ALX Oncology Receives IND Clearance from U.S. FDA for ALX2004, a Novel EGFR-targeted Antibody-drug Conjugate

Core Viewpoint - ALX Oncology has received FDA clearance for its Investigational New Drug (IND) application for ALX2004, a potential first-in-class antibody-drug conjugate (ADC) targeting EGFR-expressing solid tumors, with plans to initiate a Phase 1 clinical trial in mid-2025 [1][7]. Group 1: Product Development - ALX2004 is designed to optimize the delivery of a chemotherapy payload to tumor cells while minimizing systemic toxicity, demonstrating potent anti-tumor activity in preclinical models [2][3]. - The ADC was developed using the company's proprietary linker-payload platform, which includes a topoisomerase I inhibitor payload that enhances anti-tumor activity [3][7]. - Initial safety data from the Phase 1 clinical trial of ALX2004 is expected to be available in the first half of 2026 [7]. Group 2: Market Context - EGFR is a clinically validated therapeutic target, with overexpression found in various tumor types such as breast cancer and non-small cell lung cancer; however, there are currently no approved EGFR-targeted ADCs [2][3]. - Previous attempts to develop EGFR-targeted ADCs faced challenges due to drug design and toxicity issues, which ALX2004 aims to overcome [2][3]. Group 3: Company Overview - ALX Oncology is a clinical-stage biotechnology company focused on advancing therapies that enhance the immune system to treat cancer [5]. - The company's lead therapeutic candidate, evorpacept, is being evaluated in multiple ongoing clinical trials across various cancer indications [5].