Database for
Therapeutic Antibodies
Therapeutic Antibodies
| 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 |
| Target(s) | CSF-1R |
| Indications of clinical studies | Tenosynovial Giant Cell Tumor, Malignant Neoplasms of Female Genital Organs, solid tumors |
| 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 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 | 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 |
mAb blocks the dimerization interface of the CSF1 receptor
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |