ALX Oncology receives IND clearance from U.S. FDA for ALX2004, a novel EGFR-targeted antibody-drug conjugate

CAR-T Digest - August 2020

Weekly Digest - April 2025

07 Apr 2025: ALX Oncology received FDA clearance for its investigational new drug (IND) application for ALX2004, a novel antibody-drug conjugate (ADC) targeting EGFR-expressing solid tumor

ALX Oncology received FDA clearance for its investigational new drug (IND) application for ALX2004, a novel antibody-drug conjugate (ADC) targeting EGFR-expressing solid tumor
A Phase 1 clinical trial for ALX2004, including dose-escalation and expansion studies, is set to begin in mid-2025
ALX2004 is the first drug developed using ALX Oncology’s proprietary linker-payload platform and has shown potent anti-tumor activity in preclinical models
The molecule is designed to optimize chemotherapy delivery with reduced systemic toxicity, featuring a specialized antibody backbone, a stable linker, and a proprietary topoisomerase I inhibitor payload
EGFR is a validated cancer target found in several tumor types, but there are currently no approved EGFR-targeted ADCs due to past issues with toxicity and ineffective payloads
ALX Oncology will hold an R&D call in Q2 2025 to provide additional details on ALX2004 development