Piramal Imaging and AC Immune present first clinical data for tau PET-imaging tracer PI-2620 at the International Conference on Alzheimer's and Parkinson's Diseases and Related Neurological Disorders (AD/PD)
New Data provides research community with insights on the preclinical properties, human dosimetry and tracer binding in AD and PSP subjects
Berlin, Germany and Lausanne, Switzerland, April 3, 2017 - Piramal Imaging and AC Immune SA (Nasdaq: ACIU) today presented the pre-clinical profile and first clinical data of the investigational next generation tau PET-imaging tracer PI-2620 at the International conference on Alzheimer's and Parkinson's Diseases and Related Neurological Disorders (AD/PD) , in Vienna, Austria. These results are an important step in Piramal Imaging's mission to develop molecular imaging innovations for an earlier and more accurate diagnosis of Alzheimer's disease and other neurodegenerative disorders. PI-2620 is the result of a research collaboration between the two companies.
First results of the ongoing clinical program confirmed the favorable potential of PI-2620. In contrast to first generation tau tracers, PI-2620 did not exhibit an increased tracer uptake in choroid plexus, striatum, amygdala or other regions of non-demented control subjects. In Alzheimer's disease (AD) subjects, however, the PI-2620 tau PET-scan showed a clear pattern of high uptake particularly in the lateral temporal and frontal lobes, consistent with the expected tau pathology. Uptake in substantia nigra and globus pallidus of Progressive Supranuclear Palsy (PSP) subjects was strong.
"We are excited by the progress of this joint tau research program and are looking forward to moving PI-2620 into larger clinical trials." Said Dr. Ludger Dinkelborg, Director of the Board of Piramal Imaging. "A non-invasive, early and precise measurement of tau will lead to improved patient management and is critical for the successful development of disease modifying drugs."
Dr. Andreas Muhs, CSO of AC Immune commented: "We are very pleased with the excellent selectivity and capability of this novel tau PET imaging tracer to detect tau in several neurodegenerative diseases. The importance of such tau PET imaging agents was emphasized in recent ground-breaking AD publication(1). Researchers showed that having knowledge about tau pathology for baseline selection of Alzheimer's patients could dramatically improve the power of clinical trials and the counseling of patients regarding disease progression."
(1) JAMA Neurol. doi:10.1001/jamaneurol.2016.5953
Tau deposits, in conjunction with beta-amyloid, represent a critical pathology in AD and play an important role in non-AD neurodegenerative diseases, e.g. Frontotemporal Dementia (FTD), Progressive Supranuclear Palsy (PSP), and chronic Traumatic Brain Injury (cTBI). The spreading of tau neurofibrillary tangles across defined brain regions is associated with cognitive decline. In recent years positron emission tomography (PET) has evolved as an important tool for the detection of misfolded protein aggregates such as beta-amyloid and tau in the brain)
Abstracts presented at AD/PD conference
The pre-clinical characterization and first clinical data of PI-2620 were presented in two abstracts during the AD/PD 2017 meeting.
PI-2620 is a promising new tau PET imaging tracer with favorable properties and is currently being validated in further clinical studies. PI-2620 shows high affinity to tau in AD and non-AD pathologies (e.g. PSP, Pick's disease) and high selectivity over other targets in the brain (e.g. beta-amyloid, monoamine oxidases A and B). Pharmacokinetic studies in mice and non-human primates confirmed favorable brain penetration, rapid washout from non-target regions and overall low-background binding.
About the research collaboration
PI-2620 was discovered in a research collaboration between Piramal Imaging and AC Immune, a Swiss-based clinical stage biopharmaceutical company focused on neurodegenerative diseases. Piramal Imaging obtained the exclusive, world-wide license for research, development and commercialization of all tau PET tracers generated within the discovery program. First-in-man clinical studies were performed at Molecular Neuroimaging, a division of Invicro, New Haven, Connecticut.
About Piramal Imaging SA
Piramal Imaging SA, a division of Piramal Enterprises, Ltd., was created in 2012 with the acquisition of the molecular imaging research and development portfolio of Bayer AG. By developing novel PET tracers for molecular imaging, Piramal Imaging is focusing on a key field of modern medicine. Piramal Imaging strives to be a Molecular Imaging leader by developing innovative products that improve early detection and characterization of chronic and life threatening diseases, leading to better therapeutic outcomes and improved quality of life. For more information, please go to www.piramal.com/imaging.
About AC Immune SA
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. 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.
Piramal Imaging cautions that statements included in this press release that are not a description of historical facts are forward-looking statements that involve risks, uncertainties, assumptions and other factors which, if they do not materialize or prove correct, could cause Piramal's results to differ materially from historical results or those expressed or implied by such forward-looking statements. Such statements are based on management's beliefs as well as assumptions made by and information currently available to Piramal. The potential risks and uncertainties, many of which are beyond Piramal's control, could contribute to the uncertain nature of these statements and include, among others, risks associated with acceptance of the Piramal's products by its customers, the outcome of any clinical trial, regulatory approval of any product, development and acceptance of new products or product enhancements, operations and business interruptions or strategic changes, expansion of our networks, and the other risks and uncertainties described in Piramal's press releases and periodic filings with appropriate regulatory agencies. Piramal assumes no obligation to update any forward looking statement to reflect events or circumstances arising after the date on which it was made.
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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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