GlaxoSmithKline (GSK) and Alector, a South San Francisco, California-based clinical-stage bio/pharmaceutical company, have entered into a pact to co-develop monoclonal antibodies (mAbs) for a range of neurodegenerative diseases, in a deal worth up to $2.2 billion ($700 million upfront and up to $1.5 billion in milestones).

Under the collaboration, GSK and Alector will develop and commercialize two clinical-stage mAbs from Alector, AL001 and AL101. The drugs are designed to elevate progranulin (PGRN), a key regulator of immune activity in the brain with genetic links to multiple neurodegenerative disorders, according to information from the company.

Enrollment is currently underway for a Phase III trial for AL001 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. AL001 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 Ia trial to treat patients suffering from more prevalent neurodegenerative diseases, including Parkinson’s disease and Alzheimer’s disease.

Under the 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 AL001 and AL101, and all costs for global development will be divided between the two companies.

The companies will be jointly responsible for commercialization in the US and will share profits and losses. Alector will lead commercial efforts associated with AL001 in orphan indications, and GSK will lead the commercialization of AL101 in Alzheimer’s and Parkinson’s disease. Outside the US, GSK will be responsible for commercialization of AL001 and AL101 and Alector will be eligible for tiered royalties.

Source: GlaxoSmithKline and Alector