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AC Immune's ACI-24.060 Anti-Amyloid Beta Vaccine for Alzheimer's Shows Positive Initial Interim Safety and Immunogenicity in Phase 1b/2 ABATE Trial ACI-24.060 elicited an anti-Abeta antibody response in ABA

Key Takeaway: AC Immune announced promising interim safety and immunogenicity results for its anti-amyloid beta vaccine, ACI-24.060, in the Phase 1b/2 ABATE trial targeting Alzheimer’s disease. The vaccine was well tolerated, prompting the initiation of higher dose cohorts and the inclusion of participants with Down syndrome. Future data on amyloid plaque reduction is expected in 2024. AC Immune aims to address significant medical needs with this novel therapeutic approach.

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POSITIVE FACTORS

  • Initial interim findings showed positive safety and immunogenicity.
  • The trial has been expanded to include individuals with Down syndrome.
  • Antibody responses were observed as early as week 6 post-vaccination.

Full Press Release Details

AC Immune's ACI-24.060 Anti-Amyloid Beta
Vaccine for Alzheimer's Shows Positive Initial Interim Safety and Immunogenicity in Phase 1b/2 ABATE Trial
ACI-24.060 elicited an anti-Abeta antibody response in ABATE's first low dose cohort
ACI-24.060 was generally well tolerated with no safety concerns observed
With these findings, dosing in the second higher dose Alzheimer's cohort has begun
Screening of cohort of study participants with Down syndrome also cleared to begin
Further safety and immunogenicity findings from ABATE cohorts expected in H2 2023
Initial data on amyloid plaque reduction measured via PET imaging anticipated in 2024
Lausanne, Switzerland, January 26, 2023
- AC Immune SA (NASDAQ: ACIU), a clinical-stage biopharmaceutical company pioneering precision medicine for neurodegenerative diseases,
today announced the first interim safety, tolerability and immunogenicity findings from the Phase 1b/2 ABATE trial of its anti-amyloid-beta
(Abeta) vaccine ACI-24.060 in patients with prodromal Alzheimer's disease (AD). ABATE will now be expanded, as planned, to include
individuals with Down syndrome (DS) and to evaluate higher doses in Alzheimer's patients.
Targeting Abeta using antibodies has recently been
validated with FDA approvals of new monoclonal antibody treatments for patients with AD. By eliciting polyclonal anti-Abeta antibodies,
the ACI-24.060 anti-Abeta vaccine development program aims to ultimately deliver significant benefits to patients, their caregivers, and
healthcare systems in terms of potential safety and tolerability, low frequency dosing, low overall costs and durable responses.
Early results from the first cohort of AD patients
in ABATE showed that low dose ACI-24.060 could elicit an anti-Abeta antibody response as soon as week 6 (2 weeks after the second injection).
The data show that ACI-24.060 vaccination has been safe and well tolerated to date. As a result, dosing in ABATE's second, higher
dose AD cohort has now begun and the trial is cleared to begin screening individuals with DS for part 2 of the study.
Dr. Andrea Pfeifer, CEO of AC Immune
SA, commented: "We are delighted with the encouraging initial safety and immunogenicity findings for ACI-24.060 in ABATE reported
today. We believe ACI-24.060's successful development could provide patients with a novel therapeutic option offering numerous potential
advantages in treatment, maintenance, and prevention settings. These early findings from ABATE represent an important step towards this
goal, and we look forward to reporting more detailed data at a future conference."
Dr. Johannes Streffer, CMO of AC Immune
SA, commented: "ABATE's innovative design includes interim Abeta PET imaging analyses that can be benchmarked against
the levels of plaque clearance achieved with clinically-validated monoclonal antibodies. This will provide an opportunity for early de-risking
of ACI-24.060 and potentially a rapid transition to a pivotal program. Moreover, the inclusion of cohorts of participants with DS in the
trial positions us to potentially address the needs of a vastly underserved vulnerable population, virtually all of whom will develop
amyloid plaques and AD. While looking forward to the trial's continued advancement and upcoming data readouts, I want to thank the
participants and investigators for their participation and support."
About the Phase 1b/2
ABATE Study (ClinicalTrials.gov Identifier: NCT05462106)
study is a Phase 1b/2, multicenter, adaptive, double-blind, randomized, placebo-controlled study to assess the safety, tolerability, immunogenicity,
and pharmacodynamic effects of ACI-24.060 in subjects with prodromal Alzheimer's disease and in adults with Down syndrome. All participants
in the trial must have brain Abeta pathology confirmed by a positron emission tomography (PET) scan. The trial begins with a dose escalation
phase in AD patients, during which various doses/dosing regimens may be evaluated, and also includes individuals with DS.
ACI-24.060, derived from
AC Immune's SupraAntigen platform, has been shown in preclinical studies to induce a strong polyclonal antibody
response that matures and is maintained against both oligomeric and pyroglutamate-Abeta species, key pathological forms of Abeta believed
to drive Abeta plaque formation and disease progression. ACI-24.060 is designed to enhance the formation of broad-spectrum protective
antibodies with the same safety and tolerability previously demonstrated in the ACI-24 program in Phase 1 and 2 trials. This investigational
candidate has the potential to efficiently inhibit plaque formation and increase plaque clearance, and thereby may reduce or prevent disease
AC Immune SA is a clinical-stage biopharmaceutical
company that aims to become a global leader in precision medicine 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 broad and diversified pipeline of first- and best-in-class
assets, which currently features ten therapeutic and three diagnostic candidates, five of which are currently in Phase 2 clinical trials
and one of which is in Phase 3. AC Immune has a strong track record of securing strategic partnerships with leading global pharmaceutical
companies including Genentech, a member of the Roche Group, Eli Lilly and Company, and others, resulting in substantial non-dilutive
funding to advance its proprietary programs and >$3 billion in potential milestone payments.
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 CN, CH, GB, JP, KR, NO and RU.
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:
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. These include: the impact of Covid-19 on our business, suppliers, patients and employees and any other impact of Covid-19.
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 ACI-24.060?

ACI-24.060 is an anti-amyloid beta vaccine for Alzheimer's disease, currently in clinical trials.

What were the results of the Phase 1b/2 ABATE trial?

The trial showed positive initial safety and immunogenicity findings for ACI-24.060.

Who is included in the ABATE trial?

The trial includes patients with prodromal Alzheimer's and individuals with Down syndrome.

When can we expect more data from the ABATE trial?

Further findings from the trial are anticipated in H2 2023, with initial data in 2024.

How well was ACI-24.060 tolerated?

ACI-24.060 was generally well tolerated with no significant safety concerns reported.

Last updated: Jan 26, 2023