Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 1028 |
| INN | None |
| Status | Clinical |
| Drug code(s) | MRG002 |
| 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 | TBD |
| Linker | Valine-Citrulline (Cleavable linker) |
| Ave. DAR | 3.6 |
| Conjugated/fused moiety | Tubulin inhibitor, Monomethyl auristatin E (MMAE) |
| Discovery method/technology | None |
| Target(s) | HER2 |
| Indications of clinical studies | Breast Cancer With Liver Metastases, Non-small cell lung cancer, Urothelium Cancer, Biliary Tract Cancer, gastric cancer, breast 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) | November 15, 2018 |
| Start of Phase 2 | July 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 | No mention of NDA in INTERIM RESULTS ANNOUNCEMENT FOR THE SIX MONTHS ENDED JUNE 30, 2024 (https://en.lepubiopharma.com/upload/listedco/listconews/sehk/2024/0821/2024082100594.pdf) Plan marketing application in 2024 (https://en.lepubiopharma.com/upload/2024-04/171404093115884900.pdf) NCT05754853 Phase 3 study in urothelium cancer started in Apr 2023. Phase 2/3 study for Breast Cancer (NCT04924699) is recruiting as of March 17, 2023. In August 2022, MRG002 has been granted ODD from FDA for the treatment of GC/GEJ. NCT05141747 and NCT05263869 Phase 2 studies started in Jan and March 2022, respectively. NCT04839510 Phase 2 in HER2-positive Unresectable Locally Advanced or Metastatic Urothelium Cancer started in April 2021. NCT04837508 Phase 2 in Patients With HER2-positive Unresectable, Locally Advanced or Metastatic Biliary Tract Cancer due to start in April 2021. NCT04742153 Phase 2 in Patients With HER2-low Locally Advanced or Metastatic Breast Cancer not yet recruiting when first posted on Feb 5, 2021. NCT04492488 Phase 1/2 study in HER2-Positive Advanced Solid Tumors and Locally Advanced or Metastatic Gastric/Gastroesophageal Junction (GEJ) Cancer recruiting when posted on July 30, 2020. Clinical studies in China |
| Full address of company | No.651, Lianheng Road, Minhang District, Shanghai, CHINA Asia China https://en.lepubiopharma.com/contact/shanghai |
MRG002 is a new HER2-targeted ADC, with the monoclonal antibody in the ADC being a sugar-modified trastuzumab and the conjugated cytotoxic drug being MMAE with a cleavable vc-linker. The DAR of MRG002 is 3.6. https://tbcr.amegroups.com/article/view/58131/html Preclinical characterization: https://doi.org/10.1093/abt/tbab017
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |