Update on Therapeutic and Diagnostic Programs Targeting TDP-43
Lausanne, Switzerland, November 1, 2018 - AC Immune SA (ACIU), a Swiss-based, clinical-stage biopharmaceutical company with a broad pipeline focused on neurodegenerative diseases will provide updates on its product candidates at the Society for Neuroscience Meeting 2018, taking place in San Diego from November 3rd to 7th, 2018.
The first update will cover the wholly-owned TAR DNA binding protein 43 (TDP-43) antibody program aimed to provide novel therapeutic options for patients suffering from TDP-43 proteinopathies such as amyotrophic lateral sclerosis (ALS) and frontotemporal lobar degeneration (FTLD-TDP). The second update will be on the accompanying diagnostic program focused to deliver positron emission tomography (PET) tracers specific for misfolded and aggregated TDP-43, which is non-exclusively partnered with Biogen Inc.
The oral presentation entitled "Discovery and development of diagnostics and therapeutics for TDP-43 proteinopathies" includes data on both programs and will be presented on November 4th during the session "Tau and TDP-43 proteinopathies" (1pm to 3.15 pm, PST; Session #188, in room SDCC 5).
About the R&D programs
AC Immune is developing therapeutic monoclonal antibodies against pathological forms of the transactive response (TAR) DNA binding protein (TDP-43). Misfolded TDP-43 has been identified as the major component of pathological protein inclusions, in both ALS and frontotemporal lobar degeneration (FTLD-TDP). It has been shown that pathological TDP-43 can spread from neuron to neuron as being described for many pathological proteins in neurodegenerative disease. This mechanism creates the opportunity to interfere with the process through application of monoclonal antibodies. AC Immune is using its proprietary SupraAntigenTM technology to raise a broad panel of monoclonal antibodies targeting misfolded TDP-43 which are currently undergoing functional evaluation. This program is wholly-owned by AC Immune.
Complementary to a therapeutic approach, AC Immune is developing novel PET tracers specifically targeting pathological TDP-43 inclusions. Small molecules suitable for PET tracer development are being derived from AC Immune's proprietary MorphomerTM chemistry technology platform, which is designed to interact with misfolded and aggregated proteins. Promising small molecule hits have been identified by binding assays using patient -derived TDP-43 aggregates. The ability to precisely diagnose FTLD and other TDP-43 proteinopathies and therefore treat patients earlier and more accurately is critical to disease management that uses novel therapeutic approaches. This collaboration with Biogen Inc. was established in April 2016; it is non-exclusive, and AC Immune retains intellectual property and commercialization rights.
TDP-43 (TAR DNA binding protein 43) is a new target in the area of neurodegenerative diseases. Misfolded, aggregated TDP-43 is found in diseases such as amyotrophic lateral sclerosis (ALS), frontotemporal dementia (FTD), chronic traumatic encephalopathy and Huntington's disease. There is growing body of evidence that the pathological aggregation of TDP-43 protein also plays an important role in Alzheimer's disease. The link of clinical features and spread of pathological TDP-43 is associated with a multitude of neurodegenerative diseases including Alzheimer's disease and make misfolded TDP-43 a promising target for our antibody program.
About TDP-43-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 TDP-43-PET tracer has received regulatory approval for commercial distribution, which represents an important medical need to diagnose precisely patients suffering from TDP-43 proteinopathies such as amyotrophic lateral sclerosis (ALS) and frontotemporal lobar degeneration (FTLD). Once the TDP43-PET tracer is introduced to the body, it transiently enters the brain and binds to abnormal TDP-43 inclusions. Through the radiotracer on the tracer molecule, the imaging device detects the TDP-43 imaging agent and creates pictures reflecting the amount and distribution of misfolded TDP-43 in the brain.
About AC Immune
AC Immune is a clinical-stage Swiss-based biopharmaceutical company, listed on NASDAQ, which aims to become a global leader in precision medicine for neurodegenerative diseases. The Company designs, discovers and develops therapeutic as well as 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) and Parkinson's disease. The Company's pipeline features nine therapeutic and three diagnostic product candidates - with five product candidates currently in clinical trials. 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 the highest affinity for neurotoxic oligomers. Crenezumab is currently in two 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, Life Molecular 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.
For further information, please contact:
| In Europe |
AC Immune Corporate Communications
Phone: +41 21 345 91 34
| In the US |
AC Immune Investor Relations
Phone: +1 970 987 26 54
| Nick Miles/Toomas Kull |
Cabinet Privé de Conseils s.a.
Phone: +41 22 552 46 46
| Ted Agne |
The Communications Strategy Group Inc.
Phone: +1 781 631 3117