Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 25 |
| INN | Enfortumab vedotin |
| Status | Approved |
| Drug code(s) | ASG-22ME, ASG-22CE, AGS-22M6E |
| Brand name | Padcev |
| mAb sequence source | mAb human |
| General Molecular Category | ADC |
| Format, general category | Full length Ab conjugate |
| Format details | None |
| Isotype (Fc) | IgG1 |
| Light chain isotype | kappa |
| Linker | Valine-Citrulline, mc-val-cit PABC, Cleavable linker |
| Ave. DAR | 4 |
| Conjugated/fused moiety | Tubulin inhibitor, Monomethyl auristatin E (MMAE) |
| Discovery method/technology | None |
| Target(s) | Nectin-4 |
| Indications of clinical studies | Metastatic Urothelial Cancer and Other Malignant Solid Tumors |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Approved EU, US, Japan, Australia, Canada |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | March 15, 2011 |
| Start of Phase 2 | January 15, 2017 |
| Start of Phase 3 | June 27, 2018 |
| Date BLA/NDA submitted to FDA | July 15, 2019 |
| Year of first approval (global) | 2019 |
| Date of first US approval | December 18, 2019 |
| INN, US product name | Enfortumab vedotin, enfortumab vedotin-ejfv |
| US or EU approved indications | FDA approved treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a programmed death receptor-1 (PD-1) or programmed death ligand 1 (PD-L1) inhibitor and a platinum-containing chemotherapy. European Commission approved PADCEV™ (enfortumab vedotin) as monotherapy for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a platinum-containing chemotherapy and a PD-1/L1 inhibitor |
| Company | Agensys |
| Licensee/Partner | Astellas |
| Comments about company or candidate | Dec 2019: Accelerated approval granted by FDA. July 16, 2019: A Biologics License Application (BLA) for enfortumab vedotin has been submitted to the FDA for a potential accelerated approval as a treatment for patients with locally advanced or metastatic urothelial cancer who have previously received a PD-1/PD-L1 inhibitor and platinum-containing chemotherapy in the neoadjuvant/adjuvant, locally advanced, or metastatic setting. NCT03474107 Phase 3 study in Urothelial cancer started in June 2018. March 2018: The FDA awarded breakthrough designation to an antibody-drug conjugate as a second-line treatment for locally advanced or metastatic urothelial cancer. Oct. 10, 2017-- Seattle Genetics, Inc. and Astellas Pharma Inc. announced dosing of the first patient in EV-201, a registrational phase 2 clinical trial of enfortumab vedotin for patients with locally advanced or metastatic urothelial cancer who have been previously treated with checkpoint inhibitor (CPI) therapy. The EV-201 study will assess the antitumor activity and safety of enfortumab vedotin to support potential registration under the U.S. Food and Drug Administration’s (FDA) accelerated approval regulations. Listed as Phase 2 in Astellas pipeline dated Jan 2017; NCT03219333 Phase 2 study recruiting as of July 20 2017. NCT02091999 Phase 1 recruiting as of Jan 2017. Listed as Phase 1 in pipeline dated Feb 2013. AGS-22M6E and ASG-22CE are fully human monoclonal antibody conjugated to a cytotoxic agent monomethyl auristatin E (MMAE) targeting Nectin-4 (Agensys code name AGS-22). The main difference between AGS-22M6E and ASG-22CE is the change in cell line for antibody production. |
| Full address of company | 2225 Colorado Avenue Santa Monica, CA 90404 United States North America United States of America https://pitchbook.com/profiles/company/52729-30#overview |
DAR: ave 3-4; mc-val-cit PABC linker. The enfortumab vedotin active substance (AS) consists of fully human IgG1 mAb intermediate, AGS22C3, conjugated to the drug-linker (DL) intermediate of SGD-1006 (microtubule-disrupting agentMonomethyl auristatin E (MMAE)) via thioether bonds, forming an ADC. The ADC has an average molar drug to antibody ratio (DAR) of approximately four drug molecules per antibody, resulting in a heterogeneous mixture of active conjugated isoforms. (https://www.ema.europa.eu/en/documents/assessment-report/padcev-epar-public-assessment-report_en.pdf)
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |