Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 111 |
| INN | Blinatumomab |
| Status | Approved |
| Drug code(s) | MT103, MEDI-538, AMG 103 |
| Brand name | Blincyto |
| mAb sequence source | mAb murine |
| General Molecular Category | Bispecific |
| Format, general category | Fragment |
| Format details | scFv-scFv |
| Isotype (Fc) | None |
| Light chain isotype | TBD |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | Mouse origin |
| Target(s) | CD19, CD3 |
| Indications of clinical studies | B-precursor Acute Lymphoblastic Leukemia, non-Hodgkin lymphoma |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Approved EU, US, Japan, China, Australia |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | July 01, 2002 |
| Start of Phase 2 | January 15, 2008 |
| Start of Phase 3 | December 23, 2013 |
| Date BLA/NDA submitted to FDA | September 19, 2014 |
| Year of first approval (global) | 2014 |
| Date of first US approval | December 03, 2014 |
| INN, US product name | Blinatumomab |
| US or EU approved indications | Relapsed or refractory acute lymphocytic leukemia; Treatment of adults and children with B-cell precursor acute lymphoblastic leukemia (ALL) who are in remission but still have minimal residual disease (MRD). Monotherapy in pediatric patients age 1 and older with Philadelphia chromosome-negative CD19 positive B-cell precursor acute lymphoblastic leukemia that is refractory or in relapse following two or more prior therapies or prior allogeneic hematopoietic stem cell transplantation. Treatment of adult patients with Philadelphia chromosome negative (Ph-) CD19 positive B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1 percent (EU approval Jan 2019) |
| Company | Amgen |
| Licensee/Partner | None |
| Comments about company or candidate | March 2018: FDA grants accelerated approval of Blincyto (blinatumomab) to treat adults and children with B-cell precursor acute lymphoblastic leukemia (ALL) who are in remission but still have minimal residual disease (MRD). July 2017: FDA grants full approval for blincyto® (blinatumomab) to treat relapsed or refractory b-cell precursor acute lymphoblastic leukemia in adults and children. BLA submission announced Sep 22, 2014; May 22, 2015 PDUFA date if review period is 8 months. Partnership with Astellas for marketing in Japan; Phase 3 in ALL. Orphan and Breakthrough therapy designation in ALL. The main study MT103-211 supporting the BLA was a Phase 2, fixed-dose, open-label, single-arm trial that included a core study to assess the treatment efficacy and safety, and an additional evaluation cohort to evaluate central nervous system symptoms. Jan 2012: Amgen Inc will pay $1.16 billion to buy Micromet Inc in a deal that would give it access to a novel cancer treatment technology. October 17, 2002 press release: Micromet AG, Munich, Germany, reports preclinical data on its proprietary drug candidate MT103 , the furthest developed representative of the Company's novel class of antibody derivatives called BiTE (Bispecific T cell Engager). MT103 is currently in phase I studies in patients with B cell lymphoma, a very frequent blood-borne cancer. Phase 1 clinical trials of MT103 given repeatedly as short-term infusions: Study Numbers MT103 I/01-2001, MT103 I/01-2002, and MT103 I/01-2003. Based on the data from the previous phase 1 clinical trials using short-term infusion regimens, Micromet initiated a phase 1 dose finding clinical trial in April 2004 designed to evaluate the safety and tolerability of the continuous intravenous infusion of MT103 over 4-8 weeks at different dose levels in patients with relapsed or refractory NHL. The phase 1 clinical trial protocol is an open-label, multi-center, dose escalation study, which is being conducted by investigators in Germany. In June 2003, Micromet announced an agreement to jointly develop MT103 with MedImmune, Inc. IND 100135 was submitted 8/18/2006 by MedImmune, placed on hold 9/15/2006, discussed at a Type A meeting in 10/25/2006, and finally allowed to proceed in 2/15/2007. The sponsor for the IND changed to Micromet in 7/2009 and to Amgen Research in 3/2012. |
| Full address of company | Thousand Oaks, California, United States North America United States of America https://www.amgen.com/ |
Tandem scFv (BiTE)
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |