Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 152 |
| INN | Ublituximab |
| Status | Approved |
| Drug code(s) | TG-1101, TGTX-1101, LFB-R603, EMAB-6 |
| Brand name | BRIUMVI |
| mAb sequence source | mAb chimeric |
| 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) | CD20 |
| Indications of clinical studies | Multiple sclerosis, non-Hodgkins Lymphoma, Chronic Lymphocytic Leukemia, neuromyelitis optica and neuromyelitis optica spectrum disorder |
| Primary therapeutic area | Immune-mediated / inflammatory disorders |
| Most advanced stage of development (global) | Approved EU, US |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | October 15, 2008 |
| Start of Phase 2 | |
| Start of Phase 3 | January 15, 2015 |
| Date BLA/NDA submitted to FDA | November 01, 2020 |
| Year of first approval (global) | 2022 |
| Date of first US approval | December 28, 2022 |
| INN, US product name | Ublituximab, ublituximab-xiiy |
| US or EU approved indications | European Commission granted approval of BRIUMVI® (ublituximab-xiiy) for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features. FDA approval: Treatment of relapsing forms of multiple sclerosis (RMS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. |
| Company | LFB |
| Licensee/Partner | TG Therapeutics, Ildong Pharmaceutical |
| Comments about company or candidate | On 30 March 2023, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Briumvi, intended for the treatment of multiple sclerosis. The applicant for this medicinal product is Propharma Group The Netherlands B.V. PDUFA date September 28, 2022 for MS indication; April 15, 2022 - TG Therapeutics, Inc. announced that the Company has voluntarily withdrawn the pending Biologics License Application (BLA)/supplemental New Drug Application (sNDA) for the combination of ublituximab and UKONIQ® (umbralisib) (combination referred to as U2) for the treatment of adult patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). The decision to withdraw was based on recently updated overall survival (OS) data from the UNITY-CLL Phase 3 trial that showed an increasing imbalance in OS. BLA completed on Sep 28, 2021. Dec 1, 2020: TG Therapeutics, Inc. announced that the Company has initiated a rolling submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) requesting approval of ublituximab, the Company’s investigational glycoengineered anti-CD20 monoclonal antibody, in combination with umbralisib, the Company’s investigational once-daily, oral, dual inhibitor of PI3K-delta and CK1-epsilon, as a treatment for patients with chronic lymphocytic leukemia (CLL). The U.S. FDA previously granted Fast Track Designation to the combination of ublituximab and umbralisib (U2) for the treatment of adult patients with CLL and Orphan Drug Designation (ODD) covering ublituximab in combination with umbralisib for the treatment of CLL. The Company expects to complete the BLA rolling submission in the first half of 2021. Oct. 24, 2019: TG Therapeutics, Inc. announced that final long-term results from the Phase 3 GENUINE study demonstrated that ublituximab in combination with ibrutinib improved progression-free survival (PFS), as determined by Independent Review Committee July 2019: These long-term safety data, and the Phase 2 efficacy data support the ongoing, fully enrolled, international Phase 3 program evaluating ublituximab (administered in a rapid one-hour infusion) for the treatment of RMS. The Phase 3 trials, entitled ULTIMATE I and ULTIMATE II, are being conducted under Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA) and are being led by Lawrence Steinman, MD, of Stanford University. The data presented at the 5thCongress of the European Academy of Neurology (EAN), in Oslo, Norway and at the American Academy of Neurology 71st Annual Meeting. are available on the Publications page, located within the Pipeline section, of the Company’s website at www.tgtherapeutics.com/publications.cfm. NCT03277261 Phase 3 study in MS active not recruiting as of Jan 2019. September 25, 2018: TG Therapeutics today announced that the independent Data Safety Monitoring Board (DSMB) for the UNITY-CLL Phase 3 trial met to review ongoing data from the study and advised the Company that the interim analysis of Overall Response Rate (ORR) could not be conducted at this time as the data were not sufficiently mature to conduct the analysis. The DSMB did not provide any further guidance but plans to meet quarterly over the next year to continue to monitor the ongoing progress of the trial. Given the uncertainty surrounding the timing and the outcome of the ORR analysis, as well as the significant regulatory hurdles associated with accelerated approval for CLL, the Company is now guiding that it will focus on the primary endpoint of Progression Free Survival (PFS) to support full approval of the ublituximab plus umbralisib (U2) combination. At this time the Company is not planning to seek accelerated approval based on ORR. Two Phase 3 studies in MS (NCT03277261, NCT03277248) recruiting as of Sep 2018. Sep 15, 2017: Enrollment open for Phase 3 MS study. Aug. 01, 2017: TG Therapeutics, Inc. announced today that it has reached an agreement with the U.S. Food and Drug Administration (FDA) regarding a Special Protocol Assessment (SPA) on the design of two Phase 3 clinical trials for TG-1101 (ublituximab), the Company's glycoengineered anti-CD20 monoclonal antibody, for the treatment of relapsing forms of Multiple Sclerosis (RMS). The SPA provides agreement that the two Phase 3 trial designs adequately address objectives that, if met, would support the regulatory submission for approval of TG-1101May 23, 2017: TG Therapeutics, Inc. today announced that the independent Data Safety Monitoring Board (DSMB) of the UNITY-CLL Phase 3 trial has successfully completed a pre-specified interim analysis to assess the contribution of TG-1101 (ublituximab) and TGR-1202 in the combination regimen of TG-1101 plus TGR-1202.May 2017 press release: Phase 3 study in MS planned; received orphan drug designation for the combination of TG-1101 and TGR-1202 for the treatment of CLL and DLBCL. March 2017: TG Therapeutics reports that its blood cancer candidate TG-1101, or ublituximab, met a Phase III study's primary endpoint of achieving a higher overall response rate when combined with AbbVie's Imbruvica or ibrutinib as a treatment for patients with high-risk chronic lymphocytic leukemia. The overall response rate for the combo treatment was 80% in comparison to 47% when patients were treated solely with ibrutinibUS orphan designation for chronic lymphocytic leukemia and diffuse B-cell lymphoma (combination with small molecule TG-1202), neuromyelitis optica and neuromyelitis optica spectrum disorder. Phase 3 study started in Jan 2015; sponsor plans to file for accelerated approval based on overall response rate. As of Sep 2014, TG Therapeutics and the FDA agreed on terms of a special protocol assessment for a late-stage trial that will assess the combination of ublituximab, or TG-1101, and Imbruvica, or ibrutinib, in patients who have chronic lymphocytic leukemia.Two Phase 1/2 studies recruiting patients as of August 2013; combination studies started in Nov 2013. US and EU orphan for CLL |
| Full address of company | Les Ulis (France) Europe France https://www.groupe-lfb.com/en/the-group/governance/lfb-biotechnologies/#:~:text=LFB%20BIOTECHNOLOGIES%2C%20a%20wholly%2Downed,handling%20the%20Group's%20biotechnology%20business. |
Combination of TG-1101 and TGR-1202 referred to as TG-1303. Low fucose; produced in YB2/0 cells
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |