Budoprutug Clinical Naked monospecific

Antibody Information

Entry ID	1416
INN	Budoprutug
Status	Clinical
Drug code(s)	TNT119, VB119
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)	CD19
Indications of clinical studies	Systemic Lupus Erythematosus, Steroid-Sensitive Primary Minimal Change Disease or Primary Focal Segmental Glomerulosclerosis, Primary Membranous Nephropathy
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
Status	Active
Start of clinical phase (IND filing or first Phase 1)	May 05, 2021
Start of Phase 2	May 03, 2022
Start of Phase 3
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	Acelyrin Inc
Licensee/Partner	Eliem Therapeutics, Inc, Cancer Research UK
Comments about company or candidate	April 10, 2024, Eliem entered into an Agreement and Plan of Merger and Reorganization with Tenet Medicines, Inc. a privately held development-stage biotechnology company focused on advancing TNT119, an anti-CD19 antibody designed for a broad range of autoimmune disorders, including systemic lupus erythematosus, immune thrombocytopenia and membranous nephropathy. The Acquisition Agreement provides for the acquisition of Tenet by Eliem through the merger of a wholly owned subsidiary of Eliem into Tenet, with Tenet surviving as a wholly owned subsidiary of Eliem Feb 2024: Not listed in Acelyrin pipeline NCT04652570 is a Phase 1/2 in Adult Subjects With Primary Membranous Nephropathy started in May 2021. Sponsor is Tenet Medicines. Acelyrin acquired ValenzaBio, Inc. Founded in 2019, ValenzaBio, Inc is a developer of antibody therapy designed to provide safe and effective treatment options for patients with unmet needs. The company's pipeline therapies include several monoclonal antibodies targeting surface antigens to reduce pathogenic subpopulations of autoreactive cells, enabling researchers to devise new treatment options for patients with autoimmune and inflammatory diseases. Proof-of-mechanism for VB119 was previously established in a Phase 1 clinical trial completed by Cancer Research UK, where peripheral B-cell depletion was observed in patients after a single dose of VB119.
Full address of company	4149 Liberty Canyon Road Agoura Hills, CA 91301 North America United States of America https://www.acelyrin.com/contact

Description/comment

Humanized, immunoglobin (Ig) G1 monoclonal antibody

Additional information

Anticipated events	None
Factor(s) contributing to discontinuation	None