Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 62 |
| INN | Epcoritamab |
| Status | Approved |
| Drug code(s) | GEN3013, DuoBody-CD-3x-CD20 |
| Brand name | EPKINLY, Tepkinly |
| mAb sequence source | mAb humanized |
| General Molecular Category | Bispecific |
| Format, general category | Full length Ab |
| Format details | Duobody |
| Isotype (Fc) | IgG1 |
| Light chain isotype | kappa/lambda |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | DuoBody platform |
| Target(s) | CD20, CD3 |
| Indications of clinical studies | Diffuse Large B-Cell Lymphoma, Follicular lymphoma, Non-Hodgkin's lymphoma, chronic Lymphocytic Leukemia, Hematologic cancers |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Approved EU, US, Japan, Canada, UK |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | October 15, 2017 |
| Start of Phase 2 | |
| Start of Phase 3 | January 13, 2021 |
| Date BLA/NDA submitted to FDA | September 21, 2022 |
| Year of first approval (global) | 2023 |
| Date of first US approval | May 21, 2023 |
| INN, US product name | Epcoritamab, epcoritamab-bysp |
| US or EU approved indications | US: Treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS), including DLBCL arising from indolent lymphoma, and high-grade B‑cell lymphoma, after two or more lines of systemic therapy. EU: monotherapy for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy. |
| Company | Genmab |
| Licensee/Partner | AbbVie |
| Comments about company or candidate | May 2023 - approval in US; Sep 2023 - Approval in EU Oct 28, 2022: Genmab has Submitted Biologics License Application (BLA) to U.S. Food and Drug Administration (FDA) for epcoritamab; European Medicines Agency (EMA) has validated Marketing Authorization Application (MAA) for epcoritamab submitted by AbbVie. The submissions are supported by the EPCORE™ NHL-1 open-label, multi-center phase 2 trial evaluating the safety and preliminary efficacy of epcoritamab in adult patients with relapsed, progressive or refractory CD20+ mature B-cell non-Hodgkin’s lymphoma March 2022: Genmab A/S announced that the U.S. Food and Drug Administration (FDA) has granted orphan-drug designation to the investigational medicine, epcoritamab (DuoBody®-CD3xCD20), for the treatment of follicular lymphoma (FL) Jan 2022: Phase 2 expansion cohorts ongoing in DLBCL and FL, with potential to support regulatory submission in 2H 2022 NCT04628494 Phase 3 study started in Jan 2021. NCT04663347 Phase 1/2 study in DLBCL started in Nov 2020. November 5, 2020 I Genmab A/S (Nasdaq: GMAB) announced today that it will initiate a Phase 3 study (GCT3013-05) of epcoritamab in diffuse large B-cell lymphoma (DLBCL). The study will evaluate the efficacy and safety of subcutaneous epcoritamab, a fully-human IgG1-bispecific antibody designed to recognize and bind to both CD3 and CD20, versus investigators’ choice of chemotherapy regimen (either bendamustine and rituximab or gemcitabine, oxaliplatin, and rituximab) in patients with relapsed or refractory DLBCL. NCT04623541 Phase 1/2 in CLL due to start in Nov 2020. NCT04542824 Phase 1/2 started in Aug 2020. June 2020: AbbVie and Genmab have partnered for joint development and commercialization of cancer therapies, which include three cancer-targeting antibody candidates such as epcoritamab, a potential treatment for diffuse large B-cell lymphoma. Genmab will be eligible to receive $750 million upfront and up to $3.15 billion in potential milestone payments, while the deal gives Abbvie access to antibodies that it can combine with its own antibody drug conjugates. NCT03625037 Phase 1/2 in B cell lymphoma started June 26, 2018 still recruiting as of Aug 2019. Genmab announced that they have filed an Investigational New Drug (IND) application with the US Food and Drug Administration (FDA) for DuoBody-CD3xCD20 for the treatment of hematologic cancer in the fourth quarter of 2017 |
| Full address of company | Copenhagen, Denmark Europe Denmark https://www.genmab.com/ |
DuoBody, L234F, L235E, D265A. immunoglobulin G1-lambda/kappa, anti-[Homo sapiens CD3E (CD3 epsilon)] and anti-[Homo sapiens MS4A1 (membrane-spanning 4-domains subfamily A member 1, CD20)], monoclonal antibody, bispecific
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |