GSK, Biotech Partner on Neuro Antibodies in $2.2B Deal

(Gordon Johnson, Pixabay)

2 July 2021. GlaxoSmithKline and biotechnology company Alector Inc. agreed to co-develop two synthetic antibodies for treating neurodegenerative disorders. The licensing and collaboration deal with London-based drug maker GSK could bring Alector in South San Francisco as much as $2.2 billion if all terms of the agreement are met.

Alector designs treatments that invoke the immune system for addressing genetic factors responsible for neurological diseases. The company bases its therapies on recent research identifying genetic variations expressed in microglia, cells in the brain and spinal cord providing immune-type protections and responses. As a result, Alector’s therapies target proteins expressed by these mutations contributing to neurodegenerative disorders including Alzheimer’s disease, frontotemporal dementia or FTD, and Parkinson’s disease. FTD is a disorder marked by a gradual decline in behavior or language, similar to dementia, but usually not affecting memory.

One of the company’s lead therapy candidates, code-named AL001, is a targeted synthetic antibody to increase production of a protein called progranulin that regulates immune activity in the brain. Low levels of progranulin are associated with FTD, Alzheimer’s, and Parkinson’s disease. AL001 and a companion Alector synthetic antibody AL101 boost progranulin levels among individuals with a mutation that degrades the protein.

In July 2020, Alector reported at a professional meeting initial results from a mid-stage trial of AL001 among individuals with FTD and a progranulin mutation. The findings show the 15 participants receiving AL001 infusions every four weeks for 28 weeks reported no serious adverse effects from the treatments. In addition, recipients experienced restored levels of progranulin and a decrease in neurofilament light chain protein or NfL, in plasma, a biomarker for neurodegeneration, in their blood.

Dividing clinical development and commercialization

AL001 is now in a late-stage clinical trial testing the treatment among FTD patients with a progranulin mutation, with a mid-stage trial of AL001 planned in patients with amyotrophic lateral sclerosis or ALS. AL101 is currently in an early-stage safety trial, and Alector expects the synthetic antibody to address a number of neurological disorders.

The agreement with GSK gives Alector responsibility for early- and mid-stage clinical trials of AL001 and AL101, while GSK and Alector share responsibility and costs for late-stage trials. Overall, the two companies are also sharing responsibility for commercializing AL001 and AL101 in the U.S., while GSK is taking the lead for commercializing the therapies outside the U.S. For addressing disease types, Alector has lead responsibility for AL001’s commercialization with orphan diseases, while GSK is taking the lead on AL101 for Alzheimer’s and Parkinson’s disease.

Alector is receiving an initial payment of $700 million from GSK, and is eligible for development, regulatory, and commercial milestone payments of up to $1.5 billion. Alector is also eligible for royalties on sales of products from the collaboration.

“Working with Alector’s world class scientists,” says GSK chief scientist Hal Barron in a statement, “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.”

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