n\n\n\n
        \n
      • Common Treatment\u2011Related AEs<\/strong> \u2013 Manageable hematologic toxicity (e.g., neutropenia, anemia).<\/li>\n\n\n\n
      • Non\u2011hematologic AEs<\/strong> \u2013 Minimal, low\u2011grade oral mucosal and skin reactions.<\/li>\n\n\n\n
      • Overall Tolerability<\/strong> \u2013 Consistent with other topoisomerase\u20111 (TOP1) inhibitor\u2011based ADCs; no dose\u2011limiting toxicities reported to date.<\/li>\n<\/ul>\n\n\n\n

        Product Profile \u2013 AMT\u2011116<\/h2>\n\n\n\n
          \n
        • Target<\/strong> \u2013 CD44v9, a cell\u2011surface protein overexpressed in solid tumors and implicated in cancer\u2011stem\u2011cell signaling.<\/li>\n\n\n\n
        • Antibody<\/strong> \u2013 Proprietary humanized IgG with high affinity for CD44v9.<\/li>\n\n\n\n
        • Linker<\/strong> \u2013 Cleavable, designed for tumor\u2011specific payload release.<\/li>\n\n\n\n
        • Payload<\/strong> \u2013 Belotecan derivative (KL610023), a potent, clinically validated TOP1 inhibitor.<\/li>\n\n\n\n
        • Drug\u2011to\u2011Antibody Ratio (DAR)<\/strong> \u2013 \u2248\u202f7\u20118.<\/li>\n<\/ul>\n\n\n\n

          Forward\u2011Looking Statements<\/h3>\n\n\n\n

          The information contained herein includes forward\u2011looking statements that involve risks and uncertainties. Actual results may differ materially.<\/p>\n","protected":false},"excerpt":{"rendered":"

          Multitude Therapeutics, Inc. today released preliminary data from its ongoing Phase\u202fI\/II, open\u2011label, multicenter, dose\u2011escalation and…<\/p>\n","protected":false},"author":1,"featured_media":43864,"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":[106,35,16,17,340],"class_list":["post-43859","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-academic-conference","tag-adc-xdc","tag-cancer","tag-clinical-trial-results","tag-multitude-therapeutics"],"yoast_head":"\nMultitude\u202fTherapeutics Announces Early\u2011Stage Efficacy Signals for AMT\u2011116, a First\u2011In\u2011Class CD44v9\u2011Targeting ADC - Insight, China's Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Multitude Therapeutics, Inc. today released preliminary data from its ongoing Phase\u202fI\/II, open\u2011label, multicenter, dose\u2011escalation and expansion study of AMT\u2011116, a novel antibody\u2011drug conjugate (ADC) that targets the CD44v9 onco\u2011antigen. 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