Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 50 |
| INN | Inotuzumab ozogamicin |
| Status | Approved |
| Drug code(s) | CMC544, G5/44-calicheamicin |
| Brand name | Besponsa |
| mAb sequence source | mAb humanized |
| General Molecular Category | ADC |
| Format, general category | Full length Ab conjugate |
| Format details | None |
| Isotype (Fc) | IgG4 |
| Light chain isotype | kappa |
| Linker | AcBut acyl hydrazone-disulfide, Cleavable linker |
| Ave. DAR | 2 to 3 drugs per mAb |
| Conjugated/fused moiety | DNA binding, Calicheamicin |
| Discovery method/technology | None |
| Target(s) | CD22 |
| Indications of clinical studies | non-Hodgkin Lymphoma, Acute Lymphoblastic Leukemia, Diffuse Large B-Cell Lymphoma |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Approved EU, US, Japan, Australia |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | July 15, 2003 |
| Start of Phase 2 | |
| Start of Phase 3 | November 15, 2007 |
| Date BLA/NDA submitted to FDA | December 20, 2016 |
| Year of first approval (global) | 2017 |
| Date of first US approval | August 17, 2017 |
| INN, US product name | Inotuzumab ozogamicin |
| US or EU approved indications | Acute lymphoblastic leukemia |
| Company | Pfizer |
| Licensee/Partner | None |
| Comments about company or candidate | Approved in the EU June 29, 2017; approved in US on Aug 17, 2017 Orphan designation in EU. Breakthrough Therapy designation for ALL; as of April 2015, the mAb met the first goal of a Phase III trial by increasing the chances of complete remission among adult acute lymphoblastic leukemia patients. As of May 2013, Pfizer has discontinued Phase 3 randomized study of inotuzumab ozogamicin in relapsed or refractory aggressive non-hodgkin lymphoma (NHL) due to futility. The company will continue evaluating the compound in other hematologic malignancies such as adult acute lymphoblastic leukemia (ALL) |
| Full address of company | 66 Hudson Boulevard East, New York, NY 10001-2192 USA North America United States of America https://www.pfizer.com/contact |
S228P hinge mutation. acid-labile 4-(4′-acetylphenoxy) butanoic acid (acetyl butyrate) linker
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |