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AC Immune Clinical Data Published in Nature Communications Show Alpha-Synuclein PET Tracer ACI-12589 Has Potential as Neurodegenerative Disease Diagnostic


AC Immune Clinical Data Published in Nature Communications Show Alpha-Synuclein PET Tracer ACI-12589 Has Potential as Neurodegenerative Disease Diagnostic

  • ACI-125891 delivers the first element of a precision medicine approach by enabling early and accurate diagnosis of a-syn pathology in certain diseases
  • Clinical trial of ACI-12589 showed a specific and reproducible retention pattern in patients with MSA, a rare and difficult-to-diagnose neurodegenerative disease
  • ACI-12589 promises to catalyze accelerated development and targeted treatment of MSA and other a-synucleinopathies such as genetic Parkinson’s disease (PD)

Lausanne, Switzerland, October 27, 2023 – AC Immune SA (NASDAQ: ACIU), a clinical-stage biopharmaceutical company pioneering precision medicine for neurodegenerative diseases, today announced the publication of a peer-reviewed paper in Nature Communications showing the ability of an alpha-synuclein (a-syn) positron emission tomography (PET) tracer to identify patients with multiple system atrophy (MSA).

The clinical trial of AC Immune’s wholly owned experimental a-syn PET tracer ACI-12589 was led by the team of Oskar Hansson MD, PhD, at Lund University and Skåne University Hospital, in collaboration with associates at InviCRO LLC, with the support of a grant from The Michael J. Fox Foundation (MJFF) for Parkinson’s Research.

The Nature Communications paper describes the first-in-human trial of ACI-12589 comparing healthy control subjects to patients with a-synucleinopathies and other neurological diagnoses. It concludes that ACI-12589 showed a specific and reproducible retention pattern in patients with MSA, indicating that the PET tracer could enable earlier, more accurate diagnosis of MSA and potentially, more precise monitoring of disease progression and responses to new a-syn targeted therapeutics in development.

Dr. Andrea Pfeifer, CEO of AC Immune SA, commented: “We are proud to have this paper showing the first-ever live images of a-syn in a living human brain published in the prestigious peer-reviewed journal, Nature Communications. The data demonstrate that ACI-12589 could be an important diagnostic tool to identify, characterize and track the progression of a-syn pathology in MSA and evaluate the impact of therapeutic interventions. As the first imaging agent for a-syn, ACI-12589 represents a major step towards achieving AC Immune’s ambition of developing precision medicine for neurodegenerative diseases. We are grateful to our talented collaborators at Lund University and Skåne University Hospital and the MJFF for its continuing support for this important work.”

Dr. Marie Kosco-Vilbois, Chief Scientific Officer of AC Immune, added: “Accurately detecting a-syn in the living brains of patients is paramount, particularly in view of the challenges of diagnosing the serious diseases related to pathological a-synuclein aggregates. We are encouraged by this first success in MSA and look forward to expanding the potential clinical applications of this tracer, and others emerging from the AC Immune platform.”

1 For PET imaging, ACI-12589 is radiolabeled with 18F, denoted as [18F]ACI-12589

About AC Immune’s a-synuclein PET tracer program

AC Immune is currently evaluating the use of [18F]ACI-12589 in longitudinal studies for MSA, and for the detection of a-syn in other diseases such as genetic PD. Further building on this success, the Company is developing additional a-syn PET tracers for Parkinson’s disease (PD) using its Morphomer® technology platform. It is anticipated that these will enter clinical development in the very near future.

About AC Immune SA

AC Immune SA is a clinical-stage biopharmaceutical company that aims to become a global leader in precision medicine for neurodegenerative diseases, including Alzheimer’s disease, Parkinson’s disease, and NeuroOrphan indications driven by misfolded proteins. The Company’s two clinically validated technology platforms, SupraAntigen® and Morphomer®, fuel its broad and diversified pipeline of first- and best-in-class assets, which currently features sixteen therapeutic and diagnostic programs, five of which are currently in Phase 2 clinical trials and one of which is in Phase 3. AC Immune has a strong track record of securing strategic partnerships with leading global pharmaceutical companies including Genentech, a member of the Roche Group, Eli Lilly and Company, and others, resulting in substantial non-dilutive funding to advance its proprietary programs and >$3 billion in potential milestone payments.

SupraAntigen® is a registered trademark of AC Immune SA in the following territories: AU, EU, CH, GB, JP, RU, SG and USA. Morphomer® is a registered trademark of AC Immune SA in CN, CH, GB, JP, KR, NO and RU.

The information on our website and any other websites referenced herein is expressly not incorporated by reference into, and does not constitute a part of, this press release.

For further information, please contact:

Head of Investor Relations & Corporate Communications
Gary Waanders, Ph.D., MBA
AC Immune
Phone: +41 21 345 91 91

U.S. Investors
Corey Davis, Ph.D.
LifeSci Advisors
Phone: +1 212 915 2577

International Media
Chris Maggos
Cohesion Bureau
Phone: +41 79 367 6254

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. 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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