Preclinically, AGX101 has demonstrated a wide therapeutic window – there are no adverse clinical signs in animals at efficacious diseases. Prior clinical studies with a TM4SF1-directed radioimmunoconjugate demonstrated clinically significant responses in 60% of patients in limited dosing with negligible vascular toxicity.
Due to TM4SF1’s widespread expression in tumor cells and tumor vasculature, AGX101 has potential to treat most solid cancers. In many cancers, high TM4SF1 expression is associated with early death, suggesting that killing of high-TM4SF1 cancer cells by AGX101 may convert cancers to a less malignant form.
TM4SF1 is highly expressed during embryonic development but has low expression in all normal tissues of adults, supporting the potential for AGX101 to have a wide therapeutic margin.
In Phase 1, AGX101 will treat patients with unresectable, locally advanced, or metastatic solid tumors.