ulviprubart (ABC008) / Abcuro - LARVOL DELTA

Ulviprubart Pharmacokinetics, Pharmacodynamics (PK/PD), and Safety: Phase 1 Study Results in Patients With Inclusion Body Myositis (IBM) (EULAR 2025) - No abstract available

Clinical • P1 data • PK/PD data • Immunology • Myositis

Abcuro to Present Two Posters at the American Academy of Neurology 2025 Annual Meeting (Businesswire) - "Abcuro, Inc...today announced that the Company will present safety, pharmacokinetic, and pharmacodynamic data from the Phase 1 clinical trial evaluating ulviprubart (ABC008) for the treatment of inclusion body myositis (IBM) at the American Academy of Neurology (AAN) Annual Meeting, taking place April 5-9, 2025, in San Diego, California."

P1 data • Myositis

Pharmacokinetics, Pharmacodynamics (PK/PD), and Safety Profile of Ulviprubart: Results from a 48-week, Open-label, Phase 1 Study in Patients with Inclusion Body Myositis (IBM) (AAN 2025) - P1 | "Ulviprubart led to deep and selective depletion of peripheral blood KLRG1+ T cells in patients with IBM. Together with the favorable safety profile, these data support the continued development of ulviprubart."

Clinical • P1 data • PK/PD data • Gastrointestinal Disorder • Immunology • Myositis • CD4 • CD8 • KLRG1

A Phase 1 Study of ABC008 in Ascending (Single Ascending Dose/Multiple Ascending Dose) Study in Patients with (IBM) (clinicaltrials.gov) - P1 | N=19 | Completed | Sponsor: Abcuro, Inc. | Active, not recruiting ➔ Completed | N=30 ➔ 19 | Trial completion date: Aug 2025 ➔ Jan 2025

Enrollment change • Trial completion • Trial completion date • Immunology • Myositis

Abcuro Announces $200 Million Series C Financing to Advance Its First-In-Class Medicine in Development for Inclusion Body Myositis (Businesswire) - "Abcuro, Inc...today announced the closing of a $200 million Series C financing led by New Enterprise Associates (NEA) with Foresite Capital joining the round and participation of existing investors...Proceeds from the Series C financing will be used to complete the registrational Phase 2/3 MUSCLE clinical trial evaluating ulviprubart (ABC008), a first-in-class monoclonal antibody targeting killer cell lectin like receptor G1 (KLRG1), for the treatment of inclusion body myositis (IBM). Assuming positive results from the MUSCLE clinical trial, Abcuro plans to file a BLA and will use a portion of the proceeds to support commercial launch preparation...'We are in a strong position to execute on our clinical development plan, including completing our ongoing, registrational Phase 2/3 MUSCLE clinical trial of ulviprubart in IBM, and expect to report initial data in the first half of 2026. We will also look to fund the expansion of manufacturing capabilities and other..."

Financing • P2/3 data • Immunology • Myositis

Long-term Extension Study of Ulviprubart (ABC008) in Subjects with Inclusion Body Myositis (clinicaltrials.gov) - P2/3 | N=270 | Active, not recruiting | Sponsor: Abcuro, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Immunology • Myositis

ABC008 in Subjects with T-cell Large Granular Lymphocytic Leukemia (T-LGLL) (clinicaltrials.gov) - P1/2 | N=21 | Active, not recruiting | Sponsor: Abcuro, Inc. | Recruiting ➔ Active, not recruiting | N=30 ➔ 21 | Trial completion date: Dec 2025 ➔ Sep 2027 | Trial primary completion date: Dec 2024 ➔ Sep 2025

Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • Hematological Malignancies • Leukemia • Oncology

Long-term Extension Study of Ulviprubart (ABC008) in Subjects with Inclusion Body Myositis (clinicaltrials.gov) - P2/3 | N=270 | Recruiting | Sponsor: Abcuro, Inc. | Not yet recruiting ➔ Recruiting | Trial primary completion date: Aug 2028 ➔ Jan 2029

Enrollment open • Trial primary completion date • Immunology • Myositis

Long-term Extension Study of Ulviprubart (ABC008) in Subjects With Inclusion Body Myositis (clinicaltrials.gov) - P2/3 | N=270 | Not yet recruiting | Sponsor: Abcuro, Inc.

New P2/3 trial • Immunology • Myositis

A Phase 1 Study of ABC008 in Ascending (Single Ascending Dose/Multiple Ascending Dose) Study in Patients With (IBM) (clinicaltrials.gov) - P1 | N=30 | Active, not recruiting | Sponsor: Abcuro, Inc. | Trial completion date: May 2024 ➔ Aug 2025 | Trial primary completion date: Mar 2024 ➔ Mar 2025

Trial completion date • Trial primary completion date • Immunology • Myositis

A Study to Evaluate the Efficacy and Safety of ABC008 for Inclusion Body Myositis (clinicaltrials.gov) - P2/3 | N=231 | Recruiting | Sponsor: Abcuro, Inc.

Trial completion date • Trial primary completion date • Immunology • Myositis

A Phase 1 Study of ABC008 in Ascending (Single Ascending Dose/Multiple Ascending Dose) Study in Patients With (IBM) (clinicaltrials.gov) - P1 | N=30 | Active, not recruiting | Sponsor: Abcuro, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Immunology • Myositis

ABC008 in Subjects With T-cell Large Granular Lymphocytic Leukemia (T-LGLL) (clinicaltrials.gov) - P1/2 | N=30 | Recruiting | Sponsor: Abcuro, Inc. | N=15 ➔ 30 | Trial completion date: Dec 2023 ➔ Dec 2025 | Trial primary completion date: Dec 2023 ➔ Dec 2024

Enrollment change • Trial completion date • Trial primary completion date • Hematological Malignancies • Leukemia • Oncology • KLRG1

A Study to Evaluate the Efficacy and Safety of ABC008 for Inclusion Body Myositis (clinicaltrials.gov) - P2/3 | N=231 | Recruiting | Sponsor: Abcuro, Inc. | Active, not recruiting ➔ Recruiting

Enrollment open • Immunology • Myositis

A Study to Evaluate the Efficacy and Safety of ABC008 for Inclusion Body Myositis (clinicaltrials.gov) - P2/3 | N=231 | Active, not recruiting | Sponsor: Abcuro, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Immunology • Myositis

A Study to Evaluate the Efficacy and Safety of ABC008 for Inclusion Body Myositis (clinicaltrials.gov) - P2/3 | N=231 | Recruiting | Sponsor: Abcuro, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Immunology • Myositis

A Study to Evaluate the Efficacy and Safety of ABC008 for Inclusion Body Myositis (clinicaltrials.gov) - P2/3 | N=231 | Not yet recruiting | Sponsor: Abcuro, Inc.

New P2/3 trial • Immunology • Myositis

A Phase 1 Study of ABC008 in Ascending (Single Ascending Dose/Multiple Ascending Dose) Study in Patients With (IBM) (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: Abcuro, Inc. | Trial completion date: Dec 2023 ➔ May 2024 | Trial primary completion date: Dec 2023 ➔ Mar 2024

Trial completion date • Trial primary completion date • Immunology • Myositis • KLRG1

KLRG1 Depletion Is a Novel Therapeutic Strategy for Patients with Mature T and NK/T-Cell Lymphomas (ASH 2022) - "Duvelisib (Duv), a dual PI3K-δ/γ inhibitor (PI3Ki), has demonstrated a high ORR of 50% in phase II trials in TCLs and its ability to reprogram macrophages to an M1 phenotype in TCL PDXs. Selective depletion of tumor cells with an anti-KLRG1 depleting mAb in specific subtypes of TCLs, T-LGLL, and CLPD-NK is effective in vitro and in vivo, and its combination with Duv has marked activity in an aggressive PTCL-NOS xenograft model. A multicenter phase I/II trial of the KLRG1 depleting antibody ABC008 (Abcuro) in patients with R/R T-LGLL has been initiated."

Clinical • Cutaneous T-cell Lymphoma • Hematological Disorders • Hematological Malignancies • Immune Modulation • Inflammation • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • Solid Tumor • T Cell Non-Hodgkin Lymphoma • B3GAT1 • CD8 • KLRG1 • NCAM1 • TP63

Abcuro Initiates Phase 1/2 Trial Evaluating ABC008 in Patients with T Cell Large Granular Lymphocytic Leukemia (Businesswire) - "Abcuro...announced initiation of a Phase 1/2 dose escalation trial to evaluate the safety, tolerability, and proof-of-concept of ABC008 in patients with T cell large granular lymphocytic leukemia (T-LGLL) who suffer from anemia and/or neutropenia. ABC008 is a first-in-class anti-KLRG1 antibody capable of selectively depleting highly cytotoxic T cells, while sparing regulatory T cells, central memory T cells, and other immune cells."

Trial initiation date • Hematological Malignancies • Leukemia • Oncology

ABC008 in Subjects With T-cell Large Granular Lymphocytic Leukemia (T-LGLL) (clinicaltrials.gov) - P1/2 | N=15 | Recruiting | Sponsor: Abcuro, Inc.

New P1/2 trial • Hematological Malignancies • Leukemia • Oncology • KLRG1

A Phase 1 Study of ABC008 in Adult Patients With Inclusion Body Myositis (IBM) (clinicaltrials.gov) - P1; N=27; Recruiting; Sponsor: Abcuro, Inc.; Trial completion date: Dec 2021 ➔ Dec 2023; Trial primary completion date: Dec 2021 ➔ Dec 2023

Clinical • Trial completion date • Trial primary completion date • Immunology • Myositis

A Phase 1 Study of ABC008 in Adult Patients With Inclusion Body Myositis (IBM) (clinicaltrials.gov) - P1; N=27; Recruiting; Sponsor: Abcuro, Inc.; Not yet recruiting ➔ Recruiting

Enrollment open • Immunology • Myositis

A Phase 1 Study of ABC008 in Adult Patients With Inclusion Body Myositis (IBM) (clinicaltrials.gov) - P1; N=27; Not yet recruiting; Sponsor: Abcuro, Inc.; N=39 ➔ 27

Clinical • Enrollment change • Immunology • Myositis