ACI-3024 / AC Immune, Eli Lilly - LARVOL DELTA

AC Immune Reports Top Line Results from TAURIEL Phase 2 Trial Evaluating Semorinemab in Early Alzheimer’s Disease (GlobeNewswire) - P2, N=457; TAURIEL (NCT03289143); Sponsor: Genentech, Inc.; "AC Immune SA...today announced that Genentech, a member of the Roche Group, has informed the Company of top line results from a Phase 2 trial of the anti-Tau antibody, semorinemab, in early (prodromal to mild) Alzheimer’s disease (AD) which show that semorinemab did not meet its primary efficacy endpoint of reducing decline on Clinical Dementia Rating-Sum of Boxes (CDR-SB) compared to placebo....Additional data analyses are ongoing and Genentech plans to present the results from TAURIEL at an upcoming medical congress. The second Phase 2 (LAURIET) study of semorinemab in patients with moderate AD remains ongoing....ACI-3024 (anti-Tau inhibitor):...Phase 1 results in healthy volunteers and data disclosure are expected by Eli Lilly and Company in 2020."

P1 data • P2 data • Trial status • Alzheimer's Disease • CNS Disorders

AC Immune Reports Q1 2020 Financial Results and Provides Business Update (GlobeNewswire, AC Immune SA) - "2020 Clinical Readouts: Semorinemab, anti-Tau antibody: Phase 2 trial primary completion (estimated last patient, last visit) in prodromal/mild in Q2...ACI-35.030 anti-pTau vaccine: Phase 1b/2a in AD interim analysis in Q2; ACI-3024 small molecule Morphomer™ Tau aggregation inhibitor: Phase 1 results in healthy volunteers in Q2; data disclosed by Lilly in H2 (expected); ACI-24 in AD: Phase 2, 12-month interim analysis in H2."

P1 data • P1/2 data • P2 data • Trial completion date • Alzheimer's Disease • CNS Disorders • Tauopathies And Synucleinopathies

AC Immune reports full-year 2019 financial results and provides 2020 R&D outlook (GlobeNewswire) - "Initiation of a Phase 1b/2a clinical trial in early AD to evaluate the anti-phospho-Tau vaccine, ACI-35.030...Discontinuation by our collaboration partner Roche of the CREAD and CREAD 2 Phase 3 studies of the anti-beta-amyloid antibody, crenezumab, in people with prodromal to mild sporadic AD; 2020 Clinical Readouts: ACI-35.030 anti-pTau vaccine: Phase 1b/2a in AD interim analysis in Q2; ACI-3024 small molecule Morphomer™ Tau aggregation inhibitor: Phase 1 results in healthy volunteers in Q2; data disclosed by partner in H2 (expected)"

New P1/2 trial • P1 data • P1/2 data • Trial termination

AC Immune receives second milestone and new milestone to increase the potential deal value of Lilly Morphomer Tau partnership (AC Immune Press Release) - "AC Immune SA...today announced that it will receive a second milestone payment of CHF 10 million from Eli Lilly and Company on or before March 31, 2020 related to development progress in the small molecule Morphomer™ Tau aggregation inhibitor program....In that time, ACI-3024, a first-in-class investigational oral small molecule Tau Morphomer™ for treatment of Alzheimer’s disease (AD) and other neurodegenerative disorders, has advanced from preclinical into Phase 1 clinical development....Under the updated collaboration terms, AC Immune will now also be eligible for a new CHF 60 million potential milestone after initiation of Tau Morphomer™ Phase 2 clinical testing."

Licensing / partnership • New P2 trial

AC Immune hosts key opinion leader event: ‘Untangling’ tau pathology to treat Alzheimer’s and neurodegenerative diseases (GlobeNewswire) - "Small molecule Tau Morphomer (ACI-3024, partnered with Eli Lilly): Phase 1 interim data in Q4 2019 followed by readout of multiple ascending dose part in Q1 2020."

P1 data

AC Immune Receives First Milestone Payment from Lilly in Small Molecule Tau Morphomer™ Program (GlobeNewswire, AC Immune SA) - "Recognizes progress in ACI-3024 Small Molecule Tau Morphomer™ development. This payment is a recognition of progress in the collaboration between the two companies and follows initiation in July 2019 of the Phase 1 study of ACI-3024, a first-in-class investigational oral small molecule Tau Morphomer™ in development for treatment of Alzheimer’s disease (AD) and other neurodegenerative disorders."

Biomarker • Clinical • Financing

Small Molecules Targeting Tau Aggregation Decrease Tau Pathology and Neuroinflammation In Vivo (AAIC 2019) - "ACI-3024 demonstrated its potential to interfere and even reverse Tau aggregation and displayed efficacy in vivo in a Tauopathy model. Taken together, ACI-3024 showed a favorable pharmacokinetic and safety profile, and has the potential as a first-in-class disease-modifying compound for the large class of neurodegenerative diseases characterized by the presence of pathological Tau aggregates. Phase 1 studies with ACI-3024 are being initiated."

Preclinical

Phase update (GlobeNewswire) - Preclinical ➔ P1, Alzheimer’s Disease

Phase shift

AC Immune Initiates Phase 1 Study of ACI-3024 Small Molecule Tau Morphomer™, an Investigational Treatment for Alzheimer’s Disease (GlobeNewswire, AC Immune SA) - AC Immune SA (NASDAQ: ACIU), a Swiss-based, clinical-stage biopharmaceutical company, today announced dosing of the first subject in a Phase 1 study of ACI-3024, a first-in-class investigational oral small molecule Tau Morphomer™ inhibitor that will be studied in neurodegenerative diseases that are characterized by the presence of pathological Tau aggregates. ACI-3024 is the primary focus of a license and collaboration agreement between AC Immune and Lilly to research and develop small molecule Tau aggregation inhibitors for the treatment of AD and other neurodegenerative diseases.

Clinical • Commercial • New trial