AC Immune and Takeda Sign Agreement for Amyloid Beta Alzheimer's Therapy

AC Immune and Takeda have entered into an exclusive global option and license agreement for AC Immune’s active immunotherapy, ACI-24.060, targeting amyloid beta (Abeta) for Alzheimer’s disease treatment. The deal grants Takeda the exclusive option to license ACI-24.060 and includes an upfront payment of $100 million to AC Immune upon closing, with potential additional milestone payments amounting to $2.1 billion.

ACI-24.060 is a potential first-in-class active immunotherapy designed to elicit a strong antibody response against toxic Abeta forms that contribute to plaque formation and Alzheimer’s disease progression. This immunotherapy aims to clear existing plaques and prevent new ones from forming, potentially delaying or slowing the progression of Alzheimer’s disease. Currently, ACI-24.060 is being evaluated in a Phase 1b/2 clinical trial named ABATE. This trial is a randomized, double-blind, placebo-controlled study assessing the safety, tolerability, immunogenicity, and pharmacodynamic effects of ACI-24.060 in individuals with prodromal Alzheimer’s disease and Down syndrome.

Dr. Andrea Pfeifer, CEO of AC Immune, emphasized the significance of this partnership with Takeda, noting that it would enable AC Immune to leverage Takeda’s developmental expertise and financial resources to advance ACI-24.060 rapidly into Phase 3 trials. The collaboration is seen as a strategic move to enhance development efficiency and pave the way for addressing the complex challenges posed by Alzheimer’s disease.

According to the agreement, AC Immune will complete the ABATE trial, after which Takeda will take over and fund all subsequent clinical development. Takeda will also handle global regulatory activities and worldwide commercialization. Sarah Sheikh, Head of Neuroscience Therapeutic Area Unit and Global Development at Takeda, expressed enthusiasm about the collaboration, highlighting the innovative nature of ACI-24.060 and its potential to offer a differentiated treatment for Alzheimer’s patients.

Under the terms of the agreement, AC Immune stands to receive substantial financial benefits, including an initial $100 million payment and the possibility of earning up to $2.1 billion in additional development, commercial, and sales-based milestones. Furthermore, AC Immune will be entitled to tiered double-digit royalties on global net sales upon commercialization.

The ABATE trial continues to show promise, with no safety concerns reported so far. Early data has indicated encouraging immunogenicity, with significant anti-Abeta antibody responses observed. Results from six-month Abeta positron emission tomography (PET) imaging are anticipated in the second quarter of 2024, and 12-month data is expected by the end of 2024.

In summary, this exclusive option and license agreement between AC Immune and Takeda represents a significant step forward in the quest to develop innovative treatments for Alzheimer’s disease. By combining AC Immune’s expertise in active immunotherapies with Takeda’s strengths in neuroscience drug development and commercialization, the partnership aims to bring a novel and effective treatment to the Alzheimer’s community.