Ulviprubart Clinical Naked monospecific

Antibody Information

Entry ID	207
INN	Ulviprubart
Status	Clinical
Drug code(s)	ABC008
Brand name	None
mAb sequence source	mAb humanized
General Molecular Category	Naked monospecific
Format, general category	Full length Ab
Format details	None
Isotype (Fc)	IgG1
Light chain isotype	kappa
Linker	None
Ave. DAR	None
Conjugated/fused moiety	None
Discovery method/technology	None

Therapeutic information

Target(s)	KLRG1
Indications of clinical studies	Inclusion Body Myositis, T-cell Large Granular Lymphocytic Leukemia
Primary therapeutic area	Immune-mediated / inflammatory disorders

Development stage information

Phase lengths*

*The graph represents early-stage clinical development phase lengths. For molecules approved or under evaluation for marketing authorization in the US is provided a complete overview of all clinical development phase lengths. Phase lengths are calculated from the start of the first in human (FIH) study (Start of clinical phase). “Start of Phase 2” bar represents Phase 1 length (Start of clinical phase to start of Phase 2); “Start of Phase 3” bar represents Phase 1+2 length (Start of clinical phase to start of Phase 3); “Date BLA/NDA submitted” bar represents Phase 1+2+3 length (Start of clinical phase to Date BLA/NDA submitted); and “Date of first US approval” bar represents Phase 1 to first US approval length (Start of clinical phase to Date of first US approval).

Most advanced stage of development (global)	Phase 2/3
Status	Active
Start of clinical phase (IND filing or first Phase 1)	May 25, 2021
Start of Phase 2	September 15, 2022
Start of Phase 3	February 15, 2023
Date BLA/NDA submitted to FDA
Year of first approval (global)	None
Date of first US approval
INN, US product name	None
US or EU approved indications	None

Company information

Company	Abcuro Inc.
Licensee/Partner	None
Comments about company or candidate	February 12, 2025 – Abcuro, Inc., announced the closing of a $200 million Series C financing; 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 NCT06450886 Phase 2/3 in Inclusion Body Myositis started in Oct 2024 NCT05721573 Phase 2/3 in Inclusion Body Myositis started in Feb 2023. NCT05532722 Phase 1/2 started in Sep 2022. NCT04659031 Phase 1 started in May 2021. The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have granted Orphan Designation to ABC008 for the treatment of IBM.
Full address of company	55 Chapel St Suite 200, Newton, MA 02458, United States North America United States of America https://abcuro.com/

Description/comment

ABC008 is a humanized, afucosylated anti-KLRG1 antibody capable of selectively depleting highly cytotoxic T cells, while sparing regulatory and central memory T cells. ABC008 has been designed to treat diseases mediated by highly cytotoxic T cells, including the autoimmune muscle disease inclusion body myositis (IBM), T cell large granular lymphocytic leukemia (T-LGLL), and mature T cell malignancies.

Additional information

Anticipated events	None
Factor(s) contributing to discontinuation	None