GlaxoSmithKline has announced a new $2.2bn deal with US biotech company Alector to co-develop monoclonal antibodies for a number of neurodegenerative diseases.
The focus of the deal is two clinical-stage monoclonal antibodies – AL001 and AL101 – that are designed to bolster progranulin (PGRN) levels.
PGRN regulates immune activity within the brain and has genetic links to multiple neurodegenerative disorders.
As part of the deal, GSK and Alector will develop AL001 and AL101 for a range of these disorders, including frontotemporal dementia, amyotrophic lateral sclerosis, Parkinson’s disease and Alzheimer’s disease.
Under the terms of the deal, GSK will pay Alector $700m upfront, with further clinical development, regulatory and commercial milestone payments totalling $1.5bn.
Currently, enrolment is ongoing for a phase 3 trial of AL001 in people at risk for or with frontotemporal dementia due to a progranulin gene mutation (FTD-GRN).
AL001 is also being studied in a phase 2 trial in symptomatic frontotemporal dementia with a mutation in the C9orf72 gene, and is also scheduled to enter phase 2 development for amyotrophic lateral sclerosis (ALS) in the second half of 2021.
Meanwhile, AL101 is currently in phase 1a clinical development for the treatment of patients living with common neurodegenerative diseases such as Parkinson’s disease and Alzheimer’s disease.
“Our focus on human genetics and the science of the immune system gives us unique insights into the potential of targets such as progranulin to help patients with a number of neurodegenerative diseases,” said Hal Barron (pictured right), chief scientific officer and president R&D, GSK.
“Working with Alector’s world-class scientists will allow us to investigate the potential of these immuno-neurology therapies to help patients with frontotemporal dementia, a devastating disease without any currently approved treatments, as well as explore the ability to help patients with other neurodegenerative diseases, such as ALS, Parkinson’s and Alzheimer’s,” he added.
Alector is set to lead the global clinical development of AL001 and AL101 through to phase 2 proof-of-concept, at which point GSK will share development responsibilities for all late-stage clinical studies of the two monoclonal antibodies. The two companies will also share all costs for the global development of the candidates.
While Alector will lead the commercialisation of AL001 in orphan indications, GSK will take responsibility for commercial efforts related to AL101 in Alzheimer’s disease and Parkinson’s disease.