Avenzo Therapeutics announces FDA clearance of Investigational New Drug application for AVZO-1418, a potential best-in-class, novel EGFR/HER3 bispecific antibody-drug conjugate

CAR-T Digest - August 2020

Weekly Digest - May 2025

22 May 2025: Avenzo Therapeutics announces FDA clearance of Investigational New Drug application for AVZO-1418, a potential best-in-class, novel EGFR/HER3 bispecific antibody-drug conjugate

Avenzo Therapeutics received FDA clearance for its investigational new drug (IND) application for AVZO-1418, an EGFR/HER3 bispecific antibody-drug conjugate (ADC)
The company plans to start a Phase 1/2 open-label clinical trial later this year to evaluate safety, tolerability, and preliminary efficacy of AVZO-1418 in patients with advanced solid tumors
This IND clearance marks Avenzo second IND cleared in three weeks and their first ADC program to enter clinical testing
Preclinical studies presented at AACR 2025 demonstrated AVZO-1418 innovative design, high binding affinity for tumors co-expressing EGFR and HER3, and efficacy in various tumor models, including EGFR TKI-resistant non-small cell lung cancer
Avenzo is advancing the development of AVZO-1418 in collaboration with their partner, Duality Biotherapeutics