AC Immune prepares for a first in human study of a promising positron emission tomography (PET) tracer for Parkinson's diseas...
March 15 2018 - 5:00AM
- First potential PET tracer for Parkinson's disease
- First in human study is scheduled for the second half of
2018
- AC Immune's lead compound is highly selective for
alpha-synuclein - a key protein in Parkinson's disease
pathology
- New data will be presented at the AAT-AD/PDTM Focus Meeting
2018 in Torino, Italy, today
Lausanne, Switzerland, March 15, 2018 -
AC Immune SA (NASDAQ: ACIU), a Swiss-based, clinical stage
biopharmaceutical company with a broad pipeline focused on
neurodegenerative diseases, today announced a significant step for
a first potential PET tracer for Parkinson's disease. It plans to
initiate a first in human study, scheduled for the second half of
2018. The new compound is highly selective for alpha-synuclein
aggregates, an established target for Parkinson's disease and other
diseases with alpha-synuclein pathologies (referred to as
synucleinopathies in general). New data will be presented at the
AAT-AD/PDTM* Focus Meeting 2018 in Torino, Italy, today, March 15,
2018.
Prof. Andrea Pfeifer, CEO of AC Immune,
said: "We are excited about this significant step in our
development of potentially the first ever PET tracer for earlier
and more accurate diagnosis of Parkinson's disease. This important
milestone underlines our vision to become a global leader in
precision medicine of neurodegenerative diseases, leveraging our
proprietary technology platforms."
This next generation tracer was discovered using
the company's proprietary MorphomerTM chemistry technology
platform. AC Immune has been successfully collaborating on this
program with Biogen since April 2016. The companies will continue
to further research, develop and clinically validate this
alpha-synuclein PET tracer that will be used as an imaging
biomarker for Parkinson's disease with an aim to enable the
clinical development of new disease-modifying therapies. This
project from AC Immune is being supported by The Michael J. Fox
Foundation for Parkinson's Research (MJFF).
Jamie Eberling, PhD, Director of Research
Programs at MJFF, commented: "We are very pleased about this
next important step in the development of an alpha-synuclein
imaging agent. Having a PET tracer to detect and track Parkinson's
disease would be transformative for Parkinson's research and
patient care."
About the R&D program Such
alpha-synuclein-PET tracers would help to diagnose Parkinson's
disease earlier and more accurately. This technology has multiple
advantages including direct detection of alpha-synuclein pathology
in patients and the capacity to monitor the efficacy of
therapeutics reducing alpha-synuclein aggregates in clinical
trials. AC Immune's proprietary MorphomerTM chemistry technology
platform is designed to interact with misfolded and aggregated
proteins. Promising small molecules have been identified with good
selectivity for alpha-synuclein and suitable properties for the
development as PET ligands. The ability to precisely diagnose
Parkinson's disease and other synucleinopathies and therefore treat
patients earlier and more accurately is critical to disease
management that uses novel therapeutic approaches. This
collaboration with Biogen is non-exclusive, and AC Immune retains
intellectual property and commercialization rights.
About alpha-synuclein-PET tracers A brain
Positron Emission Tomography (PET) scan is an imaging test of the
brain involving an imaging device and an imaging agent called a PET
tracer. No alpha-synuclein-PET tracer has received regulatory
approval for commercial distribution, which represents an important
medical need, not only in Parkinson's disease but also in other
synucleinopathies such as dementia with Lewy bodies and multiple
system atrophy. Once the alpha-synuclein-PET tracer is introduced
to the body, it transiently enters the brain and binds to abnormal
alpha-synuclein protein structures (Lewy bodies, Lewy neurites
etc.). Through the radiotracer on the tracer molecule, the imaging
device detects the bound alpha-synuclein imaging agent and creates
pictures reflecting the amount and distribution of pathological
alpha-synuclein in the brain.
About Parkinson's diseaseParkinson's disease
is the second most common neurodegenerative disorder after
Alzheimer's disease. Parkinson's disease affects approximately 1%
of individuals older than 60 years and causes progressive
disability (motor and non-motor symptoms). Current therapies only
treat the symptoms of Parkinson's; there is no available treatment
that can slow or halt disease progression. The two major
neuropathological findings in Parkinson's disease are loss of
dopaminergic neurons of the substantia nigra pars compacta and the
presence of Lewy bodies and Lewy neurites in which the major
constituent is alpha-synuclein. The abnormal accumulations of
aggregated alpha-synuclein in Lewy bodies, and mutations in the
gene for alpha-synuclein in familial forms of Parkinson's disease,
have led to the belief that this protein has a central role in
Parkinson's disease. The development of alpha-synuclein pathology
appears to correlate with the loss of dopaminergic neurons and
subsequent decline in motor performance, making it a highly
relevant molecular target for diagnostic approaches.
About The Michael J. Fox FoundationAs the
world's largest nonprofit funder of Parkinson's research, The
Michael J. Fox Foundation is dedicated to accelerating a cure for
Parkinson's disease and improved therapies for those living with
the condition today. The Foundation pursues its goals through an
aggressively funded, highly targeted research program coupled with
active global engagement of scientists, Parkinson's patients,
business leaders, clinical trial participants, donors and
volunteers. In addition to funding more than $800 million in
research to date, the Foundation has fundamentally altered the
trajectory of progress toward a cure. Operating at the hub of
worldwide Parkinson's research, the Foundation forges
groundbreaking collaborations with industry leaders, academic
scientists and government research funders; increases the flow of
participants into Parkinson's disease clinical trials with its
online tool, Fox Trial Finder; promotes Parkinson's awareness
through high-profile advocacy, events and outreach; and coordinates
the grassroots involvement of thousands of Team Fox members around
the world.
About AC Immune AC 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 (AD). The Company's pipeline features nine
therapeutic and three diagnostic product candidates. The most
advanced of these is crenezumab, a humanized anti-amyloid-ß
monoclonal IgG4 antibody that targets monomeric and aggregated
forms of amyloid-ß, with highest affinity for neurotoxic oligomers
currently in Phase 3 clinical studies for AD. This global program
is being conducted by the collaboration partner Genentech (a member
of the Roche group). Other collaborations include Biogen, Janssen
Pharmaceuticals, Nestlé Institute of Health Sciences, Piramal
Imaging and Essex Bio-Technology.
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:
In EuropeBeatrix BenzAC Immune Corporate Communications
Phone: +41 21 345 91 34E-mail: beatrix.benz@acimmune.com |
In the USLisa SherAC Immune Investor RelationsPhone: +1 970
987 26 54E-mail: lisa.sher@acimmune.com |
Nick Miles/Toomas KullCabinet Privé de Conseils s.a.Phone: +41 22
552 46 46 E-mail: miles@cpc-pr.comkull@cpc-pr.com |
Ted AgneThe Communications Strategy Group Inc.Phone: +1 781 631
3117E-mail: edagne@comstratgroup.com |
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