Duality Biotherapeutics ('DualityBio') (HKEX:09606) and its partner Avenzo Therapeutics Inc, a clinical-stage biotechnology company, announced on Thursday that the US Food and Drug Administration (FDA) has cleared the investigational new drug application (IND) for AVZO-1418/DB-1418, a potential best-in-class, novel EGFR/HER3 bispecific antibody-drug conjugate (ADC).

An exclusive licensing agreement was signed by DualityBio and Avenzo in January 2025, under which Avenzo will develop, manufacture and commercialise AVZO-1418/DB-1418 globally (excluding Greater China).

A Phase 1/2 first-in-human, open-label clinical study is planned for later this year. The Phase 1 part of the study 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 tumours.