Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 178 |
| INN | Bulumtatug fuvedotin |
| Status | Clinical |
| Drug code(s) | 9MW2821 |
| 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) + Idconnect |
| Ave. DAR | 4 (Site-specific) |
| Conjugated/fused moiety | Tubulin inhibitor, Monomethyl auristatin E (MMAE) |
| Discovery method/technology | None |
| Target(s) | Nectin-4 |
| Indications of clinical studies | Cervical Cancer, Triple-Negative Breast Cancer, Urothelial Carcinoma, Solid tumors |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Phase 3 |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | January 01, 2022 |
| Start of Phase 2 | |
| Start of Phase 3 | April 15, 2024 |
| 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 | Mabwell (Shanghai) Bioscience Co. Ltd. |
| Licensee/Partner | None |
| Comments about company or candidate | NCT06692166 Phase 3 in cervical cancer started in Nov 2024. NCT06592326 Phase 3 in UC started in Aug 2024. Aug 2024: Mabwell announced its novel Nectin-4 targeting ADC (R&D code: 9MW2821) has been granted Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) for the treatment of locally advanced or metastatic urothelial carcinoma that has failed previous platinum-based chemotherapy and PD-(L)1 inhibitor therapy. July 2024: Mabwell (Shanghai) Bioscience Co., Ltd. announced that its self-developed novel Nectin-4-targeting antibody-drug conjugate (ADC: R&D Code: 9MW2821) has been granted Fast Track Designation (FTD) by the U.S. Food and Drug Administration (FDA) for the treatment of locally advanced or metastatic Nectin-4 positive triple negative breast cancer. May 7, 2024: The phase III clinical study of 9MW2821 monotherapy has officially been initiated in patients with locally advanced or metastatic urothelial carcinoma who have previously received platinum-based chemotherapy and PD-(L)1 inhibitor therapy. 9MW2821) has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA), for the treatment of esophageal cancer. https://www.prnewswire.com/news-releases/fda-grants-orphan-drug-designation-to-9mw2821-302137498.html Feb 2024: 9MW2821 has been granted Fast Track Designation by the U.S. Food and Drug Administration for the treatment of advanced, recurrent, or metastatic esophageal squamous cell carcinoma. NCT06196736 / CTR20234024 is a Phase 3 study in patients with unresectable locally advanced or metastatic urothelial carcinoma who have received prior platinum-containing chemotherapy and a PD-(L)1 inhibitor due to start in Dec 2023. December 11, 2023 I Mabwell announced that its submission to the Center for Drug Evaluation (CDE) of the National Medical Products Administration for the "A Randomized, Open-label, Controlled, Multicenter Phase III Clinical Trial of 9MW2821 versus Investigator's Choice of Chemotherapy for Treating Unresectable Locally Advanced or Metastatic Urothelial Carcinoma in Patients Previously Treated with Platinum-Containing Chemotherapy and PD-(L)1 Inhibitors" has been approved. The company will now officially initiate the Phase III clinical study of 9MW2821 for treating locally advanced or metastatic urothelial carcinoma in patients previously treated with platinum-based chemotherapy and PD-(L)1 inhibitors. NCT06079112 Phase 1/2 in Urothelial Carcinoma due to start in Oct 2023. NCT05773937 Phase 1 started in June 2022. NCT05216965 Phase 1/2 study started in June 2022. Jan 2022: The Center for Drug Evaluation (CDE) of China National Medical Products Administration has approved the investigational new drug application (IND) for 9MW2821, an anti-Nectin-4 ADC drug candidate, being developed by Shanghai Mabwell. A phase I study to evaluate the safety, tolerability, pharmacokinetic characteristics, and preliminary effectiveness in patients with advanced solid tumors started earlier this month. |
| Full address of company | BLDG 3, No 576, Libing Rd, Pudong New District, Shanghai, PRC Asia China https://www.mabwell.com/en/about.html?ab=l#mwView |
9MW2821 created based on interchain-disulfide drug conjugate technology. This novel drug contained a site-specifically conjugated humanized antibody and the cytotoxic moiety monomethyl auristatin E. Linker IDconnectTM is designed to form site-specific disulfide bonds by cross-linking the reduced cysteines in the Fab and hinge regions of an antibody, thereby rendering a highly homogeneous drug-to-antibody ratio of 4. doi.org/10.1158/1535-7163.MCT-22-0743 This drug candidate has achieved site-specific modification based on the ADC conjugate technology jointly developed by Mabwell and Shanghai Institute of Materia Medica. immunoglobulin G1-kappa, anti-[Homo sapiens NECTIN4 (nectin-4, nectin cell adhesion molecule 4, PVRL4, poliovirus receptor-related 4, PPR4, LNIR)], conjugated on an average of 8 cysteinyl residues to monomethylauristatin E (MMAE), with a ratio of 1 to 4, via a cleavable divalent linker;
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |