AC Immune Receives a Grant from The Michael J. Fox Foundation for Continued Development of Parkinson’s Disease Diagnostic Imaging Agent

Rhea-AI Summary

AC Immune (NASDAQ: ACIU) has received a new grant from The Michael J. Fox Foundation (MJFF) to advance its alpha-synuclein PET tracer, ACI-12589, bringing total funding to USD 3.7 million. This support enables enhanced clinical studies, following proof-of-concept data showcasing the tracer's ability to generate live images of alpha-synuclein in the human brain. If successful, ACI-12589 may become a pioneering diagnostic tool for Parkinson’s disease, facilitating the development of new therapies.

Positive

• New grant funding from MJFF raises total support to USD 3.7 million for ACI-12589 development.
• Clinical proof-of-concept data demonstrates ACI-12589's capability of generating live alpha-synuclein brain images.
• Potential for ACI-12589 to provide early detection and monitoring for Parkinson’s disease, aiding new therapy development.

Negative

• None.

• Previously reported clinical proof-of-concept data on ACI-12589 showed the PET tracer generating the first live images of alpha-synuclein in the human brain
• New grant funding will pave the way for enhanced clinical studies
• Total funding from The Michael J. Fox Foundation for AC Immune’s alpha-synuclein PET tracer program is now up to USD 3.7 million
  

LAUSANNE, Switzerland, Sept. 01, 2022 (GLOBE NEWSWIRE) -- AC Immune SA (NASDAQ: ACIU), a clinical-stage biopharmaceutical company pioneering precision medicine for neurodegenerative diseases, today announced that The Michael J. Fox Foundation for Parkinson’s Research (MJFF) awarded the Company a new grant to continue development of its Morphomer^®-based alpha-synuclein (a-syn) positron emission tomography (PET) tracer, ACI-12589.

AC Immune has received continuous grant support from MJFF since 2015 to develop a-syn PET tracers. This new grant brings the total MJFF funding for this program up to USD 3.7 million. If successful, AC Immune’s a-syn PET tracer program could deliver the world’s first imaging agent capable of accurately detecting and monitoring progression of Parkinson’s disease (PD). This would potentially enable and accelerate the development of novel PD therapies by providing a powerful tool for measuring the effect of novel drugs on a-syn pathology in the brain.

Earlier this year, AC Immune and its collaborators reported clinical proof-of-concept data on ACI-12589, with the PET tracer generating the first live images of a-syn in the human brain. PET images from multiple system atrophy (MSA) patients dosed with ACI-12589 showed enhanced contrast and a-syn target specificity, as well as increased tracer retention in brain areas affected by MSA disease processes. ACI-12589 also displayed pharmacokinetic and safety profiles suitable for further development as a human brain PET imaging agent.

AC Immune’s portfolio in PD covers the full spectrum of treatment modalities addressing a-syn, a well-characterized target in PD. In addition to ACI-12589, the portfolio includes the Phase 2 ready anti-a-syn vaccine, ACI-7104, as well as an anti-a-syn antibody and a Morphomer^® a-syn aggregation inhibitor, both in pre-clinical development. Together, these assets have the potential to enable a precision medicine approach to treating PD and other a-synucleinopathies, detecting the disease early and treating the right patient, with the most appropriate treatment modality, at the most effective time.

Prof. Andrea Pfeifer, CEO of AC Immune SA, commented: “We are delighted to receive this additional grant from MJFF and further expand our long-standing and highly productive relationship. The grant recognizes the exciting potential of ACI-12589 to play a key role in developing precision medicines to treat PD and other neurodegenerative diseases. Imaging agents, capable of earlier detection and disease monitoring, are a vital element in effective treatment of these conditions. The data generated so far demonstrate ACI-12589’s potential to be the first non-invasive diagnostic for alpha-synucleinopathies and underline the productivity of AC Immune’s proprietary small molecule Morphomer^® discovery platform.”

Jamie Eberling, PhD, Senior Vice President of Research Programs at MJFF, said: “The Foundation is pleased to continue its support of the development of AC Immune’s a-syn PET tracer, ACI-12589. The clinical results reported to date hold promise that a key element in the diagnosis of a-synucleinopathies like PD and other neurodegenerative diseases is now within reach.”

The USD 0.5 million provided by the new MJFF award will support ACI-12589 dosimetry studies in healthy individuals and GMP manufacturing, thus paving the way for expanded clinical development in-house and with third parties. The grant will also support ACI-12589 PET scans in additional human subjects to further evaluate disease and target specificity, with the aim of assessing potential PET signal retention in a-syn-positive PD/dementia with Lewy Body (DLB) subjects versus expected a-syn-negative Alzheimer’s disease (AD), progressive supranuclear palsy (PSP) and spinocerebellar ataxia (SCA) subjects.

AC Immune also received MJFF grants for the development of first-in-class brain penetrant small molecules targeting a-syn and the (NOD)-like receptor protein 3 (NLRP3) inflammasome pathway in PD.

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 ten therapeutic and three diagnostic candidates, six of which are currently in phase 2 clinical trials. 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 Janssen Pharmaceuticals, Inc., resulting in substantial non-dilutive funding to advance its proprietary programs and >$3 billion in potential milestone payments.

For further information, please contact:

Media Relations Saoyuth Nidh AC Immune Phone: +41 21 345 91 34 Email: saoyuth.nidh@acimmune.com	Investor Relations Gary Waanders, Ph.D., MBA AC Immune Phone: +41 21 345 91 91 Email: gary.waanders@acimmune.com
U.S. Media Shani Lewis LaVoieHealthScience Phone: +1 609 516 5761 Email: slewis@lavoiehealthscience.com	U.S. Investors Corey Davis, Ph.D. LifeSci Advisors Phone: +1 212 915 2577 Email: cdavis@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. 

FAQ

What is the significance of ACI-12589 for Parkinson's disease?

ACI-12589 aims to be the first PET tracer for imaging alpha-synuclein in the brain, potentially aiding in early diagnosis and therapy development for Parkinson's disease.

How much total funding has ACI Immune received from MJFF for ACI-12589?

The total funding from MJFF for ACI-12589 has now reached USD 3.7 million.

What were the results of the clinical trials for ACI-12589?

Previous clinical trials demonstrated ACI-12589's ability to generate live images of alpha-synuclein in the human brain, showing enhanced contrast and target specificity.

How will the new grant from MJFF be utilized?

The USD 0.5 million grant will support dosimetry studies, GMP manufacturing, and evaluations of ACI-12589 in additional human subjects.

What potential impact does ACI-12589 have on treatment development?

If successful, ACI-12589 could accelerate the development of novel therapies by providing a tool for measuring drug effects on alpha-synuclein pathology.