AC Immune Demonstrates Enhanced Performance of First-in-class Parkinson's Diagnostic Agent

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Next-generation PET tracer detects pathological alpha-synuclein with improved signal-to-noise ratio

Oral presentation at AAIC further demonstrates the strength of AC Immune's Morphomer™ platform for generating highly selective small molecule diagnostics

LAUSANNE, Switzerland, July 28, 2020 (GLOBE NEWSWIRE) -- AC Immune SA ACIU, a Swiss-based, clinical-stage biopharmaceutical company, with a broad pipeline focused on neurodegenerative diseases, today reported new data for its next generation alpha-synuclein positron emission tomography-(PET) tracer during an oral presentation at the Alzheimer's Association International Conference (AAIC) and anticipates advancing its lead compound toward clinical stage development in Q4 2020.

The compelling preclinical results demonstrate enhanced contrast and alpha-synuclein target specificity, putting AC Immune's PET tracer in a strong position to become a first-in-class precision diagnostic tool for Parkinson's disease (PD). No effective diagnostic agents exist today for PD and other alpha-synucleinopathies, such as multiple system atrophy (MSA), and Lewy Body Dementia (LBD), representing substantial unmet clinical need.

Prof. Andrea Pfeifer, CEO of AC Immune SA, commented: "I am highly encouraged by these results, as they demonstrate AC Immune's industry-leading expertise in the development of alpha-synuclein-targeting agents. There is increasing recognition of the importance of targeting the right disease pathology at the right time in neurodegenerative diseases, and AC Immune continues to lead the way towards facilitating such an approach through the parallel development of therapeutic and diagnostic agents for important targets such as alpha-synuclein, as well as more well established targets like Tau and Abeta. The data presented at AAIC are a prime example of the power of our Morphomer™ platform to facilitate the rapid optimization of our PET tracers."

Alpha-synuclein misfolding, aggregation and seeding are the molecular basis for the formation of Lewy bodies, a hallmark of PD, MSA, and LBD. The availability of non-invasive diagnostic tools that can distinguish alpha-synucleinopathies from other proteinopathies or normal physiological situations would enable – for the first time – accurate clinical diagnosis, monitoring of disease progression and benefits of drug interventions. ACI-12589 demonstrates significantly increased target occupancy compared to previous-generation candidates as well as a significantly improved signal specificity.

AC Immune's PET tracers are derived from the Company's innovative Morphomer™ discovery platform, which accelerates the design, development and synthesis of conformation-specific small molecules to power successful diagnostic and therapeutic approaches. The Morphomer™ platform has produced multiple small molecules with clinical proof-of-concept that bind selectively to pathological forms of human proteins such as alpha-synuclein and Tau.

Based on proof-of-concept data presented at this year's AAT-AD/PD™ conference, AC Immune announced that it advanced its SupraAntigen™-derived anti-alpha-synuclein therapeutic antibody candidate from discovery into preclinical development. The combined potential of AC Immune's therapeutic and diagnostic programs is based on the Company's capabilities in precision medicine and may improve the diagnosis and treatment of alpha-synuclein pathologies, which are of increasing interest in Alzheimer's disease (AD) and NeuroOrphan indications.

Dr. Capotosti's presentation was titled Developing a novel alpha-synuclein positron emission tomography (PET) tracer for the diagnosis of a-synucleinopathies. Key highlights from the presentation include:

  • ACI-3847, a first-generation alpha-synuclein-PET tracer, showed good brain uptake and very low non-specific retention in a first-in-human study in idiopathic PD patients and healthy volunteers
  • The data on ACI-3847 suggested to test the PET tracer in alpha-synuclein-pathologies with higher levels of alpha-synuclein accumulation
  • AC Immune's Morphomer™ platform also led to the discovery of ACI-12589 with excellent target occupancy and signal specificity ex vivo and an expected optimal signal-to-noise ratio in patients
  • Data presented will show ACI-12589 as a potential first- and best-in-class imaging agent for the diagnosis of PD

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, SupraAntigen™ and Morphomer™, 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 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 Genentech, a member of the Roche Group, Eli Lilly and Company and Janssen Pharmaceuticals.

For further information, please contact:

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Head of Investor Relations
Joshua Drumm, Ph.D.
AC Immune
Phone: +1 917 809 0814
Email: joshua.drumm@acimmune.com
US Media
Katie Gallagher
LaVoieHealthScience
Phone: +1 617 792 3937
Email: kgallagher@lavoiehealthscience.com
  
Global Head of Communications
Judith Moore
AC Immune
Phone: +41 79 826 63 82
Email: judith.moore@acimmune.com
European Investors & Media
Chris Maggos
LifeSci Advisors
Phone: +41 79 367 6254
Email: chris@lifesciadvisors.com

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. These include: the impact of Covid-19 on our business, suppliers, patients and employees and any other impact of Covid-19. 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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