ALE.P02

ALE.P02 is a first-in-class antibody-drug conjugate (ADC) developed by Alentis Therapeutics for the treatment of advanced or metastatic Claudin-1 positive (CLDN1+) squamous solid tumors. The drug consists of an anti-CLDN1 monoclonal antibody linked to a potent tubulin inhibitor payload. CLDN1 is typically hidden within tight junctions in healthy cells but becomes overexpressed and exposed on the surface of many squamous tumor cells, making it an attractive and selective target for cancer therapy. By binding to this unique epitope on CLDN1+ tumor cells, ALE.P02 delivers its cytotoxic payload directly into cancer cells while sparing normal tissues, potentially offering a less toxic alternative to traditional chemotherapies. Preclinical studies have shown strong tumor growth inhibition and complete regression in animal models. The FDA has granted Fast Track designation to ALE.P02 for advanced or metastatic CLDN1+ squamous cancers irrespective of organ origin. A Phase 1/2 clinical trial is ongoing in patients with various CLDN1+ squamous solid tumors including lung, head and neck, cervical, and esophageal cancers[1][3][4][5][6][7][8][9].

Other names

Claudin-1 ADCClaudin1 ADCClaudin 1 ADCCLDN1 ADCCLDN-1 ADCCLDN 1 ADC