• Program uses Denali’s Antibody Transport Vehicle (ATV) technology to cross the blood-brain barrier (BBB) and aims to increase target engagement

CAMBRIDGE, MA and South San Francisco, CA, USA I April 12, 2023 I Biogen Inc. (Nasdaq: BIIB) and Denali Therapeutics Inc. (Nasdaq: DNLI) today announced that Biogen has exercised the option to license Denali’s Antibody Transport Vehicle (ATV): Amyloid beta program (ATV:Aβ). Accumulation of Aβ plaque in the brain is a defining feature of Alzheimer’s disease (AD). Using Denali’s ATV platform to cross the blood-brain barrier (BBB), ATV:Aβ is designed to increase brain exposure and target engagement of antibody therapeutics directed against Aβ, which may enable improved plaque clearance and/or reduced amyloid-related imaging abnormalities (ARIA).

“Recent progress with Aβ-directed therapeutic antibodies enables new treatment options for people living with AD, and clinical trial data have demonstrated that clearance of aggregated Aβ is associated with benefit for patients,” said Joseph Lewcock, Ph.D., Chief Scientific Officer of Denali. “Our ATV:Aβ program is designed to safely increase exposure of the therapeutic antibody in the brain and potentially lead to improved efficacy and/or safety. We are pleased with Biogen’s decision to license ATV: Aβ and we are hopeful this will foster the development of next-generation anti- Aβ therapeutics.”   

“This decision is an important next step of our collaboration with Denali on ATV:Aβ that aims to advance the next generation of Aβ immunotherapies for the treatment of Alzheimer’s disease,” said Dominic Walsh, Head of the Neurodegenerative Research Unit at Biogen. “This program reinforces the importance of targeting Aβ and our commitment to Alzheimer’s disease.”

The option was exercised pursuant to a collaboration between Biogen and Denali announced in 2020. Following the exercise of the option, Biogen will assume responsibility for all development and commercial activities and associated expenses. Denali will receive a one-time option exercise payment and, should certain milestones be achieved, Denali will be eligible to receive potential development and commercial milestone payments and royalties based on future net sales.

About Denali’s Transport Vehicle Platform
The BBB is essential in maintaining the brain’s microenvironment and protecting it from harmful substances and pathogens circulating in the bloodstream. Historically, the BBB has posed significant challenges to drug development for central nervous system diseases by preventing most drugs from reaching the brain in therapeutically relevant concentrations. Denali’s Transport Vehicle platform is a proprietary technology designed to effectively deliver large therapeutic molecules such as antibodies, enzymes, proteins, and oligonucleotides across the BBB after intravenous administration. The Transport Vehicle technology is based on engineered Fc domains that bind to specific natural transport receptors, such as transferrin receptors, which are expressed at the BBB and deliver the Transport Vehicle and its therapeutic cargo to the brain through receptor-mediated transcytosis. In animal models, antibodies and enzymes engineered with the Transport Vehicle technology demonstrate more than 10- to 30-fold greater brain exposure than similar antibodies and enzymes without this technology. Improved exposure and broad distribution in the brain may increase therapeutic efficacy by enabling widespread achievement of therapeutically relevant concentrations of product candidates.

About Biogen
Founded in 1978, Biogen is a leading global biotechnology company that has pioneered multiple breakthrough innovations including a broad portfolio of medicines to treat multiple sclerosis, the first approved treatment for spinal muscular atrophy, and two co-developed treatments to address a defining pathology of Alzheimer’s disease. Biogen is advancing a pipeline of potential novel therapies across neurology, neuropsychiatry, specialized immunology and rare diseases and remains acutely focused on its purpose of serving humanity through science while advancing a healthier, more sustainable and equitable world.

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About Denali Therapeutics
Denali Therapeutics is a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the blood-brain barrier (BBB) for the treatment of neurodegenerative and lysosomal storage diseases. Denali pursues new treatments by rigorously assessing genetically validated targets, engineering delivery across the BBB and guiding development through biomarkers that demonstrate target and pathway engagement. Denali is based in South San Francisco. For additional information, please visit www.denalitherapeutics.com.

SOURCE: Biogen