Takeda Inks Potential $2.2B Deal for AC Immune’s Alzheimer’s Immunotherapy

Takeda US_iStock, hapabapa

Pictured: Takeda's office in Cambridge, Massachusetts/iStock, hapabapa

Takeda said Monday it is paying AC Immune $100 million upfront for an option on the global rights to a Phase Ib/II Alzheimer’s disease candidate. Factoring in milestone payments, the deal is worth up to $2.2 billion.

The deal covers ACI-24.060, an active immunotherapy that targets toxic forms of amyloid beta (Abeta). AC Immune has designed the drug candidate to drive antigen-specific antibody responses that bind to pathological forms of Abeta. After trialing a first-generation candidate, the Swiss biotech added more Abeta unrelated T-helper cell epitopes to try to improve immunogenicity.

By turning the immune system against Abeta, AC Immune is aiming to clear the plaques seen in people with Alzheimer’s. Alzinova, Araclon Biotech, Nuravax and Vaxxinity are among the companies to pursue similar anti-Abeta-targeting active immunotherapy approaches.

Takeda’s interest in the mechanism follows earlier Alzheimer’s-focused deals with Denali Therapeutics and Evotec. The Japanese drugmaker is opening another front in its attempt to treat the disease as it searches for growth drivers to offset the loss of exclusivity on ADHD therapy Vyvanse (lisdexamfetamine dimesylate). Takeda has started a $900 million restructuring effort in response to falling profits.

AC Immune is studying ACI-24.060 in subjects with prodromal Alzheimer’s and in adults with Down syndrome. In the Phase Ib/II trial, investigators are comparing three doses of the candidate and placebo in Alzheimer’s patients. Blinded interim analyses found evidence of antibody responses against Abeta. The second part of the study is assessing the therapy in non-demented adults with Down syndrome.

The biotech expects to publish six-month Abeta positron emission tomography (PET) imaging results in the second quarter of 2024. AC Immune CEO Andrea Pfeifer said in a statement that the data drop is a “potentially de-risking event ... that could enable advancement into a registrational study.” One-year Abeta PET data are expected in the fourth quarter of 2024.

AC Immune is responsible for finishing the Phase Ib/II study. If Takeda takes up its option, the Japanese drugmaker will run and fund all further clinical development. AC Immune said the option fee is in “the low-to-mid nine-figure range.”

The biotech ended March 2024 with almost 105 million Swiss francs ($116 million) in cash and other short-term financial assets. AC Immune estimates the addition of the $100 million upfront from Takeda and a milestone from a deal with Johnson & Johnson will give it the cash to fund operations for at least three years.

Nick Paul Taylor is a freelance pharmaceutical and biotech writer based in London. He can be reached on LinkedIn.

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