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ALE.P02

Generic Name
ALE.P02
Clinical Trials
Related News

Lixudebart Shows Promise in Reversing Organ Fibrosis in Phase 2 Trials

• Alentis Therapeutics' lixudebart (ALE.F02) demonstrated dose-dependent target engagement in Phase 1b and Phase 2 trials. • Early data suggests lixudebart improves organ function, with eGFR and proteinuria improvements in ANCA-RPGN patients. • The monoclonal antibody exhibited a favorable safety profile, both as a monotherapy and combined with standard care. • Lixudebart targets Claudin-1, a key protein in organ fibrosis, and has received FDA Orphan Drug designation for IPF.

FDA Grants Fast Track Designation to Alentis Therapeutics' ALE.P02 for CLDN1-Positive Solid Tumors

• The FDA has granted Fast Track designation to ALE.P02, an anti-Claudin-1 (CLDN1) antibody-drug conjugate (ADC), for CLDN1-positive squamous solid tumors. • ALE.P02, a first-in-class ADC, targets the CLDN1 epitope on cancer cells and has shown promise in preclinical studies, demonstrating complete tumor regression in xenograft models. • A first-in-human phase 1/2 trial is set to begin in Q1 2025, evaluating ALE.P02 in patients with CLDN1-positive squamous solid tumors, following the FDA's IND clearance in October 2024.

Alentis' CLDN1-Targeting ADC, ALE.P02, Receives FDA Fast Track for Advanced Squamous Cancers

• Alentis Therapeutics' ALE.P02, a first-in-class antibody-drug conjugate (ADC) targeting Claudin-1 (CLDN1), has been granted FDA Fast Track designation. • The designation aims to expedite the development of ALE.P02 for advanced or metastatic CLDN1+ squamous cancers, irrespective of the origin organ. • ALE.P02 links a tubulin inhibitor to an antibody, potentially offering a more targeted and less toxic approach for treating CLDN1-overexpressing squamous cancers. • A first-in-human clinical trial for ALE.P02 in advanced or metastatic CLDN1+ squamous solid tumors is planned to commence in Q1 2025.
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