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AC Immune Initiates Final Cohort in Ongoing Phase 1b/2 ABATE Trial of Anti-Abeta Active Immunotherapy to Treat Alzheimer's Disease Treatment of first patient in Cohort AD4 in ABATE trial triggers $12 millio

Key Takeaway: AC Immune SA has announced the initiation of the final cohort, AD4, in its ongoing Phase 1b/2 ABATE trial of the anti-Abeta immunotherapy ACI-24 for Alzheimer's disease. The dosing of the first patients in this cohort triggers a $12 million milestone payment from Takeda, which is collaborating on this project. Preliminary data indicates that ACI-24 is generally safe and has induced positive antibody responses against amyloid beta, a key factor in Alzheimer's pathology. The trial aims to expand on these findings with a total of 36 subjects treated for 12 months, followed by a potential cohort expansion to 112 participants.

Market Sentiment Analysis

POSITIVE FACTORS

  • Initiation of the final cohort in the ABATE trial signals progress.
  • AC Immune received a $12 million milestone payment from Takeda.
  • ACI-24 shows encouraging early safety and immunogenicity data.
  • Potential for substantial future milestone payments and royalties.

Full Press Release Details

AC Immune Initiates Final Cohort in Ongoing Phase
Trial of Anti-Abeta Active Immunotherapy to Treat Alzheimer's Disease
Lausanne, Switzerland, April 30, 2026 -- AC Immune SA (NASDAQ:
ACIU), a clinical-stage biopharmaceutical company pioneering precision therapeutics for neurodegenerative diseases, today announced it
dosed the first patients in Cohort AD4 in the ongoing Phase 1b/2 ABATE trial. As a result, AC Immune will receive a $12 million milestone
payment from Takeda under the partners' exclusive, worldwide option and license agreement for AC Immune's active immunotherapies
targeting toxic forms of amyloid beta (Abeta), including ACI-24 for the treatment of Alzheimer's disease (AD).
ABATE is assessing ACI-24 in subjects with prodromal AD and in adults
with Down syndrome (DS). AD4 includes subjects with prodromal AD.
Dr. Andrea Pfeifer, CEO of AC Immune SA, said: "This milestone
underscores the progress in our Phase 1b/2 ABATE trial of ACI-24. AD4 will build on the encouraging early safety and immunogenicity data
to date. It allows further evaluation of the potential of ACI-24 and, more broadly, our precision prevention approach to neurodegenerative
diseases, which encompasses a pipeline of active immunotherapies and intracellular-targeted small-molecule therapeutics to intervene at
the earliest stages of disease."
ACI-24 is an anti-Abeta active immunotherapy candidate designed to induce
a robust antibody response against the toxic forms of Abeta believed to drive plaque formation and AD progression. By inducing plaque
clearance and efficiently inhibiting plaque formation in the brain, ACI-24 has the potential to delay or slow AD progression.
ACI-24 is being investigated in the ongoing ABATE randomized, double-blind,
placebo-controlled Phase 1b/2 trial to assess its safety, tolerability, immunogenicity and pharmacodynamic effects. Data so far show that
ACI-24 is generally safe and well tolerated, and that it has generated anti-Abeta antibody responses at all tested doses.
Cohorts AD1, AD2 and AD3 enrolled a total of 74 patients who received
ACI-24 at escalating dose levels. The 12-month data readouts from Cohorts AD1, AD2 and AD3 are expected later in Q2 2026. Cohort AD4 will
include an initial group of 36 patients treated for 12 months, with follow-up of 6 months, significantly expanding the safety and biomarker
efficacy data set. A subsequent expansion of the AD4 cohort could potentially see the total number of subjects reach approximately 112
AC Immune is responsible for conducting the ABATE trial. Following the
potential option exercise, Takeda would conduct and fund all further clinical development and be responsible for all global regulatory
activities as well as worldwide commercialization.
Under the terms of the agreement with Takeda, AC Immune received an
upfront payment of $100 million and is 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 over the course of the agreement. Upon
commercialization, AC Immune will be entitled to receive tiered double-digit royalties on worldwide net sales.
This product is AC Immune's anti-Abeta active immunotherapy candidate.
The ABATE randomized, double-blind, placebo-controlled Phase 1b/2 trial of ACI-24 for treatment of Alzheimer's disease (AD) continues
fully blinded (NCT05462106). Enrolled patients are required to have a diagnosis of prodromal AD: MCI due to AD according to the National
Institute on Aging Alzheimer's Association (NIA-AA) criteria, and a PET scan at screening must be consistent with the presence
of amyloid pathology. Patients will be randomized to one of several doses of ACI-24 or placebo. Following multiple data safety monitoring
board (DSMB) reviews, no safety concerns have been raised to date, consistent with previous results. Very encouraging immunogenicity
has been shown with clear evidence of anti-Abeta antibody responses against toxic Abeta species observed in the blinded data.
AC Immune SA is a clinical-stage biopharmaceutical company and a global
leader in precision prevention for neurodegenerative diseases, including Alzheimer's disease, Parkinson's disease, and NeuroOrphan
indications driven by misfolded proteins. The Company's two clinically validated technology platforms, SupraAntigen and Morphomer ,
fuel its pipeline of first- and best-in-class assets, which currently features a range of therapeutic and diagnostic programs, including
candidates in Phase 2 and Phase 3 development. AC Immune has a strong track record of securing strategic partnerships with leading global
pharmaceutical companies, resulting in substantial non-dilutive funding to advance its proprietary programs and >$4.5 billion in potential
milestone payments plus royalties.
SupraAntigen is a registered trademark of AC Immune SA in the following
territories: AU, EU, CH, GB, JP, RU, SG and USA. Morphomer is a registered trademark of AC Immune SA in CA, CN, CH, EU, GB, JP, KR,
The information on our website and any other websites referenced herein
is expressly not incorporated by reference into, and does not constitute a part of, this press release.
For further information, please contact:
SVP, Investor Relations & Corporate Communications Gary Waanders, Ph.D., MBA AC Immune Phone: +41 21 345 91 91 Email: gary.waanders@acimmune.com
International Media Chris Maggos Cohesion Bureau Phone: +41 79 367 6254 Email: chris.maggos@cohesionbureau.com
Forward looking statements
This press release contains statements that constitute "forward-looking
statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934.
Forward-looking statements are statements other than historical fact and may include statements that address future operating, financial
or business performance or AC Immune's strategies or expectations. In some cases, you can identify these statements by forward-looking
words such as "may," "might," "will," "should," "expects," "plans,"
"anticipates," "believes," "estimates," "predicts," "projects," "potential,"
"outlook" or "continue," and other comparable terminology. Forward-looking statements are based on management's
current expectations and beliefs and involve significant risks and uncertainties that could cause actual results, developments and business
decisions to differ materially from those contemplated by these statements. These risks and uncertainties include those described under
the captions "Item 3. Key Information - Risk Factors" and "Item 5. Operating and Financial Review and Prospects"
in AC Immune's Annual Report on Form 20-F and other filings with the Securities and Exchange Commission. Forward-looking statements
speak only as of the date they are made, and AC Immune does not undertake any obligation to update them in light of new information, future
developments or otherwise, except as may be required under applicable law. All forward-looking statements are qualified in their entirety
by this cautionary statement.

Frequently Asked Questions

What is the ABATE trial studying?

The ABATE trial is examining ACI-24, an anti-Abeta immunotherapy for Alzheimer's.

How many patients are in the AD4 cohort?

The AD4 cohort includes an initial group of 36 patients treated for 12 months.

What milestone payment did AC Immune receive?

AC Immune received a $12 million milestone payment from Takeda.

What are the expected results for cohorts AD1 to AD3?

Data from cohorts AD1, AD2, and AD3 are anticipated later in Q2 2026.

How does ACI-24 aim to affect Alzheimer’s progression?

ACI-24 aims to induce antibody responses that clear plaques to slow progression.

Last updated: Apr 30, 2026