Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 1428 |
| INN | Zilovertamab vedotin |
| Status | Clinical |
| Drug code(s) | VLS-101, MK-2140 |
| 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 (Maleimidocaproyl-valine-citrulline-para-aminobenzoate; Cleavable linker) |
| Ave. DAR | 4 |
| Conjugated/fused moiety | Tubulin inhibitor, Monomethyl auristatin E (MMAE) |
| Discovery method/technology | None |
| Target(s) | ROR1 |
| Indications of clinical studies | Diffuse Large B-Cell Lymphoma, Solid tumors, Hematological malignancies |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Phase 2/3 |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | February 01, 2019 |
| Start of Phase 2 | October 19, 2020 |
| Start of Phase 3 | |
| 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 | Merck Sharp & Dohme LLC |
| Licensee/Partner | None |
| Comments about company or candidate | NCT06717347 Phase 3 in DLBCL due to start in Dec 2024. NCT06395103 Phase 2 started in Aug 2024. NCT05139017 Phase 2/3 in Diffuse Large B-Cell Lymphoma started in Jan 2022 recruiting as of last update in May 2023. Merck Sharp & Dohme LLC acquired VelosBio Inc. Oct 19, 2020: Biopharmaceutical company VelosBio has dosed the first patient in a Phase II trial of investigational drug VLS-101 in patients with solid tumours. Aug 31, 2020: The FDA has granted a Fast Track and Orphan Drug designation to VLS-101, a novel first-in-class antibody-drug conjugate targeting receptor tyrosine kinase-like orphan receptor 1 (ROR1), for the treatment of patients with mantle cell lymphoma NCT04504916 Phase 2 not yet recruiting when first posted on Aug 7 2020. NCT03833180 Phase 1 for Hematological Malignancies started in Feb 2019; results https://ash.confex.com/ash/2020/webprogram/Paper136373.html |
| Full address of company | Rahway, NJ 07065 USA North America United States of America https://www.merck.com/contact-us/ |
The anti-ROR1 antibody, UC-961, is ahumanized IgG1 monoclonal antibody (mAb) that binds with high affinity to a specific extracellular epitope of human ROR1 receptor and can block Wnt5a-induced ROR1 signaling. Nonclinical studies document that UC-961 does not react with normal adult human tissues and selectively binds to tumor cells. Because of the antibody high specificity, rapid internalization, and trafficking to lysosomes, UC-961 appears ideally suited to serve as the targeting moiety for an anti-ROR1 ADC. Accordingly, we have developed VLS-101, a UC-961-linker-monomethyl auristatin E (MMAE) ADC that preserves the high-affinity binding and specificity of UC-961 and allows for ROR1-targeted intracellular release of MMAE.
| Anticipated events | Phase 3 pending |
| Factor(s) contributing to discontinuation | None |