Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 2564 |
| INN | Otelixizumab |
| Status | Terminated |
| Drug code(s) | TRX-4, CHAGLYCD3, GSK2136525, CAMPATH-3 |
| 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 | lambda |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | Rat B cell derived |
| Target(s) | CD3 |
| Indications of clinical studies | Type 1 diabetes, psoriasis, Rheumatoid arthritis, transplant rejection |
| Primary therapeutic area | Immune-mediated / inflammatory disorders |
| Most advanced stage of development (global) | Terminated at Phase 3 |
| Status | Inactive |
| Start of clinical phase (IND filing or first Phase 1) | May 15, 1997 |
| Start of Phase 2 | October 15, 2003 |
| Start of Phase 3 | July 15, 2008 |
| 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 | Tolerx |
| Licensee/Partner | Boston Scientific, GlaxoSmithKline, Amgen, Diabetagen |
| Comments about company or candidate | Aug. 19, 2010: Boston Scientific Corporation announced the completion of its acquisition of BTG plc. pursuant to the previously announced scheme of arrangement. GSK appears to control development of this asset, but it is not listed in GSK pipeline dated July 2019 or March 2018; NCT02000817 Phase 1/2 study in diabetes started recruiting as of May 16, 2014 completed in Sep 2018. Phase 2 NCT01222078 study terminated because a Phase 3 study recently reported and demonstrated that the dose of otelixizumab in OTX113390 is not effective. Clinical study in Graves' ophthalmopathy terminated until there is a better understanding of an efficacious dose with Otelixizumab from other clinical studies. In September 2001, BTG granted Tolerx worldwide rights to develop and commercialise TRX4. In April 2005, TolerRx announced that it acquired assets for TRX4. In October 2007, GlaxoSmithKline and Tolerx announced the execution of a worldwide alliance to develop and commercialize otelixizumab. |
| Full address of company | Cambridge, MA North America United States of America https://www.linkedin.com/company/tolerx-inc./ |
Aglycosylated through ASN297ALA mutation; reduced effector function
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |