$2.1 Billion Agreement Accelerates Immunotherapies Targeting Toxic Forms of Amyloid Beta

A potential first-in-class active immunotherapy designed to delay or slow Alzheimer's disease progression may realize up to approximately $2.1 billion in new funding.

Takeda and AC Immune SA today announced an exclusive, worldwide option and license agreement for AC Immune's active immunotherapies, including ACI-24.060, which targets toxic forms of amyloid beta (Abeta).

ACI-24.060 is designed to induce a robust antibody response against the toxic forms of Abeta believed to drive plaque formation and Alzheimer's disease progression. By inducing plaque clearance and efficiently inhibiting plaque formation in the brain, ACI-24.060 has the potential to delay or slow Alzheimer's disease progression.

ACI-24.060 is being investigated in the ongoing ABATE randomized, double-blind, placebo-controlled Phase 1b/2 trial to assess the safety, tolerability, immunogenicity, and pharmacodynamic effects of the investigational immunotherapy in subjects with prodromal Alzheimer's disease and in adults with Down syndrome.

AC Immune will be responsible for completing the ABATE trial. Following the option exercise, Takeda would conduct and fund all further clinical development and be responsible for all global regulatory activities and worldwide commercialization.

"At Takeda, we are committed to tackling some of society's most debilitating illnesses, including Alzheimer's disease. We are excited to partner with AC Immune on this ground-breaking treatment approach, which leverages novel technology with the potential to offer patients a treatment with differentiated efficacy, safety, and ease of administration," said Sarah Sheikh, M.Sc., B.M., B.Ch, MRCP, Head, Neuroscience Therapeutic Area Unit and Head, Global Development at Takeda, in a press release on May 13, 2024.

"Combining AC Immune's deep experience with active immunotherapy approaches with Takeda's expertise in neuroscience drug development and commercialization, we have an incredible opportunity to deliver real impact to the Alzheimer's community."

Under the terms of the agreement, AC Immune will receive an upfront payment of $100 million and be eligible to receive an option exercise fee and additional potential development, commercial, and sales-based milestones of up to approximately $2.1 billion if all related milestones are achieved throughout the agreement.

Upon commercialization, AC Immune will be through tiered double-digit royalties on worldwide net sales. The effectiveness of Takeda's license following option exercise is subject to the termination or expiration of any applicable waiting periods under the Hart-Scott-Rodino Act.

According to the U.S. NIH, immunogenicity is "the ability of a molecule or substance to provoke an immune response." As of May 13, 2024, no U.S. FDA-approved vaccines prevent Alzheimer's disease.