Alentis Therapeutics Receives FDA Fast Track Designation for ALE.C04 for the Treatment of Claudin-1 Positive HNSCC

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 – 24 August 2023,  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 profile as 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

For more information please contact:

Alentis Therapeutics
Sariette Witte
+41 78 245 7310

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O’Patrick Wilson
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