Clazakizumab

CSL will continue to explore clazakizumab for preventing cardiovascular events in kidney disease patients, while Lilly can develop and the therapy in “additional indications.”\n Eli Lilly is paying $100 million upfront (PDF) for the right to develop CSL’s phase 3-stage IL-6 antibody that had previously been explored for organ transplant rejection.Australia-based CSL picked up the anti-interleukin-6 monoclonal antibody, called clazakizumab, as part of its acquisition of Vitaeris in 2020. Clazakizumab was designed to treat chronic antibody-mediated organ rejection (AMR), and CSL oversaw a phase 3 trial for the drug as a treatment for AMR in kidney transplant patients.But that trial was terminated early for futility during a planned interim analysis, CSL explained to Fierce.Despite the setback in AMR, the company has continued to assess clazakizumab in a phase 3 study for the prevention of cardiovascular events in patients on dialysis with end-stage kidney disease (ESKD). That trial kicked off in 2022 and is due to wrap up in 2029, according to the trial database. CSL will be hoping this study has better luck than the AMR trial, and the company highlighted to Fierce that “trials evaluating the role of IL-6 in cardiovascular risk are supported by genetic and pharmacological evidence.”“Cardiovascular outcome trials ... have a very distinct rationale from the Imagine study in chronic antibody-mediated rejection,” a spokesperson added.This morning’s deal allows CSL to continue to develop clazakizumab for the specific indication of prevention of cardiovascular events in ESKD patients. Meanwhile, Lilly will be able to develop and commercialize the therapy in “additional indications,” according to a Feb. 18 release.Beyond the $100 million upfront payment, CSL will be eligible for clinical, regulatory and commercial milestones as well as royalties on global net sales—although the companies didn’t offer a ballpark figure for these potential payouts. “This agreement marks a significant step forward in our mission to bring innovative therapies to patients worldwide,” CSL’s head of R&D Bill Mezzanotte said in the release.“Clazakizumab is a promising therapeutic candidate with the potential to significantly impact the treatment landscape for various immuno-inflammatory and cardiovascular conditions,” Mezzanotte added. “Lilly is another patient-focused organization, and we look forward to working with them to maximise the potential of this important medicine.”Buoyed with cash from its blockbuster diabetes and obesity franchise, Lilly has been on a dealmaking spree over recent months, including buying gene editing partner Verve Therapeutics for $1 billion, inflammation biotech Ventyx Biosciences for $1.2 billion and in vivo CAR-T player Orna Therapeutics for up to $2.4 billion.This story was amended Thursday Feb. 19, 2026 to include additional information provided by CSL