Budigalimab Clinical Naked monospecific

Antibody Information

Entry ID	193
INN	Budigalimab
Status	Clinical
Drug code(s)	ABBV-181
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)	PD-1
Indications of clinical studies	NSCLC, Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma, Hepatocellular Carcinoma, Head and neck cancer, Solid tumors, ovarian cancer, colorectal cancer, HIV
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)	December 15, 2016
Start of Phase 2	May 15, 2021
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	AbbVie
Licensee/Partner	None
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. NCT06032546 Phase 2 in HIV due to start in Oct 2023. NCT05822752 Phase 2 in hepatocellular carcinoma started in Aug 2023. NCT04807972 Phase 1/2 in pancreatic cancer started in May 2021 active not recruiting as of last update in Aug 2023. NCT04799353 Phase 1 in HIV started in March 2021. NCT04223804 Phase 1 in HIV started in Jan 2020 completed in Feb 2023. NCT03893955 Phase 1 study started in May 2019 recruiting as of Aug 2019; NCT03818542 in Head and Neck cancer started in Jan 2020 terminated in Sep 2020 for strategic considerations April 2019: AbbVie terminates a phase I studies in colorectal and ovarian cancers in USA due to strategic considerations (NCT03035279 and NCT03138408). Five Phase 1 studies recruiting as of July 2018.
Full address of company	North Chicago, Illinois, United States North America United States of America https://www.abbvie.com/

Description/comment

Immune checkpoint target. ABBV-181 is a humanized, recombinant, IgG1 monoclonal antibody targeting programmed cell death 1 (PD-1). L234A L235A mutations reduce effector functions https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6220479/. ABBV-1882 is a combination of ABBV-181 (anti-PD1) and ABBV-382 (anti-a4b7 mAb)

Additional information

Anticipated events	None
Factor(s) contributing to discontinuation	None