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news.ALX Oncology has received investigational new drug (IND) application clearance from the US Food and Drug Administration (FDA) for ALX2004, a new antibody-drug conjugate (ADC) aimed at treating solid tumours that express the epidermal growth factor receptor (EGFR).
Initial safety data from the trials are expected in the first half of 2026. Credit: Julia Koblitz on Unsplash.
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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.
