CSL and Alentis announce global partnership to develop and commercialise lixudebart for rare kidney and liver diseases

CSL and Alentis announce global partnership to develop and commercialise lixudebart for rare kidney and liver diseases

Alentis to receive US$355 million initial payment and up to US$1.2 billion in commercial milestones, with global profits shared

MELBOURNE, Australia and BASEL, Switzerland, Oct. 5, 2026 /PRNewswire/ -- CSL and Alentis Therapeutics today announced they have entered into an exclusive global collaboration agreement to co-develop and co-promote lixudebart, which has the potential to become a first-in-class therapy targeting claudin-1 across a range of kidney, liver and other diseases.

Lixudebart is currently being evaluated in the ongoing Phase 2 RENAL trial in patients with ANCA (antineutrophil cytoplasmic antibodies)-associated vasculitis with rapidly progressive glomerulonephritis (AAV-RPGN), a rare and potentially life-threatening autoimmune disease that can cause irreversible kidney damage and end-stage renal disease.

With a novel mechanism of action, lixudebart exerts potent anti-inflammatory and anti-fibrotic effects to potentially prevent and reverse organ damage in ANCA-associated vasculitis (AAV) and numerous other kidney, liver and lung diseases. The ongoing phase 2 trial is designed to translate these mechanistic effects into meaningful clinical impact.  

The collaboration brings together Alentis' scientific expertise as the leading clinical-stage biopharmaceutical company targeting claudin-1 and CSL's global development and commercialisation capabilities in nephrology, with a shared goal of bringing innovative and highly impactful treatment options to patients with rare kidney and liver diseases. In addition to AAV-RPGN, the two companies will advance lixudebart as a novel treatment for focal segmental glomerulosclerosis (FSGS), a rare progressive kidney disease, and for primary sclerosing cholangitis (PSC), an autoimmune chronic liver disease.

"This partnership enables us to dramatically accelerate the development of lixudebart in several indications in parallel," said Dr Mark Pruzanski, Chief Executive Officer of Alentis Therapeutics. "We are convinced CSL's demonstrated clinical development and commercialisation capabilities in AAV and kidney diseases makes them the right partner to bring lixudebart to patients. More broadly, this furthers the validation of claudin-1 as a novel therapeutic target and we are excited about the potential to accelerate the advancement of our other clinical stage assets and preclinical pipeline."

"Patients diagnosed with ANCA-associated vasculitis with rapidly progressive glomerulonephritis face rapid kidney function decline, leaving them at risk of irreversible damage even with currently available treatments," said Dr Bill Mezzanotte, EVP, Head of R&D, CSL. "We believe lixudebart has the potential to become an important new therapeutic option to help improve kidney function and prevent progression to end-stage kidney disease, first in AAV-RPGN and hopefully also in focal segmental glomerulosclerosis, while potentially showing similar benefit on liver function in primary sclerosing cholangitis. Our partnership with Alentis reflects CSL's commitment to building a leading global nephrology franchise, and our strategic intent to create high-value external partnerships."

Under the agreement, CSL and Alentis will jointly develop and co-promote lixudebart. CSL will make an initial payment to Alentis of US$355 million, with Alentis eligible to receive up to an additional US$1.2 billion in commercial milestone payments. In addition to these payments, CSL will fully fund the completion of the ongoing Phase 2 RENAL trial and planned Phase 3 trial in AAV-RPGN, the Phase 2 trials in FSGS and PSC and other supporting development activities. Once commercialised, global profits will be shared 55 per cent to CSL and 45 per cent to Alentis.

About AAV-RPGN
ANCA (antineutrophil cytoplasmic antibodies)-associated vasculitis with rapidly progressive glomerulonephritis (AAV-RPGN) is a rare, severe and potentially fatal autoimmune disease in which the body's immune system attacks small blood vessels in the kidney. RPGN is characterized by rapid loss of kidney function over a very short period (days to weeks). Despite potent immunosuppressive treatment, most patients develop significant or total loss of kidney function.

About Lixudebart
Lixudebart (formerly known as ALE.F02) is an investigational monoclonal antibody that selectively targets exposed claudin-1, a key driver of inflammatory and fibrotic signalling pathways in numerous fibrotic diseases of the kidney, liver, lung, intestine and other solid organs. In an interim analysis of 26 patients with AAV-RPGN in the ongoing Phase 2 RENAL trial, lixudebart showed promising improvement in kidney function as assessed by eGFR and proteinuria at 24 weeks. In the Phase 1b FEGATO trial in 41 patients with advanced F3/F4 liver fibrosis, lixudebart demonstrated improved liver function at 6 weeks. In both studies lixudebart showed dose-dependent claudin-1 target engagement, along with a favourable safety and tolerability profile. Lixudebart has been granted Orphan Drug designation by the FDA for the treatment of Idiopathic Pulmonary Fibrosis (IPF).

About CSL
CSL (ASX:CSL; USOTC:CSLLY) is a leading global biopharma company with a dynamic portfolio of lifesaving medicines, including those that treat haemophilia and immune deficiencies, vaccines to prevent influenza, and therapies in iron deficiency, dialysis and nephrology. Since our start in 1916, we have been driven by our promise to save lives using the latest technologies. Today, CSL - including our three businesses, CSL Behring, CSL Seqirus and CSL Vifor - provides lifesaving products to patients in more than 100 countries and employs almost 29,000 people. Our unique combination of commercial strength, R&D focus and operational excellence enables us to identify, develop and deliver innovations so our patients can live life to the fullest. For inspiring stories about the promise of biotechnology, visit CSL.com/Vita. For more information about CSL, visit CSL.com.

About Alentis
Alentis is a clinical-stage, privately held biotechnology company pioneering first-in-class antibodies and antibody-drug conjugates (ADCs) targeting claudin-1 for fibrosis and oncology indications. Beyond the company's lead antibody for fibrosis, lixudebart, Alentis is developing oncology candidates ALE.P02 and ALE.P03. These are claudin-1 targeted ADCs with a tubulin inhibitor payload and topoisomerase‑I inhibitor payload, respectively. ALE.P02 was granted Fast Track designation by FDA for the treatment of advanced or metastatic claudin-1 expressing squamous cancers, irrespective of the organ of origin. Both ADCs are currently in Phase 1/2 studies enrolling patients with a variety of solid tumor types.

Alentis was founded on the groundbreaking research in the laboratory of Prof. Thomas Baumert, MD, at the University of Strasbourg and the French National Institute of Health and Medical Research (Inserm). The company is headquartered in Basel, Switzerland. Visit www.alentis.ch

SOURCE CSL