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SEC Filings

AC IMMUNE SA filed this Form 20-F on 03/21/2019
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We are developing two diagnostic product candidates using our Morphomer technology platform. These product candidates are PET ligands that are tracers that can be used to target Tau, alpha-synuclein and TDP-43 aggregates. In May 2014, we established a license and collaboration agreement for our Tau-PET imaging program with Life Molecular Imaging. Life Molecular commenced a Phase 1 clinical study of the program in the fourth quarter of 2016. The Phase 1 clinical study of PI-2620 in AD was completed in the first quarter of 2018. An additional Phase 1 clinical study of PI-2620 in South Korea was initiated in the second quarter of 2018.


Our Tau-PET tracers are designed to bind specifically to the pathological forms of human Tau in AD and other Tauopathies. They have demonstrated an excellent PET tracer profile with their ability to cross the blood-brain barrier and a high selectivity to pathological Tau even in the early stage disease.


The severity of cognitive impairment in AD patients is correlated with the presence of Tau protein tangles, leading us to believe that an imaging agent for Tau is equally important. Our clinical candidate PI-2620 is selective for Tau over Abeta and other “off-target” binding when compared to current published Tau-PET agents in development as no binding to Abeta in vivo and no “off-target” retention in basal ganglia or choroid plexus was observed. In addition, PI-2620 can be readily radiolabeled with fluorine 18. While PET imaging has improved the diagnosis of AD by targeting Abeta, Tau imaging will further enhance the diagnosis of early AD. To date, there are no approved Tau tracers.


Figure 27: Selectivity of Tau Pet PI-2620



Ref: Stephens, A. et. al., ADPD 2018; Oden, F. et. al.; EMIM 2018


The PI-2620 Tau-PET data above shows that PI-2620 has high selectivity to pathological Tau aggregates with the absence of off-target binding as no age-related uptake in choroid plexus, striatum, amygdala, basal ganglia, or other regions is observed in healthy subjects. In contrast, Tau-typical distribution pattern is observed in MCI- and AD-subjects by PI-2620 PET.


Figure 28: Correlation of PI-2620 Tau PET with glucose hypometabolism and brain atrophy in AD



Ref: Villemagne, VL et. al., SNMMI 2018



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