AC Immune completes Recruitment for Low-Dose
Cohort of Participants in World's First Clinical Trial for
anti-Abeta Vaccine Targeting Alzheimer's Disease-like
Characteristics in Individuals with Down Syndrome
- Phase 1b study of AC Immune's ACI-24, the first anti-amyloid
vaccine for treatment of Alzheimer's disease-like characteristics
in individuals with Down syndrome
- Collaboration with University of California San Diego, CA; St.
Joseph's Hospital and Medical Center - Barrow Neurology Clinics,
Phoenix, AZ; and Massachusetts General Hospital, Boston, MA
- Alzheimer's disease-like characteristics develop in virtually
all of the Down syndrome population by age 40 with the majority
developing associated dementia by age 60
Lausanne, Switzerland, September 12,
2017 - AC Immune SA (NASDAQ: ACIU), a Swiss-based,
clinical stage biopharmaceutical company with a broad pipeline
focused on neurodegenerative diseases, today announced that it has
completed recruitment in its Phase 1b study of the first,
low-dose cohort of adults with Down syndrome (DS), a condition
affecting one in about 700 newborns. In addition to cognitive
dysfunction beginning in childhood, individuals with DS are
predisposed to develop Alzheimer's disease-like characteristics at
a much younger age and at much higher probability than the general
population.
The Phase 1b study (called 3 Star Study,
ClinicalTrials.gov Identifier: NCT02738450), is evaluating the
safety, tolerability and immunogenicity of AC Immune's anti-Abeta
vaccine ACI-24 and targeting Abeta related decline in individuals
with DS. The trial is being conducted in collaboration with the
Down Syndrome Center for Research and Treatment at the University
of California San Diego (UCSD), CA; St. Joseph's Hospital and
Medical Center and Barrow Neurological Clinics, Phoenix, AZ; and
Massachusetts General Hospital, Boston, MA. AC Immune and the
Alzheimer 's Disease Cooperative Study at UCSD coordinate the
trial.
Prof. Andrea Pfeifer, CEO of AC
Immune said: "Together with our prestigious partners, we are
advancing this study to develop a disease-modifying treatment for
Alzheimer's related symptoms and brain lesions to individuals with
Down syndrome, a population who is genetically predisposed to
Alzheimer's effects. ACI-24 is currently the only vaccine in
development targeting the associated Abeta-induced cognitive
decline in this population. We are excited to report that this
study is on target as planned and our adherence to previous
guidance underscores our commitment to being a leader in
neurodegenerative diseases."
"We believe this ground-breaking clinical trial
will enhance our understanding of early intervention and prevention
of Alzheimer's disease in general. This knowledge supports the
three pillars of our business strategy: Alzheimer's disease, other
significant neurodegenerative diseases and neuro-orphan
indications, and diagnostics of these diseases", added Prof.
Pfeifer.
Dr. William Mobley, Executive Director of the
UCSD Down Syndrome Research and Treatment Center, commented:
"We are delighted with the progress of this ground-breaking
clinical trial in adults with Down syndrome. We believe vaccination
may add important value for the Down syndrome population by
treating and preventing cognitive decline due to the presence of
increased levels of Abeta in the brain of these subjects."
About the Phase 1b trialThe main
objectives of the Phase 1b clinical trial (called 3 Star Study)
include studying safety and tolerability of ACI-24 and its effect
on induction of antibodies against Abeta. The low dose cohort trial
participants are aged 25 to 45 and will be treated for 12 months,
with a 12-month safety follow up.
The study includes up to 24 participants across
all cohorts. Interim results of the first low dose cohort are
expected in 2018. The study is being funded through a grant from
the US National Institute on Ageing, a part of the US National
Institutes of Health (NIH) with an additional grant from the LuMind
Research Down Syndrome Foundation. This is the first public/private
collaboration for a clinical trial in the field of Down
syndrome.
Ground-breaking Publication On 29 March
2016, PLOS ONE published the paper an anti-Abeta-Amyloid Vaccine
for Treating Cognitive Deficits in a Mouse Model of Down
Syndrome. The ground-breaking publication describes the use
of an established pre-clinical model for Down syndrome in which
there is an extra copy of the gene for the Amyloid Precursor
Protein (APP) and, therefore, increased levels of Abeta. The
breakthrough is the application of this model to test the impact of
an anti-Abeta vaccine. Results show that there was a clear immune
response, neuroprotection, improvement in behavior and memory
enhancement in those mice administered with the ACI-24 vaccine
compared to those in the control group.
The pre-clinical study involved scientists from
AC Immune, Lausanne, CH; the Department of Neurosciences, School of
Medicine, University of California San Diego, La Jolla, CA; and the
Department of Neurology and Neurological Sciences, Stanford Medical
School, Stanford, CA. The full publication is available at PLOS
ONE.
About Down syndromeIndividuals with Down
syndrome have an extra copy of chromosome 21 which carries the gene
for the Amyloid Beta Precursor Protein (APP) encoding the precursor
protein of Abeta, one of the hallmarks of Alzheimer's disease. An
important consequence is that individuals with Down syndrome
develop AD-like characteristics at a rate three to five times
greater than that of the general population and at a much younger
age. Further, Alzheimer's-like characteristics develop in more than
98% of people with DS over age 40 with up to 80% developing
associated dementia over the age of 60. It is estimated that there
are 6 million people with DS worldwide, with 250,000 in the United
States.
About ACI-24ACI-24 is a liposomal
therapeutic anti-Abeta vaccine candidate, owned by AC Immune and
discovered utilizing the Company's proprietary SupraAntigenTM
technology platform which focuses on vaccines and antibodies
specific to disease causing conformations. The vaccine is designed
to stimulate a patient's immune system to produce antibodies that
specifically target the oligomeric and fibrillary Abeta proteins to
prevent plaque accumulation and to enhance plaque clearance.
Preclinical data demonstrated a significant activity in plaque
reduction and memory restoration as well as a favorable safety
profile characterized by a lack of local inflammation and a mode of
action independent of inflammatory T-cells. The vaccine is
currently also being studied in a phase 1/2a clinical trial in
patients with mild to moderate AD, in which no particular safety
signals have been detected to date.
About Alzheimer's disease Evidence shows that Alzheimer's
disease develops because of a complex series of events that take
place in the brain over an extended time-period. Two proteins - Tau
and beta-amyloid (Abeta) - are recognized as major hallmarks of
neurodegeneration: tangles and other abnormal forms of Tau protein
accumulate inside the brain cells and spread between cells, while
plaques and oligomers formed by beta-amyloid occur outside the
brain cells of people with Alzheimer's disease.
Alzheimer's disease is one of the biggest
burdens of society with a dramatic and growing worldwide incidence
rate of one new case every three seconds, or 9.9 million new cases
of dementia each year. Since the incidence and prevalence of
Alzheimer's disease increase with age, the number of patients will
grow significantly as society ages. Worldwide in 2015 there were
46.8 million people living with dementia and by 2050 it is expected
that global patient numbers will triple to 131.5 million. It is
estimated that the annual societal and economic cost of dementia
has risen from US$604 billion in 2010 to US$818 billion in
2015. In the US, Alzheimer's disease is now the 6th leading
cause of death across all ages and is the fifth leading cause of
death for those aged 65 and older.
About AC ImmuneAC Immune is a clinical
stage Swiss-based biopharmaceutical company focused on
neurodegenerative diseases with four product candidates in clinical
trials. The Company designs, discovers and develops therapeutic and
diagnostic products intended to prevent and modify diseases caused
by misfolding proteins. AC Immune's two proprietary technology
platforms create antibodies, small molecules and vaccines designed
to address a broad spectrum of neurodegenerative indications, such
as Alzheimer's disease. The Company's pipeline features nine
therapeutic and three diagnostic product candidates. The most
advanced of these is crenezumab, an anti-Abeta antibody in phase 3
clinical studies that is being advanced by the collaboration
partner Genentech, Inc., a wholly owned subsidiary of Roche. Other
business partners include Biogen, Janssen Pharmaceuticals, Nestlé
Institute of Health Sciences, Piramal Imaging and Essex
Bio-Technology.
About University of California, San Diego,
Down Syndrome Research and Treatment CenterEstablished in 2009,
the Center's efforts focus on defining the genes and mechanisms
responsible for the cognitive challenges faced by people with Down
syndrome. Studies are carried out in both mouse models and in mouse
and human cellular models. The insights derived support
translation of basic science findings into new treatments, using
either existing drugs or through drug discovery. The Center's work
has resulted in conceptual innovations and several novel treatment
targets and has inspired existing trials including the study
mentioned in this press release. The Center is supported by the NIH
and private foundations, including the LuMind Research Down
Syndrome Foundation, the Alzheimer's Association, the Tau
Consortium and the Cure Alzheimer Fund.
Disclaimer NIHResearch reported in this
press release is supported by the National Institute on Aging of
the National Institutes of Health under award number R01AG047922.
The content in solely under the responsibility of AC Immune and
does not necessarily represent the official views of the National
Institutes of Health.
Forward looking statementsThis 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.
For further information please contact:
AC Immune
Prof. Andrea PfeiferChief Executive OfficerPhone: +41 21 345 91
21E-mail: andrea.pfeifer@acimmune.com |
Eva SchierCorporate Communications ManagerPhone: +41 21 345 91
34Mobile: +41 79 926 66 03E-mail: eva.schier@acimmune.com
|
Nick Miles /Toomas KullCabinet Privé de Conseils s.a.Phone: +41 22
552 46 46 E-mail: miles@cpc-pr.com kull@cpc-pr.com |
In the USTed AgneThe Communications Strategy Group
Inc.Phone: +1 781 631 3117E-mail: edagne@comstratgroup.com
|
UC San Diego
William C Mobley, MD, PhDProfessor of Neurosciences, andExecutive
Director, Down SyndromeResearch and Treatment CenterPhone: +1
858-534-9434Email: wmobley@ucsd.edu |
|
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