Duality Biotherapeutics Inc. Announces FDA Clearance for First-in-Human Clinical Study of Novel EGFR/HER3 Bispecific Antibody-Drug Conjugate

Reuters05-23

Duality Biotherapeutics Inc. Announces FDA Clearance for First-in-Human Clinical Study of Novel EGFR/HER3 Bispecific Antibody-Drug Conjugate

Duality Biotherapeutics Inc., in collaboration with its partner Avenzo Therapeutics, Inc., has announced the FDA clearance of its investigational new drug application for AVZO-1418/DB-1418, a novel EGFR/HER3 bispecific antibody-drug conjugate. The companies plan to initiate a Phase 1/2 first-in-human, open-label clinical study later this year. This study will evaluate 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. Preclinical data presented at the American Association for Cancer Research Annual Conference highlighted the drug's novel design and efficacy in various tumor models.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Duality Biotherapeutics Inc. published the original content used to generate this news brief via PR Newswire (Ref. ID: CN94998) on May 23, 2025, and is solely responsible for the information contained therein.

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Announces FDA Clearance for First-in-Human Clinical Study of Novel EGFR/HER3 Bispecific Antibody-Drug Conjugate\n    </title></head><body><div xmlns:xsd=\"http://www.w3.org/2001/XMLSchema\" xmlns:xsi=\"http://www.w3.org/2001/XMLSchema-instance\">\n<p>\n        Duality Biotherapeutics Inc., in collaboration with its partner Avenzo <a href=\"https://laohu8.com/S/LENZ\">Therapeutics</a>, Inc., has announced the FDA clearance of its investigational new drug application for AVZO-1418/DB-1418, a novel EGFR/HER3 bispecific antibody-drug conjugate. The companies plan to initiate a Phase 1/2 first-in-human, open-label clinical study later this year. This study will evaluate 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. 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