Alentis Therapeutics secures FDA IND approval for ALE.P02, an innovative CLDN1-ADC targeting squamous cancers

CAR-T Digest - August 2020

2 Oct 2024: Alentis Therapeutics secures FDA IND approval for ALE.P02, an innovative CLDN1-ADC targeting squamous cancers

Alentis Therapeutics announced that the FDA has cleared the IND application for ALE.P02, an anti-CLDN1 antibody-drug conjugate (ADC) with a tubulin inhibitor payload
A Phase 1/2 clinical trial targeting patients with CLDN1+ squamous tumors is set to begin in Q1 2025
ALE.P02 offers a first-in-class opportunity for patients with squamous cancers, including those in the head and neck, cervix, esophagus, and lung, where CLDN1 is highly expressed
ALE.P02’s clinical entry is a major advancement in the oncology pipeline, with plans for a second ADC, ALE.P03, to enter clinical trials in 2025
The design of ALE.P02 links a potent tubulin inhibitor to an antibody targeting a specific CLDN1 epitope on cancer cells, aiming to reduce toxicity compared to traditional cancer therapies