Crenezumab

Takeda Pharmaceutical is betting potentially billions of dollars on drugs designed to slow Alzheimers disease by harnessing the immune system.Through a deal announced Monday, Takeda has secured an exclusive option to license active immunotherapies from the Swiss biotechnology company AC Immune. The agreement pertains to programs targeting what many researchers believe to be a root cause of Alzheimer's a protein known as amyloid beta. Among those programs is a vaccine currently being tested in a roughly 140-person study titled Abate.Per deal terms, Takeda holds an exclusive option to license global rights to the vaccine and any other AC immunotherapy directed at amyloid beta. In exchange, AC will receive $100 million upfront.Should Takeda exercise its option, it would make another one-time payment in the low-to-mid nine-figure range. Altogether, AC could receive up to approximately $2.1 billion, provided its programs hit certain development, commercial and sales-based milestones.AC is also entitled to sales royalties on any products that stem from the deal.Combining AC Immunes deep experience with active immunotherapy approaches with Takedas expertise in neuroscience drug development and commercialization, we have an incredible opportunity to deliver real impact to the Alzheimers community, said Sarah Sheikh, Takedas head of global development and leader of the companys neuroscience therapeutic area unit, in a statement.Takeda isnt the first big pharmaceutical firm to see value in ACs research. The smaller drugmaker counts Johnson & Johnson and Eli Lilly as collaboration partners. It also licensed out to Roche an Alzheimers therapy called crenezumab, though that drug ultimately failed across a series of high-profile tests.Like crenezumab, ACs immunotherapies are meant to break up toxic accumulations of misfolded amyloid beta in the brain. The companys vaccine, though, works somewhat differently. Its designed to spur the immune system into making antibodies that specifically target these proteins.The ongoing Abate study is the most important test yet for ACs vaccine. It began about two years ago and is expected to produce results around June 2026.AC Immune remains responsible for completing the study. But, if Takeda exercises its new option, it would take charge of all further clinical development. Takeda would also lead global regulatory activities as well as worldwide commercialization.Shares of AC Immune were up about 35% Monday morning, to trade at $3.12 apiece. '

Takeda has signed a worldwide licensing agreement with Swiss biotech AC Immune to develop and commercialize ACI-24.060, an immunotherapy aimed at treating Alzheimer's disease by targeting amyloid beta plaques. Under the terms of the agreement, AC Immune will receive an upfront payment of $100 million upon the closing of the deal. Additionally, the company is eligible for an option exercise fee, along with potential milestones that could total approximately $2.1 billion if all targets are met. Upon commercialization, AC Immune will also receive tiered double-digit royalties on worldwide net sales. ACI-24.060 is currently under investigation in the ABATE phase 1b/2 trial, which is a randomized, double-blind, placebo-controlled study evaluating the safety, tolerability, immunogenicity, and pharmacodynamic effects of the immunotherapy in individuals with prodromal Alzheimer's disease and adults with Down syndrome. The partnership aims to leverage Takeda’s global presence and experience in drug development and commercialization while AC Immune continues to oversee the ongoing phase 1b/2 trial. Takeda will take responsibility for further clinical development, global regulatory activities, and worldwide commercialization upon exercise of the option. AC Immune has faced significant setbacks in its pursuit of an effective Alzheimer’s treatment. In 2019, Roche and AC discontinued a phase 3 trial of crenezumab, an early Alzheimer’s treatment, after it was found ineffective. Despite the setback to the hypothesis that blocking amyloid plaques could slow cognitive decline, Roche decided to continue a study of crenezumab on healthy individuals with a genetic predisposition to Alzheimer’s. Then in 2020, Roche and AC Immune faced another setback when their experimental Alzheimer's treatment, semorinemab, failed to enhance cognitive function in a phase 2 trial with early-stage patients. Unlike many treatments that target amyloid beta peptides, semorinemab aimed at "tau" proteins but did not prove more effective.