Alentis Therapeutics Doses First Patient in Phase 1/2 Clinical Trial of ALE.C04 in Head and Neck Squamous Cell Carcinoma (HNSCC)

This First-in-Human Study Evaluates the Safety, Tolerability and Efficacy of ALE.C04 as a Monotherapy and in Combination

Basel, Switzerland – Nov 16, 2023, Alentis Therapeutics (“Alentis”), a clinical-stage biotechnology company developing treatments for Claudin-1 positive (CLDN1+) tumors and organ fibrosis, announced today that the first patient has been dosed in a Phase 1/2 clinical trial of ALE.C04, a Claudin-1 (CLDN1) targeting investigational antibody for the treatment of CLDN1+ tumors. The patient is enrolled under the Phase I program, led by Anthony El-Khoueiry, MD, Associate Director of Clinical Research, at University of Southern California (USC) Norris Comprehensive Cancer Center, part of Keck Medicine of USC.

The open-label, multi-center, Phase 1/2 clinical trial (NCT06054477) will investigate ALE.C04 as a single agent and in combination with pembrolizumab (anti-PD-1 antibody) in 220 adults with recurrent or metastatic (R/M) head and neck squamous cell carcinoma. Endpoints include safety, tolerability, pharmacokinetics and anti-tumor efficacy.

ALE.C04 is a first-in-class antibody for treating cancer and has shown much potential in preclinical models,” said Luigi Manenti, MD, Chief Medical Officer of Alentis. “ALE.C04 is designed to kill CLDN1+ tumor cells directly and to break the check-point inhibitor treatment resistance by restoring immune cell trafficking.

Jacob Thomas, MD, principal investigator on the trial at USC Norris and Assistant Professor of Medicine at Keck School of Medicine of USC added, “Patients with R/M HNSCC have poor outcomes, and novel effective therapies are needed in this setting. The mechanism of action and preclinical data for ALE.C04 provide sound scientific rationale for its evaluation in HNSCC.

Prof. Josep Tabernero, Head of Medical Oncology at Vall d’Hebron University Hospital said, “This first-in-human trial will provide valuable information on ALE.C04 as a monotherapy and in combination with anti-PD-1 treatment. I am looking forward to the data and to developing ALE.C04 for other CLDN1+ tumors including colorectal 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. ALE.C04 received Fast Track designation from the Food and Drug Administration for the treatment of CLDN1+ HNSCC.

Head and neck squamous cell carcinoma, or HNSCC, is the 6th most common cancer worldwide and because the number of cases is quickly rising, safer and more effective treatments are urgently needed. Despite advances in treatment, the 5-year survival rate remains at about 57%.

About Alentis Therapeutics
Alentis Therapeutics, the CLDN1 company, is a clinical-stage biotech developing breakthrough treatments for CLDN1+ tumors and organ fibrosis. CLDN1 is a previously unexploited target that plays a key role in the pathology of cancer and fibrotic disease. Alentis is the leading company pioneering anti-CLDN1 antibodies to modify and reverse the course of 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 and Medical Research (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

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+41 78 245 7310

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