Eclutatug

This first-in-human study evaluates the safety, tolerability and efficacy of ALE.C04 as a monotherapy and in combination BASEL, Switzerland--(BUSINESS WIRE)-- 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. This press release features multimedia. View the full release here: 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. About 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

Fast Track designation accelerates the path to US submission for the investigational monoclonal antibody in patients with recurrent or metastatic CLDN1-positive HNSCC BASEL, Switzerland--(BUSINESS WIRE)-- Alentis Therapeutics (“Alentis”), a clinical-stage biotechnology company developing treatments for Claudin-1 positive (CLDN1+) tumors and organ fibrosis, announced today that the US Food and Drug Administration (FDA) has granted Fast Track development program for ALE.C04 for the treatment of patients with recurrent or metastatic, CLDN1-positive HNSCC. Fast Track designation aims to facilitate the development and expedite the review of new medicines that intend to treat serious or life-threatening conditions with unmet medical needs. “The FDA’s decision to grant Fast Track designation underscores ALE.C04’s potential to address a serious unmet medical need in cancer, specifically HNSCC,” said Dr. Roberto Iacone, Chief Executive Officer of Alentis. “We continue to advance our pipeline of antibodies against Claudin-1, an extraordinary target with therapeutic potential across indications in oncology and organ fibrosis.” Dr. Luigi Manenti, Chief Medical Officer of Alentis added, “We are excited with this opportunity to expedite the development of ALE.C04 in patients with recurrent or metastatic, CLDN1-positive HNSCC. The ongoing Phase 1/2 clinical trial in HNSCC will give us important information on ALE.C04’s safety and pharmacodynamic pro well as its anti-tumor efficacy as monotherapy and in combination with pembrolizumab.” 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. 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 leading 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 .