AbbVie and Voyager Therapeutics inked a collaboration deal to develop treatments for Alzheimer’s disease and other neurodegenerative diseases.
Chicago-based AbbVie and Cambridge, Massachusetts-based Voyager Therapeutics inked a collaboration deal to develop treatments for Alzheimer’s disease and other neurodegenerative diseases. AbbVie is paying $69 million upfront and up to $155 million in preclinical and Phase I option payments. Voyager is also eligible to receive up to $895 million in development and regulatory milestones for each vectorized tau antibody compound, and is eligible to tiered royalties on any commercial products that come out of the deal.
The two companies signed an exclusive strategic collaboration and option deal to develop and commercialize vectorized antibodies against the tau protein. In Alzheimer’s patients, abnormal tau protein tangles appear toward the end of the disease and are correlated with progressive neurodegeneration and severity. Current limitations for the use of biologics infusions is that only a small amount of drug can pass the blood-brain barrier. The two companies will work to develop a possible one-time therapeutic that utilizes Voyager’s gene therapy platform that generates adeno-associated viral (AAV) vectors.
“AbbVie is focused on developing treatments to meet the crushing public health crisis presented by Alzheimer’s and other neurodegenerative diseases,” said Jim Sullivan, AbbVie’s vice president of pharmaceutical discovery, in a statement. “Voyager’s vectorized antibody platform presents an innovative approach to addressing challenges in treating neurological disorders associated with the administration of biologic therapies. This collaboration has the potential to address the needs of patients who live with conditions such as Alzheimer’s disease, progressive supranuclera palsy and frontotemporal dementia.”
It seems like a particularly bold move after the most recent spate of Alzheimer’s failures. On February 14, Merck & Company announced it was halting its protocol 109, APECS Phase III clinical trial of verubecestat in Alzheimer’s disease because its risks weren’t worth the rewards. And Biogen stock took a hit after it announced it was adding 510 patients to its aducanumab Alzheimer’s trial in hopes of clearing up variability in the data.
Both of those trials, as well as numerous others, have focused on preventing the accumulation of beta-amyloid plaques or clearing them. The long list of failures has cast some doubt on the beta-amyloid theory of Alzheimer’s disease. Less attention has been paid to the tau protein tangles, largely because they appear later in the disease than beta-amyloid.
John Carroll, writing for Endpoints News, says, “Voyager is one of a group of biotechs which have been developing gene therapies that are delivered by these AAV or lentiviral vectors. The blood/brain barrier that protects our gray matter has also been a big hurdle in Alzheimer’s, blocking drugs that might address the biology of the memory wasting disease. Merck’s recent failure on the BACE approach with veribucestat underscored 15 years of steady failure in Alzheimer’s, but any winning blockbuster would make AbbVie’s sizable ante here look like small change.”
Although some companies, such as Pfizer, appear to be abandoning Alzheimer’s research, the U.S. Food and Drug Administration (FDA) recently proposed new guidelines for developing drugs for the disease, essentially lowering the bar for approval. The agency published a set of draft guidances proposing an approval pathway for Alzheimer’s drug that focuses on biomarkers.
Science writes, “the agency essentially proposed to offer an approval pathway for new drugs that could prevent the onset of the devastating symptoms of Alzheimer’s if drug developers could hit acceptable biomarkers that indicate the drug is working. And they’re likely going to continue with a new gold standard that will focus on long-term cognition alone, lowering the bar for drugs for an enormous and growing market.”
Maria Carrillo, chief science officer for the Alzheimer’s Association told Bloomberg that the FDA’s change “is a big deal to companies. It is a clear statement that the FDA understands that the science of Alzheimer’s has evolved.”
