NEW YORK – Alentis Therapeutics on Wednesday said it will begin studying the Claudin-1-targeting monoclonal antibody ALE.C04 in patients with CLDN1-positive tumors and organ fibrosis, initially focusing on those with advanced head and neck squamous cell carcinoma.
The US Food and Drug Administration has cleared the Basel, Switzerland-based firm's investigational new drug application, allowing it to begin a Phase I/II trial of ALE.C04 as a monotherapy and combined with Merck's Keytruda (pembrolizumab). Alentis expects to begin the trial during the second half of 2023.
"With ALE.C04, we aim to treat solid tumors in a unique way," Alentis Chief Medical Officer Luigi Manenti said in a statement. "By targeting exposed CLDN1 on cancer cells, our antibody remodels the extracellular matrix favoring T- and NK-cell trafficking, which in turn directly kills CLDN1-positive tumor cells and breaks the checkpoint inhibitor resistance in immune-excluded tumors."
According to Manenti, the firm has preclinical and translational data suggesting efficacy in head and neck squamous cell carcinoma, an area of high unmet need, leading Alentis to begin clinically evaluating ALE.C04 in this setting.