Anselamimab

ZURICH, Dec. 4, 2025 /PRNewswire/ -- Neurimmune today announced that it has expanded on its transthyretin amyloid cardiomyopathy (ATTR-CM) collaboration with Alexion, AstraZeneca Rare Disease by entering into an exclusive global collaboration and license agreement to develop NI009, a preclinical human monoclonal antibody designed to target and deplete lambda light chain fibrils and deposits from affected tissues and organs in light chain (AL) amyloidosis. Neurimmune is a clinical stage biopharmaceutical company building next generation therapeutics to address protein aggregation diseases with extensive experience in amyloid depletion. The collaboration stands to leverage Alexion's expertise in AL amyloidosis and strengths in late-stage rare disease drug development and expands upon the two companies' existing Phase III development of cliramitug, an investigational human monoclonal antibody designed to deplete amyloid deposits in ATTR-CM. "We are very pleased to build upon our collaboration with Alexion by adding this targeted fibril depleter program in AL amyloidosis. By leveraging our expertise in designing therapeutics that trigger immune-mediated clearance of disease-causing protein aggregates, we have developed a novel antibody that can, potentially, efficiently deplete amyloid light chain deposits. NI009 exhibits broad activity against amyloids of diverse lambda light chain subtypes across patients despite the high clonal heterogeneity of the disease," said Roger M. Nitsch, President & CEO of Neurimmune. "This announcement follows the high-level results from Alexion's CARES Phase III clinical program which demonstrated anselamimab's potential as a first-in-class fibril depleter to improve survival and cardiac outcomes in patients living with advanced AL-kappa amyloidosis, a debilitating progressive rare disease. In expanding our collaboration with Neurimmune, we aim to apply key learnings from the CARES program to develop NI009 as a complementary fibril depleter to potentially benefit more patients living with AL amyloidosis," said Gianluca Pirozzi, SVP, Head of Development, Regulatory and Safety, Alexion. AL amyloidosis is a rare, systemic and progressive disorder caused by defective plasma cells in the bone marrow. In AL amyloidosis, abnormal kappa (κ) or lambda (λ) light chain proteins produced by these plasma cells misfold, aggregate and form amyloid fibrils that deposit in tissues and organs. Left untreated, the accumulation of these toxic amyloid deposits, particularly in the heart and kidneys, can cause progressive organ damage and dysfunction and may lead to premature death, most commonly due to cardiac failure. Under the agreement, Alexion will be granted an exclusive, worldwide license to research, develop, manufacture and commercialize Neurimmune's antibodies targeting amyloid light chains. The lead candidate NI009 is currently in advanced preclinical development. Neurimmune will receive an undisclosed upfront payment and potential additional contingent milestone payments of up to $780 million payable upon achievement of certain development, regulatory and commercial milestones, as well as tiered royalties on net sales of any approved medicine resulting from the collaboration. Neurimmune will continue to be responsible for preclinical development, initial manufacturing activities and conducting the first-in-human clinical study. Alexion will be responsible for further clinical development, manufacturing, and commercialization. About Neurimmune Neurimmune is a clinical-stage biopharmaceutical company building next generation antibody therapeutics. The company pioneers amyloid depletion as a novel therapeutic mechanism to treat CNS and related protein aggregation diseases including Alzheimer's disease, amyotrophic lateral sclerosis and ATTR cardiomyopathy. Neurimmune discovered the anti-ATTR antibody cliramitug (formerly NI006, ALXN2220, Phase 3) for ATTR cardiomyopathy, the anti-misfolded SOD1 antibody AP-101 (Phase 2) for ALS, the anti-NogoA antibody NG004 (Phase 1) for spinal cord injury and the anti-amyloid light chain antibody NI009 (preclinical) for AL amyloidosis. Contact for Media: John Capodanno (US) [email protected] Martin Meier-Pfister (Switzerland) [email protected] SOURCE Neurimmune 21% more press release views with Request a Demo

AstraZeneca is doubling down on amyloid-targeting therapies, signing a deal worth up to $780 million in milestones to develop Neurimmune's preclinical monoclonal antibody for light-chain (AL) amyloidosis. Thursday's agreement, which comes with an undisclosed upfront payment, gives AstraZeneca's Alexion rare-disease unit exclusive global rights to develop and commercialise antibodies that target amyloid light chains, led by NI009. The companies last teamed up in 2022 under a $760-million collaboration for cliramitug (NI006/ ALXN2220), which is in Phase III testing in the DepleTTR-CM study for transthyretin amyloid cardiomyopathy. The renewed partnership suggests AstraZeneca is still betting on fibril-depleting strategies even though it was hit with a setback over the summer when the Phase III CARES programme testing its anti-fibril antibody anselamimab in newly diagnosed AL amyloidosis patients failed to meet its primary endpoint across two trials, though results indicated that a subgroup of participants may be more responsive than others. "We aim to apply key learnings from the CARES programme to develop NI009 as a complementary fibril depleter to potentially benefit more patients living with AL amyloidosis," said Gianluca Pirozzi, head of development, regulatory and safety at Alexion. NI009 is designed to clear lambda fibrils from affected tissues, primarily the heart and kidneys, where they drive progressive organ dysfunction. Roger Nitsch, chief executive at Neurimmune, said the therapy "exhibits broad activity against amyloids of diverse lambda light chain subtypes across patients despite the high clonal heterogeneity of the disease." Neurimmune will handle early development and the first-in-human study for NI009, while Alexion will take on further clinical development, manufacturing and commercialisation. Neurimmune could also pocket tied royalties if the drug ever hits the market. The deal comes amid fresh interest in the AL amyloidosis space. Earlier this week, Protego Biopharma raised $130 million to advance PROT-001, an oral small-molecule stabiliser designed to prevent misfolding of immunoglobulin light chains. Protego says its programme aims to intervene earlier in the pathogenic cascade by preventing toxic aggregates from forming in the first place.