Takeda may be paring back its R&D pipeline in the name of efficiency, but the Japanese pharma has still found $100 million to ensure its clinical pipeline once again features an Alzheimer’s disease drug.
The asset in question, ACI-24.060, is an anti-Abeta active immunotherapy from AC Immune “designed to induce a robust antibody response against the toxic forms of Abeta believed to drive plaque formation and Alzheimer’s disease progression,” Takeda explained in a May 13 release.
AC Immune is currently evaluating ACI-24.06 in a phase 1b/2 trial in subjects with prodromal Alzheimer’s disease as well as in adults with Down syndrome. Ninety percent of people with Down syndrome will develop Alzheimer’s, although AC Immune has been the only prominent Alzheimer's-focused company working specifically with these patients.
The Swiss biotech will continue the trial to completion, after which Takeda will hand over more cash if it wants to take up the option to oversee the drug’s journey through the clinic, to regulators and hopefully to commercialization.
The option exercise fee and additional milestone payments could add up to $2.1 billion for AC Immune, which will also be in line for tiered double-digit royalties on worldwide sales.
An early readout from the trial over a year ago may explain why Takeda is so keen to get involved. Back in January 2023, AC Immune reported that ACI-24.060 elicited an anti-Abeta antibody response as early as Week 6, meaning the therapy may help prevent or clear plaques in the brain thought to cause the cognitive decline in Alzheimer’s. Since then, AC Immune has upped the dose and also enrolled patients with Down syndrome.
The wait will soon be over to find out whether ACI-24.060 actually reduces amyloid plaques, which AC Immune intends to measure by PET imaging. Six-month imaging results are expected by the end of June, with 12-month results due in the second half of the year.
“We believe the maximum impact of ACI-24.060 can best be realized by partnering with Takeda at this critical juncture in its development, which will help us move rapidly into phase 3,” AC Immune CEO Andrea Pfeifer, Ph.D., said in the release.
“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 3 trials in Alzheimer’s disease while allowing us to focus on completing phase 1b/2 development and accelerating our efforts to replicate this success with enhanced funding for our early-stage pipeline,” Pfeifer added.
It marks the latest Alzheimer’s partnership for the Swiss company, which is working with Johnson & Johnson’s Janssen unit on a pTau-focused immunotherapy called ACI-35.030. At the start of 2024, Roche’s Genentech subsidiary ended an 18-year relationship with AC Immune, handing back global rights to a pair of candidates targeting amyloid beta and tau after suffering a series of setbacks in the clinic.
Takeda also struggled with its own previous clinical-stage Alzheimer’s bet—an antibody transport vehicle in collaboration with Denali Therapeutics that was discarded last year after phase 1 data suggested it would have a “narrow therapeutic window.” The two companies are continuing to work together in the neuroscience space in the form of a frontotemporal dementia therapy called TAK-594.
“At Takeda, we are committed to tackling some of society’s most debilitating illnesses, including Alzheimer’s disease,” Sarah Sheikh, head of the neuroscience therapeutic area unit and head of global development at Takeda, said in this morning’s release.
“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,” Sheikh added.
Takeda’s push back into Alzheimer’s comes as the Tokyo-based pharma confirmed to Fierce Biotech it is closing a San Diego research site as part of a “multi-year efficiency program” that has also seen the drugmaker scrap cancer, gut and inflammation drugs.