- Tau small molecules (Tau Morphomers) demonstrate target-specific reduction of pathological Tau as well as cognitive and
functional improvement
- Significant reduction of microglia activation enhances the benefits on Tau pathology
- Tau Morphomers are capable of crossing the blood brain barrier and show a promising safety profile
- Selected Tau Morphomers have entered IND/CTA* enabling studies; Phase 1 to commence by the end of 2018
Lausanne, Switzerland, April 5, 2018 - AC Immune SA (NASDAQ: ACIU), a Swiss-based, clinical stage biopharmaceutical company
with a broad pipeline focused on neurodegenerative diseases, today announced that several Tau Morphomer candidates have
demonstrated target-specific reduction of pathological Tau and cognitive and functional improvement in proof-of-concept studies in
Alzheimer's disease. In addition to the Tau inhibition, a significant parallel reduction of microglia activation and
neuroinflammation has been observed; another key factor in Alzheimer's and other neurodegenerative diseases. Tau Morphomers are the
first candidates derived from AC°Immune's proprietary MorphomerTM platform generating therapeutic CNS small molecules
with high selectivity for misfolded proteins in multiple proteinopathies.
Prof. Andrea Pfeifer, CEO of AC Immune, said: "AC Immune has one of the largest Tau pipelines in the industry and our various
therapies intervene at key points in the pathway of Alzheimer's disease. The specifically designed Tau Morphomers have a unique
mode of action, inhibit intracellular Tau pathology the source of Tau spreading and reduce neuroinflammation. Hence, they are
well-positioned to be used in mono- and combination therapies of neurodegenerative diseases."
Prof. Andrea Pfeifer will present at the H.C. Wainwright Global Life Sciences
Conference:
Le Meridien Plaza Hotel
Monte Carlo, Monaco
April 8-10, 2018
Session: Monday, April 9th, 9:25-9:50am CET
Salon Atlantic W (2nd Floor)
Link to Webcast
|
* IND: Investigational New Drug; CTA: Clinical Trial Application
About the Company's Tau pipeline
The Company's broad Tau pipeline covers the full range of approaches: small molecules (Morphomers), antibodies, vaccines and
diagnostics.
Product
candidate |
Target |
Target
Indication |
Partner |
Status |
ACI-35
(Anti-pTau vaccine) |
Tau |
AD1 treatment |
Janssen Pharmaceuticals |
Phase 1b |
Anti-Tau antibody |
Tau |
AD treatment |
Genentech* |
Phase 2 |
Morphomer Tau
(Tau inhibitor, small molecule) |
Tau |
AD treatment |
|
Pre-clinical |
Tau-PET2 imaging agent |
Tau |
Diagnostics; AD and PSP3 |
Piramal Healthcare |
Advancing to longitudinal study |
1 Alzheimer's disease
2 Positron emission tomography
3 Progressive supranuclear palsy
* Genentech, a member of the Roche group
About Tau Morphomers
Several chemical series of small molecules (MorphomersTM) have been identified which selectively and potently reduce
toxic intracellular misfolded and aggregated Tau.
Targeting intracellular misfolded and aggregated Tau is widely recognized as an important and attractive
approach for interfering with the spread of Tau pathology throughout the brain. The activity of Tau may act as a seed that induces
native endogenous Tau forms to misfold and aggregate into toxic species.
In proof-of-concept Tauopathy models, reduction of Tau pathology was also accompanied by a reduction of
associated neuroinflammatory markers - another key pathologic feature of Alzheimer's disease (AD).
Lead compounds have been identified which display excellent ADME (absorption, distribution, metabolism and
elimination or excretion) and pharmacokinetics properties suitable for targeting the central nervous system. Two candidates in
clinical studies are currently undergoing further preclinical safety assessment, with the goal to initiate a clinical Phase°1 study
by end 2018.
About the MorphomerTM technology platform
The rational chemical design enables AC Immune to generate small molecules, also known as MorphomersTM, which bind
highly specifically to misfolded proteins, break up neurotoxic aggregates and inhibit their aggregation and seeding. Other key
assets of the robust library of Morphomers include promising CNS drug features such as excellent brain penetration, bioavailability
and metabolic stability which are important for the development of both therapeutic and diagnostic agents for multiple
neurodegenerative diseases.
Three therapeutic (Morphomer Tau, Morphomer Abeta and Morphomer a-syn) and two diagnostic development candidates
(Tau-PET imaging agent and a-syn-PET imaging agent) originate from the MorphomerTM technology platform.
About Tau in Alzheimer's disease and neurodegenerative diseases
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 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 throughout
the brain is closely associated with the onset and progression of cognitive decline, underscoring the importance of Tau-targeted
therapies.
About AC Immune
AC Immune is a clinical stage Swiss-based biopharmaceutical company focused on neurodegenerative diseases with five 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. Crenezumab is currently in Phase 3 clinical studies for AD, under a global program 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 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. 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.
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