Based in Basel, Alentis Therapeutics clinical-stage biotechnology company developing treatments for Claudin-1 positive (CLDN1+) tumours and organ fibrosis. Its second candidate, ALE.C04 has received the FDA clearance as a monotherapy, paving the way into oncology. The company will start the Phase 1/2 clinical trial in head and neck squamous cell carcinoma in H2 2023.
Alentis Therapeutics is developing a portfolio of first-in-class anti-CLDN1 monoclonal antibodies (mAbs) that bind to CLDN1 exposed outside of the tight junction to treat cancers and fibrotic diseases. Its second portfolio candidate, 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: remodelling 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.
The target cancer indication, 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 the first-line setting. However, the need for new treatment options remains high.
“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 favouring T- and NK-cell trafficking, which in turn directly kills CLDN1+ tumor cells and breaks the check-point inhibitor resistance in immune-excluded tumours,” 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.”
Following the FDA clearance for ALE.C04 as a monotherapy in combination with pembrolizumab, Alentis plans to start its first-in-human clinical trial in recurrent or metastatic HNSCC during the second half of 2023.
(Press release/RAN)
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