ALX2004 has been designed using the company’s topoisomerase I inhibitor payload platform to enhance anti-tumour activity and improve patient outcomes in EGFR-expressing tumours.
The molecule, developed entirely within ALX Oncology’s laboratories, features an engineered antibody backbone to optimise anti-EGFR activity, a stable linker, and a topoisomerase I payload that is expected to produce an enhanced bystander effect.
Based on the FDA clearance, the company anticipates the commencement of Phase I clinical trials for ALX2004 in mid-2025.
Initial safety data from these trials are expected to be available in the first half of 2026.
ALX Oncology CEO Jason Lettmann said: “Clinical advancement of our first ADC and the first drug candidate developed on our proprietary linker-payload platform is an important milestone in our mission to deliver breakthrough therapies that will help transform the future of cancer treatment.
“We meticulously designed all aspects of ALX2004 – the antibody backbone, linker and payload – to optimise the targeted delivery of a powerful chemotherapy payload to tumour cells while minimising systemic toxicity.”
EGFR is a protein found on the surface of cells that plays a crucial role in regulating cell growth. Its overexpression is associated with multiple tumour types, including colorectal carcinoma, breast cancer, non-small cell lung cancer and head and neck squamous cell carcinoma.
It has been validated clinically as a therapeutic target, with several targeted antibodies and small molecules approved by the FDA.