Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 495 |
| INN | Cendakimab |
| Status | Clinical |
| Drug code(s) | CC-93538, RPC4046; ABT-308, 13C5.5 |
| 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 |
| Target(s) | IL-13 |
| Indications of clinical studies | Eosinophilic gastroenteritis, Atopic dermatitis, Asthma, Eosinophilic Esophagitis |
| Primary therapeutic area | Immune-mediated / inflammatory disorders |
| Most advanced stage of development (global) | Phase 3 |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | October 15, 2009 |
| Start of Phase 2 | August 05, 2014 |
| Start of Phase 3 | February 22, 2021 |
| 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 | AbbVie |
| Licensee/Partner | Bristol Myers Squibb |
| Comments about company or candidate | July 2024: Phase 3 trial evaluating the efficacy and safety of cendakimab in patients with eosinophilic esophagitis met both co-primary endpoints. Phase 3 studies for Eosinophilic gastroenteritis (NCT05214768) and Eosinophilic esophagitis (NCT04753697, NCT04991935) are recruiting as of May 17, 2023. NCT05214768 Phase 3 started in March 2022 has primary completion date in Sep 2023. NCT04991935 Phase 3 started in Sep 2021. NCT04753697 is a Phase 3 study to Evaluate the Efficacy and Safety of CC-93538 in Adult and Adolescent Participants With Eosinophilic Esophagitis, started in Feb 15, 2021 has primary completion date in May 2024. Listed as Phase 2 in BMS pipeline in June 2020. Phase 2 results published in Gastroenterology. 2019 Feb;156(3):592-603.e10. doi: 10.1053/j.gastro.2018.10.051.Not listed in Celgene pipeline accessed online in Aug 2018. NCT02098473 Phase 2 study completed in Jan 2017. Listed in Celgene pipeline dated Aug 2017; Celgene acquired Receptos in Aug 2015. AbbVie licensed asset to Receptos in March 2013; AbbVie holds an exclusive option to enter into a global co-development collaboration for RPC4046 with Receptos following results of the planned Phase 2 study and regulatory discussions with the FDA. Receptos initiated the Phase II trial for RPC4046 in eosinophilic sophagitis in Aug 2014. |
| Full address of company | North Chicago, Illinois, United States North America United States of America https://www.abbvie.com/ |
None
| Anticipated events | Data readout in 2024 for Phase 3 NCT04753697 and NCT05214768 studies |
| Factor(s) contributing to discontinuation | None |