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DRUG:

TG-1801

i
Other names: TG-1801, NI-1701, TG 1801, TG1801, NI 1701, NI1701
Associations
Trials
Company:
Light Chain Biosci, TG Therap
Drug class:
CD19 inhibitor, CD47 inhibitor
Related drugs:
Associations
Trials
4ms
Study of TG-1801 Alone or in Combination With Ublituximab in Subjects With B-Cell Lymphoma or Chronic Lymphocytic Leukemia (clinicaltrials.gov)
P1, N=21, Terminated, TG Therapeutics, Inc. | N=60 --> 21 | Trial completion date: Dec 2024 --> Jun 2024 | Active, not recruiting --> Terminated | Trial primary completion date: Dec 2024 --> Jun 2024; Strategic/Business Decision
Enrollment change • Trial completion date • Trial termination • Trial primary completion date • Combination therapy
|
Briumvi (ublituximab-xiiy) • TG-1801
8ms
Study of TG-1801 in Subjects With B-Cell Lymphoma (clinicaltrials.gov)
P1, N=50, Completed, TG Therapeutics, Inc. | Active, not recruiting --> Completed
Trial completion
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Briumvi (ublituximab-xiiy) • TG-1801
9ms
Study of TG-1801 in Subjects With B-Cell Lymphoma (clinicaltrials.gov)
P1, N=50, Active, not recruiting, TG Therapeutics, Inc. | Trial completion date: Dec 2023 --> Mar 2024 | Trial primary completion date: Dec 2023 --> Mar 2024
Trial completion date • Trial primary completion date
|
Briumvi (ublituximab-xiiy) • TG-1801
9ms
Study of TG-1801 Alone or in Combination With Ublituximab in Subjects With B-Cell Lymphoma or Chronic Lymphocytic Leukemia (clinicaltrials.gov)
P1, N=60, Active, not recruiting, TG Therapeutics, Inc. | Recruiting --> Active, not recruiting
Enrollment closed
|
Briumvi (ublituximab-xiiy) • TG-1801
11ms
Trial completion date • Trial primary completion date • Combination therapy
|
Briumvi (ublituximab-xiiy) • TG-1801
11ms
Study of TG-1801 in Subjects With B-Cell Lymphoma (clinicaltrials.gov)
P1, N=50, Active, not recruiting, TG Therapeutics, Inc.
Trial completion date • Trial primary completion date
|
Briumvi (ublituximab-xiiy) • TG-1801
1year
Phase classification • Combination therapy
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Briumvi (ublituximab-xiiy) • TG-1801
1year
Study of TG-1801 Alone or in Combination With Ublituximab in Subjects With B-Cell Lymphoma or Chronic Lymphocytic Leukemia (clinicaltrials.gov)
P1b, N=60, Recruiting, TG Therapeutics, Inc. | Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2023 --> Dec 2024
Trial completion date • Trial primary completion date • Combination therapy
|
Briumvi (ublituximab-xiiy) • TG-1801
over1year
G protein-coupled receptor 183 mediates the sensitization of Burkitt lymphoma tumors to CD47 immune checkpoint blockade by anti-CD20/PI3Kδi dual therapy. (PubMed, Front Immunol)
Cell response to TG-1801 alone or combined with the U2 regimen associating ublituximab to the PI3Kδ inhibitor umbralisib, was analyzed by proliferation assay, western blot, transcriptomic analysis (qPCR array and RNA sequencing followed by gene set enrichment analysis) and/or quantification of antibody-dependent cell death (ADCC) and antibody-dependent cell phagocytosis (ADCP). Genetic depletion and pharmacological inhibition of GPR183 impaired ADCP initiation, cytoskeleton remodeling and cell migration in 2D and 3D spheroid B-NHL co-cultures, and disrupted macrophage-mediated control of tumor growth in B-NHL CAM xenografts. Altogether, our results support a crucial role for GPR183 in the recognition and elimination of malignant B cells upon concomitant targeting of CD20, CD47 and PI3Kδ, and warrant further clinical evaluation of this triplet regimen in B-NHL.
Journal • Checkpoint inhibition • IO biomarker • Checkpoint block
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CD19 (CD19 Molecule) • PIK3CD (Phosphatidylinositol-4 5-Bisphosphate 3-Kinase Catalytic Subunit Delta) • GPR183 (G Protein-Coupled Receptor 183) • SIRPA (Signal Regulatory Protein Alpha)
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Ukoniq (umbralisib) • Briumvi (ublituximab-xiiy) • TG-1801
2years
First-in-Human (FIH) Study of the Fully-Human Kappa-Lambda CD19/CD47 Bispecific Antibody TG-1801 in Patients (pts) with B-Cell Lymphoma (ASH 2022)
Combination of CD47 blockade with the anti-CD20 antibody rituximab has resulted in encouraging clinical activity (Advani 2018), and CD19 is also an established target of multiple B-NHL therapies...A 3+3 design was also utilized to evaluate two dose levels of TG-1801 (300 mg and 400 mg) with a standard dose of ublituximab (900 mg)... TG-1801 monotherapy and combination therapy demonstrates clinical activity, particularly in relapsed and refractory DLBCL, with an acceptable preliminary safety profile. This study (NCT03804996) has completed enrollment.
Clinical • P1 data
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CD19 (CD19 Molecule) • CD47 (CD47 Molecule) • SIRPA (Signal Regulatory Protein Alpha)
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CD47 expression
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Rituxan (rituximab) • Briumvi (ublituximab-xiiy) • TG-1801
over2years
CD47xCD19 bispecific antibody triggers recruitment and activation of innate immune effector cells in a B-cell lymphoma xenograft model. (PubMed, Exp Hematol Oncol)
The study described the mechanisms afforded by the CD47xCD19 bispecific antibody, NI-1701, at controlling tumor growth in lymphoma mouse model. NI-1701 is currently being evaluated in a Phase I clinical trial for the treatment of refractory or relapsed B-cell lymphoma (NCT04806035).
Preclinical • Journal
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CD8 (cluster of differentiation 8) • IFNG (Interferon, gamma) • SIRPA (Signal Regulatory Protein Alpha)
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TG-1801
over2years
NI-2601, an Fc-active CD47xPD-L1 bispecific antibody that selectively targets CD47 on PD-L1-positive tumors (AACR 2022)
The latter is also used in our CD47xCD19 bispecific antibody NI-1701/TG-1801, currently in phase I clinical trials (NCT03804996, NCT04806035)...NI-2601 demonstrated effective blockade of PD-1/PD-L1 interaction, and T-cell activation in vitro, similar to the anti-PD-L1 clinical benchmarks atezolizumab and avelumab...Thus, NI-2601 is able to harness Fc-effector function to eliminate PD-L1-positive tumor cells while sparing PD-L1-negative cells, such as RBC or platelets. Pharmacokinetic and tolerability studies in non-human primate are planned for 2022.
PD(L)-1 Biomarker • IO biomarker
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CD47 (CD47 Molecule) • SIRPA (Signal Regulatory Protein Alpha)
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PD-L1 expression • PD-L1 negative
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Tecentriq (atezolizumab) • Bavencio (avelumab) • NI-2601 • TG-1801