#AstraZeneca #Switzerland #Zurich #AL Amyloidosis #Neurimmune

Neurimmune Strengthens Collaboration with AstraZeneca

In a significant move forward, Neurimmune announced on December 4, 2025, that it has broadened its partnership with AstraZeneca's Alexion division. The goal of this strengthened collaboration is to develop and commercialize NI009, an innovative preclinical human monoclonal antibody aimed at addressing AL amyloidosis, a rare disorder characterized by protein misfolding which leads to life-threatening organ damage.

Renowned for its pioneering work with antibody therapeutics, Neurimmune focuses on strategies that target and eliminate harmful protein aggregates. Under this new agreement, Alexion will obtain exclusive global rights to research, develop, manufacture, and market Neurimmune’s promising antibody targets against lambda light chain proteins implicated in AL amyloidosis.

Roger M. Nitsch, CEO of Neurimmune, expressed his enthusiasm, stating that this collaboration aims not just to improve existing treatments but to exploit the therapeutic potential of NI009 in effectively clearing amyloid light chain deposits. Leveraging expertise from previous collaborations, particularly the ongoing Phase III trial of cliramitug—a monoclonal antibody developed for ATTR cardiomyopathy—Neurimmune is poised for breakthroughs in this domain.

Furthermore, this initiative is bolstered by positive insights gathered from Alexion’s CARES Phase III clinical trial results. These results have positioned ANSELAMIMAB as a promising fibril depleter in treating advanced AL-kappa amyloidosis, highlighting the urgency and necessity of effective treatment modalities within this patient population.

Gianluca Pirozzi, Senior Vice President of Alexion, articulated the excitement around this expanded collaboration, indicating that the lessons learned from the CARES program will be instrumental in furthering the development of NI009. This platform, designed to tackle amyloidosis, is vital for addressing this complex and heterogenous condition that severely affects patient health.

Understanding AL amyloidosis is crucial for grasping the significance of the NI009 initiative. It is a systemic illness that arises due to dysfunctional plasma cells in the bone marrow, leading to the abnormal production of light chain proteins. These proteins misfold, aggregate, and ultimately form harmful amyloid fibrils that accumulate in vital organs like the heart and kidneys, causing irreversible damage and, without treatment, premature mortality.

Neurimmune’s comprehensive approach to amyloid depletion positions it as a leader within the biopharmaceutical landscape, focusing on next-generation antibody therapies that address protein aggregation diseases. Their portfolio not only includes NI009 but also notable antibodies like cliramitug for ATTR cardiomyopathy and AP-101 for ALS, indicating a robust commitment to combating challenging medical conditions.

Under the terms of the collaboration, Neurimmune is set to receive an undisclosed upfront payment along with potential milestone payments totaling up to $780 million contingent upon the successful achievement of key developmental, regulatory, and commercial benchmarks. Additionally, they will also benefit from tiered royalties from any resulting net sales of approved therapies that emerge from this partnership.

Neurimmune will continue overseeing the preclinical development process and initial manufacturing activities while also conducting the critical first-in-human clinical studies for NI009. Subsequently, Alexion will take charge of the advanced clinical development, further manufacturing, and eventual commercialization of the therapy.

This collaboration not only reflects shared ambitions between Neurimmune and AstraZeneca but also signals hope for individuals suffering from AL amyloidosis who urgently need innovative solutions for their rare disease.

Conclusion

As the collaboration unfolds, the healthcare community watches closely, anticipating that this partnership may usher in a new era of effective treatment options for a condition long deemed challenging to manage.