Full Press Release Details
AC Immune's Alzheimer's Disease Vaccine-candidate
ACI-35.030 Selected for Further Development
Lausanne, Switzerland, November 30, 2022
- AC Immune SA (NASDAQ: ACIU), a clinical-stage biopharmaceutical company pioneering precision medicine for neurodegenerative diseases,
today announced that based on the Phase 1b/2a interim data, ACI-35.030, a potential first-in-class anti-phosphorylated-Tau (pTau) vaccine
candidate, has been selected for further development. The ACI-35.030 anti-pTau vaccine candidate is being developed in collaboration with
Janssen Pharmaceuticals, Inc. (Janssen), part of the Janssen Pharmaceutical Companies of Johnson & Johnson.
Dr. Andrea Pfeifer, CEO of AC Immune SA, commented:
"The selection of ACI-35.030 for further development is a significant step for this collaboration. Early clinical testing showed
that ACI-35.030 was generally well tolerated and induced specific activity against the pathological species of Tau, including the neurotoxic
pTau and enriched paired helical filaments (ePHF) species, both of which are closely implicated in Alzheimer's disease (AD). The
excellent performance of ACI-35.030 in the trial participants (average age approximately 65 years) potentially opens promising avenues
for AD treatment and prevention, which could offer an important societal impact. We thank the team at Janssen for their contributions
of valuable knowledge, expertise, and resources to support this collaboration."
selection of ACI-35.030 is supported by new clinical data from the Phase 1b/2a trial presented at the Clinical Trials on Alzheimer's
Disease (CTAD) Conference 2022. The results show that ACI-35.030 treatment
rapidly leads to the strong and durable induction of antibodies specific for pathological forms of Tau such as pTau and its aggregated
form, ePHF. The ACI-35.030-induced antibody response was sustained and could be periodically boosted over a period of 72 weeks. The vaccine
candidate was generally well tolerated. The decision to select ACI-35.030 follows the comparison, presented at CTAD, demonstrating its
strengths relative to a protein conjugate vaccine, JACI-35.054, an alternative anti-pTau vaccine also being evaluated in parallel in
the Phase 1b/2 trial.
Dr. Andrea Pfeifer, CEO of AC Immune SA, added:
"Looking forward into 2023 AC Immune will have three vaccine candidates in Phase 2 development, highlighting the Company's
position as a leader in active vaccination for neurodegenerative diseases. Importantly, our vaccine programs are complemented by additional
therapeutic and diagnostic candidates driving our precision medicine approach in neurodegenerative diseases. Some programs have already
generated significant revenues from collaborations with companies such as Janssen, Eli Lilly, Genentech (Roche), and Life Molecular Imaging.
Collectively, these programs form the most comprehensive pipeline in neurodegenerative disease, with clinical candidates targeting Tau,
Abeta, and alpha-synuclein. We look forward to advancing these programs towards additional value creating milestones as our pipeline matures
About the SupraAntigen platform
AC Immune's clinically validated SupraAntigen
platform uses proprietary liposomes to rapidly generate novel vaccines (SupraAntigen -V) for active immunization
as well as best-in-class monoclonal antibodies (SupraAntigen -A) for passive immunization against key neurodegenerative
disease targets. Products generated by the platform are highly specific for the pathological conformations of misfolded proteins and
are well tolerated. The SupraAntigen platform has successfully generated multiple vaccine and antibody candidates that
have been validated in clinical studies and has led to multiple global partnerships with world-leading pharmaceutical companies. In addition
to targeting amyloid-beta and Tau, AC Immune has generated conformation-specific antibodies against emerging neurodegenerative disease
targets including alpha-synuclein, TDP-43 and the NLRP3-ASC inflammasome pathway.
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 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 and SG. 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 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 BioConfidant S rl Phone: +41 79 367 6254 Email: maggos@bioconfidant.ch | U.S. Media Shani Lewis LaVoieHealthScience Phone: +1 609 516 5761 Email: slewis@lavoiehealthscience.com |
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