CSL (ASX: CSL) and Basel, Switzerland-based Alentis Therapeutics have entered into an exclusive global collaboration to co-develop and co-promote lixudebart (formerly ALE.F02), an investigational monoclonal antibody targeting claudin-1 under development for rare kidney and liver diseases. Under the deal, CSL is making an initial payment of USD 355 million while Alentis will be eligible for up to USD 1.2 billion in commercial milestone payments.
Lixudebart selectively targets exposed CLDN1, described by the company as a key driver of inflammatory and fibrotic signalling in fibrotic diseases of the kidney, liver, lung and other organs. The antibody is in the Phase II RENAL trial in ANCA-associated vasculitis with rapidly progressive glomerulonephritis (AAV-RPGN); an interim analysis of 26 patients showed improved eGFR and proteinuria at 24 weeks, with dose-dependent target engagement and a favorable safety and tolerability profile, according to the company. In the Phase Ib FEGATO trial in 41 patients with advanced F3/F4 liver fibrosis, the companies said lixudebart improved liver function at six weeks. The FDA has granted lixudebart Orphan Drug designation for idiopathic pulmonary fibrosis.
Under the agreement, CSL will fully fund the ongoing Phase II RENAL trial, a planned Phase III in AAV-RPGN, and planned Phase II trials in focal segmental glomerulosclerosis (FSGS) and primary sclerosing cholangitis (PSC). Once commercialized, global profits will be shared 55% to CSL and 45% to Alentis.
The collaboration covers Alentis' fibrosis antibody program; ALE.P02, a CLDN1-directed antibody-drug conjugate (ADC) with a tubulin inhibitor payload that received FDA Fast Track designation in November 2024, and ALE.P03, a CLDN1-directed ADC with a topoisomerase-I inhibitor payload, are both in Phase I/II studies and remain outside the CSL deal.