Livmoniplimab Clinical Naked monospecific

Antibody Information

Entry ID	191
INN	Livmoniplimab
Status	Clinical
Drug code(s)	ABBV-151, ARGX-115, PR-1762844
Brand name	None
mAb sequence source	mAb chimeric/humanized
General Molecular Category	Naked monospecific
Format, general category	Full length Ab
Format details	None
Isotype (Fc)	IgG4
Light chain isotype	kappa
Linker	None
Ave. DAR	None
Conjugated/fused moiety	None
Discovery method/technology	Camelid-derived; SIMPLE Antibody

Therapeutic information

Target(s)	GARP/TGF beta complex
Indications of clinical studies	NSCLC, Hepatocellular Carcinoma, Solid tumors
Primary therapeutic area	Cancer

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)	February 21, 2019
Start of Phase 2
Start of Phase 3	January 15, 2024
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	argenx
Licensee/Partner	Eli Lilly and Company
Comments about company or candidate	NCT06236438 Phase 2/3 in NSCLC to evaluate the optimized dose, adverse events, and efficacy of livmoniplimab in combination with budigalimab started in April 2024. NCT06109272 Phase 2/3 in Hepatocellular Carcinoma in combination with budigalimab started in January 2024. NCT05822752 Phase 2 in hepatocellular carcinoma started in Aug 2023. NCT03821935 Phase 1 study started in Feb 2019 recruiting as of last update in Dec 2022. August 2018: argenx announced the exercise by AbbVie of its exclusive license option to develop and commercialize ARGX-115, an antibody targeting the novel immuno-oncology target glycoprotein A repetitions predominant (GARP). April 2017: arGen-X recd. $10 million for preclinical milestone AbbVie Inc. acquired an exclusive option from argenx N.V. to license ARGX-115, a preclinical mAb against leucine-rich repeat containing 32 (LRRC32; GARP), to treat cancer. argenx will be responsible for R&D through IND-enabling studies, after which AbbVie may exercise the option. Licensed from de Duve Institute/Uni Catholique de Louvain; discovery using SIMPLE Antibody platform. GARP is a check-point inhibitor
Full address of company	1101 EB Amsterdam, Netherlands Europe Netherlands https://www.argenx.com/contact-us

Description/comment

Immune checkpoint target. ABBV-151 is a monoclonal antibody (mAb) that binds to the GARP-TGFβ1 complex and blocks TGFβ1 release. Glycoprotein A repetitions predominant (GARP), also known as Leucine-rich repeat containing 32 (LRRC32). Hinge-stabilized

Additional information

Anticipated events	None
Factor(s) contributing to discontinuation	None