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FDA Clearance of Investigational New Drug Application Received for Novel EGFR/HER3 Bispecific Antibody-Drug Conjugate AVZO-1418/DB-1418
Duality Biotherapeutics ("DualityBio", HKEX:09606) partner Avenzo Therapeutics, Inc. ("Avenzo"), a clinical-stage biotechnology company developing next-generation oncology therapies, today announced clearance by the U.S. Food and Drug Administration (FDA) of its investigational new drug application (IND) for AVZO-1418/DB-1418, a potential best-in-class, novel EGFR/HER3 bispecific antibody-drug conjugate (ADC).
About this update from Duality Biotherapeutics, Inc.
[{"type":"text","content":"Phase 1/2 first-in-human clinical study planned this year","length":57,"tagName":"p","attribs":{}},{"type":"text","content":"SHANGHAI and SAN DIEGO, May 22, 2025 /PRNewswire/ -- Duality Biotherapeutics ("DualityBio", HKEX:09606) partner Avenzo Therapeutics, Inc. ("Avenzo"), a clinical-stage biotechnology company developing next-generation oncology therapies, today announced clearance by the U.S. Food and Drug Administration (FDA) of its investigational new drug application (IND) for AVZO-1418/DB-1418, a potential best-in-class, novel EGFR/HER3 bispecific antibody-drug conjugate (ADC).","length":486,"tagName":"p"},{"type":"image","alt":"(PRNewsfoto/Duality Biologics)","displaySize":"","headline":null,"caption":"(PRNewsfoto/Duality Biologics)","className":"","disableSlideshowImg":false,"size":{"original":{"width":400,"height":123,"url":"https://media.zenfs.com/en/prnewswire.com/8aab499770cc13543bfea972151c9da2"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/pmkaiGi44kW_ql_ytw5NNw--/YXBwaWQ9aGlnaGxhbmRlcjt3PTcwNTtoPTIxNztjZj13ZWJw/https://media.zenfs.com/en/prnewswire.com/8aab499770cc13543bfea972151c9da2","width":400,"height":123}},"href":"https://mma.prnewswire.com/media/2566332/Duality_Biologics_logo_Logo.html","hrefExternal":true,"rel":"nofollow"},{"type":"text","content":"On January 7th, 2025, DualityBio and Avenzo announced that they entered into an exclusive license agreement, pursuant to which Avenzo will develop, manufacture and commercialize AVZO-1418/DB-1418, a potential best-in-class EGFR/HER3 bispecific ADC, globally (excluding Greater China).","length":290,"tagName":"p"},{"type":"text","content":"Under the IND, a Phase 1/2 first-in-human, open-label clinical study is planned to initiate later this year. The Phase 1 portion will assess the safety, tolerability, and preliminary clinical activity of AVZO-1418/DB-1418 as a single agent and in combination therapy in patients with advanced solid tumors.","length":306,"tagName":"p"},{"type":"text","content":"Preclinical data for AVZO-1418/DB-1418 were presented for the first time at the American Association for Cancer Research (AACR) Annual Conference in April 2025 and highlighted AVZO-1418/DB-1418's novel design and additive binding affinity in EGFR and HER3 co-expressing tumor cells. In addition, AVZO-1418/DB-1418 demonstrated efficacy in...