Anti-Claudin-1 antibodies and ADCs as a promising
approach for oncology and fibrosis
Novel therapies for fibrosis and cancer
We develop first-in-class anti-Claudin-1 antibodies and antibody-drug conjugates (ADCs) for the treatment of organ fibrosis and Claudin-1 positive (CLDN1+) tumors. 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.
Lixudebart – fibrosis
Lixudebart (formerly ALE.F02) is a first-in-class therapy targeting claudin-1. With a novel mechanism of action, lixudebart exerts potent anti-inflammatory and anti-fibrotic effects to potentially prevent and reverse organ damage.
CSL Partnership
Alentis and CSL have a global partnership to co-develop and co-commercialize lixudebart in rare kidney and liver diseases, including ANCA-associated vasculitis (AAV), focal segmental glomerulosclerosis (FSGS), and primary sclerosing cholangitis (PSC). The collaboration brings together Alentis’ scientific expertise as the leading clinical-stage biopharmaceutical company targeting claudin-1 and CSL’s global development and commercialization capabilities in nephrology.
- Phase 1 trial in healthy volunteers (SAD and MAD results) – Completed
- Phase 1b trial in advanced liver fibrosis (topline results) – Completed
- Phase 2 trial in ANCA-associated vasculitis with renal involvement (NCT06047171, interim results) – Ongoing
- Phase 2 trial in focal segmental glomerulosclerosis – Planned
- Phase 2 trial in primary sclerosing cholangitis – Planned
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) – Ongoing
- ALE.P03 first-in-human clinical trial in CLDN1+ solid tumors (NCT07169734) – Ongoing