Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 2161 |
| INN | Epratuzumab |
| Status | Terminated |
| Drug code(s) | IMMU-103, HUIMMU-hLL2; AMG412 |
| 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) | CD22 |
| Indications of clinical studies | Acute Lymphoblastic Leukaemia, Systemic Lupus Erythematosus, Waldenstrom Macroglobulinemia, Lymphoma |
| 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) | June 15, 1997 |
| Start of Phase 2 | |
| Start of Phase 3 | September 15, 2000 |
| 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 | Gilead Sciences Inc |
| Licensee/Partner | UCB, Amgen |
| Comments about company or candidate | Oct 2020: Gilead Sciences acquired biotech company Immunomedics in a $21 billion deal Epratuzumab not listed in ImmunoMedics pipeline accessed online Aug 2019; no commercially sponsored studies are listed as active or active not recruiting patients on clinicaltrials.gov. Y-90 Epratuzumab is no longer listed in Immunomedics' pipeline for the treatment of mantle cell lymphoma as of Feb 2018. Still listed in ImmunoMedics pipeline as of July 2018. 2012-000793-30 IntReALL-SR-2010 study in childhood relapsed ALL is ongoing as of July 2018; sponsored by Charité - University Hospital of Berlin. License agreement with UCB terminated in Feb 2016. July 2015: Epratuzumab missed its primary endpoints in the identical Phase III EMBODY 1 and EMBODY 2 trials to treat systemic lupus erythematosus (SLE). UCB said there was no statistically significant difference between patients treated with epratuzumab plus standard therapy vs. placebo plus standard therapy. The primary endpoint was percentage of patients meeting treatment response criteria at week 48 as measured by the BILAG-based combined lupus assessment. UCB spokesperson Andrea Christopher declined to comment on next steps for the program. UCB has rights to epratuzumab for autoimmune indications, while Immunomedics retains rights in cancer indications. The humanized mAb targeting CD22 is in a Phase III trial in pediatric patients with relapsed acute lymphoblastic leukemia and in Phase II studies in adults with ALL and non-Hodgkin's lymphoma. Not in Amgen pipeline dated April 2017. |
| Full address of company | 333 Lakeside Drive Foster City, CA 94404 North America United States of America https://www.gilead.com/our-company/us-locations |
I-131, Y-90, RNAse versions made; naked version in Phase 3
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |