JNJ-2056 / AC Immune, J&J - LARVOL DELTA (2024)

AC Immune Reports First Quarter 2024 Financial Results and Provides a Corporate Update (Yahoo Finance UK) - "ACI-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 2024...ACI-35.030 anti-pTau active immunotherapy First patient treated in ReTain Phase 2b clinical trial expected in the coming months..." P2 data • Trial status • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Parkinson's Disease ACI-35.030 ANTI-PHOSPHO-TAU ACTIVE IMMUNOTHERAPY PRODUCES ANTIBODIES THAT PREVENT PATHOLOGICAL TAU SEEDING IN VITRO (ADPD 2024) - "Clinical stage active anti-pTau immunotherapy, ACI-35.030, induced antibodies in NHP which reduced PHF-induced Tau seeding in vitro. This antibody functionality models the capacity for prevention of cell-to-cell Tau spreading in vivo, further supporting the biological rationale and plausibility of ACI-35.030 for a potential clinical benefit and Alzheimer's disease-modifying effect." Preclinical • Alzheimer's Disease • 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) - "AC Immune’s wholly-owned anti-alpha-synuclein (a-syn) active immunotherapy, to treat Parkinson’s disease (PD). Enrollment of cohort 1 in the Phase 2 VacSYn clinical trial evaluating ACI-7104.056, is completed, with 16 patients randomized, and cohort 2 enrollment and randomization has begun. No safety concerns have been reported to date with no reports of moderate or severe adverse events. Safety and immunogenicity updates from the trial will be reported in H2 2024.ACI-35.030: AC Immune’s partnered investigational targeted active immunotherapy, selective for pathological phosphorylated Tau (pTau)....Under the terms of the licensing agreement, AC Immune has received a milestone payment of CHF15 million and expects to receive another milestone payment of CHF 25 million related to achieving an undisclosed enrollment target in 2025." Enrollment closed • Licensing / partnership • P2 data • CNS Disorders • Parkinson's Disease AC Immune’s Targeted Anti-pTau Active Immunotherapy for Alzheimer’s Disease Advances into Phase 2b Trial (GlobeNewswire) - "AC Immune SA...today announced that its development partner has programmed the launch of a Phase 2b clinical study to evaluate ACI-35.030 (JNJ-64042056) in patients with preclinical Alzheimer’s disease (AD), those individuals not yet showing symptoms....Under the terms of the licensing agreement with Janssen Pharmaceuticals, Inc. (Janssen), a Johnson & Johnson company, AC Immune will now receive a milestone payment of CHF 15 million and will receive another milestone payment of CHF 25 million related to achieving a non-disclosed enrollment target....The Phase 2b ReTain trial is a potentially registration-enabling trial and is a randomized, multicenter, double-blind, placebo-controlled clinical study in participants with preclinical AD to assess the clinical effect of active immunization with ACI-35.030." Commercial • New P2b trial • 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 ACI-35.030 anti-phospho-Tau active immunotherapy for the treatment of early Alzheimer's Disease (AD): Update from the Phase 1b/2a study data and perspectives. (CTAD 2023) - P1/2 | "Background: Two active immunotherapies, ACI-35.030 (liposomal formulation) and JACI-35.054 (conjugated formulation), targeting phosphorylated-Tau (pTau) are currently being tested in a Phase 1b/2a clinical trial (NCT04445831) to evaluate the safety, tolerability and immunogenicity of different doses of these clinical candidates. In general, the liposome-based active immunotherapy ACI-35.030 showed a better antibody profile in terms of rapid response, higher responder rate, hom*ogeneity of the antibody response across study participants, epitope coverage and evidence of antibody maturation towards pathologic forms of Tau. ACI-35.030 has been selected to move into the next stage of clinical development in preclinical AD." P1/2 data • Alzheimer's Disease • CNS Disorders • Dementia 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 A Study to Evaluate the Safety, Tolerability and Immunogenicity of Tau Targeted Vaccines in Participants With Early Alzheimer's Disease (clinicaltrials.gov) - P1/2 | N=57 | Completed | Sponsor: AC Immune SA | Active, not recruiting ➔ Completed Trial completion • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia • Aβ42 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 Advantages of next generation SupraAntigen® platform liposomal vaccines to immunize against pathological targets of Alzheimer’s disease (CTAD 2022) - " For Abeta, several vaccines were generated as follows: a liposome-based SupraAntigen® vaccine (i.e., optimized ACI-24) containing the antigenic peptide Abeta 1-15, an adjuvant and a universal T-helper cell peptide; and CRM-conjugated vaccines containing various antigenic Abeta peptides (e.g., ACC-001) or full-length Abeta (i.e., AN1792) mixed with adjuvant...This was in line with the epitope mapping data, which demonstrated strong binding to the phosphorylated residues for the ACI-35.030-induced antibodies... For both Abeta and Tau targeting vaccines, the liposome-based SupraAntigen® vaccines demonstrated a superior quality of the IgG repertoire generated post-immunization. The responses in NHPs were well tolerated, hom*ogenous, robust and boostable over time, while broadly engaging relevant pathological epitopes. For Abeta, the liposome-based SupraAntigen® vaccine generated the highest titers of antibodies specifically targeting pyroGlu-Abeta." Alzheimer's Disease • CNS Disorders ACI-35.030 and JACI-35.064, two novel anti-phospho-Tau vaccines for the treatment of Alzheimer’s Disease: Interim Phase 1b/2a data on safety, tolerability and immunogenicity (CTAD 2022) - P1/2 | "The clinical study is successfully ongoing despite the challenges of being performed during the restrictions of the Covid-19 pandemic demonstrating that vaccination with either ACI-35.030 or JACI-35.054 is safe and well tolerated, inducing IgG responses to the immunizing peptide as well as ePHF. However, overall ACI-35.030 emerges as the superior vaccine candidate in terms of responder rate, number of immunizations to achieve the initial antibody titer, hom*ogeneity of the antibody response across subjects, epitope coverage, with evidence of antibody maturation towards pathologic forms of Tau. As both vaccines contain the same antigenic peptide sequence, the differences observed so far in antibody response can be ascribed to the different technologies used to present the antigenic peptide to the immune system." Clinical • P1/2 data • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Infectious Disease • Novel Coronavirus Disease AC Immune’s Alzheimer’s Disease Vaccine-candidate ACI-35.030 Selected for Further Development (GlobeNewswire) - P1b/2a | N=57 | NCT04445831 | Sponsor: AC Immune SA | “AC Immune SA…announced that based on the Phase 1b/2a interim data, ACI-35.030…has been selected for further development….The results show that ACI-35.030 treatment rapidly leads to the strong and durable induction of antibodies specific for pathological forms of Tau such as pTau and its aggregated form, ePHF. The ACI-35.030-induced antibody response was sustained and could be periodically boosted over a period of 72 weeks. The vaccine candidate was generally well tolerated. The decision to select ACI-35.030 follows the comparison, presented at CTAD, demonstrating its strengths relative to a protein conjugate vaccine, JACI-35.054, an alternative anti-pTau vaccine also being evaluated in parallel in the Phase 1b/2 trial. ‘Looking forward into 2023 AC Immune will have three vaccine candidates in Phase 2 development...for neurodegenerative diseases.’” New P2 trial • P1/2 data • Alzheimer's Disease • CNS Disorders • Dementia AC Immune to Present Progress of Alzheimer’s Disease Programs targeting Abeta and Tau at the 15th CTAD Conference (GlobeNewswire) - "AC Immune SA...announced the upcoming presentations of its vaccine technology SupraAntigen®, and of its anti-Tau and anti-Abeta investigational candidates, at the 15th Clinical Trials on Alzheimer’s Disease (CTAD) conference in San Francisco, California (United States) and online, on November 29 – December 2, 2022. During the conference, Prof. Johannes Streffer, AC Immune’s Chief Medical Officer, will present interim data from the anti-phospho-Tau vaccine program currently in a Phase 1b/2a study. 'During the conference, Prof. Johannes Streffer, AC Immune’s Chief Medical Officer, will present interim data from the anti-phospho-Tau vaccine program currently in a Phase 1b/2a study.'...In addition, there will be presentations on fluid biomarkers covering partnered programs for the Phase 2 crenezumab anti-Abeta antibody and Phase 2 semorinemab anti-Tau antibody, both partnered with Genentech." Biomarker • Clinical data • P1/2 data • P2 data • Alzheimer's Disease • CNS Disorders A Study to Evaluate the Safety, Tolerability and Immunogenicity of Tau Targeted Vaccines in Participants With Early Alzheimer's Disease (clinicaltrials.gov) - P1/2 | N=57 | Active, not recruiting | Sponsor: AC Immune SA | Recruiting ➔ Active, not recruiting Enrollment closed • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia AC Immune ACI-35.030 Phase 1b/2a Trial Interim Data Confirm Consistent Safety and Potent Immunogenicity of pTau Alzheimer’s Vaccine in High-dose Cohort (Yahoo Finance) - P1/2 | N=56 | NCT04445831 | Sponsor: AC Immune SA | “AC Immune SA…announced new interim 10-week data from the high-dose cohort of a placebo-controlled Phase 1b/2a trial evaluating ACI-35.030, a first-in-class phosphorylated-Tau (pTau) vaccine candidate in participants with early Alzheimer’s disease (AD)….New interim data from the Phase 1b/2a trial show that the high-dose of ACI-35.030 led to the strong induction of antibodies selective for pTau and its aggregated form, enriched paired helical filaments (ePHF). These data are consistent with those previously announced for the trial’s mid-dose cohort that showed median anti-pTau antibody titers increasing from baseline by two orders of magnitude at week 2 after a first injection.” P1/2 data • Alzheimer's Disease • CNS Disorders AC Immune Announces Interim Phase 1b/2a Data Showing that its ACI-35.030 Anti-pTau Alzheimer’s Vaccine Generates a Potent Immune Response (GlobeNewswire) - P1/2, N=56; NCT04445831; Sponsor: AC Immune SA; "At CTAD, AC Immune’s Chief Medical Officer Johannes Streffer gave an on-demand oral presentation featuring data from an ongoing, placebo-controlled Phase 1b/2a trial evaluating ACI-35.030 in participants with early Alzheimer’s disease (AD). Results from the trial show that ACI-35.030 treatment led to the strong induction of antibodies specific for pathological forms of Tau such as pTau and its aggregated form, enriched paired helical filaments (ePHF)." P1/2 data • Alzheimer's Disease • CNS Disorders ACI-35.030, a novel anti-phospho-Tau vaccine for the treatment of Alzheimer’s Disease: Interim Phase 1b/2a data on safety, tolerability and immunogenicity (CTAD 2021) - P1/2 | "ACI-35.030 was safe, well tolerated, and induced a potent antigen-specific antibody response with the first 2-dose levels; remarkable for a vaccine against a self-protein in an aged population. Based on these data, an expansion of the second dose level sub-cohort and dose-escalation to the 3rd dose-level sub-cohort have been initiated to generate a larger dataset of safety, tolerability and immunogenicity in order to prepare for subsequent clinical steps." Clinical • P1/2 data • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Tau PET AC Immune Reports Third Quarter 2021 Financial Results and Provides Corporate Update (GlobeNewswire) - “Clinical Milestones: ACI-35.030 anti-pTau vaccine: reported Phase 1b/2a interim results in AD patients in Q1 (second highest dose); further Phase 1b/2a interim analysis in Q4 (highest dose)….Clinical expenses (+0.6 million): The Company increased expenditures across multiple clinical programs, predominantly for ACI-35-030 driven by R&D cost sharing and increased patient enrollments into the Phase 1b/2a study. This increase was offset as the Company incurred less expense for ACI-24 for AD as the prior six-month safety period completed.” Commercial • P1/2 data • Alzheimer's Disease • CNS Disorders New Data on AC Immune’s Abeta and pTau Clinical Programs in Alzheimer’s Disease To Be Presented at CTAD 2021 (GlobeNewswire) - “AC Immune SA…announces that new data on its investigational Alzheimer’s disease (AD) candidates semorinemab, ACI-35.030 and ACI-24 will be featured in the scientific program of the Clinical Trials on Alzheimer’s Disease (C-TAD) Conference, taking place virtually and in person in Boston, on November 9-12, 2021.” Clinical data • Alzheimer's Disease • CNS Disorders A Study to Evaluate the Safety, Tolerability and Immunogenicity of Tau Targeted Vaccines in Participants With Early Alzheimer's Disease (clinicaltrials.gov) - P1/2; N=56; Recruiting; Sponsor: AC Immune SA; N=32 ➔ 56 Clinical • Enrollment change • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia • MRI AC Immune Announces Expansion of Phase 1b/2a phospho-Tau Alzheimer’s Vaccine Trial and Provides a Program Update (Streetinsider.com) - "AC Immune...and its strategic partner Janssen Pharmaceuticals, Inc., have expanded the ongoing Phase 1b/2a clinical trial of the Companies’ first-in-class anti-phosphorylated-Tau (pTau) vaccine candidate ACI-35.030 for the treatment of Alzheimer’s disease (AD)....In parallel, the trial continues to evaluate patients in the highest dose cohort, for which the first interim results will be available in Q4 2021." P1/2 data • Alzheimer's Disease • CNS Disorders • Tauopathies And Synucleinopathies AC Immune Reports First Quarter 2021 Financial Results and Provides Corporate Update (GlobeNewswire) - "Achieved and Anticipated 2021 milestones: ACI-35.030 anti-pTau vaccine: reported Phase 1b/2a in AD interim results in Q1 (second highest dose); further Phase 1b/2a interim analysis in Q4 (highest dose); JACI-35.054 alternative anti-pTau vaccine: Phase 1b/2a in AD interim analysis in Q2 (low dose); ACI-24 in AD: reported Phase 2, 12-month interim analysis in Q1; 18-month interim analysis in Q2;" P1/2 data • P2 data • Alzheimer's Disease • CNS Disorders • Dementia • Tauopathies And Synucleinopathies (Streetinsider.com) - "ACI-35.030 anti-pTau vaccine: Phase 1b/2a interim analysis in Q4 (highest dose)…JACI-35.054 alternative anti-pTau vaccine: Phase 1b/2a in AD interim analysis in Q2 (low dose)…Alpha-synuclein imaging agent: advanced third-generation candidate to first-in-human clinical study in Q1; readout expected in Q3...ACI-24 in AD: reported Phase 2, 12-month interim analysis in Q1; 18-month interim analysis in Q2...Semorinemab anti-Tau antibody: Phase 2 trial primary completion (estimated last patient, last visit) in moderate AD in Q2...Alpha-synuclein small molecule inhibitor: identified first biologically active small molecule in Q1; start in vivo proof-of-concept studies in Q3..." Clinical data • P1/2 data • P2 data • Trial completion • Alzheimer's Disease • CNS Disorders • Tauopathies And Synucleinopathies AC Immune to Highlight Promising Alzheimer’s Vaccine at the SVB Leerink 10th Annual Global Healthcare Conference (GlobeNewswire) - "AC Immune...today announced that it will participate in the upcoming SVB Leerink 10th Annual Global Healthcare Conference, taking place virtually on February 22–26, 2021....Prof. Pfeifer will also highlight AC Immune’s novel anti-phospho-Tau (pTau) vaccine candidate ACI-35.030, including recent interim Phase 1b/2a results that showed promising immunogenicity and safety in patients with early Alzheimer’s disease." P1/2 data • Alzheimer's Disease • CNS Disorders • Tauopathies And Synucleinopathies References