ACI-24.060 / AC Immune, Takeda - LARVOL DELTA

3440: INDUSTRY SYMPOSIUM 02 (NO CME/CPD CREDIT): Unlocking active immunotherapy for tailored prevention strategies in neurodegenerative diseases (ADPD 2025) - "Günther Staffler will present ACI-7104.056, an anti-a-syn active immunotherapy currently evaluated in the Phase 2 VacSYn trial in early PD...Lennert Steukers will then present the ReTain Phase 2b trial, the first prevention trial for an active immunotherapy in preclinical Alzheimer's, evaluating ACI-35.030/JNJ-2056, an anti-pTau active immunotherapy...Anke Post will provide an update on ACI-24.060, an anti-Abeta active immunotherapy being evaluated in the ABATE Phase 1b/2 trial in both early Alzheimer's disease (AD) and Down syndrome-associated Alzheimer's (DSAD). We will conclude with a Q&A to discuss how active immunotherapies, early detection and biomarker-driven strategies might reshape the future of prevention and treatment in Alzheimer's and Parkinson's diseases."

IO biomarker • Alzheimer's Disease • CNS Disorders • Developmental Disorders • Genetic Disorders • Movement Disorders • Parkinson's Disease

ANTI-ABETA ACTIVE IMMUNOTHERAPY IN EARLY AD AND DSAD: ACI-24.060 IN THE PHASE 1B/2 ABATE STUDY (ADPD 2025) - "Supported by AC Immune"

P1/2 data • CNS Disorders

AC Immune Announces Upcoming Presentations and Industry Symposium on Active Immunotherapies at AD/PD™ 2025 (GlobeNewswire) - "AC Immune SA...announced upcoming presentations highlighting its precision medicine pipeline at the International Conference on Alzheimer’s and Parkinson’s Diseases (AD/PD 2025) taking place in Vienna, Austria, on April 1 – 5, 2025. AC Immune will host an industry symposium highlighting advances in the clinical development of active immunotherapies featuring key opinion leaders, industry experts and AC Immune leadership."

Clinical data • Alzheimer's Disease • Parkinson's Disease

Biomarkers. (PubMed, Alzheimers Dement) - "Data from longitudinal biomarker studies are informing the design and conduct of clinical trials targeting AD in people with DS."

Biomarker • Clinical • Journal • Alzheimer's Disease • CNS Disorders • Dementia • Developmental Disorders • Genetic Disorders

Drug Development. (PubMed, Alzheimers Dement) - "ACI-24.060 induced antibody responses in NHPs with 3-log preferential binding to oligomeric versus monomeric Abeta, similar to lecanemab and strong binding to both Abeta oligomers and pyroglutamate-Abeta species. Induced antibodies were in the range of levels of donanemab and lecanemab relevant for Abeta clearance in human AD patients. Therefore, ACI-24.060, with its dual target effect (pyroglutamate-Abeta and Abeta oligomers) and its FDA Fast Track designation, represents a potential breakthrough active immunotherapy for Alzheimer's disease."

Journal • Alzheimer's Disease • CNS Disorders

AC Immune Showcasing its Novel Morphomer-Antibody Drug Conjugate (morADC) Platform for the Treatment of Neurodegenerative Diseases at AAIC 2024 (GlobeNewswire) - "AC Immune SA...today announced three oral presentations highlighting its precision medicine pipeline at the annual Alzheimer’s Association International Conference (AAIC 2024), taking place in Philadelphia, PA, on July 28 - August 1, 2024."

Preclinical • Alzheimer's Disease • CNS Disorders

Active immunotherapy, ACI-24.060, induces anti-Abeta antibodies with binding profiles mirroring clinically validated monoclonal antibodies (AAIC 2024) - "ACI-24.060 induced antibody responses in NHPs with 3-log preferential binding to oligomeric versus monomeric Abeta, similar to lecanemab and strong binding to both Abeta oligomers and pyroglutamate-Abeta species. Induced antibodies were in the range of levels of donanemab and lecanemab relevant for Abeta clearance in human AD patients. Therefore, ACI-24.060, with its dual target effect (pyroglutamate-Abeta and Abeta oligomers) and its FDA Fast Track designation, represents a potential breakthrough active immunotherapy for Alzheimer’s disease."

Clinical • Alzheimer's Disease • CNS Disorders

Selection of Biomarkers and Clinical Endpoints for Clinical Trials Targeting Down syndrome-related Alzheimer’s disease (DSAD) (AAIC 2024) - "Data from longitudinal biomarker studies are informing the design and conduct of clinical trials targeting AD in people with DS."

Biomarker • Clinical • Alzheimer's Disease • CNS Disorders • Dementia • Developmental Disorders • Genetic Disorders

AC Immune and Takeda Sign Exclusive Option and License Agreement for Active Immunotherapy Targeting Amyloid Beta for Alzheimer’s Disease (GlobeNewswire) - "Takeda...and AC Immune SA... announced an exclusive, worldwide option and license agreement for AC Immune’s active immunotherapies targeting toxic forms of amyloid beta (Abeta), including ACI-24.060 for the treatment of Alzheimer’s disease....ACI-24.060 is being investigated in the ongoing ABATE randomized, double-blind, placebo-controlled Phase 1b/2 trial....AC Immune will be responsible for completing the ABATE trial....Under the terms of the agreement, AC Immune will receive an upfront payment of $100 million and be eligible to receive an option exercise fee and additional potential development, commercial and sales-based milestones of up to approximately $2.1 billion if all related milestones are achieved over the course of the agreement."

Licensing / partnership • Alzheimer's Disease

A Study to Assess the Effects of ACI-24.060 in Alzheimer's Disease and in Down Syndrome (ABATE Study) (clinicaltrials.gov) - P1/2 | N=140 | Recruiting | Sponsor: AC Immune SA | Phase classification: P1b/2 ➔ P1/2

Phase classification • Alzheimer's Disease • CNS Disorders • Developmental Disorders • Genetic Disorders

ANTI-ABETA LIPOSOMAL VACCINE, ACI-24.060, RETAINS MEMORY IN AN AGGRESSIVE MOUSE MODEL OF ALZHEIMER'S DISEASE (ADPD 2024) - "The widely used 5xFAD mice that reportedly recapitulates many AD-related phenotypes including amyloid plaques, neuron loss and pronounced amyloidosis, displayed severe cognitive decline before 11 months of age. Treatment with the Abeta targeting vaccine, ACI-24.060, maintained both learning and memory capabilities to the levels of non-diseased animals. These neurological functional results are consistent with the accumulating immunohistochemical data on the activity of ACI-24.060 and strongly support its continued clinical development."

Preclinical • Alzheimer's Disease • Amyloidosis • CNS Disorders

AC Immune Reports Second Quarter 2023 Financial Results And Provides A Corporate Update (AC Immune Press Release) - "ACI-24.060 anti-Abeta active immunotherapy: Additional interim safety and immunogenicity data from AD cohorts of ABATE study expected in H2 2023; Interim safety and immunogenicity data from DS cohort of ABATE study expected in H2 2023; Initial Abeta-PET data on amyloid plaque reduction in AD expected in H1 2024; ACI-7104.056 anti-a-syn active immunotherapy: Completion of recruitment of first cohort in the Phase 2 VacSYn study in Parkinson's disease expected in H2 2023; ACI-35.030 anti-pTau active immunotherapy: Initiation of next trial in AD expected in H2 2023 (to be followed by a milestone payment); Semorinemab anti-Tau antibody: Results from the open-label extension of the Phase 2 Lauriet trial in mild-to-moderate AD expected in H2 2023..."

Enrollment status • New trial • P1/2 data • P2 data • Alzheimer's Disease • CNS Disorders • Parkinson's Disease • Tauopathies And Synucleinopathies

AC Immune Progress Update on Phase 2 Active Immunotherapy Clinical Pipeline for Alzheimer's and Parkinson diseases (GlobeNewswire) - P1b/2 | N=140 | ABATE (NCT05462106) | Sponsor: AC Immune SA | "The ABATE randomized, double-blind, placebo-controlled Phase 1b/2 trial of ACI-24.060 for treatment of Alzheimer’s disease (AD) continues fully blinded, with cohorts 1 and 2 enrolled and cohort 3 enrollment to be completed in January. Following data safety monitoring board (DSMB) review, no safety concerns have been raised to date, consistent with previous results. Immunogenicity of the vaccine is very encouraging with clear evidence of anti-Abeta antibody responses against toxic Abeta species observed in the blinded data. The six-month Abeta positron emission tomography (PET) imaging results are expected in H1 2024, and the 12-month Abeta PET data are expected in H2 2024."

Enrollment status • P1/2 data • Alzheimer's Disease • CNS Disorders

AC Immune Reports Third Quarter 2023 Financial Results and Provides a Corporate Update (GlobeNewswire) - "ACI-24.060 anti-Abeta active immunotherapy: Additional interim safety and immunogenicity data from AD cohorts of ABATE study expected in Q4 2023; First Abeta-PET data on amyloid plaque reduction in AD following 6 months of treatment expected in H1 2024; ACI-7104.056 anti-a-syn active immunotherapy: Completion of cohort 1 enrollment and initial safety findings in the Phase 2 VacSYn study in PD expected by year-end; ACI-35.030 anti-pTau active immunotherapy: Initiation of next trial in AD expected in Q4 2023 (to be followed by a milestone payment); Anti-TDP-43 antibody: Advancement of candidate into preclinical development (tox) expected in Q4 2023..."

New trial • P1/2 data • P2 data • Preclinical • Alzheimer's Disease • Amyotrophic Lateral Sclerosis • CNS Disorders • Parkinson's Disease

Anti-Abeta liposomal vaccine, ACI-24.060, induces anti-Abeta antibodies with binding profiles mirroring clinically validated monoclonal antibodies (CTAD 2023) - "In NHP, a liposomal anti-Abeta vaccine, ACI-24.060 induced antibody responses with strong binding to pathological Abeta oligomers and pyroglutamate-Abeta species. Importantly, the preference in binding of the polyclonal antibodies to oligomeric versus monomeric Abeta mirrored that of lecanemab, with a similar 3 log differential. Binding of the polyclonal antibodies to pyroglutamate-Abeta was in the range of binding of clinically relevant concentrations of donanemab."

Clinical • Alzheimer's Disease • CNS Disorders • Developmental Disorders • Genetic Disorders

AC Immune Announces Upcoming Presentations at the 16th CTAD Conference (GlobeNewswire) - "AC Immune SA...today announced upcoming presentations highlighting its precision medicine pipeline at the 16th Clinical Trials on Alzheimer’s Disease (CTAD) Conference, taking place in Boston, USA, on October 24-27, 2023."

Biomarker • P1/2 data • Preclinical • Alzheimer's Disease • CNS Disorders

4. An innovative clinical trial designed to evaluate the effects of ACI-24.060 in Alzheimer's Disease and in Down syndrome (ABATE Study) (AAIC 2023) - P1b/2 | "The field of biomarker-based translational medicine has been mobilized by the clinical evaluation of targeting of toxic abeta fragments and aggregates in monoclonal antibody trials. As shown we are utilizing these advances in an innovative clinical trial design for an efficient, evidence-based translational medicine approach to test ACI-24.060 as a novel Abeta vaccine candidate. This approach allows the parallel investigation of ACI-24.060 for the treatment and prevention of both sporadic AD and DSAD."

Clinical • IO biomarker • Alzheimer's Disease • CNS Disorders • Developmental Disorders • Genetic Disorders

AC Immune Showcasing Precision Medicine Programs at AAIC 2023 (GlobeNewswire) - "AC Immune SA...today announced upcoming presentations at the annual Alzheimer’s Association International Conference (AAIC 2023), taking place in Amsterdam, The Netherlands, on July 16-20, 2023...The presentations will include a poster detailing the design of the Phase 1b/2 ABATE trial evaluating the ACI-24.060 anti-amyloid-beta (Abeta) active immunotherapy in patients with Alzheimer’s disease and individuals with Down syndrome. In addition, AC Immune scientists have organized a 'Perspectives Session' focused on TDP-43 proteinopathy in neurodegenerative diseases. Finally, an oral presentation will be given showing detailed data on ACI-12589, AC Immune’s novel positron emission tomography (PET) tracer targeting alpha-synuclein."

Biomarker • Clinical protocol • Preclinical • Alzheimer's Disease • Amyotrophic Lateral Sclerosis • CNS Disorders • Dementia • Frontotemporal Lobar Degeneration

AC Immune Receives FDA Fast Track Designation for Anti-Amyloid-beta Active Immunotherapy, ACI-24.060, to Treat Alzheimer’s Disease (GlobeNewswire) - "AC Immune SA...today announced that it has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for its wholly-owned anti-amyloid beta (Abeta) active immunotherapy (vaccine)-candidate, ACI-24.060, for treatment of Alzheimer’s disease. This follows FDA clearance of the Investigational New Drug (IND) application enabling expansion to the USA of the ongoing Phase 1b/2 ABATE study of ACI-24.060 in patients with AD and individuals with DS. Furthermore, the first individual with DS has been dosed in ABATE."

Fast track designation • IND • Trial status • Alzheimer's Disease • CNS Disorders • Developmental Disorders

AC Immune to Host Key Opinion Leader Webinar on Early Diagnosis and Prevention of Alzheimer’s Disease (GlobeNewswire) - "AC Immune SA...will host a key opinion leader (KOL) webinar on early diagnosis and prevention of Alzheimer’s disease on Tuesday, April 18, 2023 at 10:30 AM EDT / 4:30 PM CEST....Drs. Blennow and Frisoni will discuss improved techniques and agents in development to detect and monitor Alzheimer’s disease at earlier stages in order to enable the development and use of therapeutic vaccines to delay or even prevent the onset of irreversible clinical symptoms. The discussion will also cover how the availability of biomarkers measurable by brain imaging and in biofluids as clinical endpoints may enable a Precision Medicine approach for agents treating pre-symptomatic patients....Johannes Streffer, MD, Chief Medical Officer, will close the formal presentations by discussing AC Immune’s two clinical-stage Alzheimer’s disease vaccines targeting amyloid-beta (ACI-24.060) and phosphorylated Tau (ACI-35.030)."

Clinical data • Alzheimer's Disease • CNS Disorders

AC Immune’s ACI-24.060 Anti-Amyloid Beta Vaccine for Alzheimer’s Shows Positive Initial Interim Safety and Immunogenicity in Phase 1b/2 ABATE Trial (GlobeNewswire) - P1b/2 | N=140 | ABATE Study (NCT05462106) | Sponsor: AC Immune SA | “Further safety and immunogenicity findings from ABATE cohorts expected in H2 2023. Initial data on amyloid plaque reduction measured via PET imaging anticipated in 2024. AC Immune SA…announced the first interim safety, tolerability and immunogenicity findings from the Phase 1b/2 ABATE trial…ABATE will now be expanded…to include individuals with Down syndrome (DS) and to evaluate higher doses in Alzheimer’s patients….Early results from the first cohort of AD patients in ABATE showed that low dose ACI-24.060 could elicit an anti-Abeta antibody response as soon as week 6 (2 weeks after the second injection). The data show that ACI-24.060 vaccination has been safe and well tolerated to date. As a result, dosing in ABATE’s second, higher dose AD cohort has now begun and the trial is cleared to begin screening individuals with DS..."

Biomarker • P1/2 data • Trial status • Alzheimer's Disease • CNS Disorders • Developmental Disorders • Tauopathies And Synucleinopathies

AC Immune Reports Third Quarter 2022 Financial Results and Provides a Corporate Update (GlobeNewswire) - “Achieved and Anticipated 2022 Clinical Milestones: ACI-24.060 anti-Abeta vaccine: Phase 1b safety and immunogenicity data readout in AD and decision to move into DS expected in Q4 2022. Submission of U.S. Investigational New Drug (IND) application planned in Q1 2023….Crenezumab anti-Abeta antibody: Reported detailed results from Phase 2 API-ADAD study in autosomal dominant AD. Additional fluid biomarker data to be presented at CTAD 2022 Conference. Semorinemab anti-Tau antibody: Additional biomarker data from the Phase 2 Lauriet study in mild-to-moderate AD expected at CTAD 2022 Conference.”

Biomarker • IND • P1 data • P2 data • Alzheimer's Disease • CNS Disorders

AC Immune to Present at the Jefferies London Healthcare Conference (GlobeNewswire) - “AC Immune SA…announced that company management will participate in a fireside chat and one-on-one investor meetings during the 2022 Jefferies London Healthcare Conference, which is taking place from November 15 – 17, 2022….During the fireside chat, AC Immune’s CEO Dr. Andrea Pfeifer will provide an overview of the company’s precision medicine approach and pipeline, which includes therapeutic and diagnostic candidates collectively designed to shift the neurodegenerative disease treatment paradigm towards earlier diagnosis and disease prevention. Dr. Pfeifer will also highlight the three additional clinical readouts the company expects to report by year-end. These include an interim analysis of safety and immunogenicity data from the Phase 1b/2 ABATE study...in patients with prodromal Alzheimer’s disease and individuals with Down syndrome."

Clinical • Clinical data • P1/2 data • Alzheimer's Disease • CNS Disorders

AC Immune Announces Upcoming Presentations at the Alzheimer’s Association International Conference (GlobeNewswire) - “New data from the API ADAD Study to be presented in AAIC Focused Topic Session. New Phase 2 results from investigator-sponsored trial of the Tau PET tracer PI-2620 in Alzheimer’s disease. First-time presentation of innovative biomarker-based translational clinical trial design to evaluate ACI-24.060 in sporadic Alzheimer’s disease and in people with Down syndrome. Additional data from proof-of-concept clinical study of ACI-12589 PET tracer to detect alpha-synuclein in the brains of living patients. AC Immune SA…announced 10 upcoming presentations that will be delivered at the Alzheimer’s Association International Conference (AAIC) in San Diego, California (United States) and online, July 31 – August 4, 2022.”

Clinical protocol • P2 data • Preclinical • Alzheimer's Disease • CNS Disorders • Developmental Disorders