Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 1776 |
| INN | Depatuxizumab mafodotin |
| Status | Terminated |
| Drug code(s) | ABT-414 |
| Brand name | None |
| mAb sequence source | mAb humanized |
| General Molecular Category | ADC |
| Format, general category | Full length Ab conjugate |
| Format details | None |
| Isotype (Fc) | IgG1 |
| Light chain isotype | kappa |
| Linker | Maleimidocaproyl (mc: Non-cleavable linker) |
| Ave. DAR | 3.8 |
| Conjugated/fused moiety | Tubulin inhibitor, Monomethyl auristatin F (MMAF) |
| Discovery method/technology | None |
| Target(s) | EGFR |
| Indications of clinical studies | Solid tumors, Glioblastoma Multiforme, squamous non-small cell lung cancer, pediatric brain tumors |
| 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) | October 15, 2012 |
| Start of Phase 2 | February 15, 2015 |
| Start of Phase 3 | December 15, 2015 |
| 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 | AbbVie |
| Licensee/Partner | None |
| Comments about company or candidate | July 2019: Removed from AbbVie pipeline. May 2019: AbbVie announced the Phase 3 INTELLANCE-1 study of the ADC depatuxizumab mafodotin in patients with newly diagnosed glioblastoma (GBM), whose tumors have epidermal growth factor receptor amplification, demonstrated no survival benefit for patients receiving the ADC at an interim analysis. An Independent Data Monitoring Committee recommended the study be stopped. No new safety findings were observed. Enrollment in all ongoing depatuxizumab mafodotin studies has been halted. NCT03419403 Phase 3 study for Management of Ocular Side Effects in Subjects With Glioblastoma Receiving Depatuxizumab Mafodotin recruiting as of July 2018. NCT02573324 is Phase 2b/3 study; still recruiting as of Oct 2017. US pediatric disease designation for pediatric patients with diffuse intrinsic pontine glioma. NCT02343406 Phase 2 started in Feb 2015. NCT01741727 official title is A Phase 1/2 Study Evaluating the Safety, Pharmacokinetics and Efficacy of ABT-414 in Subjects With Advanced Solid Tumors Likely to Over-Express the Epidermal Growth Factor Receptor. US and EU orphan drug designation for glioblastoma. Molecule targts a unique epitope of EGFR |
| Full address of company | North Chicago, Illinois, United States North America United States of America https://www.abbvie.com/ |
ADC version of ABT-806
| Anticipated events | None |
| Factor(s) contributing to discontinuation | Lack of efficacy |