Ph1/2 Clinical Trial in Head and Neck Squamous Cell Carcinoma Expected to Start H2 2023

BASEL, Switzerland I June 14, 2023 I Alentis Therapeutics (“Alentis”), the clinical-stage biotechnology company developing treatments for Claudin-1 positive (CLDN1+) tumors and organ fibrosis, announced today the FDA cleared an IND application for ALE.C04 as a monotherapy and in combination with pembrolizumab, in a first-in-human clinical trial in recurrent or metastatic Head and Neck Squamous Cell Carcinoma (HNSCC) that is expected to start during the second half of 2023.

“With ALE.C04 we aim to treat solid tumors in a unique way. 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+ tumor cells and breaks the check-point inhibitor resistance in immune-excluded tumors,” said Dr. Luigi Manenti, Chief Medical Officer of Alentis. “The high unmet medical need, strong scientific rationale and our compelling preclinical and translational data makes HNSCC an ideal first indication for ALE.C04 as a monotherapy and in combination with anti-PD-1 treatment.”

Dr. Roberto Iacone, Chief Executive Officer of Alentis added, “The IND clearance for ALE.C04 is an important step for Alentis as it marks our entry into the oncology space. The planned Phase 1/2 study will tell us a lot about the anti-tumor efficacy of our antibody to treat CLDN1+ tumors. We are the leading company targeting CLDN1 across organ fibrosis and cancer.”

About ALE.C04
ALE.C04 is a first-in-class monoclonal antibody developed to specifically target exposed CLDN1 on cancer cells. This investigational antibody is designed to treat cancer in two ways: remodeling of the extracellular matrix, leading to improved NK and T-cell trafficking and direct tumor cell killing through the effector function. This unique mechanism of action provides ALE.C04 with therapeutic potential as a monotherapy and, in combination with check-point inhibitors.

About Head and Neck Squamous Cell Carcinoma
HNSCC is the sixth most common type of cancer worldwide and its incidence continues to rise. Besides surgery, chemotherapy and/or radiation therapy additional approved therapies include cetuximab, and pembrolizumab. Pembrolizumab monotherapy has shown an overall survival improvement in first line setting. However, the need for new treatment options remains high.

About Alentis Therapeutics
Alentis Therapeutics, the CLDN1 company, is a clinical-stage biotech developing breakthrough treatments for CLDN1+ tumors and organ fibrosis. Alentis is the only company pioneering a novel approach to modify and reverse the course of disease by targeting CLDN1, a previously unexploited target that plays a key role in the pathology of cancer and fibrotic disease.

Alentis was founded in 2019 based on ground-breaking research in the laboratory of Prof. Thomas Baumert, MD at the University of Strasbourg and the French National Institute of Health (Inserm). Alentis is headquartered in pharma-biotech hub Basel, Switzerland with an R&D subsidiary in Strasbourg, France and clinical operations in the US. Visit

SOURCE: Alentis Therapeutics