Angiex has dosed the first patient in the Phase I study of AGX101, a therapy aimed at treating solid cancers by targeting Transmembrane-4 L-six family member-1 (TM4SF1), a small membrane with tetraspanin topology.
The company’s lead product, AGX101, is the first nuclear-delivered antibody-drug conjugate (ND-ADC).
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The first-in-human Phase I study is an open-label trial focusing on dose-escalation and expansion to evaluate the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of AGX101.
It will explore doses up to 10mg/kg in patients with various solid tumours and determine the recommended dose for Phase II studies.
Angiex co-founder and CEO Paul Jaminet said: “TM4SF1 is an emerging cancer target with exciting features: expression in two compartments of the tumour, tumour cells and the tumour vasculature; broad expression in malignant cancers, but the limited expression in normal tissue; and a novel internalisation pathway enabling delivery of chemotherapeutic payloads directly to the nucleus of cells in the tumour environment.
“Preclinical studies have supported AGX101’s ability to attack cancers by multiple mechanisms of action and demonstrated a broad therapeutic margin in animals. We believe AGX101 has the potential to help clinical cancer patients, especially in indications with high unmet need.”
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By GlobalDataPreclinical results have shown positive results for AGX101, with a broad therapeutic window and no adverse signs at effective doses.
Previous clinical research on a TM4SF1-targeted radioimmunoconjugate yielded significant responses in 60% of patients with minimal vascular toxicity.
AGX101’s potential is underscored by the widespread expression of TM4SF1 in tumour cells and vasculature, suggesting its applicability across a range of solid cancers.
TM4SF1’s limited expression in adult normal tissues further supports the anticipated wide therapeutic margin of AGX101.
The company secured investigational new drug clearance from the US Food and Drug Administration for AGX101 in November 2023.
