Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 978 |
| INN | Zenocutuzumab |
| Status | Approved |
| Drug code(s) | MCLA-128 |
| Brand name | BIZENGRI® |
| mAb sequence source | mAb humanized |
| General Molecular Category | Bispecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG1 |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | None |
| Target(s) | HER2, HER3 |
| Indications of clinical studies | Breast cancer, pancreatic cancer, solid tumors |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Approved US |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | January 15, 2015 |
| Start of Phase 2 | January 15, 2018 |
| Start of Phase 3 | |
| Date BLA/NDA submitted to FDA | |
| Year of first approval (global) | 2024 |
| Date of first US approval | December 04, 2024 |
| INN, US product name | Zenocutuzumab, zenocutuzumab-zbco |
| US or EU approved indications | Treatment of adults with pancreatic adenocarcinoma or non–small cell lung cancer (NSCLC) that are advanced unresectable or metastatic and harbor a neuregulin 1 (NRG1) gene fusion who have disease progression on or after prior systemic therapy |
| Company | Merus B.V. |
| Licensee/Partner | Partner Therapeutics, Inc. |
| Comments about company or candidate | Dec 2, 2024: Merus N.V., a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics® and Triclonics®) and Partner Therapeutics, Inc., a private, fully-integrated biotechnology company with a focus in hematology and oncology, announced they have entered into an agreement in which Merus has exclusively licensed to PTx the right to commercialize zenocutuzumab for the treatment of NRG1 fusion-positive (NRG1+) cancer in the United States. Nov 5, 2024: Merus N.V. announced that the United States Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) goal date for zenocutuzumab Biologics License Application (BLA) currently under priority review. The US FDA has extended the PDUFA goal date to February 4, 2025 to enable sufficient time to review information recently submitted by the Company in response to a CMC information request. May 06, 2024: Merus N.V. announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review a Biologics License Application (BLA) for the bispecific antibody zenocutuzumab (Zeno) in patients with neuregulin 1 fusion (NRG1+) non-small cell lung (NSCLC) and NRG1+ pancreatic (PDAC) cancer. https://ir.merus.nl/news-releases/news-release-details/merus-announces-us-fda-acceptance-and-priority-review-biologics Oct 2023: After discussions with regulators, Merus is planning to seek approval for Zeno in the first half of 2024. The therapy was granted a breakthrough tag from the FDA this summer. Sufficient clinical data expected in 1H24 to support potential BLA submissions. June 29, 2023 Merus N.V. announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for zenocutuzumab (Zeno) for the treatment of patients with advanced unresectable or metastatic NRG1 fusion (NRG1+) pancreatic cancer following progression with prior systemic therapy or who have no satisfactory alternative treatment options. This designation for Zeno follows a Fast Track Designation for the treatment of patients with metastatic solid tumors harboring NRG1 gene fusions (NRG1+ cancer) that have progressed on standard of care therapy on January 7, 2021 and Orphan Drug Designation for the treatment of patients with pancreatic cancer on July 27, 2020. NCT05588609 Phase 2 study in NSCLC or prostate cancer started in Nov 2022 recruiting as of last update in Dec 2022. Jan 2021: Merus N.V., a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics® and Triclonics™) for cancer, announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to Zenocutuzumab (Zeno) for the treatment of patients with metastatic solid tumors harboring NRG1 gene fusions (NRG1+ cancers) that have progressed on standard of care therapy. July 2020: Merus N.V, announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to Zenocutuzumab (Zeno) for the treatment of patients with pancreatic cancer. NCT04100694 early access study in solid tumors posted as 'available' as of Sep 24, 2019; no phase given. Phase 2 metastatic breast cancer cohort update planned for 4Q 2019; Phase 1/2 single agent trial amended to focus on solid tumors harboring Neuregulin 1 (NRG1) gene fusions. 2018-01-26: Merus N.V., a clinical-stage immuno-oncology company developing innovative bispecific antibody therapeutics (Biclonics®), today announced that the first patient has been dosed in a Phase 2, open-label, multi-center international clinical trial to evaluate MCLA-128 in two metastatic breast cancer (MBC) populations including HER2-positive MBC patients and hormone receptor positive/HER2-low MBC patients. NCT03321981 Phase 2 study still recruiting as of Aug 2018. Phase 1/2 started in Europe; NCT02912949 Phase 1/2 study still recruiting as of Oct 2017 |
| Full address of company | CT Utrecht, The Netherlands Europe Netherlands https://merus.nl/about/contact/ |
cLC-hetero-H-chain IgG; ADCC-enhanced, full-length IgG bispecific antibody that simultaneously targets the growth factor receptors HER2 and HER3 (i.e., targets dimer). Humanized as per De Nardis et al, JBC 2017, 292:14706-17. Defucosylated using GlymaxX technology
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |