Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 2319 |
| INN | Gancotamab |
| Status | Terminated |
| Drug code(s) | MM-302 |
| Brand name | None |
| mAb sequence source | mAb human |
| General Molecular Category | Immunoconjugate, Unconventional ADC, Immunoliposome |
| Format, general category | Fragment conjugate |
| Format details | scFv-liposome |
| Isotype (Fc) | None |
| Light chain isotype | TBD |
| Linker | PEG-DSPE (polyethylene glycol-distearoylphosphatidylethanolamine) |
| Ave. DAR | None |
| Conjugated/fused moiety | Topoisomerase II inhibitor, Doxorubicin liposome |
| Discovery method/technology | Phage display-derived |
| Target(s) | HER2 |
| Indications of clinical studies | Breast Cancer |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Terminated at Phase 2/3 |
| Status | Inactive |
| Start of clinical phase (IND filing or first Phase 1) | March 15, 2011 |
| Start of Phase 2 | |
| Start of Phase 3 | July 15, 2014 |
| 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 | Merrimack Pharmaceuticals |
| Licensee/Partner | None |
| Comments about company or candidate | Not listed in Merrimack pipeline as of July 2017. Dec 21, 2016: Following a recent independent Data and Safety Monitoring Board (DSMB) recommendation and subsequent futility analysis, it has decided to stop the Phase 2 HERMIONE study of MM-302 (HER2 antibody-targeted liposomal doxorubicin) in HER2-positive metastatic breast cancer patients who had previously been treated with trastuzumab (Herceptin®), pertuzumab (Perjeta®) and ado-trastuzumab emtansine. NCT02213744 Phase 2/3 study started in July 2014; terminated in Jan 2017 for not showing benefit over control per DMC and confirmed via futility analysis. The Phase 2 trial was designed with input from the U.S. Food and Drug Administration (FDA) to support a potential accelerated approval application. |
| Full address of company | One Broadway, 14th floor, Cambridge, MA 02142 North America United States of America https://www.merrimack.com/contact/ |
scFv-targeted liposome containing doxorubicin https://doi.org/10.1186/s12885-016-2385-z
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |