TGTX: 6 Funds Holding, Catalyst in 17d

TGTX: 6 Funds Holding, Catalyst in 17d | BiotechEdge

BiotechnologyCEO: Michael S. WeissIPO: 2010Website ↗

Based in New York City and established in 1993, TG Therapeutics, Inc. is a biopharmaceutical company that has advanced to the commercial stage. Its core mission revolves around the acquisition, advancement, and marketing of novel therapeutic solutions. The company's focus areas specifically include B-cell related cancers (malignancies) and various autoimmune disorders. Among its significant investigational therapeutic candidates is Ublituximab, a distinctive glycoengineered monoclonal antibody currently undergoing evaluation. It targets B-cell non-Hodgkin lymphoma, chronic lymphocytic leukemia (CLL), and the relapsing forms of multiple sclerosis. Another compound in its pipeline is Umbralisib, an orally administered inhibitor designed to block PI3K-delta and CK1-epsilon enzymes. This treatment is being investigated for its effectiveness against CLL, marginal zone lymphoma, and follicular lymphoma. TG Therapeutics is also developing Cosibelimab, an IgG1 human monoclonal antibody that functions by binding to programmed death-ligand 1 (PD-L1) and subsequently preventing its interaction with PD-1 and B7.1 receptors. Furthermore, the company is advancing TG-1701, an oral, covalently-bound Bruton's tyrosine kinase (BTK) inhibitor, notably more selective for BTK compared to ibrutinib in laboratory screenings. Completing this clinical-stage portfolio is TG-1801, a bispecific antibody engineered to simultaneously target CD47 and CD19. Beyond its clinical-stage assets, the company possesses various licensed preclinical programs, including those addressing BET, interleukin-1 receptor associated kinase-4, and GITR. To enhance its research and development capabilities, TG Therapeutics has forged collaboration agreements with entities such as Checkpoint Therapeutics, Inc., Jiangsu Hengrui Medicine Co., Novimmune SA, Ligand Pharmaceuticals Incorporated, and Jubilant Biosys. The company also maintains strategic alliances with partners including LFB Biotechnologies S.A.S, GTC Biotherapeutics, LFB/GTC LLC, Ildong Pharmaceutical Co. Ltd., and Rhizen Pharmaceuticals, S A.

Catalysts

Phase 2Q2 2015UblituximabNon-Hodgkins Lymphoma, B-cell Lymphoma, Waldenstrom's MacroglobulinemiaNCT01647971

Primary: Number of Participants with Adverse Events as a Measure of Safety and Tolerability (Subjects will be followed for 4 weeks)Enrollment:39/39Sites: 8NA, TREATMENT

Phase 2Q4 2015UblituximabChronic Lymphocytic Leukemia, Mantle Cell LymphomaNCT02013128

Primary: To evaluate the safety of ublituximab in combination with ibrutinib in patients with select B-cell malignancies (28 days (1 cycle of therapy))Enrollment:66/66Sites: 18NA, TREATMENT

Phase 2PositiveQ3 2017UblituximabMultiple SclerosisNCT02738775

Primary: Responder Rate of B-Cell Depletion at Week 4 (Week 4)Enrollment:49/49Sites: 12RANDOMIZED, DOUBLE, TREATMENT

Phase 3Q2 2020UblituximabChronic Lymphocytic LeukemiaNCT02301156

Primary: Overall Response Rate (ORR) (Up to 62 months)Enrollment:126/126Sites: 88RANDOMIZED, TREATMENT

Phase 3PositiveQ3 2020UblituximabRelapsing Multiple Sclerosis (RMS)NCT03277261

Primary: Annualized Relapse Rate (ARR) (Up to 96 weeks)Enrollment:549/549Sites: 14RANDOMIZED, QUADRUPLE, TREATMENT

Phase 3PositiveQ3 2020UblituximabRelapsing Multiple Sclerosis (RMS)NCT03277248

Primary: Annualized Relapse Rate (ARR) (Up to 96 weeks)Enrollment:545/545Sites: 13RANDOMIZED, QUADRUPLE, TREATMENT

Phase 2NegativeQ2 2021UmbralisibChronic Lymphocytic LeukemiaNCT02742090

Primary: Progression-free Survival (From Day 1 to the earlier of the first documentation of definitive disease progression or death (Up to 61.7 months))Enrollment:51/51Sites: 15NA, TREATMENT

Phase 2PositiveQ1 2022UmbralisibMarginal Zone Lymphoma, Waldenstrom Macroglobulinemia, Non Follicular Indolent Non-Hodgkin LymphomaNCT03364231

Primary: Overall Response Rate (ORR) as Assessed by Revised Response Criteria for Non- Hodgkin's Lymphoma (Lugano Classification) and Consensus-Based 6th International Workshop on Waldenstrom's Macroglobulinemia (IWWM) (Every 3 cycles (1 Cycle = 28 days) from Day 1 Cycle 1 up to approximately 4.2 years)Enrollment:21/21Sites: 4NON_RANDOMIZED, TREATMENT

Phase 2NegativeQ2 2022UblituximabFollicular Lymphoma, Small Lymphocytic LymphomaNCT03828448

Primary: Overall Response Rate (ORR) (Up to 22 months)Enrollment:34/34Sites: 3NA, TREATMENT

Phase 2NegativeQ2 2022UblituximabChronic Lymphocytic LeukemiaNCT04016805

Primary: Rate of Undetected Minimal Residual Disease (U-MRD) (Up to approximately 23 months)Enrollment:41/41Sites: 3NON_RANDOMIZED, TREATMENT

Phase 2NegativeQ2 2022TGR-1202Chronic Lymphocytic Leukemia, Non Hodgkin LymphomaNCT03207256

Primary: Adverse Events of TGR-1202 and/or TGR-1202 + ublituximab treatment, including delayed toxicities (Evaluated at each planned visit through study completion, an average of 2 years)Enrollment:51/51Sites: 17NON_RANDOMIZED, TREATMENT

Phase 2NegativeQ2 2022VenetoclaxChronic Lymphocytic Leukemia, Non-Hodgkin LymphomaNCT03379051

Primary: Determine Acceptable Adverse Events That Are Related to Treatment (12 months)Enrollment:78/78Sites: 3NON_RANDOMIZED, TREATMENT

Phase 2NegativeQ2 2022UblituximabChronic Lymphocytic LeukemiaNCT02656303

Primary: Overall Response Rate (ORR) as Per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Criteria (Up to 76 months)Enrollment:116/116Sites: 87NON_RANDOMIZED, TREATMENT

Phase 3NegativeQ2 2022UblituximabDiffuse Large B-Cell Lymphoma, Follicular Lymphoma, Marginal Zone LymphomaNCT02793583

Primary: Overall Response Rate (Every 8-12 weeks, up to 2 years)Enrollment:710/710Sites: 168RANDOMIZED, TREATMENT

Phase 2Q4 2022UblituximabRelapsing Remitting Multiple SclerosisNCT03381170

Phase 3NegativeQ4 2022UblituximabChronic Lymphocytic Leukemia, Small Lymphocytic LymphomaNCT03801525

Phase 3NegativeQ1 2023ObinutuzumabChronic Lymphocytic LeukemiaNCT02612311

Phase 3Q4 2026UblituximabRelapsing Multiple SclerosisNCT07211633

Primary: Area Under the Curve From Week 0 to Week 24 (AUC0-W24) of Ublituximab (Up to Week 24)Enrollment:Target 360Sites: 48RANDOMIZED, TREATMENT

Phase 3Q1 2027UblituximabRelapsing Multiple SclerosisNCT05877963

Primary: Part A and Part C: Percentage of Participants With no Change or Reduction in Number of T1 Gd-Enhancing Lesions From Baseline to Week 48 (Baseline up to Week 48)Enrollment:Target 800Sites: 51RANDOMIZED, DOUBLE, TREATMENT

Phase 2Q3 2027UblituximabMultiple SclerosisNCT07503873

Phase 2Q3 2028UblituximabMyasthenia GravisNCT07673744

Phase 2Q4 2028UblituximabSchizophreniaNCT07680946

Phase 3Q1 2030UblituximabRelapsing Multiple SclerosisNCT07220252

Primary: Part A: Area Under the Curve From Week 0 to 24 (AUC0-W24) of Ublituximab (Predose and multiple timepoints up to Week 24)Enrollment:Target 240Sites: 3RANDOMIZED, QUADRUPLE, TREATMENT

Phase 3Q2 2032UblituximabRelapsing Multiple Sclerosis (RMS)NCT04130997

TG Therapeutics Inc.

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