AC Immune has lined up its third pharma partner in Alzheimer’s disease, and the pact comes with a hefty biobucks package.
Takeda will pay AC Immune $100 million upfront to snag the exclusive option to license the Swiss biotech’s anti-amyloid vaccine, which is in Phase 1b/2 testing in the US and Europe. If the drugmaker opts to further develop the immunotherapy, dubbed ACI-24.060, it could dish out up to another $2.1 billion in option fees and milestones, the companies said Monday morning.
News of the pact sent AC Immune’s shares $ACIU up more than 30% in early Monday trading.
Takeda, which announced big prioritizations last week, steps into AC Immune’s partner roster four months after a nearly two-decade collaborator departed. Roche and Genentech scrapped their work with AC Immune earlier this year on two antibodies after clinical setbacks. AC Immune is also working with Johnson & Johnson on an anti-tau vaccine and with Eli Lilly on other tau-focused projects for the memory-robbing disease.
AC Immune expects its candidate with Takeda will prevent the buildup of toxic amyloid beta — the decades-old target of many Alzheimer’s drugs in the biopharma industry — and boost the clearance of such plaques. The randomized ABATE study, begun in June 2022, is testing ACI-24.060 against placebo in people with prodromal Alzheimer’s disease and in adults with Down syndrome.
A vaccine could avoid some of the hurdles that others have faced in the Alzheimer’s treatment landscape, analysts noted, such as brain swelling and bleeding known as amyloid-related imaging abnormalities, or ARIA.
“ACI-24 to-date has not been associated with ARIA adverse effects, potentially a safety benefit and possibly removing the need for expensive MRI monitoring,” Jefferies analyst Lucy Codrington wrote in a Monday morning note. The Jefferies team wrote that the vaccine could launch in 2028 and reach peak sales of $2.3 billion. Those estimates could change, though, as the vaccine is still early in clinical testing.
The biotech will finish the ABATE trial. Takeda will have an undisclosed amount of time to decide whether to move forward after getting access to “predefined clinical data on the first three AD patient cohorts,” the biotech said in an SEC filing. The option fee is in the “low-to-mid hundred million USD,” AC Immune said in the SEC paperwork. The two companies entered into the deal on Saturday.
Andrea Pfeifer“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 said in a press release.
Takeda doesn’t currently list an Alzheimer’s treatment candidate in its consolidated pipeline. Last summer, it axed the Phase 1-stage TAK-920 with partner Denali Therapeutics.
Fellow Japanese pharma Eisai and its partner Biogen have received regulatory approvals for their anti-amyloid treatment Leqembi, which has had a gradual rollout over the past year. Eli Lilly, meanwhile, waits in the FDA loading zone and will sit in front of an advisory committee that’s set to discuss its candidate, donanemab, next month.
AC Immune also reported quarterly earnings on Monday. The company said it now has cash runway for “at least three years.”
Editor’s note: This story was updated to include analyst commentary and stock reaction.