Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 837 |
| INN | Ozekibart |
| Status | Clinical |
| Drug code(s) | JCT205, INBRX-109 |
| Brand name | None |
| mAb sequence source | mAb humanized |
| General Molecular Category | Naked monospecific |
| Format, general category | Fragment-Fc |
| Format details | (VHH-VHH)2-Fc |
| Isotype (Fc) | IgG1 |
| Light chain isotype | None |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | Camelid-derived |
| Target(s) | DR5 |
| Indications of clinical studies | Chondrosarcoma, Solid Tumors Including Sarcomas |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Phase 2 pivotal |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | October 05, 2018 |
| Start of Phase 2 | June 15, 2021 |
| 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 | Inhibrx Biosciences Inc. |
| Licensee/Partner | Transcenta Holding Limited |
| Comments about company or candidate | Jan 2024: all non-101 assets and liabilities, including INBRX-105, INBRX-106, INBRX-109, Inhibrx's non-101 discovery pipeline and its corporate infrastructure, will be spun out from the Company into a new publicly traded company, Inhibrx Biosciences, Inc. Pivotal phase 2 study for Conventional Chondrosarcoma (NCT04950075) is recruiting as of May 15, 2023 Aug. 15, 2022: Inhibrx, Inc. announced that the European Commission, based on a positive opinion issued by the European Medicines Agency, has granted orphan medicinal product designation to INBRX-109 for the treatment of chondrosarcoma. NCT04950075 study still recruiting patients as of last update in July 2022. June 21, 2021 I Inhibrx, Inc.announced initiation of a potential registration-enabling Phase 2 study (NCT04950075) of INBRX-109 in conventional chondrosarcoma. In January 2021, the U.S. Food and Drug Administration (FDA) granted Fast Track designation to INBRX-109 for the treatment of patients with unresectable or metastatic conventional chondrosarcoma. NCT03715933 Phase 1 started in Oct 2018 recruiting as of last record update in July 2019. Human Phase 1 trial of INBRX-109 in US demonstrate a favorable safety profile, with no meaningful liver enzyme elevations observed. Single agent expansion cohorts are now enrolling in colorectal and gastric adenocarcinomas as well as mesothelioma. It has also been cleared by NMPA for clinical testing in China. |
| Full address of company | La Jolla, CA 92037 North America United States of America https://inhibrx.com/ |
JCT205 (INBRX-109) is a humanized IgG1 antibody binding to DR5, a death domain-containing transmembrane protein. It is originally designed by INHIBRX to maximize therapeutic index of DR5 activation. Through a tetravalent format, JCT205 clusters four receptors, and in preclinical studies led to tumor, but not liver, cell death. Four sdAb (heavy chain only antibodies) fused to Fc. IgG1 (no light chain) with the following mutations: E233del, L234del, L235del (Reduced CDC and ADCC). Immunoglobulin, anti-(human death receptor 5) (human-Lama glama clone IF5 single-domain VHH fragment) fusion protein with peptide linker (GGS)2 fusion protein with immunoglobulin anti-(human death receptor 5) (human-Lama glama clone IF5 single-domain VHH fragment) fusion protein with peptide linker (GGGG) fusion protein with immunoglobulin G1 [de-269-glutamic acid,de-270-leucine,de-271- leucine] (human γ1-chain C region C-terminal fragment), dimer
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |