AC Immune and Takeda Enter Exclusive License Agreement for Amyloid Beta Immunotherapy in Alzheimer’s Disease

Takeda (TSE:4502/NYSE:TAK) and AC Immune SA (NASDAQ: ACIU) have announced an exclusive, global option and license agreement for AC Immune’s active immunotherapies targeting toxic forms of amyloid beta (Abeta), including ACI-24.060 for Alzheimer’s disease treatment.

ACI-24.060 is an anti-Abeta active immunotherapy candidate designed to induce a strong antibody response against toxic forms of Abeta that drive plaque formation and Alzheimer’s disease progression. By promoting plaque clearance and inhibiting plaque formation in the brain, ACI-24.060 aims to delay or slow Alzheimer’s disease progression. It is currently being evaluated in the ongoing ABATE Phase 1b/2 trial, which is randomized, double-blind, and placebo-controlled, to assess its safety, tolerability, immunogenicity, and pharmacodynamic effects in subjects with prodromal Alzheimer’s disease and adults with Down syndrome.

Dr. Andrea Pfeifer, CEO of AC Immune, stated, “As pioneers in active immunotherapy, we are developing an innovative approach that could transform Alzheimer’s disease treatment and address the complex challenges faced by patients and the broader community. Partnering with Takeda at this critical stage in ACI-24.060’s development will enable us to move swiftly into Phase 3 trials, leveraging Takeda’s developmental expertise, strategic vision, and financial resources. This partnership allows us to focus on completing Phase 1b/2 development and advancing our early-stage pipeline with enhanced funding.”

AC Immune will complete the ABATE trial, after which Takeda will take over all further clinical development, global regulatory activities, and worldwide commercialization upon exercising the option.

Sarah Sheikh, M.Sc., B.M., B.Ch, MRCP, Head of the Neuroscience Therapeutic Area Unit and Global Development at Takeda, commented, “At Takeda, we are dedicated to addressing society’s most debilitating illnesses, including Alzheimer’s disease. We are thrilled to collaborate with AC Immune on this innovative treatment approach, leveraging novel technology to offer patients a potentially differentiated treatment in terms of efficacy, safety, and ease of administration. Combining AC Immune’s expertise in active immunotherapy with Takeda’s neuroscience drug development and commercialization capabilities, we have a significant opportunity to make a real impact on the Alzheimer’s community.”

Per the agreement, AC Immune will receive a $100 million upfront payment and may receive an option exercise fee and additional development, commercial, and sales-based milestones up to approximately $2.1 billion if all milestones are met. Upon commercialization, AC Immune will be entitled to tiered double-digit royalties on global net sales.

Further details about the agreement are available in the Form 6-K filed today by AC Immune with the U.S. Securities and Exchange Commission (SEC). The effectiveness of Takeda’s license after option exercise is subject to the termination or expiration of any applicable waiting periods under the Hart-Scott-Rodino Act.

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