Anti-Claudin-1 antibodies as a promising
approach in oncology and fibrosis

Novel therapies for cancer and fibrosis

We develop first-in-class anti-Claudin-1 antibodies and antibody-drug conjugates (ADCs) for the treatment of Claudin-1 positive (CLDN1+) tumors and organ fibrosis. We are rapidly advancing our two lead monoclonal antibodies (mAbs) through clinical development.

Our preclinical programs are next-generation anti-CLDN1 therapies, including ADCs, bispecific antibodies, and T-cell engagers.

Research and development pipeline

Claudin-1 – a promising therapeutic target

Claudin-1 is a member of the tight junction protein family; its essential role is binding epithelial cells together. In fibrosis and many cancers, Claudin-1 is overexpressed and exposed outside of tight junctions. Here it drives the remodeling of the extracellular matrix, forming a physical barrier that protects tumors from the immune system and causes organ failure in fibrosis. Our founder, Prof. Thomas Baumert discovered an antibody that only binds exposed Claudin-1, unlocking a new promising approach to modify the course of disease.

Roehlen et al, Sci Transl med. 2022

ALE.C04 – oncology

ALE.C04 is a first-in-class monoclonal antibody developed for CLDN1+ cancer indications. It is designed to selectively kill CLDN1+ tumor cells and open the collagen barrier to enable immunotherapies and the immune system to attack the tumor.

ALE.P02 & ALE.P03 – ADCs for oncology

ALE.P02 and ALE.P03 are first-in-class antibody-drug conjugates (ADCs) in preclinical development for CLDN1+ cancer indications.

  • ALE.P02 is undergoing GLP toxicology studies, with a first-in-human clinical trial planned in patients with CLDN1+ tumors.
  • For ALE.P03, GLP toxicology studies are being planned.

Lixudebart – fibrosis

Lixudebart (formerly ALE.F02) is a first-in-class antibody developed for liver, kidney and lung fibrosis, in particular for ANCA-associated vasculitis and idiopathic pulmonary fibrosis (IPF). It is designed to reverse fibrosis by blocking fibrotic signaling and opening the collagen barrier to preserve or restore organ function.

  • Phase 1 trial in healthy volunteers (SAD and MAD results) – Completed
  • Phase 1/2 trial in ANCA-associated vasculitis with renal involvement (NCT06047171) – Recruiting
  • Phase 1b trial in advanced liver fibrosis (NCT05939947) – Recruiting
  • Phase 2 trial in idiopathic pulmonary fibrosis – Planned