They will use Denali’s Antibody Transport Vehicle technology to get the therapies past the blood-brain barrier so they are able to work where they are needed — in the brain.
The barrier is a membrane that separates blood from the brain and central nervous system fluids. It prevents bacteria and other invaders from reaching the brain. But it allows beneficial substances such as water, certain gases and molecules to reach the brain, along with glucose and amino acids that are critical to nerve cell functioning.
One of the challenges of treating neurological diseases is creating a therapy that get past the blood-brain barrier.
Denali will direct the partners’ therapy development efforts and cover any costs that lead to Investigational New Drug filings for the treatments. A company must make such filings before it can begin the clinical trial process that leads to the drugs’ approval.
Takeda has an option to join in the therapy development efforts and work with Denali to market them. The option includes taking part in the therapies’ clinical trials program. If Takeda exercises the option, it will share development and trials costs with Denali.
The partners will work together on marketing any therapies they develop in the United States and China. Takeda will have the right to commercialize treatments in all other markets worldwide.
Denali will receive a $150 million up-front payment from Takeda in cash and its partner’s purchase of Denali stock. In addition, Denali will be eligible for development and commercial milestone payments as a therapy advances toward approval.
“We are excited to partner with the Denali team, whose innovative technology is uniquely poised to deliver the next generation of antibody therapeutics for patients,” Emiliangelo Ratti, head of Takeda’s neuroscience therapy program, said in a press release.
“We are impressed with Takeda’s commitment to developing treatments for difficult-to-treat neurodegenerative diseases and look forward to partnering with them to bring medicines to patients,” said Dr. Ryan Watts, Denali’s chief executive officer.
In April 2017, Takeda pumped $15 million into an Aquinnah Pharmaceuticals initiative to move potential treatments for Alzheimer’s, amyotrophic lateral sclerosis and other neurodegenerative diseases to the clinical-trial stage.
The treatments target complex structures of proteins and RNA molecules called stress granules. In healthy people, the granules are involved in cell repair. But in neurodegenerative diseases, they accumulate in tissue, contributing to the development and progression of the disorders.