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20-F
AC IMMUNE SA filed this Form 20-F on 03/21/2019
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Advancing our product candidates, in partnership or alone, from clinical development to regulatory approval and potential commercialization. Our products include:

 

·Crenezumab. The parent of our collaboration partner discontinued as of January 2019, the phase 3 clinical trials in AD but is continuing the Colombian prevention trial in genetically pre-disposed people at risk of developing familial AD. The overall beneficial safety profile was confirmed in the CREAD studies, supporting crenezumab’s application in healthy individuals with risk of developing AD.

 

·ACI-24. We own the global rights to ACI-24 and we continue to develop ACI-24 in-house as a therapeutic candidate.

 

ACI-24 in AD. One phase 2 study has been initiated in 2018 in order to assess the safety, tolerability, immunogenicity and target engagement of ACI-24 formulations in mild AD patients. The previous phase 1/2 study has been terminated and the clinical study report will be completed in 2019.

 

ACI-24 in DS. Our Phase 1b clinical study of ACI-24 in individuals with Down syndrome, intended to assess safety, tolerability and immunogenicity at two doses, is ongoing. Recruitment in the high dose cohort has been successfully completed in 2018. To date, no serious adverse events and no early withdrawal have been observed in any of the two study cohorts supporting a favorable safety and tolerability profile. Preliminary assessment of the new low dose cohort demonstrated an IgG response as early as 4 weeks.

 

·ACI-35. The Phase 1b clinical study delivered encouraging results. Janssen and AC Immune plan to move the anti-Tau vaccine program forward to start a Phase 1b/2a in 2019; this is supported by scientific advice from the UK regulatory authority, MHRA.

 

·Anti-Tau antibody candidate. Our collaboration partner, Genentech, is conducting an anti-Tau antibody candidate (RG6100) through a Phase 2 clinical study, which started in the fourth quarter of 2017. The anti-Tau antibody is proposed to slow the prion-like propagation of Tau pathology which coincides with both clinical symptoms and disease progression in AD.

 

·Morphomer Tau. In collaboration with our partner, Lilly, we are researching and developing Tau Morphomer aggregation inhibitor small molecules with a first indication in Alzheimer’s disease. We are currently in preclinical activities and will begin Phase 1 in 2019.

 

·Diagnostic candidates. In addition to the above product candidates, we will continue to develop our complementary diagnostic product candidates for Tau, alpha-synuclein and TDP-43 to advance these through clinical development, either independently or with collaboration partners.

 

Expanding into other neurodegenerative and neuro-orphan diseases

 

We will continue to leverage our proprietary technology platforms to develop product candidates that share the same disease targets like misfolded Abeta, Tau, alpha-synuclein and TDP-43 proteins, which are the key features of many neurodegenerative diseases. We pursue selected neuro-orphan indications, such as progressive supranuclear palsy (PSP) and other Tau-related orphan diseases, such as frontotemporal dementia and corticobasal degeneration. Pursuing neuro-orphan indications may enable us to obtain a streamlined regulatory approval pathway and favorable reimbursement treatment of any approved products.

 

Accelerating the advancement of our diagnostic portfolio

 

We are also developing a complementary diagnostics portfolio. We currently have three diagnostics candidates in our pipeline that we developed using our Morphomer platform that targets Tau, alpha-synuclein and TDP-43. Our Tau-PET imaging agent PI-2620 has completed Phase 1 studies in AD, including proof-of-concept in AD and healthy volunteers, dosimetry, and test/re-test in AD and healthy volunteers. We are working with our partner, Life Molecular Imaging, to advance PI-2620 through the clinical development process in AD and expand the use of PI-2620 to non-AD Tauopathies such as PSP. We are also developing proprietary PET imaging diagnostics for diseases resulting from the misfolding of alpha-synuclein and TDP-43 proteins.

 

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