Nerve cells affected by Alzheimer's disease, illustration

Takeda has signed a deal with Swiss biotech AC Immune to complete development and commercialize its Alzheimer’s amyloid-beta vaccine, which is currently in Phase I/II trials.

AC Immune will receive an upfront payment of $100 million and will then be eligible for additional fees of $2.1 billion if all development, commercialization, and sales milestones are achieved. AC Immune will also be eligible for royalties on sales of the therapy if it reaches the market.

The vaccine, currently known as ACI-24.060, is an immunotherapy against amyloid beta that is designed to trigger a strong antibody response against the plaque forming, toxic forms of the protein. By doing this, the therapy should clear existing plaque and stop further amyloid plaques from forming in the brain of those with the condition.

“This agreement allows us to leverage the developmental expertise, strategic vision and financial capacity of an accomplished organization that has demonstrated its ability to execute the type of comprehensive global program required for Phase III trials in Alzheimer’s disease while allowing us to focus on completing Phase Ib/II development and accelerating our efforts to replicate this success with enhanced funding for our early-stage pipeline,” said Andrea Pfeifer, CEO of AC Immune.

The Alzheimer’s disease therapeutics field had a boost last year with the approval of Eisai and Biogen’s antibody drug lecanemab, designed to target amyloid beta. It has a significant, if modest, benefit in people with early-stage Alzheimer’s.

Before last year, the field had struggled for a long time with no new therapies being approved for many years and a large number of failed clinical trials. Since last year, interest has increased in the Alzheimer’s field both in terms of investment and development and many clinical trials are ongoing.

AC Immune has been in the field for some time, and while it experienced failures of some of it’s earlier drug candidates, it is hoping its newer immunotherapy approach may be more effective. It also has an anti-tau vaccine in development, which it is working on in collaboration with Johnson & Johnson.

The Phase I/IIb study of ACI-24.060, known as the ABATE study, began in 2022 and is still recruiting. It is aimed at people with mild Alzheimer’s disease in danger of progressing and adults with Down Syndrome, the majority of whom go on to develop Alzheimer’s in later life. Although the results of this trial are unknown, earlier studies showed no major safety concerns and a broad immune response to amyloid beta oligomers in preclinical studies.

After completion of the ABATE trial, if results are positive then Takeda will move the candidate therapy forward into late-stage trials.

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