Cendakimab Terminated Naked monospecific

Antibody Information

Entry ID	495
INN	Cendakimab
Status	Terminated
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

Therapeutic information

Target(s)	IL-13
Indications of clinical studies	Eosinophilic gastroenteritis, Atopic dermatitis, Asthma, Eosinophilic Esophagitis
Primary therapeutic area	Immune-mediated / inflammatory disorders

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)	Terminated at Phase 3
Status	Inactive
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 information

Company	AbbVie
Licensee/Partner	Bristol Myers Squibb
Comments about company or candidate	Feb 2025: BMS announces decision not to commercialize cendakimab. 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/

Description/comment

None

Additional information

Anticipated events	None
Factor(s) contributing to discontinuation	None