Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 60 |
| INN | Itolizumab |
| Status | Approved |
| Drug code(s) | EQ001, H-T1, T1-h |
| Brand name | Alzumab |
| 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) | CD6 |
| Indications of clinical studies | Graft v host disease, Lupus nephritis, Plaque psoriasis, rheumatoid arthritis |
| Primary therapeutic area | Immune-mediated / inflammatory disorders |
| Most advanced stage of development (global) | Approved India |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | July 02, 2006 |
| Start of Phase 2 | |
| Start of Phase 3 | |
| Date BLA/NDA submitted to FDA | |
| Year of first approval (global) | 2013 |
| Date of first US approval | |
| INN, US product name | Itolizumab |
| US or EU approved indications | None |
| Company | Biocon |
| Licensee/Partner | Equillium |
| Comments about company or candidate | Dec 2019: FDA granted Fast Track designation for lupus nephritis. Oct 2019: Equillium announced it has initiated the EQUALISE Phase Ib clinical trial of itolizumab (EQ001) in patients with lupus nephritis and provided an update on its ongoing clinical programs. February 26, 2019: Equillium, Inc. today announced that it plans to develop EQ001 for the treatment of lupus nephritis (LN). Equillium remains on track to initiate the EQUATE Phase 1b/2 trial in acute graft-versus-host disease (aGVHD) in the first quarter of 2019 and initiate a proof-of-concept trial in severe asthma in the second quarter of 2019. Feb 2019: Equillium, Inc. announced that the U.S. FDA has granted Orphan Drug designations for EQ001 for both the prevention and treatment of acute graft-versus-host disease (aGVHD). Dec 2018: Equillium, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for EQ001 for the treatment of acute graft-versus-host disease (aGVHD). The Company is planning to initiate a Phase 1b/2 clinical trial in early 2019, called the EQUATE trial, which will evaluate EQ001 for the treatment of patients presenting with aGVHD. Sep 2018: Equillium plans to initially develop EQ001 for the treatment of acute graft-versus-host disease (aGVHD), chronic graft-versus-host disease (cGVHD), severe asthma and at least one additional indication. The Company expects to initiate a Phase Ib/II clinical trial of EQ001 in patients with aGVHD in early 2019 and a Phase II clinical trial of EQ001 in patients with cGVHD in the first half of 2019. They also plan to initiate a proof-of-concept clinical trial in severe asthma in the first half of 2019. Equillium continues to evaluate additional indications for future development and plan to select a fourth indication in the first half of 2019. May 2017: Equillium acquired U.S. and Canadian rights to itolizumab pursuant to a collaboration and license agreement with Biocon (subsequently assigned to Biocon Limited, or together, Biocon). Alzumab(TM) expected to be launched in the Indian market in Q2 FY14. Biocon, Asia's premier biotechnology Company today, announced positive results from its Double Blind, Placebo Controlled, Phase 3, TREAT-PLAQ Study with Itolizumab in chronic plaque psoriasis. Itolizumab, the first humanized anti CD-6 monoclonal antibody, successfully met the pre-specified primary endpoint of significant improvement in PASI-75 (Psoriasis Area and Severity Index) score after 12 weeks of treatment in patients with moderate to severe psoriasis compared to placebo. It also met multiple secondary endpoints after 12 and 28 weeks of treatment. Approved in India in January 2013. |
| Full address of company | 20th KM, Hosur Road, Electronic City, Bengaluru 560100, Karnataka, India Asia India https://www.biocon.com/more/contact-us/ |
None
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |