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GSK and Alector announce global collaboration in immuno-neurology for two clinical stage first-in-class monoclonal antibodies for neurodegenerative diseases.

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Published:6th Jul 2021
GlaxoSmithKline plc and Alector announced a strategic global collaboration for the development and commercialisation of two clinical-stage, potential first-in-class monoclonal antibodies (AL 001 and AL 101) designed to elevate progranulin (PGRN) levels.

PGRN is a key regulator of immune activity in the brain with genetic links to multiple neurodegenerative disorders, making it one of the most attractive genetically validated targets for the development of new immuno-neurology treatments. The collaboration brings together Alector’s leading immuno-neurology expertise with GSK’s R&D focus on the science of the immune system and human genetics, proven late-stage drug development capabilities and global footprint.

As part of the recent Investor Update day on 23 June 2021, GSK committed to an R&D approach focused on maximising opportunities by leveraging an increased understanding of the science of the immune system and human genetics. The collaboration with Alector on AL 001 and AL 101, two antibodies designed to elevate PGRN levels and potentially slow the progression of FTD and other neurological disorders, provides GSK access to a promising clinical programme in immuno-neurology.

Enrolment is currently underway for a pivotal Phase III trial for AL 001 in people at risk for or with frontotemporal dementia due to a progranulin gene mutation (FTD-GRN). FTD-GRN is a rapidly progressing and severe form of dementia found most frequently in people less than 65 years old at the time of diagnosis and has no approved treatments.

AL 001 is also currently in a Phase II study in symptomatic FTD patients with a mutation in the C9orf72 gene and is planned to enter Phase II development for amyotrophic lateral sclerosis (ALS) in the second half of 2021. AL101 is in a Phase 1a clinical trial and is designed to treat patients suffering from more prevalent neurodegenerative diseases, including Parkinson’s disease and Alzheimer’s disease.

Terms of the Collaboration : Under the terms of the collaboration agreement, Alector will receive $700 million in upfront payments. In addition, Alector will be eligible to receive up to an additional $1.5 billion in clinical development, regulatory and commercial launch-related milestone payments. Alector will lead the global clinical development of AL001 and AL101 through Phase II proof-of-concept. Thereafter, Alector and GSK will share development responsibilities for all late-stage clinical studies for AL 001 and AL 101 and all costs for global development will be divided between the two companies.

The companies will be jointly responsible for commercialisation in the U.S. and will share profits and losses. Alector will lead commercial efforts associated with AL 001 in orphan indications and GSK will lead the commercialisation of AL 101 in Alzheimer’s and Parkinson’s disease. Outside the U.S., GSK will be responsible for commercialisation of A L001 and AL 101 and Alector will be eligible for tiered royalties.

Condition: Dementia:Frontotemporal
Type: drug

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