A Phase 1b/2, Multicenter, Adaptive, Double-blind, Randomized, Placebo-controlled Study to Assess the Safety, Tolerability, Immunogenicity, and Pharmacodynamic Effects of ACI-24.060 in Subjects With Prodromal Alzheimer's Disease and in Adults With Down Syndrome (ABATE)

The purpose of this study is to assess the safety, tolerability, immunogenicity and pharmacodynamic effects of ACI-24.060 in subjects with prodromal Alzheimer's disease and in non-demented adults with Down syndrome.

Start Date21 Jun 2022

Sponsor / Collaborator

AC Immune SA

[+1]

NCT04373616 / WithdrawnPhase 2

A Phase 2 Double-blind, Randomized, Placebo-controlled Study to Assess the Safety, Tolerability and Target Engagement of ACI-24 in Adults With Down Syndrome

This study is a prospective multicenter, placebo-controlled, double-blind, randomized study to assess the effect of one dose ACI-24 versus placebo over a 74-week treatment period and 26-week safety follow-up period.

Start Date01 Oct 2021

Sponsor / Collaborator

AC Immune SA

EUCTR2018-000445-39-FI / Not yet recruitingPhase 2

A Phase II Double-Blind, Randomized, Placebo-Controlled, Adaptive Design Study to Assess the Safety, Tolerability, Immunogenicity and Target Engagement of ACI-24 Formulations in Patients with Mild Alzheimer’s Disease

Start Date19 Jun 2018

Sponsor / Collaborator

AC Immune SA

100 Clinical Results associated with ACI-24

100 Translational Medicine associated with ACI-24

100 Patents (Medical) associated with ACI-24

Literatures (Medical) associated with ACI-24

01 Jul 2023·Research in microbiology

Early expression of capsule during Bacillus anthracis germination

Article

Author: Goossens, Pierre L ; Tournier, Jean-Nicolas ; Mock, Michèle ; Fastenackels, Solène

Bacillus anthracis is a spore-forming bacterium that produces two major virulence factors, a tripartite toxin with two enzymatic toxic activities and a pseudo-proteic capsule. One of the main described functions of the poly-gamma-d-glutamate capsule is to enable B. anthracis bacilli to escape phagocytosis. Thus, kinetics of expression of the capsule filaments at the surface of the emerging bacillus during germination is an important step for the protection of the nascent bacilli. In this study, through immunofluorescence and electron microscopic approaches, we show the emergence of the capsule through a significant surface of the exosporium in the vast majority of the germinating spores, with co-detection of BclA and capsular material. This suggests that, due to an early capsule expression, the extracellular life of B. anthracis might occur earlier than previously thought, once germination is triggered. This raises the prospect that an anti-capsular vaccine may play a protective role at the initial stage of infection by opsonisation of the nascent encapsulated bacilli before their emergence from the exosporium.

01 Jun 2022·JAMA neurologyQ1 · MEDICINE

Safety, Tolerability, and Immunogenicity of the ACI-24 Vaccine in Adults With Down Syndrome

Q1 · MEDICINE

Article

Author: Evans, A. Carol ; Pfeifer, Andrea ; Streffer, Johannes ; Beth, Gregory ; Rafii, Michael S. ; dos Santos, Antonio Melo ; Sabbagh, Marwan N. ; Hliva, Valerie ; Delpretti, Saskia ; Skotko, Brian G. ; Sol, Olivier ; Rissman, Robert A. ; Feldman, Howard H. ; Evans, Casey ; Kosco-Vilbois, Marie ; Fournier, Nicolas ; Gray, Julian A. ; Burke, Anna D. ; Yuan, Shauna H. ; Vukicevic, Marija ; Mobley, William C. ; Pulsifer, Margaret

Importance:

Individuals with Down syndrome (DS) are at high risk of developing Alzheimer disease due to an increased dose of the amyloid precursor protein gene, APP, which leads to increased levels of full-length APP and its products, including amyloid-β (Aβ). The liposome-based antiamyloid ACI-24 vaccine is intended to treat neurological disorders caused by misfolded Aβ pathological protein. However, the safety, tolerability, and immunogenicity of the ACI-24 vaccine among adults with DS have not been fully examined.

Objective:

To assess the safety and tolerability of the ACI-24 vaccine among adults with DS as well as its ability to induce immunogenicity measured by anti-Aβ immunoglobulin G titers.

Design, Setting, and Participants:

This multicenter double-blind placebo-controlled dose-escalation phase 1b randomized clinical trial was conducted at 3 US academic medical centers with affiliated Down syndrome clinics between March 30, 2016, and June 29, 2020. A total of 20 adults with DS were screened; of those, 16 adults were eligible to participate. Eligibility criteria included men or women aged 25 to 45 years with cytogenetic diagnosis of either trisomy 21 or complete unbalanced translocation of chromosome 21. Between April 27, 2016, and July 2, 2018, participants were randomized 3:1 into 2 dose-level cohorts (8 participants per cohort, with 6 participants receiving the ACI-24 vaccine and 2 receiving placebo) in a 96-week study. Participants received 48 weeks of treatment followed by an additional 48 weeks of safety follow-up.

Interventions:

Participants were randomized to receive 7 subcutaneous injections of ACI-24, 300 μg or 1000 μg, or placebo.

Main Outcomes and Measures:

Primary outcomes were measures of safety and tolerability as well as antibody titers.

Results:

Among 16 enrolled participants, the mean (SD) age was 32.6 (4.4) years; 9 participants were women, and 7 were men. All participants were White, and 1 participant had Hispanic or Latino ethnicity. Treatment adherence was 100%. There were no cases of meningoencephalitis, death, or other serious adverse events (AEs) and no withdrawals as a result of AEs. Most treatment-emergent AEs were of mild intensity (110 of 132 events [83.3%]) and unrelated or unlikely to be related to the ACI-24 vaccine (113 of 132 events [85.6%]). No amyloid-related imaging abnormalities with edema or cerebral microhemorrhage and no evidence of central nervous system inflammation were observed on magnetic resonance imaging scans. Increases in anti-Aβ immunoglobulin G titers were observed in 4 of 12 participants (33.3%) receiving ACI-24 (2 receiving 300 μg and 2 receiving 1000 μg) compared with 0 participants receiving placebo. In addition, a greater increase was observed in plasma Aβ1-40 and Aβ1-42 levels among individuals receiving ACI-24.

Conclusions and Relevance:

In this study, the ACI-24 vaccine was safe and well tolerated in adults with DS. Evidence of immunogenicity along with pharmacodynamic and target engagement were observed, and anti-Aβ antibody titers were not associated with any adverse findings. These results support progression to clinical trials using an optimized formulation of the ACI-24 vaccine among individuals with DS.

Trial Registration:

ClinicalTrials.gov Identifier: NCT02738450.

04 Jan 2022·Brain communications

An amyloid beta vaccine that safely drives immunity to a key pathological species in Alzheimer’s disease: pyroglutamate amyloid beta

Article

Author: Depretti, S. ; Rentero, I. ; Donati, P. ; Rincon-Restrepo, M. ; Giriens, V. ; Beuzelin, M. ; Siegert, S. ; Rivot, S. ; Gesbert, A. ; Pfeifer, A. ; Fiorini, E. ; Lopez-Deber, P. ; Vukicevic, M. ; Kosco-Vilbois, M. H. ; Morici, C. ; Ayer, M. ; Babolin, C. ; Piot, N. ; Bravo-Veyrat, S. ; Streffer, J. ; Carpintero, R.

Abstract:

Pyroglutamate amyloid beta3–42 (pGlu-Abeta3–42), a highly amyloidogenic and neurotoxic form of Abeta, is N-terminally truncated to form a pyroglutamate and has recently been proposed as a key target for immunotherapy. Optimized ACI-24, a vaccine in development for the treatment and prevention of Alzheimer’s disease, focuses the antibody response on the first 15 N-terminal amino acids of Abeta (Abeta1–15). Importantly, clinical data with an initial version of ACI-24 incorporating Abeta1–15, established the vaccine’s safety and tolerability with evidence of immunogenicity. To explore optimized ACI-24’s capacity to generate antibodies to pGlu-Abeta3–42, pre-clinical studies were carried out. Vaccinating mice and non-human primates demonstrated that optimized ACI-24 was well-tolerated and induced an antibody response against Abeta1–42 as expected, as well as high titres of IgG reactive with pyroGlu-Abeta. Epitope mapping of the polyclonal response confirmed these findings revealing broad coverage of epitopes particularly for Abeta peptides mimicking where cleavage occurs to form pGlu-Abeta3–42. These data are in striking contrast to results obtained with other clinically tested Abeta targeting vaccines which generated restricted and limited antibody diversity. Taken together, our findings demonstrate that optimized ACI-24 vaccination represents a breakthrough to provide a safe immune response with a broader Abeta sequence recognition compared to previously tested vaccines, creating binders to pathogenic forms of Abeta important in pathogenesis including pGlu-Abeta3–42.

News (Medical) associated with ACI-24

17 Sep 2024

·pipelinereview.com

AC Immune Receives Second Milestone Payment Following Progress in Phase 2b ReTain Trial of ACI-35.030 in Preclinical Alzheimer’s Disease

LAUSANNE, Switzerland I September 17, 2024 I AC Immune SA (NASDAQ: ACIU), a clinical-stage biopharmaceutical company pioneering precision therapeutics for neurodegenerative diseases, today announced that it will receive the second ReTain-related milestone payment (CHF 24.6 million) under its agreement with Janssen Pharmaceuticals, Inc. (Janssen), a Johnson & Johnson company. The milestone payment has been triggered by the rapid rate of prescreening in the potentially registrational Phase 2b ReTain trial investigating active-immunotherapy candidate ACI-35.030 (now called “JNJ-2056”) to treat preclinical (pre-symptomatic) Alzheimer’s disease (AD). With last December’s milestone payment, this brings the total milestone payments received for ACI-35.030 related to this trial to CHF 40 million. Dr. Andrea Pfeifer, CEO of AC Immune SA, commented: “This early milestone demonstrates that the medical community and members of the public believe, as we do, that second generation therapeutics for Alzheimer’s disease, like our active immunotherapy targeting pathological phosphorylated-Tau protein (pTau), may provide an important benefit to those diagnosed early, prior to the development of disease symptoms. Early diagnosis and treatment are needed to combat neurodegeneration. “This payment also re-affirms the quality and productivity of AC Immune’s technology platforms and drug development capabilities. We have now received a total of approximately CHF 425 million in milestone and upfront payments from all of our collaboration deals to date, and there are outstanding potential milestone payments exceeding CHF 4.3 billion, plus royalties on potential sales. Importantly, in these challenging financial markets, this milestone payment adds to our already solid financial position, providing us with three years of cash for operations, in which time we expect to achieve several potentially transformational milestones.” JNJ-2056 received Fast Track designation from the U.S. Food and Drug Administration (FDA) in July, an important recognition of its differentiation and its potential value for patients. It is the second active immunotherapy from AC Immune to achieve this regulatory milestone, after ACI-24.060, which targets Abeta. AC Immune’s PI-2620 Tau-PET diagnostic, which is in Phase 3 development, also received Fast Track designation this August. ACI-35.030 has been shown in Phase 1b/2a clinical testing to induce an antibody response targeting pTau while sparing normal endogenous forms of Tau. ReTain has attracted a high level of interest among potential participants with the rate of prescreening outperforming expectations. “The Phase 2b ReTain trial is a potentially important step in the fight against neurodegeneration, as it is the first time any active immunotherapy is being tested in the preclinical AD population. Active immunotherapies like ACI-35.030 could offer therapeutic advantages, together with improved convenience and access, and the recent Fast Track designation is an important recognition of its potential value for patients,” Dr. Pfeifer said. About the Phase 2b ReTain Study (ClinicalTrials.gov Identifier: NCT06544616 ) The Phase 2b ReTain trial is a potentially registration-enabling randomized, multicenter, double-blind, placebo-controlled clinical study in participants with preclinical AD to assess the clinical effect of active immunization with JNJ-64042056 (JNJ-2056). It is designed to test the hypothesis that JNJ-2056 has a disease-modifying effect that can delay or prevent the onset of cognitive impairment or other clinical symptoms in individuals with preclinical AD through inhibition of seeding and spreading of pathological Tau. The study will include approximately 500 participants with preclinical AD (cognitively normal, Tau positive), who will be randomized in a 1:1 ratio to a single dose level of JNJ-2056 or placebo and administered as intramuscular injections for a maximum of 4 years. It is currently being conducted at more than 40 clinical trial sites in the U.S., Japan, UK and Australia, and more are expected to open shortly. The primary endpoint will measure cognitive decline as assessed by the Preclinical AD Cognitive Composite 5 (PACC-5) score. The key secondary efficacy endpoint will assess the effect of JNJ-2056 on the propagation and/or accumulation of Tau pathology compared with placebo, as measured by Tau PET imaging. The ReTain trial is fully funded and conducted by Janssen Pharmaceuticals, Inc. (Janssen), a Johnson & Johnson company, pursuant to a global license, development and commercialization agreement. About ACI-35.030 (JNJ-2056) ACI-35.030, derived from AC Immune’s SupraAntigen® platform, has been shown in clinical studies to induce a strong polyclonal antibody response that matures and is maintained against key pathological forms of Tau believed to drive Tau aggregation and disease progression. ACI-35.030 is designed to enhance the formation of broad-spectrum protective antibodies against pTau. This investigational candidate has the potential to reduce pathological Tau spreading in the early stages of AD, and thereby may reduce or prevent disease progression. About AC Immune SA 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. SOURCE: AC Immune

Phase 2License out/inImmunotherapyFast Track

28 Aug 2024

·www.globenewswire.com

AC Immune’s PI-2620 Tau-PET Diagnostic in Phase 3 Receives Fast Track Designation in Three Neurodegenerative Conditions

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, LMIThis Fast Track designation applies across Alzheimer’s disease, progressive supranuclear palsy, and corticobasal degenerationFollows two previous Fast Track designations for ACI-35.030 and ACI-24.060 active immunotherapiesAffirms AC Immune’s leadership and commitment to bringing precision medicine to the management of neurodegenerative diseases 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 (CBD). 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.” About PI-2620PI-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). About AC Immune SA 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 CommunicationsGary Waanders, Ph.D., MBAAC ImmunePhone: +41 21 345 91 91Email: gary.waanders@acimmune.comU.S. InvestorsCorey Davis, Ph.D.LifeSci AdvisorsPhone: +1 212 915 2577 Email: cdavis@lifesciadvisors.comInternational MediaChris MaggosCohesion BureauPhone: +41 79 367 6254Email: chris.maggos@cohesionbureau.com Forward looking statementsThis 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. Attachment 20240828_ACIU_PI-2620 FastTrack_Final_CLEAN

ImmunotherapyPhase 3Fast TrackPhase 2License out/in

06 Aug 2024

·www.globenewswire.com

AC Immune Reports Second Quarter 2024 Financial Results and Provides a Corporate Update

AC Immune Reports Second Quarter 2024 Financial Results and Provides a Corporate Update Announced exclusive option and license agreement with Takeda for ACI-24.060 on May 13 for $100 million upfront and total potential milestones of up to approximately $2.1 billionACI-24.060 ABATE Phase 2 trial in Alzheimer’s disease (AD) on track with enrolment expectationsACI-7104.056 VacSYn Phase 2 trial of anti-a-syn active immunotherapy in Parkinson’s disease (PD) on track for safety and immunogenicity interim data in H2 2024Potent inhibitor of the inflammatory NLRP3 pathway, ACI-19764, demonstrates promising preclinical results and may be broadly applicable to treat CNS and non-CNS diseasesCash balance of CHF 175.2 million at quarter end, including CHF 92.3 million from Takeda, provides sufficient runway for three years Lausanne, Switzerland, August 6, 2024 – AC Immune SA (NASDAQ: ACIU), a clinical-stage biopharmaceutical company pioneering precision therapeutics for neurodegenerative diseases, today reported results for the quarter ended June 30, 2024, and provided a corporate update. Dr. Andrea Pfeifer, CEO of AC Immune SA, commented, “AC Immune is entering the second half of 2024 with tremendous momentum. We are excited about the recently announced partnership with Takeda for ACI-24.060 as a potential best-in-class Abeta-targeted active immunotherapy. Enrollment in the ABATE Phase 2 trial of ACI-24.060 in AD continues to progress as planned.” “We are also excited to be advancing our preclinical programs, some of which were recently featured in multiple presentations at the AAIC 2024 conference. Our novel morADC platform, a synergistic combination of our SupraAntigen® and Morphomer® platforms, has significant potential for enhanced targeted interventions for a variety of neurodegenerative diseases and also offers opportunities for simultaneous combination approaches. These morADCs are already showing promise in multiple preclinical models, and we look forward to sharing more details on this and on other preclinical development programs in an upcoming R&D day. Our solid financial position, enhanced by the Takeda partnership, enables us to drive clinical and preclinical development, leveraging the core competency of AC Immune that is anchored by our foundational expertise in neurodegenerative disease drug discovery.” Q2 2024 and Subsequent Highlights AC Immune and Takeda signed an exclusive option and license agreement for AC Immune’s active immunotherapies targeting Abeta, including ACI-24.060 for AD. Under the terms of the agreement, AC Immune received an upfront payment of $100 million from Takeda and, if all related milestones are achieved over the course of the agreement, is eligible to receive payments of up to approximately $2.1 billion including an option exercise fee and additional potential development, commercial and sales-based milestones. Upon commercialization, AC Immune will be entitled to receive tiered double-digit royalties on worldwide net sales.Enrolment in the ACI-24.060 ABATE Phase 2 AD trial continues.We also completed the regulatory toxicology studies for the anti-TDP-43 monoclonal antibody candidate in Q2 which will enable us to proceed with IND filing.Our targeted NLRP3 inhibitor candidates continue to show excellent promise in preclinical results featured at the AD/PD™ 2024 conference: ACI-19764 is a brain penetrant small molecule in preclinical development that directly binds and inhibits NLRP3. Its activity in vitro and in vivo was demonstrated in two models of neuroinflammation. In addition, ACI-19764 demonstrated an excellent safety profile and optimal exposure for sustained NLRP3 inhibition in the brain.AC Immune intends to file an IND from the NLRP3 program in the near future. AC Immune’s preclinical programs were featured in multiple presentations at the Alzheimer’s Association International Conference (AAIC) 2024: A new class of neurodegenerative disease-fighting drugs: morADC (Morphomer®- antibody drug conjugates), presented by Madiha Derouazi (Chief Scientific Officer, AC Immune), featured data from AC Immune’s proprietary morADC platform. Results demonstrated the ability of morADCs to penetrate the blood brain barrier in vivo and produce potent catalytic activity in vitro compared to the parental monoclonal antibody or small molecule alone.Active immunotherapy, ACI-24.060, induces anti-Abeta antibodies with binding profiles mirroring clinically validated monoclonal antibodies, presented by Emma Fiorini (AC Immune), featured results from non-human primates demonstrating that ACI-24.060 induced antibody responses in a similar range of levels of donanemab and lecanemab and with preferential oligomeric Abeta binding as compared to monomeric Abeta.Discovery and preclinical development of [18F]ACI-19626, a first-in-class TDP-43 PET tracer, presented by Tamara Seredenina (AC Immune), described the selection of [18F]ACI-19626 for evaluation as a potential PET tracer for detection and monitoring progression of TDP-43 aggregates based on its favorable affinity, selectivity and pharmacokinetic properties. Board and Management Share Purchases: Members of the Board of Directors and certain members of executive management purchased shares in AC Immune SA during Q2 2024, following the announcement of the exclusive option and license agreement with Takeda for ACI-24.060. As a foreign private issuer (FPI), individual shareholdings will be disclosed in the Annual Report on Form 20-F. Anticipated 2024 Milestones ACI-24.060anti-Abeta active immunotherapy ABATE Phase 2 trial in AD on track with enrolment expectations ACI-7104.056anti-a-syn active immunotherapy Interim safety and immunogenicity update from the Phase 2 VacSYn study in Parkinson’s disease expected in H2 2024 ACI-35.030anti-pTau active immunotherapy First patient treated in ReTain Phase 2b clinical trial expected in the coming months TDP-43-PET tracer Phase 1 initiation expected in H2 2024 ACI-15916 a-syn-PET tracer IND-enabling studies in PD expected to be completed in H2 2024 Analysis of Financial Statements for the Quarter Ended June 30, 2024 Cash Position: The Company had a total cash balance of CHF 175.2 million (CHF 103.1 million as of December 31, 2023), composed of CHF 51.6 million in cash and cash equivalents and CHF 123.6 million in short-term financial assets. The Company’s cash balance provides sufficient capital resources for three years, assuming the potential milestone payment of CHF 24.6 million related to achieving an undisclosed enrolment target for our ACI-35.030, and no other milestones.Contract Revenues: The Company recorded CHF 0.7 million in contract revenues for the three months ended June 30, 2024, compared to nil in the comparable prior period. For the three months ended June 30, 2024, our contract revenues of CHF 0.7 million were related to the efforts made under the agreement with Takeda.R&D Expenditures: R&D expenses for the three months ended June 30, 2024, were CHF 17.1 million compared to CHF 13.7 million in the comparable period in 2023. The increase was due mainly to higher clinical expenses, driven by the ramp-up activities for our Phase 2 VacSYn study evaluating ACI-7104.056 in early PD and for the expansion of the ABATE study in our ACI-24.060 active immunotherapy.G&A Expenditures: G&A increased by CHF 0.9 million to CHF 4.6 million, mostly due to an increase in legal fees related to business development and licensing activities, as well as salaries and related costs, largely attributable to the higher expenses from equity awards granted in 2024, which have a higher fair value based on our share price development.Other Operating Income: The Company recognized less than CHF 0.1 million in grant income from Target ALS grants.IFRS Loss for the Period: The Company reported a net loss after taxes of CHF 22.8 million for the three months ended June 30, 2024, compared with a net loss of CHF 16.8 million for the comparable period in 2023. About AC Immune SA 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 CommunicationsGary Waanders, Ph.D., MBAAC ImmunePhone: +41 21 345 91 91Email: gary.waanders@acimmune.comU.S. InvestorsCorey Davis, Ph.D.LifeSci AdvisorsPhone: +1 212 915 2577 Email: cdavis@lifesciadvisors.comInternational MediaChris MaggosCohesion BureauPhone: +41 79 367 6254Email: chris.maggos@cohesionbureau.com Forward looking statementsThis 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. Condensed Consolidated Balance Sheets (Unaudited)(In CHF thousands) As of June 30, December 31, 2024 2023Assets Non-current assets Property, plant and equipment 2,926 3,376Right-of-use assets 3,235 3,508Intangible asset 50,416 50,416Long-term financial assets 415 361Total non-current assets 56,992 57,661Current assets Prepaid expenses 3,864 6,437Accrued income 402 246Other current receivables 1,153 622Accounts receivable — 14,800Short-term financial assets 123,560 24,554Cash and cash equivalents 51,564 78,494Total current assets 180,543 125,153Total assets 237,535 182,814 Shareholders' equity and liabilities Shareholders’ equity Share capital 2,212 2,089Share premium 476,074 474,907Treasury shares (218) (105)Currency translation differences (35) (51)Accumulated losses (354,608) (316,197)Total shareholders’ equity 123,425 160,643 Non-current liabilities Long-term deferred contract revenue 5,170 —Long-term lease liabilities 2,542 2,825Net employee defined benefit liabilities 5,868 5,770Total non-current liabilities 13,580 8,595 Current liabilities Trade and other payables 1,435 1,679Accrued expenses 11,895 11,087Short-term deferred income 45 138Short-term deferred contract revenue 86,468 —Short-term lease liabilities 687 672Total current liabilities 100,530 13,576Total liabilities 114,110 22,171Total shareholders’ equity and liabilities 237,535 182,814 Condensed Consolidated Statements of Income/(Loss) (Unaudited)(In CHF thousands, except for per-share data) For the Three Months For the Six Months Ended June 30, Ended June 30, 2024 2023 2024 2023Revenue Contract revenue 687 — 687 —Total revenue 687 — 687 — Operating expenses Research & development expenses (17,138) (13,682) (32,303) (27,555)General & administrative expenses (4,551) (3,681) (9,522) (7,787)Other operating income/(expense), net 41 317 109 725Total operating expenses (21,648) (17,046) (41,716) (34,617)Operating loss (20,961) (17,046) (41,029) (34,617) Financial income 739 259 1,368 468Financial expense (34) (27) (70) (124)Exchange differences (2,504) (16) (891) (67)Finance result, net (1,799) 216 407 277 Loss before tax (22,760) (16,830) (40,622) (34,340)Income tax expense — (3) — (6)Loss for the period (22,760) (16,833) (40,622) (34,346)Loss per share: (0.23) (0.20) (0.41) (0.41) Condensed Consolidated Statements of Comprehensive Income/(Loss) (Unaudited)(In CHF thousands) For the Three Months For the Six Months Ended June 30, Ended June 30, 2024 2023 2024 2023Loss for the period (22,760) (16,833) (40,622) (34,346)Items that will be reclassified to income or loss in subsequent periods (net of tax): Currency translation differences — (8) 16 (16)Items that will not to be reclassified to income or loss in subsequent periods (net of tax): Remeasurement gains on defined-benefit plans — — — —Total comprehensive loss (net of tax) (22,760) (16,841) (40,606) (34,362) Attachment 20240805_ACIU_Q2_Earnings_Final

License out/inImmunotherapyPhase 2Financial StatementPhase 1

100 Deals associated with ACI-24

R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Plaque, Amyloid	Phase 2	US	AC Immune SA	21 Jun 2022
Plaque, Amyloid	Phase 2	ES	AC Immune SA	21 Jun 2022
Plaque, Amyloid	Phase 2	GB	AC Immune SA	21 Jun 2022
Down Syndrome	Phase 2	-	AC Immune SA	01 Oct 2021
Alzheimer Disease	Phase 2	SE	AC Immune SA	01 Dec 2015

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02738450 (3-Star, Pubmed \| JAMA Neurol) Manual	Phase 1	Down Syndrome	16	ACI 24	vexepscywr(rhitevlhlh) = wgpueszlmq izjkndlcjm (nmzxjdwymk )	Positive	09 May 2022
				Placebo	vexepscywr(rhitevlhlh) = kkxkmmwlkl izjkndlcjm (nmzxjdwymk )

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Chat with Hiro

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis

ACI-24

Overview

Basic Info

Gene Sequence

Related

R&D Status

Clinical Result

Translational Medicine

Deal

Core Patent

Clinical Trial

Approval

Regulation