ProCase (AB002) / Aronora, Ligand - 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

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

A fully human pan VL9 HLA-E TCRm antibody enables functional dissection of HLA-E biology and checkpoint signaling. (PubMed, iScience) - "It additionally disrupts the NKG2A checkpoint, restoring cytotoxic lymphocyte function and enabling mechanistic and therapeutic mapping of HLA-E restricted peptide presentation. Together, these findings position ABX002 as a transformative tool for dissecting the landscape and biology of canonical peptide restriction in cancer immunity."

Journal • Oncology • HLA-E • KLRC1

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

Using AI in Forward-Backward Translation of Questionnaires for Men Invited to Prostate Cancer Screening: Methodological Study. (PubMed, JMIR Form Res) - "AI can be an effective tool in the translation process, offering time and resource savings while maintaining accuracy. However, human involvement is still needed to optimize translation."

Journal • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Effects of protein C activator AB002 on hemorrhage and lesion volume in a rat model of collagenase-induced intracerebral hemorrhage (ISC 2026) - P2 | "Here, we evaluated whether AB002 affects hemorrhage or lesion volume in a rat model of collagenase-induced intracerebral hemorrhage (ICH), in comparison to vehicle or tenecteplase (TNK).Procedures were approved by the institutional animal care and use committee. No differences were observed between groups in mortality, neuroscores, or body weight.AB002 did not worsen hemorrhage or lesion volume in a rat model of ICH and did not impair neurological outcomes. We conclude that administration of the protein C activator AB002 before TNK thrombolysis may be reasonably safe and offer a broad therapeutic benefit in AIS and other thrombotic emergencies without an increased bleeding risk."

Preclinical • Cardiovascular • Cerebral Hemorrhage • Hematological Disorders • Ischemic stroke • Nephrology • Thrombosis

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

Endogenous Protein C Activation with AB002 Improves Outcomes in a Rat Model of Acute Ischemic Stroke (ASH 2023) - P2 | "8 to 9-week-old male rats (275-377 g) were anesthetized under isoflurane and a small laser-Doppler probe was affixed to the skull to monitor cortical perfusion and verify vascular occlusion and reperfusion. Treatment with AB002 during ischemia reduced infarct volume and improved outcomes in the rat experimental stroke model. Considering its neuroprotective and antithrombotic properties, we propose that early treatment with AB002 may confer outcome benefit for patients experiencing acute thrombotic emergencies."

Preclinical • Anesthesia • Cardiovascular • Hematological Disorders • Ischemic stroke • Myocardial Ischemia • Reperfusion Injury • Thrombosis

Evaluating a Prostate Cancer Education and Navigation to Screening Program for Black Men in South Carolina, U.S. (PubMed, Cancer Control) - "A pre-test survey assessed prostate cancer knowledge using the validated PROCASE Knowledge Index...Among the 568 SC AMEN Program participants, 475 participants (83.6%) either completed a prostate cancer screening (n = 266; 46.8%) or have scheduled a screening appointment (n = 209; 36.8%). The remaining 24 participants (4.2%) continue to be navigated to a screening appointment, and 69 (12.2%) have refused navigation.ConclusionThe SC AMEN Program fostered the study participants' appointments with a clinician to discuss their prostate cancer risk and need for screening."

Journal • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

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

AB002. DNA methylation-regulated genes contribute to temozolomide (TMZ) resistance by scaffolding paraspeckle proteins. (PubMed, Chin Clin Oncol) - "Our results reveal that HSD52 in GBM could serve as a therapeutic target to overcome TMZ resistance, enhancing the clinical benefits of TMZ chemotherapy."

Epigenetic controller • Journal • Ataxia • Brain Cancer • CNS Disorders • CNS Tumor • Genetic Disorders • Glioblastoma • Glioma • Immunology • Mental Retardation • Movement Disorders • Oncology • Primary Immunodeficiency • Solid Tumor • Targeted Protein Degradation • ATRX • DNMT1 • TCF12 • USP7

Safety and tolerability of the protein C activator AB002 in end-stage renal disease patients on hemodialysis: a randomized phase 2 trial. (PubMed, Commun Med (Lond)) - P2 | "As far as we are aware, this proof-of-concept study is the first clinical trial assessing the therapeutic potential of protein C activation. The results herein support additional investigation of AB002 to safely prevent and treat thrombosis in at-risk populations."

Clinical • Journal • P2 data • Cardiovascular • Chronic Kidney Disease • Hematological Disorders • Inflammation • Nephrology • Renal Disease • Thrombosis

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

Cytoprotective E-WE thrombin reduces disease severity in a murine model of relapsing-remitting multiple sclerosis. (PubMed, Am J Physiol Cell Physiol) - "Both methylprednisolone and E-WE thrombin reduced demyelination and immune cell recruitment. These results provide rationale for considering engineered forms of thrombin biased toward anticoagulant and cytoprotective activity as a therapeutic strategy and perhaps effective alternative to high-dose methylprednisolone for management of acute relapsing MS attacks."

Journal • Preclinical • CNS Disorders • Immunology • Inflammation • Multiple Sclerosis

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

Concept Mapping with Black Men: Barriers to Prostate Cancer Screening and Solutions. (PubMed, J Cancer Educ) - "The mean age of respondents was 52 (±10), 50% were rural, 37% were college-educated, 56% with income <$44,500, and 22% with PROCASE Knowledge Index ≤5...Our study identified specific barriers to PCS among AA with diverse sociodemographic backgrounds. Culturally sensitive interventions delivered by trained healthcare professionals, peers, and relatable role models, can potentially increase PCS among AA men."

Journal • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Generation of two human induced pluripotent stem cell lines (ABi001-A and ABi002-A) from cone dystrophy with supernormal rod response patients caused by KCNV2 mutation. (PubMed, Stem Cell Res) - "PBMCs from donors have been reprogrammed into iPSC lines. Derived clones were characterized with mutation sequencing, analysis of common pluripotency-associated markers at the protein levels, and in vitro differentiation studies."

Journal • Preclinical • Achromatopsia • Retinal Disorders

A Phase 2 Trial of the Protein C Activator AB002 in End-Stage Renal Disease Patients on Chronic Hemodialysis (ASH 2021) - P2 | "In a preclinical baboon thrombosis model, AB002 rapidly interrupted thrombus development with no observable hemostasis impairment, and was similar in antithrombotic efficacy to high-dose enoxaparin while appearing superior to interventional tissue-plasminogen activator. In ESRD patients undergoing heparin-free hemodialysis, AB002 was well-tolerated and reduced thrombus accumulation in the hemodialysis circuit without observable hemostasis impairment. The results of this study support further clinical evaluation of AB002 as a novel drug candidate to limit thrombus development or device-initiated clotting in patients with elevated bleeding risk, including ESRD patients on chronic heparin-free hemodialysis."

Clinical • P2 data • Cardiovascular • Chronic Kidney Disease • Hematological Disorders • Nephrology • Renal Disease • Thrombosis

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

A Phase 2 Trial Evaluating the Safety and Antithrombotic Efficacy of AB002, a First-in-class Protein C Activator in End-stage Renal Disease Patients on Heparin-free Hemodialysis (ISTH 2022) - P2 | "AB002 demonstrated a favorable safety profile, with no treatment-related adverse events. Clinically relevant bleeding did not occur in any patient, and AB002 did not affect time to hemostasis at the vascular access site. Drug exposure was confirmed by a transient, dose-dependent elevation of APC-PCI."

Clinical • P2 data • Cardiovascular • Chronic Kidney Disease • Hematological Disorders • Nephrology • Renal Disease • Thrombosis