Acumen Pharmaceuticals signed a collaboration agreement with Lonza that covers the manufacture of sabirnetug (ACU193), an antibody targeting toxic soluble amyloid beta oligomers (AβOs) for the treatment of Alzheimer’s Disease (AD), for clinical development and commercialization, if approved.
Lonza will manufacture the sabirnetug drug substance at its next-generation, manufacturing facility in Portsmouth, NH, equipped with 2,000L single-use bioreactors. Acumen officials say they will leverage Lonza’s regulatory expertise, experience in antibody manufacturing, and global manufacturing network from 2,000L to 20,000L.
Early trigger and persistent driver of Alzheimer’s
Sabirnetug is the first humanized monoclonal antibody to demonstrate selective target engagement of AβOs in a Phase I first-in-human study, according to Acumen. As AβOs are an early trigger and persistent driver of Alzheimer’s-associated synaptic dysfunction and neurodegeneration, sabirnetug addresses an underlying cause of Alzheimer’s by preventing toxic AβOs from binding to dendritic spines and by preserving neuronal function, notes Stefan Egli, global head of mammalian biologics at Lonza.
“Our collaboration with Acumen showcases our flexibility in enabling innovative biotech companies to advance their innovative therapies on accelerated timelines,” he says. “We are excited that our new, next-generation single-use manufacturing facility in Portsmouth will be used to manufacture a cGMP drug substance that could bring new treatment options to patients suffering from Alzheimer’s disease.”
“As we progress into Phase II clinical development of sabirnetug as a potentially best-in-class treatment for early AD, we are acutely aware that patients and their families are in urgent need of safe, effective treatment options for this devastating disease,” adds James Doherty, president and chief development officer at Acumen.