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AC Immune's PI-2620 Tau-PET Diagnostic in Phase 3 Receives Fast Track Designation in Three Neurodegenerative Conditions PI-2620 is in Phase 3 development in Alzheimer's disease by AC Immune's partner, LMI T

Key Takeaway: AC Immune announced that its partner Life Molecular Imaging has received Fast Track Designation from the FDA for the Tau-PET diagnostic, PI-2620, targeting Alzheimer's disease and other neurodegenerative conditions. This designation aims to accelerate development and review processes for crucial diagnostics. PI-2620 is currently in Phase 3 trials and has shown potential for accurately imaging Tau pathology, which could lead to improved diagnosis and treatment of various neurodegenerative diseases. The company aims for this designation to enhance precision prevention efforts in clinical settings.

Market Sentiment Analysis

POSITIVE FACTORS

  • PI-2620 received Fast Track Designation from the FDA.
  • This designation highlights the potential for earlier diagnosis of neurodegenerative diseases.
  • The diagnostic could significantly improve patient care by detecting Tau pathology.
  • AC Immune's strong partnerships have led to substantial potential funding.

Full Press Release Details

AC Immune's PI-2620 Tau-PET Diagnostic
Fast Track Designation in Three Neurodegenerative Conditions
Lausanne, Switzerland, August 28, 2024 -
AC Immune SA (NASDAQ: ACIU), a clinical-stage biopharmaceutical company pioneering precision therapeutics for neurodegenerative diseases,
today announced that its partner Life Molecular Imaging (LMI) has received Fast Track Designation for the Tau positron emission tomography
(PET) diagnostic, [18F]PI-2620, from the U.S. Food and Drug Administration (FDA) in three neurodegenerative conditions.
Fast Track designation for [18F]PI-2620 has been
granted for clinical development in Alzheimer's disease (AD), progressive supranuclear palsy (PSP), and corticobasal degeneration
The FDA's Fast Track program is designed
to accelerate the development and review of drugs that address serious conditions and fulfill unmet medical needs. This designation underscores
the broadening view in the medical community that early and accurate diagnoses of neurodegenerative disease may lead to improved outcomes,
thanks to emerging treatments.
PI-2620 is a next-generation PET imaging agent
currently in Phase 3 clinical development for detecting Tau pathology in Alzheimer's disease. The compound is also being investigated
in other neurodegenerative diseases by many academic researchers and in drug development trials. Tau proteins are a hallmark of several
neurodegenerative disorders including AD, PSP, CBD, and frontotemporal lobar dementia (FTLD), and accurately imaging the pathology could
significantly enhance disease diagnosis and improve patient care.
Dr. Andrea Pfeifer, CEO of AC
Immune SA, commented: "Fast Track designation for PI-2620 is an important reflection of its potential to accurately diagnose
Alzheimer's and other neurodegenerative diseases. Early diagnosis of these conditions will be key for effective treatment before
irreversible damage occurs, and is an essential element in our goal of achieving precision prevention. The FDA has previously granted
Fast Track status to two of our active immunotherapies in Phase 2 development, ACI-35.030 and ACI-24.060, which target phospho-Tau and
Abeta, respectively. The designation for PI-2620 is a further recognition of AC Immune's drug discovery and development platform
and of how we, together with our partners, continue to drive innovation."
PI-2620 was discovered
and developed as part of a research collaboration between AC Immune and LMI. LMI has the exclusive, worldwide license for research, development
and commercialization of Tau-PET tracers generated within the discovery program. It has demonstrated robust brain uptake and fast wash-out
in non-target regions, a broad imaging window between 30- and 90-minutes post-injection for AD, and excellent reproducibility between
test and retest scans. The absence of significant off-target binding enables PI-2620 to detect and quantify early Tau deposition in the
brain, a hallmark of neurodegenerative diseases. PI-2620 is currently under investigation in several clinical studies as a targeted radiopharmaceutical
for the detection of Tau deposits in the human brain. PI-2620 also shows promise for non-AD tauopathies like progressive supranuclear
palsy (PSP) and corticobasal syndrome (CBS).
AC Immune SA is a clinical-stage biopharmaceutical
company and a global leader in precision prevention 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, including five in Phase 2 development and one in Phase 3. AC Immune
has a strong track record of securing strategic partnerships with leading global pharmaceutical companies, resulting in substantial non-dilutive
funding to advance its proprietary programs and >$4.5 billion in potential milestone payments plus royalties.
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:
SVP, Investor Relations & Corporate Communications Gary Waanders, Ph.D., MBA AC Immune Phone: +41 21 345 91 91 Email: gary.waanders@acimmune.com U.S. Investors Corey Davis, Ph.D. LifeSci Advisors Phone: +1 212 915 2577 Email: cdavis@lifesciadvisors.com
International Media Chris Maggos Cohesion Bureau Phone: +41 79 367 6254 Email: chris.maggos@cohesionbureau.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. 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.

Frequently Asked Questions

What is AC Immune's PI-2620 Tau-PET diagnostic?

PI-2620 is a Tau positron emission tomography (PET) diagnostic for detecting Tau pathology.

Which conditions received Fast Track Designation for PI-2620?

Fast Track Designation was granted for Alzheimer's disease, PSP, and corticobasal degeneration.

What does Fast Track Designation mean?

It accelerates the development and review of drugs addressing serious conditions and unmet needs.

What makes PI-2620 unique in Tau detection?

It offers robust brain uptake and detects early Tau deposition without significant off-target binding.

What is AC Immune's goal with PI-2620?

The goal is to achieve precision prevention through early and accurate diagnoses of neurodegenerative diseases.

Last updated: Aug 28, 2024