{"id":40835,"date":"2025-10-17T14:00:00","date_gmt":"2025-10-17T14:00:00","guid":{"rendered":"https:\/\/www.prnasia.com\/story\/archive\/4800599_CN00599_0"},"modified":"2025-10-17T14:00:00","modified_gmt":"2025-10-17T14:00:00","slug":"multitude-therapeutics-announces-promising-interim-phase-i-ii-results-from-the-ongoing-first-in-human-study-evaluating-its-cd44v9-directed-antibody-drug-conjugate-amt-116-in-heavily-pretreated-egfr","status":"publish","type":"post","link":"https:\/\/transmediavictoria.net.au\/?p=40835","title":{"rendered":"Multitude Therapeutics Announces Promising Interim Phase I\/II Results from the Ongoing First-in-Human Study Evaluating its CD44v9-directed Antibody-Drug-Conjugate, AMT-116, in Heavily Pretreated EGFR Wild-type Non-Small Cell Lung Cancer (NSCLC) and Other Advanced Solid Tumors at the 2025 ESMO Annual Meeting"},"content":{"rendered":"<div id=\"dvContent\" readability=\"137.88502673797\">\n<p class=\"prntac\"><i>AMT-116 is a potential first-in-class CD44v9-directed Topoisomerase I inhibitor-based ADC <\/i><\/p>\n<p class=\"prntac\"><i>AMT-116 demonstrated a favorable safety profile, with manageable hematologic and Gastrointestinal toxicities <\/i><\/p>\n<p class=\"prntac\"><i>Promising efficacies were observed in patients with heavily pretreated EGFR Wild-type NSCLC and other advanced solid tumors without CD44v9 pre-selection<\/i><\/p>\n<p><span class=\"legendSpanClass\"><span class=\"xn-location\">SHANGHAI<\/span><\/span>, <span class=\"legendSpanClass\"><span class=\"xn-chron\">Oct. 17, 2025<\/span><\/span> \/PRNewswire\/ &#8212; Multitude Therapeutics, Inc., a clinical-stage company focused on the development of antibody-drug-conjugate (ADC) drugs, today announced initial data from its ongoing phase I\/II open-label, multicenter dose escalation and expansion study evaluating AMT-116, a CD44v9-directed ADC, in patients with EGFR wild-type NSCLC and other advanced solid tumors. The data are being presented on <span class=\"xn-chron\">October 17th<\/span> at the 2025 European Society for Medical Oncology (ESMO) Annual Meeting being held in <span class=\"xn-location\">Berlin, Germany<\/span>.<\/p>\n<p>Phase I\/II clinical trials are being conducted across <span class=\"xn-location\">Australia<\/span>, US and <span class=\"xn-location\">China<\/span>. This first-in-human study will evaluate the Maximum Tolerated Dose (MTD) \/ the Recommended Phase II Dose (RP2D), safety, tolerability, anti-tumor activity, pharmacokinetics, pharmacodynamics and immunogenicity of AMT-116, in patients with advanced solid tumors. The Phase Ia portion will determine the recommended doses for expansion, and the Phase Ib\/II portion will focus on further characterizing safety and efficacy in select tumor types.<\/p>\n<p>As of <span class=\"xn-chron\">July 17th, 2025<\/span>, safety data are available for 164 patients who have received AMT-116 once every two weeks (Q2W) at doses ranging from 1.5 to 5.0 mg\/kg. Primary tumor types are NSCLC, NPC (nasopharyngeal carcinoma), anal carcinoma and salivary gland cancer. In heavily pretreated EGFR Wild-type NSCLC patients, with prior lines of therapy ranging from 1-5, promising efficacy was observed regardless CD44v9 expression status. The overall response rate (ORR) was 40% (6\/15), and the disease control rate (DCR) was 93% (14\/15), in EGFR Wild-type NSCLC at dose levels <u>&gt;<\/u>3 mg\/kg. Among five EGFR Wild-type NSCLC patients at 5.0 mg\/kg, ORR was 80% (4\/5) and DCR was 100% (5\/5). Preliminary antitumor activity was also observed in patients with NPC, anal carcinoma and salivary gland cancer at <u>&gt;<\/u>3mg\/kg, with ORRs of 50% (3\/6), 60% (3\/5) and 33% (2\/6), respectively. Antitumor activity was observed across patients with varying levels of CD44v9 expression. The safety profile of AMT-116 was consistent with that of other Topoisomerase I inhibitor-based ADCs, with manageable hematologic toxicities as the most common treatment-related adverse events. Only low-grade and infrequent mucosal and skin toxicities were observed, demonstrating a favorable tolerability profile.<\/p>\n<p>&#8220;We are excited by the impressive and durable efficacy shown in the early results of AMT-116, especially in unselected heavily pretreated EGFR Wild-type NSCLC and several other advanced solid tumors. The efficacies of AMT-116 observed so far are consistent with its broad tumor expression profile observed in preclinical studies, while the greatly reduced mucosal and skin toxicities reflect the desired outcome of a carefully selected linker-payload platform aimed at mitigating potential on-target toxicities from normal tissue expression. With these encouraging results, we are further expanding the clinically efficacious dose levels of 4 mg\/kg Q2W and 5 mg\/kg Q2W cohorts in select tumor types to explore the full potential of this novel ADC for greater patient benefit in NSCLC and beyond,&#8221; said Dr. <span class=\"xn-person\">Shu-Hui Liu<\/span>, co-founder and CSO of Multitude Therapeutics.<\/p>\n<p>Mini Oral Presentation Details:<\/p>\n<p><b>Title:<\/b>&nbsp;Updated ongoing Phase I\/II clinical trial results of AMT-116, a first-in-class anti-CD44v9 antibody-drug conjugate (ADC), in patients with advanced solid tumors<br \/><b>Mini Oral Session Title:<\/b> Developmental therapeutics<br \/><b>Date and Time<\/b>: <span class=\"xn-chron\">October 17th<\/span> \u2013 <span class=\"xn-chron\">04:05 PM<\/span><br \/><b>Location:<\/b> Heidelberg Auditorium &#8211; Hall 6.2<br \/><b>Presentation number:<\/b> 922MO<\/p>\n<p><b>About AMT-116<br \/><\/b>AMT-116, a CD44v9 ADC, is composed of a proprietary antibody with high CD44v9 binding affinity, a hydrolysable linker, and a belotecan derivative payload (a novel and clinically validated topoisomerase-1 inhibitor, named KL610023, collaborating with Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (6990.HK)). CD44v9 is involved in broad biological pathways and has an implicated role in cancer stem cells. The target is a highly abundant protein and is overexpressed broadly in solid tumors with a restrictive normal tissue expression. AMT-116 has a drug-to-antibody ratio of 7-8. AMT-116 is being evaluated in a phase I\/II study in patients with EGFR Wild-type NSCLC and other advanced solid tumors. Additional information on the <span class=\"xn-location\">Australia<\/span>\/US Phase I (NCT05725291) and China Phase I\/II (NCT06782334) trials can be found at <a href=\"https:\/\/clinicaltrials.gov\/\" target=\"_blank\" rel=\"nofollow noopener\">clinicaltrials.gov<\/a>.&nbsp;<\/p>\n<p><b>About Multitude Therapeutics<br \/><\/b>Multitude Therapeutics is a clinical-stage company focused on the development of ADC drugs. Multitude Therapeutics has two technology platforms: MabArray\u2122\u2014 an antibody platform for discovering novel cell surface tumor antigens to identify first-in-class targets, and T1000- exatecan \u2014 a new linker-payload technology for developing ADCs, which allows ADCs prepared with this platform to achieve a better balance of the bystander effect, efficacy, and safety. The combination of MabArray\u2122 and T1000-exatecan generates significant synergistic effects, enabling Multitude Therapeutics to build an ADC &#8220;atlas&#8221; that is expected to treat malignant tumors with high unmet medical needs and achieve higher and more durable responses.<\/p>\n<p>Based on the above technology platforms, Multitude Therapeutics currently has several ADCs in development, including three potential first-in-class target ADCs. Moreover, several ADCs, including all-new target ADCs, have entered the clinical stage, where they have demonstrated promising safety and efficacy and provided preliminary validation of the company&#8217;s platform technology. For further information, please visit <a href=\"http:\/\/www.multitudetherapeutics.info\/\" target=\"_blank\" rel=\"nofollow noopener\">www.multitudetherapeutics.info<\/a><\/p>\n<\/p><\/div>\n<p>Source: Multitude Therapeutics, Inc.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>AMT-116 is a potential first-in-class CD44v9-directed Topoisomerase I inhibitor-based ADC AMT-116 demonstrated a favorable safety profile, with manageable hematologic and Gastrointestinal toxicities Promising efficacies were observed in patients with heavily pretreated EGFR Wild-type NSCLC and other advanced solid tumors without CD44v9 pre-selection SHANGHAI, Oct. 17, 2025 \/PRNewswire\/ &#8212; Multitude Therapeutics, Inc., a clinical-stage company focused [&hellip;]<\/p>\n","protected":false},"author":8,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[20],"tags":[],"class_list":["post-40835","post","type-post","status-publish","format-standard","hentry","category-business-news"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.9 - 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