Weekly Digest - November 2024
CAR-T Digest - August 2020
CAR-T Digest - August 2020
CAR-T Digest - August 2020
CAR-T Digest - August 2020
Weekly Digest - November 2024
20 Nov 2024: FDA Fast Tracks ALE.P02 for CLDN1-Poisitive Solid Cancers
- The FDA granted fast track designation to ALE.P02, an anti-Claudin-1 (CLDN1) ADC, for the treatment of CLDN1-positive squamous solid tumors
- P02 is a first-in-class ADC that targets the CLDN1 epitope, which is overexpressed in certain squamous solid tumors, offering a potentially less toxic treatment compared to traditional cancer therapies
- The FDA cleared the investigational new drug (IND) application for ALE.P02 in October 2024, allowing the initiation of a first-in-human phase 1/2 trial, expected to start in Q1 2025
- Alentis Therapeutics is also developing a second CLDN1-targeting ADC, ALE.P03, which uses a topoisomerase I inhibitor linked to the anti-CLDN1 antibody, with preclinical data showing promising results in inhibiting tumor growth
