AC Immune SA to Receive Milestone Payment for Anti-Tau Antibody Moving into Phase 2 Trial for Alzheimer's Disease
November 02 2017 - 6:23AM
- AC Immune to receive third milestone payment of CHF 14
million under collaboration agreement with Genentech
- Phase 2 to evaluate effects of anti-Tau antibody in people
with prodromal-to-mild Alzheimer's disease
- Phase 1 data to be presented today at CTAD conference,
Boston, USA
Lausanne,
Switzerland, November 2, 2017 - AC Immune SA (NASDAQ: ACIU), a
Swiss-based, clinical stage biopharmaceutical company with a broad
pipeline focused on neurodegenerative diseases, today announced
that Genentech, a member of the Roche Group, has dosed the first
patient in a Phase 2 clinical trial for Alzheimer's disease (AD)
with an anti-Tau monoclonal antibody known as RO7105705. This
investigational medicine was discovered and humanized as part of
the company's collaboration with Genentech. Upon the dosing of the
first patient in the Phase 2 clinical trial, AC Immune becomes
eligible to receive a milestone payment of CHF 14 million, which is
expected to be paid in the fourth quarter of 2017. This will be the
third milestone payment under the 2012 strategic collaboration and
licensing agreement with Genentech for anti-Tau antibodies for the
treatment of AD and other neurodegenerative diseases. AC Immune
also has a licensing agreement for the anti-Abeta antibody
crenezumab, which is in Phase 3 clinical studies being conducted by
Genentech.
Prof. Andrea Pfeifer, CEO of AC Immune,
commented: "We are delighted that our collaboration partner
Genentech is taking this anti-Tau antibody into Phase 2. Tau
pathology is widely recognized to be closely associated with
cognitive decline and neurodegeneration in Alzheimer's disease and
other tauopathies." She continued "Our unique understanding of the
pathology of misfolding proteins is exemplified by the depth of our
pipeline and the range of our collaborations."
About the Phase 2 clinical trialThe Phase
2 clinical trial is conducted by Genentech and will enroll 360
patients to assess the safety, tolerability and efficacy of the
anti-Tau monoclonal antibody RO7105705 in people with
prodromal-to-mild AD. Participants will receive one of three active
doses or placebo for 72 weeks, followed by a 96-week optional open
label extension. Primary endpoints include safety measures and the
composite functional and cognitive endpoint CDR (Clinical Dementia
Rating scale) sum-of-boxes score. Change from baseline in Tau
pathological burden is an important exploratory endpoint.
Phase 1 results to be presented at CTAD conference
BostonThe start of the Phase 2 clinical trial follows the
completion of a Phase 1 clinical trial that involved 75 subjects
and evaluated the safety, tolerability, pharmacokinetics and
preliminary activity of RO7105705 in people with
mild-to-moderate AD and in healthy volunteers. Preliminary data
relating to the single and multiple dose cohorts were presented at
the International Conference on Alzheimer's & Parkinson's
Disease (AD/PD) in March 2017 (Kerchner et al, Genentech) and the
Alzheimer's Association International Conference (AAIC) in July
2017 (Kerchner et al, Genentech). The full analysis of the Phase 1
will be presented by Dr. Kerchner at the Clinical Trials on
Alzheimer's Disease (CTAD) conference today, November 2, 2017
(3:00pm EST | 8:00pm CET) in Boston, USA. RO7105705 was
administered at single doses of up to 16,800 mg in healthy
volunteers and multiple doses of 8,400 mg in healthy volunteers and
patients with AD. No dose-limiting toxicities were observed.
RO7105705 exhibited a dose proportional pharmacokinetic profile,
indicated CNS exposure and showed a median half-life of more than
32 days. Plasma total Tau concentration increased with increasing
drug doses and was greater in participants with AD than in healthy
volunteers, suggesting a pharmacodynamic signal.
About the anti-Tau antibody
(RO7105705)RO7105705 is an IgG4 humanized anti-Tau monoclonal
antibody in clinical development for the treatment of AD and other
neurodegenerative diseases. It shows a high specificity for
pathological Tau and is designed to intercept the cell-to-cell
spread of pathological Tau in the extracellular space of the brain.
This investigational medicine was discovered and humanized as part
of AC Immune's collaboration with Genentech.
About the license agreementIn June 2012,
AC Immune entered into a strategic collaboration agreement with
Genentech to commercialize AC Immune's anti-Tau antibodies for use
as immunotherapeutics. The value of this exclusive, worldwide
alliance is potentially greater than CHF 400 million and includes
upfront and milestone payments. In addition to milestones, AC
Immune will be eligible to receive royalties on sales at percentage
rates ranging from the mid-single digits to high-single digits. The
agreement also provides for collaboration on additional indications
developed as part of the same anti-Tau antibody program, as well as
a potential anti-Tau diagnostic product. To date, AC Immune has
received payments totaling CHF 45 million excluding the CHF 14
million milestone payment which AC Immune became eligible to
receive upon commencement of the Phase 2 clinical study.
About Tau in Alzheimer's disease and
neurodegenerative diseasesIt 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 amyloid-beta (Abeta) - are recognized as major
hallmarks of AD. Pathological forms of Tau aggregate inside neurons
to form neurofibrillary tangles, and appear to propagate by
cell-to-cell spread between neurons. By contrast, Abeta-containing
plaques and oligomers form outside the brain cells of people with
AD. Tau protein is mostly present in neurons and functions as a
component of the cytoskeleton inside the cells. Misfolded Tau
protein aggregates in AD and other Tau-related neurodegenerative
diseases (e.g. progressive supranuclear palsy, frontotemporal
dementia and others). In AD, accumulation of Tau pathology occurs
later than the accumulation of Abeta pathology. The progression of
Tau pathology through the brain is closely associated with the
onset and progression of cognitive decline, underscoring the
importance of Tau-targeted therapies. Please follow this link
to learn more about the biology of Alzheimer's disease and the
importance of Tau as a target in AD.
About Alzheimer's diseaseAD 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 were 46.8 million people
living with dementia and by 2050 it is expected that global patient
numbers will triple to 131.5 million. 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. The total US national
costs of caring for dementia patients are estimated at USD 259
billion in 2017 and are projected to increase by 400% to USD 1.1
trillion in 2050 in the US alone.
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 AD. 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 conducted by the collaboration partner Genentech. 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 EuropeEva SchierAC Immune Corporate Communications Phone:
+41 21 345 91 34E-mail: eva.schier@acimmune.com |
In the USLisa SherAC Immune Investor Relations Phone: +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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