- Strong commitment to potential disease-modifying
therapy
- New Phase 3 CREAD2 trial to investigate 750
participants
- Current Phase 3 CREAD1 trial of 750 participants expected to
read out 2020
Lausanne, Switzerland, February 28, 2017
- AC Immune SA (NASDAQ: ACIU), a Swiss-based, clinical stage
biopharmaceutical company focused on neurodegenerative diseases,
today announced that its partner Genentech, member of Roche group,
has decided to start a second Phase 3 clinical trial of the
Alzheimer's therapy crenezumab, an anti-Abeta antibody. This new
trial CREAD2 will recruit 750 patients with prodromal or mild
Alzheimer's disease. This new trial complements the current Phase 3
CREAD1 trial of 750 participants with prodromal or mild Alzheimer's
disease, expected to read out in 2020[1]. Trial design details of
CREAD2 are not yet available but will be posted on
ClinicalTrials.Gov in due course. Crenezumab was discovered by AC
Immune using its SupraAntigen technology platform and out-licensed
to Genentech in 2006 as a potential therapy for Alzheimer's
disease. AC Immune will not receive any milestone payments for the
start of this second Phase 3 trial since the company already
received a milestone payment when the CREAD1 trial started.
Prof. Andrea Pfeifer, CEO of AC Immune,
commented: "We are delighted with the strong commitment of our
partner Genentech to developing crenezumab as a potential disease
modifying therapy for Alzheimer's. Given the recent disappointing
results of other therapies, all of us in the Alzheimer's community
need to redouble our efforts to combat one of society's biggest
challenges. We remain confident about the potential of crenezumab
given it is distinct from other beta amyloid antibodies,
predominantly blocking oligomers in the brain, and has a clinical
development program that is using higher dosing and targeting
earlier stages of Alzheimer's disease."
Recent data supporting Genentech
decisionImportant data to support the unique binding and
increased dosing of crenezumab were presented by Genentech in
December 2016 at the 9th Clinical Trials on Alzheimer's disease
Conference (CTAD) in San Diego, USA.
Genentech has developed a comprehensive
drug-disease progression model which predicts, relative to the
Phase 2 trials, an increased potential of the CREAD Phase 3
clinical trial in patients with prodromal-to-mild Alzheimer by
using the higher dose of 60mg/kg of crenezumab.
The safety and pharmacokinetic data of the Phase
1b dose escalation study support the continued treatment of
patients with crenezumab at a higher dose of 60mg/kg. Furthermore,
a paper was published in Scientific Reports on 20 December 2016
titled "Structure of crenezumab complex with Abeta shows loss of
beta-hairpin" (www.nature.com/articles/srep39374). This publication
describes the crystal structure of crenezumab targeting the beta
amyloid oligomers. There is strong scientific evidence which
suggests that those oligomers are the toxic form of Abeta and may
be primarily responsible for neurotoxicity when compared to
monomers and fibrils of the misfolded Abeta protein. Crenezumab is
shown to bind to a unique sequential, conformational epitope that
only exists in the aggregated form of Abeta. This binding induces
essential molecular interactions to break up and thereby
solubilizes the oligomeric form of Abeta. These insights highlight
crenezumab's unique mechanism of action, particularly regarding
Abeta oligomers, and provide a strong rationale for the evaluation
of crenezumab as a potential AD therapy.
About CrenezumabCrenezumab was discovered
by AC Immune using its SupraAntigen technology platform and
out-licensed to Genentech in 2006 as a potential therapy for
Alzheimer's disease. Crenezumab is a fully humanized IgG4
monoclonal antibody that binds all forms of misfolded Abeta
proteins, but especially to Abeta oligomers, to prevent and break
up Abeta aggregation and promote Abeta disaggregation. The IgG4
subclass has reduced the effector function, allowing microglia to
clear Abeta from the brain while minimizing an inflammatory
response.
Genentech is currently evaluating the clinical
efficacy and safety of Crenezumab in a Phase 3 clinical trial,
CREAD, in 750 participants with prodromal or mild Alzheimer's
disease, which started in Q1 2016 and is expected to read out in
2020. In addition crenezumab was chosen by an international panel
of experts, including the US National Institutes of Health, for use
in a first-ever prevention trial in Alzheimer's disease in a large
extended family in Colombia (API ADAD) in 2012.
About the out-licensing agreement In 2006
AC Immune closed an exclusive out-licensing agreement for its
anti-Abeta antibody program with Genentech, under
which Genentech develops crenezumab for the treatment of
Alzheimer's disease. AC Immune received an upfront payment and
milestone payments upon the start of phase 1, phase 2 and
phase 3 respectively. The contract provides potential total
revenues of over USD 300 million for AC Immune through payments
upon successful completion of clinical and regulatory milestones in
Alzheimer's disease and additional applications.
Additionally, the company is entitled to receive royalties on
net sales of products resulting from this partnership.
About Alzheimer's disease It is becoming
increasingly clear that Alzheimer's disease develops because of a
complex series of events that take place in the brain over a long
period of time. 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
AD.
AD 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 AD increase with age,
the number of patients will grow significantly as society ages.
Worldwide in 2015 there are 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, AD 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 seven
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 member of the Roche Group. Other
business partners include Biogen, Janssen Pharmaceuticals, Nestlé
Institute of Health Sciences and Piramal Imaging.
Forward looking statementsThis press
release may contain 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, but are not limited to, the timing and
conduct of clinical trials of AC Immune's product candidates, the
clinical utility of AC Immune's product candidates, the timing or
likelihood of regulatory filings and approvals, AC Immune's
intellectual property position and AC Immune's financial position.
These risks and uncertainties also include those described under
the captions "Risk Factors" and "Management's Discussion and
Analysis of Financial Condition and Results of Operations" in AC
Immune's Registration Statement on Form F-1 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:
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 Kull Cabinet Privé de Conseils s.a.Phone :
+41 22 321 45 40E-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
|
[1] www.clinicaltrials.gov Identifier
NCT02670083
Attachments:
http://www.globenewswire.com/NewsRoom/AttachmentNg/6bb8581c-1ba4-4e4e-9ab5-c077f869ae1e
AC Immune (NASDAQ:ACIU)
Historical Stock Chart
From Mar 2024 to Apr 2024
AC Immune (NASDAQ:ACIU)
Historical Stock Chart
From Apr 2023 to Apr 2024