IBC-Ab002 / ImmunoBrain Checkpoint - LARVOL DELTA

Immunotherapy with a short-lived anti-PD-L1 antibody in Alzheimer’s disease: a phase 1b, randomized, double-blind trial. (PubMed, Nat Med) - P1 | "While Alzheimer's disease (AD) is initiated by amyloid plaque accumulation, its progression involves local neuroinflammation that the brain cannot resolve when age-related dysfunction of the systemic immune system limits peripheral immune support. The safety and tolerability profile supports further clinical development of systemic, intermittently administered IBC-Ab002 in early AD. ClinicalTrials.gov registration: NCT05551741 ."

Clinical • First-in-human • IO biomarker • Journal • P1 data • Alzheimer's Disease • CNS Disorders • Inflammation • Solid Tumor

ImmunoBrain…announced the peer-reviewed publication in Nature Medicine of Phase 1b data from IBC-01-01 evaluating IBC-Ab002, its investigational anti-PD-L1 antibody, in patients with early Alzheimer's disease (PRNewswire) - "At the end of the 48-week trial using a novel short-acting checkpoint inhibitor, most patients receiving the highest dose showed reductions across a panel of neuronal and synaptic biomarkers, including neurogranin, total Tau, and pTau181, in cerebrospinal fluid. The treatment was shown to achieve target engagement, and to be well tolerated at all doses. Safety and tolerability profile support further evaluation of IBC-Ab002 as a differentiated checkpoint immunotherapy approach in Alzheimer's disease."

P1 data • Alzheimer's Disease

From Bench To Bedside: Safety And Biomarker Effects Of Anti-PD-L1 IBC-Ab002 Immunotherapy In Early Alzheimer'S Patients (AAIC 2026) - No abstract available

Biomarker • Clinical • IO biomarker • Alzheimer's Disease • CNS Disorders

PD-L1 IMMUNE CHECKPOINT BLOCKADE IN EARLY ALZHEIMER'S DISEASE: TOPLINE RESULTS FROM THE PHASE IB IBC-01-01 STUDY (ADPD 2026) - "IBC-01-01 is a First-in-Human Phase Ib study assessing safety, tolerability, and preliminary efficacy of IBC-Ab002, a proprietary anti-PD-L1 monoclonal antibody specifically engineered for neurodegenerative disorders. IBC-01-01 represents a novel and innovative approach being investigated as a potential therapeutic for AD and dementia treatment more broadly by leveraging the physiological role of the immune system in brain repair. The results of this study will provide initial data about the potential of this approach, and will inform the design of the planned Phase 2 study."

Checkpoint block • Checkpoint inhibition • First-in-human • IO biomarker • P1 data • Alzheimer's Disease • CNS Disorders • Dementia • Inflammation • APOE • GFAP

ImmunoBrain Presents Clinical Data for First Immune Checkpoint Therapy Approach in Alzheimer's Disease at AD/PD 2026 (PRNewswire) - "The Phase 1b clinical trial (IBC-01-01) was a randomized, double-blind, placebo-controlled study that enrolled 40 patients with early AD across sites in the U.K., the Netherlands, and Israel...All immune-related adverse events were generally mild and manageable, with no serious adverse events related to the study drug and no cases of amyloid-related imaging abnormalities (ARIA). CSF biomarker analysis (Neurogranin, total-Tau, and pTau181) at a dose of 30 mg/kg of IBC-Ab002, compared to placebo, is concordant with potential synaptic and neuronal protection...The company is currently designing the next phase of clinical development incorporating cognitive endpoints."

P1 data • Alzheimer's Disease

ImmunoBrain to Present Topline Phase 1b Clinical Data for Immune Checkpoint Treatment in Alzheimer's Disease at AD/PD 2026 (PRNewswire) - "The presentation will include safety, tolerability and biomarker data in the first 40 patients dosed across four intravenous infusions of IBC-Ab002 or placebo across five escalating dose cohorts."

Biomarker • P1 data • Alzheimer's Disease

A First in Human Study of IBC-Ab002 in Persons With Early Alzheimer's Disease (AD) (clinicaltrials.gov) - P1 | N=40 | Completed | Sponsor: Immunobrain Checkpoint | Active, not recruiting ➔ Completed

First-in-human • Trial completion • Alzheimer's Disease • CNS Disorders • APOE

Unraveling the Immune Puzzle: Role of Immunomodulation in Alzheimer's Disease. (PubMed, J Neuroimmune Pharmacol) - "Preclinical studies of immunomodulatory agents, including salidroside, festidinol, astragalin, sulforaphane, BM-MSC, simvastatin, Ab-T1, hTREM2, and XENP345, demonstrate promising effects. Additionally, clinical investigations of drugs such as simufilam, AL002, TB006, VGL101, DNL919, XPro1595, astragalus, and IBC-Ab002 underscore the therapeutic potential of targeting immune pathways in AD. This review emphasizes how neuroinflammation, microglial activation, and peripheral immune responses contribute to disease progression. By exploring immunomodulatory mechanisms, the article sheds light on potential therapeutic targets that could help mitigate AD pathology which may pave the way for novel interventions preventing neurodegeneration in AD."

Journal • Review • Alzheimer's Disease • CNS Disorders • Immunology • Oncology • CTNNB1 • TNFA

A First in Human Study of IBC-Ab002 in Persons With Early Alzheimer's Disease (AD) (clinicaltrials.gov) - P1 | N=40 | Active, not recruiting | Sponsor: Immunobrain Checkpoint | Recruiting ➔ Active, not recruiting

Enrollment closed • Alzheimer's Disease • CNS Disorders • APOE

Harnessing Peripheral Immunity in Early Alzheimer's Disease: Safety and Tolerability of IBC-Ab002 in a Phase 1b Clinical Trial (CTAD 2024) - No abstract available

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

A First in Human Study of IBC-Ab002 in Persons With Early Alzheimer's Disease (AD) (clinicaltrials.gov) - P1 | N=40 | Recruiting | Sponsor: Immunobrain Checkpoint | Trial completion date: Dec 2024 ➔ Nov 2025 | Trial primary completion date: Oct 2024 ➔ Nov 2025

Trial completion date • Trial primary completion date • Alzheimer's Disease • CNS Disorders • APOE

HARNESSING PERIPHERAL IMMUNITY: EARLY INSIGHTS FROM IBC-01-01 PHASE I TRIAL DEVELOPING A NOVEL IMMUNE-BASED THERAPY IN ALZHEIMER'S DISEASE. (ADPD 2024) - "Unlike conventional treatments that directly target brain pathology, this trial assesses the safety, pharmacokinetics, and preliminary efficacy of a new anti-PD-L1 antibody, IBC-Ab002. IBC-01-01 adopts an innovative approach in AD treatment, employing for the first time an immune checkpoint inhibitor for the treatment of dementia. Initial findings suggest a promising pharmacological and safety profile, with evidence of intended peripheral target engagement and immune activation. These insights could mark the beginning of a paradigm shift in AD immunotherapy, supporting the contention of the systemic immune system's role in managing neurodegenerative diseases."

IO biomarker • P1 data • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia • Oncology

IBC-Ab002 Fc modifications for fast clearance are associated with advantageous safety profile (AAIC 2023) - "We demonstrate that the clearance rate of the antibody inversely-relates to the probability of developing an adverse immune response, and that no delayed long-term irAEs are expected once full clearance of the antibody was achieved. Overall, these findings suggest that shortening the half-life of anti-PD-L1 antibodies in treatments that do not necessitate continuous exposure can considerably increase the safety profile."

Clinical • Alzheimer's Disease • CNS Disorders • Diabetes • Immune Modulation • Immunology • Metabolic Disorders • Oncology • Type 1 Diabetes Mellitus

ImmunoBrain Checkpoint Doses First Patients in Phase 1b Clinical Trial of IBC-Ab002 for Alzheimer’s Disease (PRNewswire) - "ImmunoBrain Checkpoint Inc...announced that it has dosed the first two patients in the Phase 1b IBC-01-01 clinical trial investigating IBC's lead program, IBC-Ab002 for patients with early Alzheimer's disease....IBC-01-01 [NCT05551741] is a randomized, double-blind, placebo-controlled, first-in-human Phase 1b clinical trial designed to evaluate safety, tolerability, pharmacokinetics and exploratory markers of efficacy of IBC-Ab002 in patients with early Alzheimer's disease....Conducted in Israel, the UK, and the Netherlands, IBC plans to enroll 40 participants."

Trial status • Alzheimer's Disease • CNS Disorders

A First in Human Study of IBC-Ab002 in Persons With Early Alzheimer's Disease (AD) (clinicaltrials.gov) - P1 | N=40 | Recruiting | Sponsor: Immunobrain Checkpoint | Not yet recruiting ➔ Recruiting | Initiation date: Oct 2022 ➔ Feb 2023

Enrollment open • Trial initiation date • Alzheimer's Disease • CNS Disorders • APOE

FIRST-IN-HUMAN CLINICAL TRIAL OF IBC-AB002, A PROPRIETARY HUMAN ANTI-PD-L1 ANTIBODY, IN PERSONS WITH EARLY ALZHEIMER’S DISEASE: TRIAL DESIGN AND OBJECTIVES. (CTAD 2022) - "Immune checkpoint blockade via inhibition of the PD-1/PD-L1 pathway is a novel and promising potential approach for modulating the adaptive immune system to treat AD, and perhaps other neurodegenerative conditions as well."

Clinical • IO biomarker • P1 data • Alzheimer's Disease • CNS Disorders • Immune Modulation • Immunology • Inflammation • Solid Tumor

A First in Human Study of IBC-Ab002 in Persons With Early Alzheimer's Disease (AD) (clinicaltrials.gov) - P1 | N=40 | Not yet recruiting | Sponsor: Immunobrain Checkpoint

New P1 trial • Alzheimer's Disease • CNS Disorders • APOE