Pharma Focus Europe

Alentis Therapeutics Granted FDA Clearance for ALE.C04 Development in Treating CLDN1+ Tumors

Thursday, June 15, 2023

Alentis Therapeutics, a biotechnology company focused on developing treatments for Claudin-1 positive (CLDN1+) tumors and organ fibrosis, has received FDA clearance for its IND (Investigational New Drug) application for ALE.C04. This clearance allows Alentis to conduct a clinical trial in patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC), using ALE.C04 as a monotherapy and in combination with pembrolizumab. The trial is scheduled to begin in the second half of 2023.

ALE.C04 is a monoclonal antibody designed to target CLDN1, which is exposed on cancer cells. It works by remodeling the extracellular matrix, improving the trafficking of T and NK cells, and directly killing CLDN1+ tumor cells. This unique mechanism of action gives ALE.C04 potential as both a monotherapy and in combination with checkpoint inhibitors.

Dr. Luigi Manenti, Medical Director of Alentis, explained the significance of targeting CLDN1 and remodeling the extracellular matrix in treating solid tumors and overcoming resistance to checkpoint inhibitors. He believes that HNSCC, with its significant unmet medical need, is an ideal indication to study the efficacy of ALE.C04.

Dr. Roberto Iacone, CEO of Alentis, expressed his excitement about the FDA clearance for ALE.C04, which marks the company's entry into the field of oncology. He emphasized that Alentis is the first company to target CLDN1 in both organ fibrosis and cancer.

Head and neck squamous cell carcinoma is a prevalent type of cancer, and its incidence is increasing. Current treatment options include surgery, chemotherapy, radiation therapy, and approved therapies such as cetuximab and pembrolizumab. While pembrolizumab has shown improved overall survival as a monotherapy, there is still a significant need for new therapeutic options in HNSCC. Alentis aims to address this need by evaluating the anti-tumor efficacy of ALE.C04 in the upcoming phase 1/2 clinical trial.

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