Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 2136 |
| INN | Lumiliximab, gomiliximab |
| Status | Terminated |
| Drug code(s) | IDEC-152 |
| Brand name | None |
| mAb sequence source | mAb primatized |
| 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 | Cyno monkey B cell derived |
| Target(s) | CD23 |
| Indications of clinical studies | Asthma, chronic lymphocytic leukemia |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Terminated at Phase 2/3 |
| Status | Inactive |
| Start of clinical phase (IND filing or first Phase 1) | February 15, 2000 |
| Start of Phase 2 | March 01, 2004 |
| Start of Phase 3 | November 15, 2006 |
| 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 | Biogen |
| Licensee/Partner | Seikagaku Corporation |
| Comments about company or candidate | IDEC acquired by Biogen IDEC had exclusive commercial rights of IDEC-152 in North America, Central America and South America. Seikagaku Corporation had licensed its commercial rights in Europe and Asia. IND for IDEC-152 filed in October 1999 and a Phase I clinical trial in allergic asthma began in February 2000 to evaluate its safety, tolerability and pharmacokinetics. Phase 2/3 LUCID study in CLL started in Nov 2006; first patient was dosed Jan 22, 2007. An interim analysis failed to show sufficient efficacy of the combination of lumiliximab with FCR. The study was therefore stopped early for lack of efficacy. Br J Haematol. 2014 Nov;167(4):466-77. doi: 10.1111/bjh.13061. Lumiliximab was granted Fast Track and Orphan Drug designations by the U.S. Food and Drug Administration (FDA) for CLL. |
| Full address of company | Cambridge, MA 02142, United States North America United States of America https://www.biogen.com/company/contact-us.html |
Human Fc. Lumiliximab, a macaque-human primatized monoclonal antibody, targets the CD23 antigen, which has limited expression on activated B cells.
| Anticipated events | None |
| Factor(s) contributing to discontinuation | Lack of efficacy |