Database for
Therapeutic Antibodies
Therapeutic Antibodies
| 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 |
| 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 |
| 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 | 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/ |
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
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |