ACIU AC Immune SA

7.02
-0.11  -2%
Previous Close 7.13
Open 7.02
52 Week Low 4.42
52 Week High 12.5
Market Cap $510,021,631
Shares 72,652,654
Float 31,782,720
Enterprise Value $292,726,966
Volume 156,745
Av. Daily Volume 605,018
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Upcoming Catalysts

Drug Stage Catalyst Date
Semorinemab (LAURIET)
Alzheimer’s disease
Phase 2
Phase 2
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ACI-35.030
Alzheimer’s Disease
Phase 1/2
Phase 1/2
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Drug Pipeline

Drug Stage Notes
ACI-24 (anti-Abeta vaccine)
Alzheimer's disease-like characteristics in individuals with Down syndrome
Phase 1b
Phase 1b
Phase 1b data presented at AAIC July, 2021.
JACI-35.054 alternative anti-pTau vaccine
Alzheimer’s disease
Phase 1/2
Phase 1/2
Phase 1/2 trial ongoing.
ACI-24
Alzheimer’s disease (AD)
Phase 2
Phase 2
Phase 2 interim analysis June 2, 2021. Good safety confirmed.
Semorinemab
Alzheimer’s disease
Phase 2
Phase 2
Phase 2 top-line data did not meet endpoints - September 23, 2020.
ACI-3024
Alzheimer’s disease
Phase 1
Phase 1
Phase 1 trial has completed.
Crenezumab - CREAD 2
Alzheimer’s disease
Phase 3
Phase 3
Phase 3 trial terminated following interim analysis indicating primary endpoint would not be met.
Crenezumab - CREAD 1
Alzheimer’s disease
Phase 3
Phase 3
Phase 3 trial terminated following interim analysis indicating primary endpoint would not be met.

Latest News

  1. ACI-24 generated an encouraging immune response that correlated with a signal of target engagement in patients with Down syndrome (DS)

    Full Phase 1b results support the continued clinical development of anti-Abeta vaccine approaches in DS-related Alzheimer's disease (AD)

    LAUSANNE, Switzerland, July 29, 2021 (GLOBE NEWSWIRE) -- AC Immune SA (NASDAQ:ACIU), a clinical-stage biopharmaceutical company pioneering precision medicine for neurodegenerative diseases, today outlined two presentations being delivered at the Alzheimer's Association International Conference (AAIC) 2021, taking place both in Denver, USA and virtually from July 26-30, 2021.

    The presentations highlight precision medicine approaches to enable the early detection and prevention…

    ACI-24 generated an encouraging immune response that correlated with a signal of target engagement in patients with Down syndrome (DS)

    Full Phase 1b results support the continued clinical development of anti-Abeta vaccine approaches in DS-related Alzheimer's disease (AD)

    LAUSANNE, Switzerland, July 29, 2021 (GLOBE NEWSWIRE) -- AC Immune SA (NASDAQ:ACIU), a clinical-stage biopharmaceutical company pioneering precision medicine for neurodegenerative diseases, today outlined two presentations being delivered at the Alzheimer's Association International Conference (AAIC) 2021, taking place both in Denver, USA and virtually from July 26-30, 2021.

    The presentations highlight precision medicine approaches to enable the early detection and prevention of neurodegenerative diseases by targeting amyloid beta (Abeta) and alpha-synuclein (a-syn). The first virtual oral presentation includes the full results from a first-of-its-kind Phase 1b clinical trial evaluating the anti-Abeta vaccine ACI-24 in adults with DS. Previously announced topline data from the trial showed that ACI-24 generated evidence of immunogenicity along with a positive pharmacodynamic response and a favorable safety and tolerability profile.

    The Phase 1b study results showed that ACI-24 was safe and well tolerated in adults with DS. No serious adverse events or evidence of central nervous system (CNS) inflammation, meningoencephalitis, or ARIA (amyloid-related imaging abnormalities), including ARIA-E (edema) and ARIA-H (hemorrhage), were reported. Data also showed that administration of ACI-24 resulted in encouraging immune responses that correlated with increases in plasma Abeta, which are indicative of target engagement.

    Dr. Michael Rafii, Medical Director of the Alzheimer's Therapeutic Research Institute and Associate Professor of Neurology at the Keck School of Medicine, Lead Investigator of the study, commented: "Individuals with DS represent a homogenous genetic population that are predisposed to AD, which highlights the value of this landmark Phase 1b study and the innovation in AC Immune's approach. Importantly, the results of this study show a signal of target engagement that correlates with immune response against Abeta and support the continued evaluation of anti-Abeta vaccine approaches in these patients. This may enable a shift towards earlier treatment and ultimately prevention of AD, and would be a critical advance as the damage neurons undergo in neurodegenerative diseases cannot be reversed by currently available therapies."

    Prof. Andrea Pfeifer, CEO of AC Immune SA, commented: "The full data set from our Phase 1b DS study are promising and highlight AC Immune's expertise in active vaccination approaches for neurodegenerative disease. Based on these results, we plan to advance an optimized formulation of ACI-24 into late-stage clinical testing to treat and prevent the progression of DS-related AD. This formulation has demonstrated enhanced immunogenicity against the two most toxic Abeta species in non-human primates, positioning it to be a potential breakthrough in Abeta vaccination. We look forward to the program's continued advancement, which we believe will be accelerated by the recent validation of Abeta as a surrogate trial endpoint in AD."

    Prof. Johannes Streffer, CMO of AC Immune SA, commented: "Through an active vaccination approach, we aim to prevent neurodegeneration rather than simply slow its progression. As almost all subjects with DS go on to develop AD-like symptoms, this is an ideal patient population in which to gain critical insights and expertise into the development of vaccines for a variety of neurodegenerative diseases. We thus expect the promising results and learnings from this trial to accelerate the advancement of not only our ACI-24 program, but our entire world-leading pipeline of active vaccines for neurodegeneration."    

    In addition, AC Immune is also presenting a poster on ACI-12589, a first-in-class positron emission tomography (PET) imaging tracer targeting a-syn that is being developed as a first-in-class diagnostic for Parkinson's disease (PD). Previously reported preclinical data confirm that the Morphomer®-derived candidate has a desirable brain-PET ligand pharmacokinetic profile in non-human primates. These and other prior data demonstrating ACI-12589's signal specificity on tissue samples from patients with alpha-synucleinopathies, including PD, multiple system atrophy (MSA) and dementia with Lewy bodies (DLB) are being discussed in this poster presentation.

    Prof. Pfeifer continued, "Through the development of companion diagnostics such as ACI-12589 in PD, we are working to better enable the advancement of the neurodegenerative disease treatment paradigm towards earlier treatment and prevention. We expect the continued development of this program, alongside the advancement of our recently acquired industry-leading anti-a-syn vaccine, to solidify our position at the forefront of PD drug development. We are pleased to have the opportunity to discuss ACI-12589 with the scientific community at AAIC ahead of the anticipated readout from its first-in-human study later this quarter."

    Scientific updates at AAIC, July 26–30, 2021

    Title:ACI-24 in adults with Down syndrome: Results of a Phase 1b, randomized, placebo-controlled study (3 Star Trial)
    Date:Thursday, July 29, 2021 | 10:00 am - 11:15 pm MT
    Presenter:Oral presentation by Dr. Michael S. Rafii, Alzheimer's Therapeutic Research Institute, Keck School of Medicine of University of Southern California
      
    Title:[18F]ACI-12589, a novel alpha-synuclein radiotracer as a biomarker in patients with Parkinson's disease and other synucleinopathies
    Date:July 26–30, 2021  
    Presenter:Poster presentation by Dr. Francesca Capotosti, AC Immune SA

    About AC Immune SA

    AC Immune SA is 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 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.

    SupraAntigen® and Morphomer® are registered trademarks of AC Immune SA in the following territories: AU, CH, EU, JP, and GB. Morphomer® is also a registered trademark of AC Immune SA in CN and NO.

    For further information, please contact:

    Media Relations

    Saoyuth Nidh

    AC Immune

    Phone: +41 21 345 91 34

    Email:



    Investor Relations

    Yves Kremer, Ph.D.

    AC Immune

    Phone: +41 21 345 91 90

    Email:



    U.S. Media

    Katie Gallagher

    LaVoie Health Science

    Phone: +1 617 792 3937

    Email:
    U.S. Investors

    Chris Maggos

    LifeSci Advisors

    Phone: +1 917 809 0814

    Email:



    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.



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    • AFFiRiS to receive AC Immune stock valued at USD 58.7 million in exchange for its portfolio of therapeutics targeting alpha-synuclein and USD 5 million in cash
    • AFFiRiS to focus on partnering to further develop its SAIT and monoclonal antibody for cardiovascular disease and for Huntington's disease, respectively

    VIENNA, Austria, July 27, 2021 (GLOBE NEWSWIRE) -- AFFiRiS AG, a clinical-stage biotechnology company that has been engaged in the development of novel disease-modifying Specific Active Immunotherapies (SAITs), today announced that AC Immune SA (NASDAQ:ACIU), a clinical-stage biopharmaceutical company pioneering precision medicine for neurodegenerative diseases, is acquiring AFFiRiS' anti-alpha-synuclein programs targeting neurodegenerative…

    • AFFiRiS to receive AC Immune stock valued at USD 58.7 million in exchange for its portfolio of therapeutics targeting alpha-synuclein and USD 5 million in cash
    • AFFiRiS to focus on partnering to further develop its SAIT and monoclonal antibody for cardiovascular disease and for Huntington's disease, respectively

    VIENNA, Austria, July 27, 2021 (GLOBE NEWSWIRE) -- AFFiRiS AG, a clinical-stage biotechnology company that has been engaged in the development of novel disease-modifying Specific Active Immunotherapies (SAITs), today announced that AC Immune SA (NASDAQ:ACIU), a clinical-stage biopharmaceutical company pioneering precision medicine for neurodegenerative diseases, is acquiring AFFiRiS' anti-alpha-synuclein programs targeting neurodegenerative diseases caused by misfolded forms of human self-proteins. All acquired programs are based on AFFiRiS´ AFFITOME® technology.

    The all-stock acquisition is valued at USD 58.7 million. Under the terms of the agreement, AC Immune is acquiring all of AFFiRiS´ assets and underlying intellectual property related to active vaccine candidates targeting alpha-synuclein and USD 5 million in cash for 7.1 million shares of AC Immune common stock based on a price of USD 8.26 per common share.

    "We are delighted that AC Immune, a company with complementary active immunotherapies, will further advance our industry-leading anti-alpha-synuclein vaccine candidate, developed to slow the progression of disease and help to improve the lives of patients. On the back of our encouraging published data from Phase 1 clinical studies in Parkinson's disease and multiple system atrophy (MSA), and preclinical proof of principle data in dementia with Lewy bodies (DLB), now was the right time to generate value from these programs through an asset sale," commented Noel Barrett, PhD, CEO of AFFiRiS AG. "The acquisition of these programs by this pioneer in precision medicine and active vaccination for neurodegenerative diseases validates our AFFITOME® technology platform and the development projects based on it." He added: "The transaction also allows us to focus on the partnering for further development of AFFiRiS' other programs in cardiometabolic and neurodegenerative disease indications, such as candidates targeting PCSK9 in hypercholesterolemia and the monoclonal antibody C6-17 to treat Huntington's disease."

    "As long-term investors in AFFiRiS, we are confident that AFFiRiS' active immunotherapy program will favourably contribute to AC Immune's portfolio of transformative medicines by delivering much needed patient-friendly, highly innovative disease-modifying therapies to patients suffering from neurodegenerative diseases," added Michael Motschmann, Chairman of AFFiRiS' Supervisory Board and General Partner of MIG AG, one of the founding investors of AFFiRiS.

    The acquisition is subject to customary regulatory approval in Austria and expected to complete at the beginning of Q4 2021.

    About AFFiRiS AG:

    AFFiRiS is a clinical-stage biotechnology company located in Vienna, Austria, with a vision of using the immune system to identify and target human proteins central to the development and progression of neurodegenerative and cardiometabolic diseases, based on its proprietary patented AFFITOME® technology. The Company's ultimate goal is to improve the lives of patients suffering from these diseases by providing specific immunotherapies.

    Following the sale of its SAIT anti-alpha-synuclein programs to AC Immune in an all-stock transaction, AFFiRiS will concentrate on partnering activities to facilitate the further development of its programs in cardiovascular and neurodegenerative disease indications. AFFiRiS published positive Phase 1 clinical results with active immunotherapies targeting PCSK9 to treat the cardiovascular condition hypercholesterolemia. In addition, AFFiRiS will focus on partnering activities to enable the further development of the monoclonal antibody mAB C6-17 targeting mutated huntingtin (mtHTT) protein, which causes Huntington's disease. This is a neurodegenerative, hereditary disease characterized by changes in personality, cognitive impairment and loss of motor function, leading to death over a period of 10 to 30 years.

    For further information, please visit www.affiris.com and follow us on LinkedIn and Twitter.

    Contact AFFiRiS AG:Media contact:
    Dr. Cornelia KutzerMC Services
    Communication and Business DevelopmentJulia Hofmann
    E P +49 89 210228 0
    W www.affiris.comE

    About SAIT:

    https://affiris.com/approach/#overview-of-sait

    About neurodegenerative diseases:

    https://affiris.com/neurodegenerative-diseases



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  2. All-stock transaction maintains AC Immune's strong cash position

    USD 25 million private placement led by premier investor Athos Service GmbH

    Transactions expand and accelerate AC Immune's therapeutic development in Parkinson's disease

    AC Immune to immediately launch clinical development of acquired vaccine into an adaptive, biomarker-based Phase 2 study in Parkinson's disease

    Conference call scheduled today at 8:30 am ET / 2:30 pm CET

    LAUSANNE, Switzerland, July 27, 2021 (GLOBE NEWSWIRE) -- AC Immune SA (NASDAQ:ACIU), a clinical-stage biopharmaceutical company pioneering precision medicine for neurodegenerative diseases, today announced that it is acquiring Affiris' portfolio of therapeutics targeting alpha-synuclein (a-syn…

    All-stock transaction maintains AC Immune's strong cash position

    USD 25 million private placement led by premier investor Athos Service GmbH

    Transactions expand and accelerate AC Immune's therapeutic development in Parkinson's disease

    AC Immune to immediately launch clinical development of acquired vaccine into an adaptive, biomarker-based Phase 2 study in Parkinson's disease

    Conference call scheduled today at 8:30 am ET / 2:30 pm CET

    LAUSANNE, Switzerland, July 27, 2021 (GLOBE NEWSWIRE) -- AC Immune SA (NASDAQ:ACIU), a clinical-stage biopharmaceutical company pioneering precision medicine for neurodegenerative diseases, today announced that it is acquiring Affiris' portfolio of therapeutics targeting alpha-synuclein (a-syn), notably Affiris PD01, a clinically-validated active vaccine candidate for the treatment of Parkinson's disease, as well as cash. The all-stock asset acquisition is valued at USD 58.7 million. AC Immune's cash position, as well as the Company's investor base, is also being strengthened by a total of USD 30 million in gross proceeds stemming from the asset acquisition and a parallel financing that are adding Athos Service GmbH (Strüngmann family office), First Capital Partner GmbH (Egger Family Office)1 and MIG Fonds2, the lead investors in Covid-19 vaccine innovator BioNTech SE, as new AC Immune shareholders.

    Under the terms of the agreement, AC Immune is acquiring all of Affiris' assets and underlying intellectual property related to active vaccine candidates targeting a-syn and USD 5 million in cash for 7.1 million shares based on a price of USD 8.26 per common share. This share price represents a 10.7% premium compared to the closing price of AC Immune shares as of July 23, 2021.

    Concurrent with the asset acquisition, AC Immune announced a private placement transaction with a select group of investors led by Athos Service GmbH with additional participation from First Capital Partner GmbH. Gross proceeds from the private placement will be USD 25 million, based on the same financial terms as for the acquisition of the therapeutic anti-a-syn portfolio. Another lead BioNTech and Affiris investor, MIGoFonds, is also becoming a new AC Immune shareholder via its prior ownership of the anti-a-syn assets acquired. In total, AC Immune is issuing 10.1 million shares in conjunction with the asset acquisition and related financing, in exchange for the aforementioned anti-a-syn assets valued at USD 53.7 million and USDo30 million in cash.

    With the support of their new premier investors, who are highly experienced in active vaccination, AC Immune will leverage its own extensive expertise in vaccine development and neurodegenerative diseases to immediately launch clinical development of ACI-7104, the optimized formulation of PD01, into an adaptive, biomarker-based Phase 2 study. This trial will evaluate an initial dose-response of the optimized formulation focusing on immunogenicity against a-syn and pathological a-syn species. Additionally, progression of motor and non-motor symptoms of Parkinson's disease will be monitored, together with digital, imaging and fluid biomarkers.

    Michael Motschmann, General Partner of MIG Fonds, added: "AC Immune is uniquely positioned to successfully advance the industry-leading anti-a-syn vaccine program developed by Affiris and its investors. The program will benefit from AC Immune's deep expertise in precision medicine and active vaccination approaches for neurodegenerative diseases. We are thrilled to be joining their high-quality investor base and believe this transaction will be of great benefit to our shareholders and the millions of patients suffering from neurodegenerative diseases around the world."

    Thomas Strüngmann, Co-Founder of Athos Service GmbH, commented: "We have learned from Covid-19 that collaboration can accelerate the development of safe and efficacious vaccines that can be deployed broadly to deliver highly effective protection for very large populations. This is why we strongly endorse this transaction with AC Immune, a global leader in vaccine development in neurodegeneration with an impressive precision medicine pipeline and record of execution. We look forward to working with the Company to potentially translate what has been done for infectious diseases to neurodegenerative diseases like Parkinson's and Alzheimer's."

    Prof. Andrea Pfeifer, CEO of AC Immune SA, commented: "We believe very strongly that active vaccination will play an important role in the long-term management and possible prevention of neurodegenerative diseases. By acquiring a clinically validated vaccine program against a-syn, we are advancing AC Immune to the forefront of Parkinson's disease drug development, with a wholly-owned a-syn portfolio that now covers a full spectrum of treatment modalities addressing this well-characterized target."

    "We are also proud to welcome three of the foremost investors in vaccine development, the Strüngmann Family's Athos Service, First Capital Partner GmbH and MIG Fonds, to AC Immune. As the lead investors in BioNTech, they have a globally recognized track record of identifying and supporting successful vaccine technologies. Their support of Affiris and now AC Immune serves as an endorsement of an active immunization approach for Parkinson's disease, and provides key external validation for AC Immune's unmatched expertise in the development of vaccines for neurodegenerative diseases."

    Parkinson's disease is causally linked to pathological aggregation and deposition of a-syn, a drug target that has been validated in clinical studies using monoclonal antibodies. Affiris PD01 is a vaccine designed to generate a target-specific antibody response against pathological oligomeric a-syn. Randomized Phase 1 results published in The Lancet Neurology showed that PD01 generated substantial, long-lasting and boostable antibody responses against pathological forms of a-syn that were accompanied by target engagement and signals of clinical efficacy. These data also showed that PD01 had a favorable safety and tolerability profile. This anti-a-syn vaccine complements AC Immune's existing portfolio of clinical and preclinical candidates addressing a-syn, which includes an anti-a-syn antibody, a small molecule aggregation inhibitor, and a first-in-class diagnostic imaging agent, which together may enable a precision medicine approach to treating Parkinson's disease and other alpha-synucleinopathies. With this acquisition, AC Immune becomes a leader in the development of therapeutics and diagnostics for Parkinson's disease.

    AC Immune's expertise in active vaccine development is based on its SupraAntigen®-V vaccine platform, which has been shown to generate powerful, target-specific, polyclonal antibody responses that are in the range of therapeutic monoclonal antibodies. Earlier this year, the Company reported highly encouraging readouts from its ongoing Alzheimer's disease vaccine programs targeting phospho-Tau and pathological amyloid beta (Abeta) including the most toxic oligomeric and pyroglutamate Abeta species. With the recent accelerated approval of the passive immunotherapy Aduhelm™ based on Abeta biomarker data and encouraging clinical results for the anti-Abeta antibody donanemab that demonstrate the potential benefit of targeting pyroglutamate Abeta species, AC Immune is positioned to greatly accelerate the potential time-to-market for its optimized Abeta vaccine. AC Immune is leveraging its extensive vaccine expertise to enrich and accelerate the development of ACI-7104 for Parkinson's disease and other a-synucleinopathies.

    The acquisition is subject to customary regulatory approval in Austria and expected to complete at the beginning of Q4 2021.

    Conference Call Information

    AC Immune will hold a conference call today, July 27, 2021, at 8:30 am ET / 2:30 pm CET. Interested participants and investors may access the conference call by dialing:

    • 877-407-0792 (U.S.)
    • +1 201-689-8263 (International)
    • Conference ID: 13721912

    A live webcast will be accessible via the Events section of the Company's website. An archive of the webcast will be available for 90 days beginning at approximately 9:30 am ET / 3:30 pm CET, today, July 27, 2021.

    About AC Immune SA

    AC Immune SA is 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 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.

    SupraAntigen® and Morphomer® are registered trademarks of AC Immune SA in the following territories: AU, CH, EU, JP, and GB. Morphomer® is also a registered trademark of AC Immune SA in CN and NO.

    References:

    1. https://firstcapitalpartner.de/index.html
    2. https://www.mig-fonds.de/home.html

    For further information, please contact:

    Media Relations

    Saoyuth Nidh

    AC Immune SA

    Phone: +41 21 345 91 34

    Email:

    Investor Relations

    Yves Kremer, Ph.D.

    AC Immune SA

    Phone: +41 21 345 91 90

    Email:

      
    U.S. Media

    Katie Gallagher

    LaVoie Health Science

    Phone: +1 617 792 3937

    Email:

    U.S. Investors

    Chris Maggos

    LifeSci Advisors

    Phone: +1 917 809 0814

    Email:



    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.

    Figures accompanying this announcement are available at:

    https://www.globenewswire.com/NewsRoom/AttachmentNg/5242c349-2642-4a4f-8deb-0b8bf5680015

    https://www.globenewswire.com/NewsRoom/AttachmentNg/932e5e0e-7391-4d7d-ab76-0843d0b8c7dc



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  3. LAUSANNE, Switzerland, June 25, 2021 (GLOBE NEWSWIRE) -- AC Immune SA (NASDAQ:ACIU), a clinical-stage biopharmaceutical company pioneering precision medicine for neurodegenerative diseases, today announced that AC Immune held its Annual General Meeting per Swiss law. Shareholders cast their votes through the independent proxy appointed by the shareholders.

    Shareholders re-elected Douglas Williams, Martin Velasco, Peter Bollmann, Alan Colowick, Tom Graney, Carl June, Werner Lanthaler, Andrea Pfeifer and Roy Twyman to their positions on the Board of Directors. Douglas Williams and Martin Velasco will continue to serve as Chairman and Vice-Chairman of the Board, respectively.

    Douglas Williams, Chairman of the Board of Directors of AC Immune…

    LAUSANNE, Switzerland, June 25, 2021 (GLOBE NEWSWIRE) -- AC Immune SA (NASDAQ:ACIU), a clinical-stage biopharmaceutical company pioneering precision medicine for neurodegenerative diseases, today announced that AC Immune held its Annual General Meeting per Swiss law. Shareholders cast their votes through the independent proxy appointed by the shareholders.

    Shareholders re-elected Douglas Williams, Martin Velasco, Peter Bollmann, Alan Colowick, Tom Graney, Carl June, Werner Lanthaler, Andrea Pfeifer and Roy Twyman to their positions on the Board of Directors. Douglas Williams and Martin Velasco will continue to serve as Chairman and Vice-Chairman of the Board, respectively.

    Douglas Williams, Chairman of the Board of Directors of AC Immune, commented: "Despite impact from COVID-19, AC Immune has maintained its business on track. In fact, the Company is emerging from the pandemic with plans to accelerate development of key clinical programs, in particular its Alzheimer's disease vaccines targeting Tau and Abeta. These industry-leading programs continue to demonstrate good safety and robust, lasting immunization against key pathological proteins, including phospho-Tau and both oligomeric and pyroglutamate Abeta, respectively. As the treatment focus for AD shifts earlier and potentially into the prevention setting, pioneering active vaccination positions AC Immune to become a global leader with a highly differentiated approach and clinically validated candidates. I am thankful to our Shareholders for their trust in the Board to lead AC Immune in its next phase of development."

    Shareholders also approved all resolutions at the AGM as proposed by the Board of Directors. Prior to the meeting, the Board withdrew agenda items 6.2 and 6.3.

    The meeting was held in accordance with the requirements of the COVID-19 Ordinance 3, issued by the Swiss Federal Council.

    About AC Immune SA 

    AC Immune SA is 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 nine therapeutic and three diagnostic candidates, six of which are currently in 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.

    SupraAntigen® and Morphomer® are registered trademarks of AC Immune SA in the following territories: AU, CH, EU, JP, and GB. Morphomer® is also a registered trademark of AC Immune SA in CN and NO.

    For further information, please contact:

    Head of Investor Relations and

    Corporate Communications

    Joshua Drumm, Ph.D.

    AC Immune

    Phone : +1 917 809 0814

    Email:

    U.S. Media

    Katie Gallagher

    LaVoie Health Science

    Phone: +1 617 792 3937

    Email:

      
     European Investors & Media

    Chris Maggos

    LifeSci Advisors

    Phone : +41 79 367 6254

    Email :

    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.



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  4. Optimized vaccine candidate generates enhanced polyclonal antibody response against pyroglutamate Abeta in non-human primates

    Phase 2 interim analysis of ACI-24 confirms good safety and tolerability profile in people with mild Alzheimer's disease

    LAUSANNE, Switzerland, June 02, 2021 (GLOBE NEWSWIRE) -- AC Immune SA (NASDAQ:ACIU), a clinical-stage biopharmaceutical company pioneering precision medicine for neurodegenerative diseases, today provided key clinical and preclinical updates for its SupraAntigen®-derived liposomal vaccine candidates, which are designed to convey active, long-lasting immunization against pathological forms of amyloid-beta (Abeta). AC Immune is completing a Phase 2 study of its first clinical candidate, ACI-24…

    Optimized vaccine candidate generates enhanced polyclonal antibody response against pyroglutamate Abeta in non-human primates

    Phase 2 interim analysis of ACI-24 confirms good safety and tolerability profile in people with mild Alzheimer's disease

    LAUSANNE, Switzerland, June 02, 2021 (GLOBE NEWSWIRE) -- AC Immune SA (NASDAQ:ACIU), a clinical-stage biopharmaceutical company pioneering precision medicine for neurodegenerative diseases, today provided key clinical and preclinical updates for its SupraAntigen®-derived liposomal vaccine candidates, which are designed to convey active, long-lasting immunization against pathological forms of amyloid-beta (Abeta). AC Immune is completing a Phase 2 study of its first clinical candidate, ACI-24, in people with mild Alzheimer's disease (AD), and is also advancing an optimized ACI-24 formulation, which demonstrates enhanced and sustained immunogenicity in non-human primate studies, particularly against key pathological forms of Abeta such as oligomeric and pyroglutamate Abeta.

    Pyroglutamate Abeta (pyroGlu-Abeta) is a highly neurotoxic form of Abeta that is N-terminally truncated and post-translationally modified to form pyroglutamate. Extracellular pyroGlu-Abeta is an important target for immunotherapy, as the peptide's altered biochemical properties make it more prone to aggregate compared to full-length Abeta, and it is a major component of Abeta plaques. Passive immunization with a monoclonal antibody specific for pyroglutamate Abeta demonstrated encouraging clinical results in a recently published Phase 2 clinical study.

    In non-human primates, vaccination with the optimized ACI-24 vaccine generated a strong, conformation-specific antibody response against oligomeric and pyroGlu-Abeta. A robust boosting effect was also observed, the magnitude of which was substantially greater against pyroGlu-Abeta compared to full-length Abeta (approx. 8-fold vs 4-fold increase, respectively, between the 3rd and 5th injections). Epitope mapping studies using sera from immunized cynomolgus monkeys showed the strongest signals for sites binding to peptides covering N-terminal regions of Abeta located just beyond where cleavage occurs to form pyroGlu-Abeta (amino acids 3-10, 4-11, 5-12). This further supports the strong response observed against this key pathological variant.

    Prof. Andrea Pfeifer, CEO of AC Immune SA, commented: "We believe the optimized ACI-24 formulation represents a potential breakthrough in Abeta vaccination, as it elicits a strong immune response against oligomeric and truncated Abeta, the suggested key culprits in the Abeta pathway driving early Alzheimer's disease. These exciting preclinical results, combined with the encouraging clinical safety and efficacy we have demonstrated to date for our optimized pTau vaccine ACI-35.030 as well as our first anti-Abeta vaccine candidate ACI-24, highlight the strength and versatility of our SupraAntigen®-V platform for delivering safe and long-lasting active immunization against key proteinopathies in neurodegenerative diseases. We are planning to file an Investigational New Drug (IND) application for the optimized ACI-24 formulation by year-end, followed by an accelerated clinical development in Down syndrome-related AD, with start of Phase 2 as early as 2022/23."

    In addition, AC Immune completed an 18-month interim assessment of safety and tolerability in the Phase 2 study evaluating ACI-24 in patients with mild AD. Confirming earlier interim results, there have been no safety concerns nor evidence for CNS inflammation or ARIA (amyloid-related imaging abnormalities) related to ACI-24 in any subject. AC Immune will complete the Phase 2 study with the 24-month analysis on the basis of currently enrolled patients.

    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. Antibodies generated by the platform are highly specific for the pathological conformations of misfolded proteins and show good safety in AD patients and animals. The SupraAntigen® platform has successfully generated two vaccines and two monoclonal 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 Abeta and Tau, AC Immune has generated conformation-specific antibodies against emerging targets in neurodegenerative diseases including alpha-synuclein, TDP-43 and the NLRP3 inflammasome pathway.

    About AC Immune SA

    AC Immune SA is 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 nine therapeutic and three diagnostic candidates, six of which are currently in 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.

    SupraAntigen® and Morphomer® are registered trademarks of AC Immune SA in the following territories: AU, CH, EU, JP, and GB. Morphomer® is also a registered trademark of AC Immune SA in CN and NO.

    For further information, please contact:

    Head of Investor Relations and

    Corporate Communications

    Joshua Drumm, Ph.D.

    AC Immune

    Phone : +1 917 809 0814

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    LaVoie Health Science

    Phone: +1 617 792 3937

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    Chris Maggos

    LifeSci Advisors

    Phone : +41 79 367 6254

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