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AC Immune Advances phospho-Tau Alzheimer's Vaccine in Phase 1b/2a Study Interim data confirm the promising safety, tolerability and Tau-specific immunogenicity observed in the previous clinical study ACI-35

Key Takeaway: AC Immune Advances phospho-Tau Alzheimer's Vaccine in Phase 1b/2a Study Interim data confirm the promising safety, tolerability and Tau-specific immunogenicity observed in the previous clinical study ACI-35.030 is a clinical stage vaccine generated with the proprietary Supra

Full Press Release Details

AC Immune Advances phospho-Tau Alzheimer's
Vaccine in Phase 1b/2a Study
Interim data confirm the promising safety,
tolerability and Tau-specific immunogenicity observed in the previous clinical study
ACI-35.030 is a clinical stage vaccine
generated with the proprietary SupraAntigen platform addressing proteinopathies across neurodegenerative diseases
Lausanne, Switzerland, July 16, 2020
- AC Immune SA (NASDAQ: ACIU), a Swiss-based, clinical-stage biopharmaceutical company with a broad pipeline focused on neurodegenerative
diseases, today announced the initiation of the second highest dosing group in the Company's Phase
1b/2a clinical trial evaluating ACI-35.030 for the treatment of Alzheimer's disease (AD). The decision to advance
to the higher dosing group follows encouraging interim safety, tolerability and immunogenicity results from the initial dosing
Immunization with anti-Tau vaccines has
become an important strategy for the treatment of AD and other neurodegenerative diseases characterized by Tau pathology. ACI-35.030,
which is being developed in collaboration with Janssen Pharmaceuticals, Inc., is the first
AD vaccine candidate designed to generate a specific antibody response against pathologic phospho-Tau (pTau) proteins in the brain.
Anti-pTau antibodies generated by ACI-35.030 have the potential to reduce the spread and seeding of Tau pathology throughout the
Prof. Andrea Pfeifer, CEO of AC Immune
SA, commented: "The fact that ACI-35.030 shows encouraging safety and immunogenicity at the lowest dose in this elderly
patient population is highly meaningful and we look forward to quickly enrolling this next dosing group. Tau-targeted approaches
may have a much broader therapeutic window to potentially disrupt, slow or prevent disease progression at both early and advanced
disease stages. Pathological pTau occurs early in the disease process, years before accumulation of Tau deposits. Therefore, our
pTau-targeting approach holds significant promise for the treatment of AD at different disease stages."
This Phase 1b/2a trial is a randomized,
multicenter, double-blind, placebo-controlled clinical study with a primary objective to assess the safety, tolerability and immunogenicity
of different doses of ACI-35.030 over a 48-week treatment phase in patients with early AD. Other endpoints will assess clinical
and cognitive parameters as well as additional immunogenicity and safety parameters.
The ACI-35.030 anti-pTau vaccine is the
second vaccine under investigation generated from AC Immune's SupraAntigen platform, along with ACI-24, a proprietary
anti-amyloid beta (Abeta) vaccine currently in Phase 1b/Phase 2 clinical development in two separate indications. The Company's
pipeline is also advancing two monoclonal antibodies, semorinemab, an anti-Tau antibody in Phase 2 development and crenezumab,
an anti-Abeta antibody in Phase 2 development, both partnered with Genentech/Roche.
ACI-35.030 is a potent liposomal anti-pTau
active investigational vaccine designed to elicit antibodies against phosphorylated pathological Tau protein, in order to reduce
and facilitate the clearance of related Tau aggregates, slowing the progression of Tau-pathology and/or treating the underlying
It builds on the success of AC Immune's
ACI-35 vaccine, which demonstrated an early target-specific antibody response against pTau after the first injection in the vast
majority of patients in a Phase 1b study in mild-to-moderate AD. In preclinical studies, ACI-35.030 retained the excellent non-clinical
safety profile and the highly specific antibody response against phosphorylated pathological Tau produced by ACI-35, while demonstrating
an enhanced and more homogeneous antibody response.
AC Immune is developing the ACI-35.030 vaccine
in collaboration with Janssen Pharmaceuticals, Inc. under a 2014
licensing agreement to develop and commercialize therapeutic anti-Tau vaccines for the treatment of AD and potentially
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
is utilizing two proprietary discovery platforms, SupraAntigenTM and MorphomerTM, 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 five currently in clinical trials. It has collaborations with major pharmaceutical companies including
Roche/Genentech, Eli Lilly and Company, and Janssen Pharmaceuticals Inc.
For further information, please contact:
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.
Last updated: Jul 16, 2020