Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 1029 |
| INN | Becotatug vedotin |
| Status | Clinical |
| Drug code(s) | MRG003 |
| 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 | Valine-Citrulline (Cleavable linker) |
| Ave. DAR | ___ |
| Conjugated/fused moiety | Tubulin inhibitor, Monomethyl auristatin E (MMAE) |
| Discovery method/technology | None |
| Target(s) | EGFR |
| Indications of clinical studies | Gastric cancer, Nasopharyngeal Carcinoma, Biliary Tract Cancer, Non-small cell lung cancer, Colorectal cancer, head and neck cancer |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Phase 3 |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | May 09, 2018 |
| Start of Phase 2 | September 15, 2020 |
| Start of Phase 3 | April 15, 2023 |
| 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 | LEPU Biopharma, Shanghai Miracogen Inc. |
| Licensee/Partner | None |
| Comments about company or candidate | July 2024: MRG003: Owing to the encouraging clinical data, MRG003 was granted BTD by the FDA. Overall, MRG003 was granted BTD, ODD and FTD on NPC from the FDA and BTD from the CDE. Plan marketing application in 2024 (https://en.lepubiopharma.com/upload/listedco/listconews/sehk/2024/0821/2024082100594.pdf; https://en.lepubiopharma.com/upload/2024-04/171404093115884900.pdf) NCT05751512 Phase 3 in Squamous Cell Carcinoma of the Head and Neck to start in Mar 2023; CTR20223356 first patient dosed on April 4, 2023. MRG003 has been granted ODD from FDA and BTD from CDE in September 2022 for the treatment of NPC. Five Phase 2 studies recruiting as of June 2022. NCT04838964 Phase 2 in Biliary Tract Cancer due to start in April 2021. NCT04838548 Phase 2 in NSCLC started in Sep 2020; NCT05188209 Phase 2 in gastric cancer started in May 2021. Clinical studies in China |
| Full address of company | No.651, Lianheng Road, Minhang District, Shanghai, CHINA Asia China https://en.lepubiopharma.com/contact/shanghai |
MRG003 is a novel antibody drug conjugate (ADC) composed of a fully human anti-EGFR IgG1 monoclonal antibody conjugated to a microtubule disrupting agent monomethyl auristatin E (MMAE). MRG003 is presently being tested in an ongoing phase I study for safety, pharmacokinetics, and preliminary antitumor activity in patients (pts) with solid tumors (CTR20180310). https://ascopubs.org/doi/abs/10.1200/JCO.2020.38.15_suppl.3550.
| Anticipated events | Marketing application submission planned in H2 2024 |
| Factor(s) contributing to discontinuation | None |