Otilimab Terminated Naked monospecific

Antibody Information

Entry ID	2094
INN	Otilimab
Status	Terminated
Drug code(s)	GSK3196165, MOR103, MOR-04357
Brand name	None
mAb sequence source	mAb human
General Molecular Category	Naked monospecific
Format, general category	Full length Ab
Format details	None
Isotype (Fc)	IgG1
Light chain isotype	lambda
Linker	None
Ave. DAR	None
Conjugated/fused moiety	None
Discovery method/technology	Phage display-derived (HuCAL library); Produced in PER.C6 cells

Therapeutic information

Target(s)	GM-CSF
Indications of clinical studies	COVID-19, Osteoarthritis, Rheumatoid Arthritis, Multiple Sclerosis
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)	December 15, 2007
Start of Phase 2	July 15, 2015
Start of Phase 3	May 16, 2019
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	MorphoSys AG
Licensee/Partner	GSK
Comments about company or candidate	Not listed in GSK pipeline dated Apr 26, 2023. Oct 2022: While the ContRAst-1 and ContRAst-2 trials met their primary endpoints, the efficacy demonstrated is unlikely to transform patient care for this difficult-to-treat patient population. Assessment of efficacy and safety data from the ContRAst programme is ongoing, however the limited efficacy demonstrated does not support a suitable benefit/risk profile for otilimab as a potential treatment for RA. As a result, GSK has decided not to progress with regulatory submissions. GSK H1 2022 report: Anticipated reg submission in 2023. MorphoSys Aug 2022 update: GSK expects a pivotal data readout of the phase 3 ContRAst program investigating otilimab for rheumatoid arthritis by the end of 2022. NCT04376684 is a Phase 2 study in COVID-19 patients. NCT04333147 Phase 3 in RA not yet recruiting when first posted on April 3, 2020. NCT04134728 Phase 3 in RA not yet recruiting as of Oct 22, 2019. NCT03980483 Phase 3 in RA started recruiting in May 2019. NCT03970837 Phase 3 study in RA started recruiting June 4, 2019. Oct 2018: Top-line data from GSK3196165’s Phase IIb BAROQUE trial included various secondary endpoints which produced statistically significant improvements, but the primary endpoint of the trial, DAS28(CRP)<2.6 at week 24, did not reach statistical significance. Aug 2018: Discontinued - Phase-II for Osteoarthritis in Germany, Netherlands, United Kingdom, Poland and USA. Total of 4 Phase 2 studies (3 in RA, 1 in OA) completed as of Jan 2018. NCT02504671 Phase 2 in RA recruiting as of Sep 2015. NCT01517282 Phase 1/2 recruiting as of Feb 2014. GSK in charge of development as of July 2014
Full address of company	MorphoSys AG, Semmelweisstr. 7, 82152 Planegg, Germany Europe Germany https://www.morphosys.com/en/contact-us

Description/comment

Immunoglobulin G1, anti-(human granulocyte-macrophage colony-stimulating factor) (human monoclonal GSK3196165 heavy chain), disulfide with human monoclonal GSK3196165 lambda-chain, dimer

Additional information

Anticipated events	None
Factor(s) contributing to discontinuation	Lack of efficacy