Tau-PET Tracer PI-2620 Could Set New Standards for an Improved Diagnosis of Progressive Supranuclear Palsy

Results published in JAMA Neurology demonstrate the potential for a best-in-class diagnostic tool

BERLIN, Germany and LAUSANNE, Switzerland, July 7, 2020 – Life Molecular Imaging and AC Immune SA (NASDAQ: ACIU) announce the publication of clinical data of the investigational Tau-positron emission tomography (PET) tracer PI-2620 in patients with progressive supranuclear palsy (PSP). The tracer is shown to be a promising biomarker for the improved detection and characterization of this currently untreatable, fatal disease.

The observational study, which is published now in JAMA Neurology1 , is a multi-center evaluation led by nuclear medicine physicians and neurologists from Munich and Leipzig, Germany, together with researchers at study sites in New Haven, Cologne and Melbourne. The results indicate that PI-2620 could facilitate an earlier and more reliable diagnosis of PSP, where previous Tau tracers and other biomarkers failed. The accumulation of 4R Tau protein deposits in specific brain regions is a pathological hallmark of PSP. PI-2620 shows signals in those regions of PSP patients and allows excellent discrimination from disease controls at the single-subject level by both visual inspection and quantitative analyses of brain scans.

These new results in PSP further demonstrate PI-2620’s excellent characteristics as a strong diagnostic tool for studying Tau-related diseases following recent publications about its capabilities in early and more advanced Alzheimer’s disease,2-6 .

PI-2620 was discovered in a research collaboration with Life Molecular Imaging and AC Immune, Life Molecular Imaging has the exclusive world-wide license for research, development and commercialization of Tau-PET tracers generated within the discovery program. PI-2620 is currently under investigation in several clinical studies as a targeted radiopharmaceutical for the detection of Tau deposits in the human brain.

Dr. Andrew Stephens, Chief Medical Officer at Life Molecular Imaging, said: “This large multi-center study demonstrates the power of PI-2620 as a biomarker to study 4R Tau-related diseases like PSP. The detection and monitoring of the underlying Tau pathology with PI-2620 for both 4R-Tauopathies like PSP and corticobasal degeneration (CBD), as well as 3R/4R Tauopathies like Alzheimer’s disease will advance the field, leading to appropriate patient selection and monitoring target engagement in clinical trials of emerging therapeutic agents.”

Prof. Andrea Pfeifer, CEO of AC Immune SA, added: “This real-world study provides first evidence that PI-2620 could provide an earlier and more accurate diagnosis of PSP. Highly specific PET tracers are a critical tool in the patient pathway to achieve an accurate diagnosis, a particular challenge in the complex spectrum of neurodegenerative disorders and often not achievable through clinical presentation alone. Such capabilities would enable early, targeted therapeutic interventions for PSP patients and enhance the research community’s ability to better advance more effective treatments and cures.”

PSP is an orphan disease that affects up to 18 out of every 100,000 individuals worldwide. Patients can be challenging to diagnose because they show symptoms, such as movement difficulties, stiffness, clumsiness, cognitive impairment and frequent falls that are also present in many neurodegenerative diseases, like Parkinson’s disease (PD). Misdiagnosis of PSP hampers drug development due to heterogeneous study populations, mixing patients with Tau-related pathologies and patients suffering from other proteinopathies.


  1. Brendel et al. “Assessment of 18F-PI-2620 as a Biomarker in Progressive Supranuclear Palsy” JAMA Neurology Online first
  2. Kroth et al. “Discovery and Preclinical Characterization of 18F-PI-2620, a Next-Generation Tau PET Tracer for the Assessment of Tau Pathology in Alzheimer’s Disease and Other Tauopathies“ Eur J Nucl Med Mol Imaging. 2019 Sep;46(10):2178-2189
  3. Mueller et al., “Tau PET imaging with 18F-PI-2620 in Patients with Alzheimer Disease and Healthy Controls: A First-in-Humans Study” J Nucl Med. 2020 Jun;61(6):911-919
  4. Bullich et al., “Evaluation of Dosimetry, Quantitative Methods, and Test-Retest Variability of 18F-PI-2620 PET for the Assessment of Tau Deposits in the Human Brain” J Nucl Med. 2020 Jun;61(6):920-927
  5. Beyer et al., “Early-phase 18F-PI-2620 tau-PET imaging as a surrogate marker of neuronal injury” Eur J Nucl Med Mol Imaging. 2020 Apr 21. w Online ahead of print
  6. Mormino et al., “Tau PET imaging with 18F-PI-2620 in aging and neurodegenerative diseases”. Eur J Nucl Med Mol Imaging. 2020 Jun 23. 04923-7 Online ahead of print

About Life Molecular Imaging (LMI)

LMI (formerly Piramal Imaging) was formed in 2012 with the acquisition of the molecular imaging research and development portfolio of Bayer Pharma AG, and is now part of the Alliance Medical Group, an integrated business including research and development laboratories, a network of cyclotrons, radiopharmacies and imaging facilities. By developing novel PET tracers for molecular imaging, LMI is focusing on a key field of modern medicine. LMI strives to be a leader in the Molecular Imaging field 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. Please visit:

About AC Immune SA
AC Immune SA is a Nasdaq-listed clinical-stage biopharmaceutical company, which aims to become a global leader in precision medicine for neurodegenerative diseases. The Company utilizes two proprietary platforms, SupraAntigenTM and MorphomerTM, to design, discover and develop small molecule and biological therapeutics as well as diagnostic products intended to diagnose, prevent and modify neurodegenerative diseases caused by misfolding proteins. The 3 / 3 Company’s pipeline features nine therapeutic and three diagnostic product candidates, with six currently in clinical trials. It has collaborations with major pharmaceutical companies including Roche/Genentech, Eli Lilly and Company and Janssen Pharmaceuticals.

For further information, please contact:

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Neuraceq® - Product Indications And Use

PRODUCT INDICATIONS AND USE: Neuraceq is indicated for Positron Emission Tomography (PET) imaging of the brain to estimate β-amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer’s Disease (AD) and other causes of cognitive decline. A negative Neuraceq scan indicates sparse to no neuritic plaques and is inconsistent with a neuropathological diagnosis of AD at the time of image acquisition; a negative scan result reduces the likelihood that a patient’s cognitive impairment is due to AD. A positive Neuraceq scan indicates moderate to frequent amyloid neuritic plaques; neuropathological examination has shown this amount of amyloid neuritic plaque is present in patients with AD, but may also be present in patients with other types of neurologic conditions as well as older people with normal cognition. Neuraceq is an adjunct to other diagnostic evaluations.

Limitations: Limitations of Use
A positive Neuraceq scan does not establish the diagnosis of AD or any other cognitive disorder. The safety and effectiveness of Neuraceq have not been established for Predicting the development of dementia or other neurologic conditions or monitoring responses to therapies.



  • Risk for Image Misinterpretation and other Errors
    Errors may occur in the Neuraceq estimation of brain neuritic β-amyloid plaque density during image interpretation [see Clinical Studies (14)]. Image interpretation should be performed independently of the patient’s clinical information. The use of clinical information in the interpretation of Neuraceq images has not been evaluated and may lead to errors. Errors may also occur in cases with severe brain atrophy that limits the ability to distinguish gray and white matter on the Neuraceq scan. Errors may also occur due to motion artifacts that result in image distortion. Neuraceq scan results are indicative of the presence of brain neuritic β-amyloid plaques only at the time of image acquisition and a negative scan result does not preclude the development of brain neuritic β-amyloid plaques in the future.
  • Radiation Risk
    Neuraceq, similar to other radiopharmaceuticals, contributes to a patient's overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk of cancer. Ensure safe handling to protect patients and health care workers from unintentional radiation exposure [see Dosage and Administration.


  • The most commonly reported adverse reactions in clinical trials were injection site pain (3.4%), injection/appliucation site erythema (1.7%), injection site irritation (1.1%).


  • Drug-drug interaction studies have not been performed in patients to establish the extent, if any, to which concomitant medications may alter Neuraceq image results.


  • Pregnancy: All radiopharmaceuticals, including Neuraceq, have a potential to cause fetal harm depending on the stage of fetal development and the magnitude of the radiopharmaceutical dose. If considering Neuraceq administration to a pregnant woman, inform the patient about the potential for adverse pregnancy outcomes based on the radiation dose from the drug and the gestational timing of exposure.
  • Lactation: There are no data on the presence of florbetaben F 18 injection in human milk, the effects on the breastfed infant, or the effects of florbetaben F 18 injection on milk production. Exposure of Neuraceq to a breastfed infant can be minimized by temporary discontinuation of breastfeeding. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Neuraceq and any potential adverse effects on the breastfed child from Neuraceq or from the underlying maternal condition.
  • Pediatric Use: Neuraceq is not indicated for use in pediatric patients.
  • Geriatric Use: No overall differences in safety were observed between older and younger subjects

A pharmacological overdose of Neuraceq is unlikely given the relatively low doses used for diagnostic purposes. In the event of administration of a radiation overdose with Neuraceq, the absorbed organ dose to the patient should be reduced by increasing elimination of the radionuclide from the body by inducing frequent micturition. Prior to Neuraceq administration, please read the full Prescribing Information for additional Important Safety Information.