Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 2208 |
| INN | Inolimomab |
| Status | Terminated |
| Drug code(s) | Leukotac |
| Brand name | None |
| mAb sequence source | mAb murine |
| 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 | Mouse origin |
| Target(s) | CD25 |
| Indications of clinical studies | Graft-versus-host disease |
| 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) | January 01, 2004 |
| Start of Phase 2 | December 15, 2006 |
| Start of Phase 3 | May 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 | Biotest AG |
| Licensee/Partner | ELSALYS BIOTECH |
| Comments about company or candidate | 2023: BLA status unknown, no recent developments have been reported July 23, 2020: ElsaLys Biotech announced the U.S. Food and Drug Administration agreement to start the LEUKOTAC (inolimomab) submission process for a Biologics License Application (BLA) for the treatment of Steroid-Refractory acute graft-versus-host disease (aGvHD), grade II-IV adult patients. The Biologics License Application (BLA) will be reviewed under the FDA’s Real-Time Oncology Review pilot program (RTOR program). Inolimomab has shown a robust and long-lasting response Rate in steroid-refractory acute graft versus host disease (SR-aGvHD) in a randomized multicentre controlled parallel-group Phase III study (INO-107 - EUDRACT 2007-005009-24). In addition, Inolimomab demonstrated a clear advantage in long-term survival compared to control group treated with ATG (Anti-Thymo Globulin). Since December 24, 2019, the French National Agency for the Medicines and Health Products Safety (ANSM) granted a cohort ATU for inolimomab in France in this indication (also including pediatric patients). In June 2020, FDA accepted the application for Leukotac under the RTOR pilot program. The next step in the BLA Submission process to the FDA will be the Chemistry, Manufacturing and Controls (CMC) pre-BLA meeting in September 2020. ElsaLys Biotech is owned by Mediolanum Farmaceutici Spa as of May 2020. NCT04289103 Phase 3 study in Steroid Refractory GVHD not yet recruiting when first posted on March 3, 2020. January 23, 2019: ELSALYS BIOTECH presents the results from long-term follow-up of INO-107 Phase III study patients up to 8.5 years. These results have been published in a Letter to Blood signed by the investigators demonstrating clinical benefit of inolimomab (LEUKOTAC®) in acute steroid-resistant graft versus host disease (SR-aGvHD). March 2018: ELSALYS BIOTECH announced that by the end of 2018, the Company will submit a request for a cohort Temporary Use Authorisation (TUA) to the National Agency for Drug Safety (ANSM). ELSALYS BIOTECH aims to obtain a conditional market authorisation (AMMc) for LEUKOTAC® in 2020 for Europe and marketing approval in the United States in 2021. Oct 2017: ELSALYS BIOTECH has acquired from JAZZ PHARMACEUTICALS the development and commercialization rights of LEUKOTAC® (inolimomab). ELSALYS BIOTECH is currently preparing requests for compassionate use authorization of the drug for patients with severe steroid-resistant aGvHD with the different national health authorities (Named Patient Basis or cohort Temporary Authorization for Use[2] evaluated in France by the ANSM, the National Agency for Medicines and health products Safety). Discussions with the US Food and Drug Administration (FDA) are expected to start as early as 2018. As published in 2016, the primary endpoint of randomized phase III trial was not achieved. The lack of a statistically significant effect confirms the need for development of more effective treatments for acute GvHD; This trial is registered to https://www.clinicaltrialsregister.eu/ctr-search/search as EUDRACT 2007-005009-24. Blood 2016 :blood-2016-09-738625; doi: https://doi.org/10.1182/blood-2016-09-738625. Not listed in Jazz Pharma pipeline as of Feb 2016. Phase 3 study (EudraCT Number: 2007-005009-24) ongoing in France, completed in Belgium; preliminary data expected in mid-2015. LEUKOTAC® has received an orphan designation in Europe and the United States. Date of first phase 1 estimated. |
| Full address of company | Landsteinerstraße 5, 63303 Dreieich Europe Germany https://www.biotest.com/de/en/contact.cfm |
None
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |