Cetrelimab Clinical Naked monospecific

Antibody Information

Entry ID	843
INN	Cetrelimab
Status	Clinical
Drug code(s)	JNJ-63723283
Brand name	None
mAb sequence source	mAb human
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	None

Therapeutic information

Target(s)	PD-1
Indications of clinical studies	Hepatitis B, Non-Muscle Invasive Bladder Cancer Unresponsive to Intravesical Bacillus Calmette-Guerin, Urothelial Carcinoma, prostate cancer, Multiple myeloma, Advanced cancer
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 3
Status	Active
Start of clinical phase (IND filing or first Phase 1)	November 01, 2016
Start of Phase 2	December 30, 2020
Start of Phase 3	December 07, 2020
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	Janssen Research & Development LLC
Licensee/Partner	Xoma
Comments about company or candidate	Phase 3 studies for Bladder cancer (NCT04658862, NCT05714202) are active non recruiting as of October 2024. Listed as Phase 2 and 3 for bladder cancer in J&J pipeline dated Oct 15, 2024 (https://s203.q4cdn.com/636242992/files/doc_financials/2024/q3/Pipeline/JNJ-Pipeline-3Q2024.pdf) September 15, 2024 – Johnson & Johnson (NYSE:JNJ) announced today additional results from the pivotal Phase 2b SunRISe-1 study, supporting the safety and efficacy profile of investigational TAR-200 for the treatment of patients with Bacillus Calmette-Guérin (BCG)-unresponsive, high-risk non-muscle-invasive bladder cancer. Phase 3 studies for Bladder cancer (NCT04658862, and the new NCT05714202) are recruiting as of May, 2023. NCT04658862 Phase 3 in bladder cancer started in Dec 2020 NCT04640623 Phase 2 due to start in Dec 2020. NCT02908906 Phase 1 study recruiting as of Nov 2016. NCT03547037 Phase 1 study started in Aug 2018
Full address of company	Raritan, New Jersey, United States North America United States of America https://www.janssen.com/

Description/comment

Immune checkpoint target. Cetrelimab was generated by phage panning against human and cynomolgus monkey (cyno) PD-1 extracellular domains (ECDs) and affinity maturation. Cancer Chemother Pharmacol. 2022; 89(4): 515–527. Published online 2022 Mar 17. doi: 10.1007/s00280-022-04415-5

Additional information

Anticipated events	None
Factor(s) contributing to discontinuation	None