Emactuzumab Clinical Naked monospecific

Antibody Information

Entry ID	1203
INN	Emactuzumab
Status	Clinical
Drug code(s)	RO5509554, RG7155
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)	CSF-1R
Indications of clinical studies	Tenosynovial Giant Cell Tumor, Malignant Neoplasms of Female Genital Organs, solid tumors
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 15, 2011
Start of Phase 2	July 15, 2014
Start of Phase 3	July 18, 2022
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	Hoffmann-La Roche
Licensee/Partner	SynOx Therapeutics
Comments about company or candidate	NCT05417789 Phase 3 in Tenosynovial Giant Cell Tumor started in Apr 2024 August 2022, Emactuzumab designated as an Orphan Medicinal Product in Europe. NCT05417789 Phase 3 study in Tenosynovial Giant Cell Tumor started in July 2022. November 30, 2020 – Celleron Therapeutics, the UK-based company developing personalised medicines for cancer patients, announces the formation of a new spin out, SynOx Therapeutics, as a vehicle for the continued development of emactuzumab as an effective treatment for tenosynovial giant cell tumours. Aug 2020: Celleron Therapeutics announced the signing of a licensing agreement with Roche providing Celleron exclusive world-wide rights for the clinical development, manufacturing and commercialization of emactuzumab. The closing is expected by end of 2020 after all conditions have been met. Dec 2019: Roche announced that Emactuzumab in combination with Tecentriq for the treatment of Phase I development has been removed from the pipeline. NCT03193190 Phase 1/2 study recruiting as of last update in June 2019; not found in Roche pipeline dated July 25, 2019. Listed as Phase 1 in Roche pipeline accessed online Sep 2 2018. NCT02323191 Phase 1 study recruiting as of Sep 2 2018. NCT01494688 Phase 1 study completd in Feb 2018; advanced to Phase 2 according to Roche pipeline update on July 24, 2014. Phase 2 NCT02923739 study sponsored by M.D. Anderson Cancer Center started May 5, 2017 active not recriuting as of Sep 2 2018.
Full address of company	Basel, Switzerland Europe Switzerland https://www.roche.com/about

Description/comment

mAb blocks the dimerization interface of the CSF1 receptor

Additional information

Anticipated events	None
Factor(s) contributing to discontinuation	None