FDA Clears Alentis Therapeutics' IND for Squamous Cancer Drug ALE.P02

Alentis Therapeutics, a biotech firm advancing clinical-stage treatments for Claudin-1 positive (CLDN1+) tumors and organ fibrosis, announced that the U.S. Food & Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for ALE.P02. ALE.P02 is an antibody-drug conjugate (ADC) targeting CLDN1 with a tubulin inhibitor payload. The company is set to begin a Phase 1/2 clinical trial for patients with CLDN1+ squamous tumors in the first quarter of 2025.

ADCs have been recognized for their potential in oncology, according to Luigi Manenti, Chief Medical Officer of Alentis. Squamous cancers, particularly those originating in the head and neck, cervix, esophagus, and lung, often exhibit high CLDN1 expression. ALE.P02 offers a novel therapeutic option for patients requiring new treatments after first-line therapies have failed.

Tony Mok, Professor of Clinical Oncology at the Chinese University of Hong Kong, emphasized the excitement surrounding anti-CLDN1 ADCs. He noted that ALE.P02 shows particular promise for squamous cancers like head and neck squamous cell carcinoma (HNSCC) and non-small cell lung cancer (NSCLC), where CLDN1 is frequently overexpressed. The need for new treatment options in these cancer types is substantial, and the results of the upcoming Phase 1/2 study are highly anticipated.

Roberto Iacone, Chief Executive Officer of Alentis, highlighted the significance of ALE.P02 entering clinical trials as a major advancement in the company’s oncology pipeline. He mentioned that insights gained from human clinical trials of lixudebart (ALE.F02), the backbone antibody for Alentis' ADCs, will be leveraged to maximize the development of ALE.P02. Additionally, Alentis plans to initiate a first-in-human clinical trial for its second ADC program, ALE.P03, which employs a topoisomerase I inhibitor payload, in 2025.

ALE.P02 represents a first-in-class ADC. It combines a potent tubulin inhibitor with an antibody that specifically targets a unique CLDN1 epitope exposed on cancer cells. This targeted approach has the potential to be a powerful new tool against squamous cancers that overexpress CLDN1, offering the possibility of reduced toxicity compared to traditional cancer treatments.

Alentis Therapeutics focuses on developing treatments for CLDN1+ tumors and organ fibrosis. The company is pioneering the development of anti-CLDN1 antibodies and ADCs that aim to modify and potentially reverse the progression of these diseases. CLDN1 is a critical, yet previously unexploited, target in cancer and fibrotic disease pathology.

Founded on pioneering research by Prof. Thomas Baumert at the University of Strasbourg and Inserm, Alentis is headquartered in the pharmaceutical and biotech hub of Basel, Switzerland. The company also has an R&D subsidiary in Strasbourg, France, and conducts clinical operations in the United States.