Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 1484 |
| INN | Obexelimab |
| Status | Clinical |
| Drug code(s) | ZB012, XMAB5871 |
| Brand name | None |
| mAb sequence source | mAb humanized |
| General Molecular Category | Naked monospecific |
| 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) | CD19 |
| Indications of clinical studies | Warm Autoimmune Hemolytic Anemia, IgG4-related disease, Systemic Lupus Erythematosus, rheumatoid arthritis |
| Primary therapeutic area | Immune-mediated / inflammatory disorders |
| Most advanced stage of development (global) | Phase 3 |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | July 15, 2011 |
| Start of Phase 2 | February 15, 2016 |
| Start of Phase 3 | September 15, 2022 |
| 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 | Xencor |
| Licensee/Partner | Bristol Myers Squibb, Zenas BioPharma Ltd, Amgen |
| Comments about company or candidate | Sept. 05, 2023 Zenas BioPharma announced that it has entered into a license and collaboration agreement with Bristol Myers Squibb Company to develop and commercialize obexelimab for autoimmune diseases in Japan, South Korea, Taiwan, Singapore, Hong Kong and Australia. NCT05786573 Phase 3 in Warm Autoimmune Hemolytic Anemia started in June 2023 recruiting as of last update in Sep 2024. NCT05662241 Phase 3 in IgG4 Related Disease started in Sep 2022 recruiting as of last update in Aug 2024. Nov 2022: Zenas BioPharma Secures $118 Million to Advance Its Broad Pipeline of Autoimmune Disease Therapeutics; Proceeds to fund global Phase 3 registration program for the company’s lead product candidate, Obexelimab, and support the clinical development of other pipeline programs In November 2021, Xencor entered into a second product license agreement with Zenas and granted Zenas the exclusive worldwide rights to develop and commercialize obexelimab, which uses the XmAb Immune Inhibitor Fc Domain and targets CD19 with its variable domains. May 2021: Still listed in Xencor pipeline, but no clinical studies are ongoing. (https://investors.xencor.com/static-files/243d3a74-a45c-4796-a9c8-a2d0b44b9181) Available for licensing as of Feb 2019. NCT02725476 Phase 2 study completed in Dec 2018 is identified as Phase 3 EudraCT2017-002214-31. NCT02725515 Phase 2 study in SLE completed in July 2018. Aug 2018: Company expects to initiate Phase 3 trial in the second half of 2018. Following a Type B End of Phase 2 meeting with the U.S. Food and Drug Administration (FDA), Xencor expects this randomized, placebo-controlled, double-blinded trial to evaluate the addition of XmAb5871 to standard-of-care in approximately 250 to 350 patients with IgG4-RD. June 2017: Xencor, Inc. (NASDAQ: XNCR), a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies for the treatment of autoimmune diseases, asthma and allergic diseases and cancer, today announced interim data from an ongoing, open-label, pilot Phase 2 study of XmAb®5871 in patients with active IgG4-Related Disease (IgG4-RD). Data show that 93% of patients achieved a response to therapy, 12 of them within two weeks of their first dose. May 2017: An orphan drug designation was granted by the FDA for Xencor's lead drug candidate, XmAB5871, as a treatment for patients with IgG4-related disease. March 7, 2016: Company announced dosing the first patient in a Phase 2 trial of XmAb®5871 in patients with IgG4-Related Disease (IgG4-RD). The Company also announced dosing the first patient in a Phase 2 trial of XmAb5871 in patients with Systemic Lupus Erythematosus (SLE). Phase 1/2 started in Feb 2013. In October 2014, Xencor announced that it has regained all development and commercial rights to XmAb5871 by seeking and obtaining a termination of the prior option and collaboration agreement and executing a new right-of-first-negotiation agreement with Amgen. Xencor approached Amgen to end the original collaboration to allow the Company the freedom to pursue alternative clinical and commercial paths. Amgen agreed, provided Xencor grant them a right of first negotiation for a license to XmAb5871. Xencor has been leading all clinical development of XmAb5871 to date. The new agreement announced requires Xencor to first discuss with Amgen any proposed license prior to seeking other partners. This right expires upon the earlier of the initiation of Phase III clinical testing of XmAb5871, a change of control of Xencor, or October 2019. |
| Full address of company | Pasadena, California, United States North America United States of America https://xencor.com/ |
Not identical to XMAB-5574; XmAb5871 is a humanized and Fc engineered monoclonal antibody that uses a uniquely selective dual-targeting mechanism for B cell inhibition by co-engaging CD19 and CD32b (via Fc). Obexelimab (XmAb5871) uses the XmAb Immune Inhibitor Fc Domain and targets CD19 with its variable domain. Obexelimab is designed to inhibit the function of B cells. https://www.sciencedirect.com/science/article/abs/pii/S2665991323001571 and also https://cdn.who.int/media/docs/default-source/international-nonproprietary-names-(inn)/pl119.pdf?sfvrsn=63c30f39_7&download=true
| Anticipated events | Expected data readout for INDIGO P3 study in Oct 2025 |
| Factor(s) contributing to discontinuation | None |