Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 2303 |
| INN | Tebotelimab |
| Status | Terminated |
| Drug code(s) | MGD013 |
| Brand name | None |
| mAb sequence source | mAb human |
| General Molecular Category | Bispecific |
| Format, general category | Fragment-Fc |
| Format details | 2+2 symmetric, (DART)2-Fc |
| Isotype (Fc) | IgG4 |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | None |
| Target(s) | LAG-3, PD-1 |
| Indications of clinical studies | Melanoma, Head & neck cancer, Hepatocellular carcinoma, gastric cancer, Solid tumors |
| 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) | August 01, 2017 |
| Start of Phase 2 | |
| Start of Phase 3 | September 15, 2019 |
| 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 | Macrogenics |
| Licensee/Partner | None |
| Comments about company or candidate | June 2024: MacroGenics currently has no active/ongoing tebotelimab studies, as per a company presentation. Assumed to be terminated; first quarter 2023 (http://ir.macrogenics.com/news-releases/news-release-details/macrogenics-provides-update-corporate-progress-and-first-6) there is no mention of tebotelimab. July 08, 2022 I MacroGenics, Inc. announced that effective as of July 7, 2022, the Company closed the Phase 2 study (CP-MGA271-06) evaluating the investigational regimen of enoblituzumab (Fc-optimized B7-H3-directed monoclonal antibody) in combination with either retifanlimab (anti-PD-1 monoclonal antibody) or tebotelimab (PD-1 × LAG-3 bispecific DART® molecule) in the first-line treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN).The decision to discontinue the study was based on an internal review of safety data, which included the occurrence of seven fatalities potentially associated with hemorrhagic events in both arms of the study (of 62 total patients treated). Feb 2022: MacroGenics' partner in Greater China, Zai Lab, recently informed the Company that it has decided to discontinue development of tebotelimab for indications it was enrolling in its territory and is evaluating future development plans in other indications. NCT04212221 Phase 1/2 in hepatocellular carcinoma not yet recruiting as of Jan 1 2020. NCT04082364 Combination Margetuximab, INCMGA00012, MGD013, and Chemotherapy Phase 2/3 Trial in HER2+ Gastric/GEJ Cancer (MAHOGANY) started in Sep 2019. NCT03219268 Phase 1 started Aug 2017 still recruiting as of last record update in July 2019. Nov 2018: Zai Lab obtained regional development and commercialization rights for MGD13 in mainland China, Hong Kong, Macau and Taiwan IND filed in 2017. MGD013 is intended to enable co-blockade of two immune checkpoint molecules co-expressed on T cells, PD-1 and LAG-3, with a single agent. MGD013 is a Dual-Affinity Re-Targeting, or DART®, molecule that recognizes both PD-1 and LAG-3 on T cells and has a prolonged serum half-life. |
| Full address of company | Rockville, Maryland, United States North America United States of America https://macrogenics.com/ |
Immune checkpoint inhibitor. MGD013 is a tetravalent bispecific Fc-bearing Dual-Affinity Re-Targeting (DART®) molecule with a human IgG4 backbone
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |