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

Novel therapies for cancer and fibrosis

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

Our preclinical programs are next-generation anti-CLDN1 modalities.

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.P02 & ALE.P03 – ADCs for oncology​

ALE.P02 and ALE.P03 are first-in-class antibody-drug conjugates (ADCs) in development for CLDN1+ cancer indications. Our ADCs are designed to deliver potent cancer drugs selectively and directly into the CLDN1+ tumor tissue, while sparing healthy tissue.

ALE.P02 received FDA Fast Track designation.

  • ALE.P02 Phase 1/2 in CLDN1+ squamous solid tumors (NCT06747585) – Recruiting
  • ALE.P03 first-in-human clinical trial in CLDN1+ solid tumors – Planned
Learn more

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, advanced liver fibrosis 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 1b trial in advanced liver fibrosis (topline results) – Completed
  • Phase 1/2 trial in ANCA-associated vasculitis with renal involvement (NCT06047171, interim results) – Ongoing
  • Phase 2 trial in idiopathic pulmonary fibrosis – Planned
Learn more