CSL Limited entered into an exclusive licensing agreement with Eli Lilly and Company which grants Lilly certain rights to develop and commercialize clazakizumab, an anti-interleukin-6 (IL-6) monoclonal antibody.

Clazakizumab was originally developed by Vitaeris Inc. and joined CSL’s pipeline after the company acquired Vitaeris back in 2020.²

The monoclonal antibody targets IL-6, a cytokine involved in immune regulation, hematopoiesis and vascular inflammation.¹ Elevated IL-6 levels have been linked to chronic inflammation and a range of immuno-inflammatory and cardiovascular diseases and by inhibiting IL-6 from binding to its receptor, clazakizumab is designed to reduce inflammatory signaling associated with disease progression.¹

“Clazakizumab has been a promising monoclonal antibody in the Transplant therapeutic area since we started working with Vitaeris several years ago,” said Bill Mezzanotte, M.D., executive vice president and head of R&D at CSL Behring.“Acquiring Vitaeris and their associate expertise helps us to continue to grow our strategic scientific platform of recombinant proteins and antibodies. We look forward to continuing to advance this treatment candidate as a potential option for people experiencing rejection, an area where current treatment options for transplant recipients are limited, at best.”

What are the details of the licensing agreement?

Under terms of the agreement, CSL is expected to retain exclusive rights to develop and commercialize clazakizumab for the prevention of cardiovascular events in patients with end-stage kidney disease (ESKD).¹

The company is currently advancing the Phase III POSIBIL6ESKD trial (NCT05485961), evaluating the safety and efficacy of the therapy in dialysis patients at risk of major cardiovascular events.

Supporting the Phase III program, earlier mid-stage data demonstrated significant anti-inflammatory effects in dialysis patients at elevated cardiovascular risk. In a Phase 2b dose-finding study, adults with cardiovascular disease and/or diabetes receiving maintenance dialysis and elevated high-sensitivity C-reactive protein were randomized to receive clazakizumab at doses of 2.5 mg, 5 mg, or 10 mg every four weeks, or placebo.³

The primary endpoint was change in hs-CRP at 12 weeks.

Clazakizumab reduced hs-CRP levels by 86%, 90%, and 92% in the 2.5 mg, 5 mg and 10 mg groups, respectively, compared with placebo, meeting the primary endpoint.³

Between 79% and 82% of treated patients achieved hs-CRP levels below 2 mg/L, versus none in the placebo arm.³ The therapy also reduced additional inflammatory and cardiovascular biomarkers, including fibrinogen, serum amyloid A, secretory phospholipase A2 and lipoprotein(a), while increasing serum albumin levels at 12 weeks.

“This agreement marks a significant step forward in our mission to bring innovative therapies to patients worldwide. Clazakizumab is a promising therapeutic candidate with the potential to significantly impact the treatment landscape for various immuno-inflammatory and cardiovascular conditions. Lilly is another patient-focused organization, and we look forward to working with them to maximize the potential of this important medicine,” said Mezzanotte.

What are the financial details of the licensing agreement?

Per the terms of the agreement, Lilly will explore development, global regulatory approval and commercialization of clazakizumab in additional indications beyond ESKD-related cardiovascular risk.¹ CSL is expected to receive an upfront payment of $100 million and will be eligible for additional clinical, regulatory and commercial milestone payments, as well as royalties on global net sales.

The transaction remains subject to customary closing conditions, including required regulatory clearances.

Sources

1. CSL and Lilly enter Licensing Agreement for clazakizumab CSL Limited February 18, 2026 CSLandLillyenterLicensingAgreementforclazakizumab.pdf
2. CSL Behring to Acquire Biotech Company Vitaeris CSL Limited June 8, 2020 https://www.cslbehring.nl/-/media/cslb-netherlands/documents/vitaeris-deal-news-release_final_060420.pdf
3. IL-6 inhibition with clazakizumab in patients receiving maintenance dialysis: a randomized phase 2b trial National Library of Medicine May 25, 2024 https://pubmed.ncbi.nlm.nih.gov/38796655/