Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 2535 |
| INN | Futuximab, modotuximab |
| Status | Terminated |
| Drug code(s) | SYM004 |
| Brand name | None |
| mAb sequence source | mAb chimeric |
| General Molecular Category | Mixture of 2 |
| 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) | EGFR |
| Indications of clinical studies | Glioma, Lung cancer, Head and Neck cancers, Colorectal Cancer |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Terminated at Phase 3 |
| Status | Inactive |
| Start of clinical phase (IND filing or first Phase 1) | February 15, 2010 |
| Start of Phase 2 | July 15, 2011 |
| Start of Phase 3 | April 21, 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 | Institut de Recherches Internationales Servier |
| Licensee/Partner | Merck KGaA |
| Comments about company or candidate | Nov 2023: All studies are completed, withdrawn or terminated Included in Servier pipeline in Jan 2023, but not in pipeline updated in May 2023. NCT05223673 Phase 3 in colorectal cancer started in April 2022 terminated as of last update in Sep 2023. Decision based on strategic reasons related to limited development options left in metastatic colorectal cancer. Study design described in Annals of Oncology (2022) 33 (suppl_7): S136-S196. 10.1016/annonc/annonc1048 Included in NCT05162755 Phase 1 study started in Oct 2021. Anti-EGFR listed as Phase 2 for colorectal cancer in Servier pipeline as of Dec 2020. As of Dec 2020, all clinical studies on clinicaltrials.gov are withdrawn, terminated or complete. Symphogen acquired by Servier in June 2020. Listed in Symphogen pipeline accessed online Aug 7 2019, but due to the financial requirements associated with a Phase 3 trial, management has decided to advance Sym004 through partnering only. Results published in April 2018 indicate Sym004 did not improve OS in an unselected population of patients with mCRC and acquired anti-EGFR resistance. A prospective clinical validation of Sym004 efficacy in a ctDNA molecularly defined subgroup of patients with refractory mCRC is warranted. (JAMA Oncol. 2018 Apr 12;4(4):e175245. doi: 10.1001/jamaoncol.2017). In June 2013, Symphogen received a milestone payment from Merck KGaA, related to the successful achievement of specific development objectives for Sym004; Phase 1 and 1/2 studies recruiting as of Feb 2014. |
| Full address of company | France Europe France https://institut-servier.com/en/ |
mAbs target non-overlapping epitopes of EGFR. INN of modotuximab formerly Zatuximab
| Anticipated events | None |
| Factor(s) contributing to discontinuation | Portfolio prioritization/business decision |