TG-1101 (ublituximab) is an investigational therapy being developed by TG Therapeutics to treat hematologic cancers, which are cancers that begin in blood-forming tissue such as bone marrow, or in the cells of the immune system.

TG-1101 is currently being investigated in patients with lymphoma, leukemia, and in a type of non-Hodgkin’s lymphoma (NHL) called Waldenstrom macroglobulinemia.

How TG-1101 works

TG-1101 is a type of immunotherapy called a monoclonal antibody. Antibodies are proteins produced by certain types of immune system cells to attack foreign substances in the body. They circulate in the body until they find and attach to a specific antigen.

TG-1101 is an antibody that recognizes the CD20 antigen present on the surface of certain hematologic cancer cells. When TG-1101 binds to CD20, it stimulates the immune system to destroy the cancer cells containing the CD20 antigen.

TG-1101 in clinical trials

A Phase 1/2 clinical trial (NCT01647971) was undertaken to determine the maximum tolerated dose, safety, and effectiveness of TG-1101 in patients with B-cell NHL treated with Rituxan (rituximab) and whose disease returned after a period of improvement or became resistant to treatment. The results of the trial were published early in 2017 in the British Journal of Haematology and showed that TG-1101 was well-tolerated, with the most common adverse effects being infusion-site reactions, fatigue, fever, and diarrhea. TG-1101 also was seen to be effective, with 45% of patients responding to treatment. Of those, 13% showed a complete response, and 32% a partial response.

TG-1101 is currently being tested in combination with TGR-1202 (umbralisib) and Treanda (bendamustine) in patients with diffuse large B-cell lymphoma and follicular lymphoma in a Phase 1/1b clinical trial (NCT02006485). Updated data from this trial were presented in June 2017 at the 14th International Conference on Malignant Lymphoma (ICML) and showed that the triple combination was highly active and well-tolerated in patients with aggressive lymphomas. No discontinuation of treatment due to adverse effects was observed. The trial is still recruiting participants at sites across the U.S.

A Phase 2b clinical trial (NCT02793583) called UNITY-NHL is testing the safety and effectiveness of TG-1101 plus TGR-1202 and Treanda in previously treated patients with NHL. Based on positive results from the first interim analysis of the study, the trial will continue to recruit participants at 83 study locations in the U.S., Poland, and the U.K.

A Phase 1/2 trial (NCT02013128) is evaluating the safety and effectiveness of TG-1101 in combination with Imbruvica (ibrutinib) in patients with several types of advanced-stage hematologic cancers. Results from patients with mantle cell lymphoma were presented at the 2015 American Society of Hematology Annual Meeting and subsequently published in the scientific journal Blood. They showed that the combination was well-tolerated and effective. Of the 15 patients studied, 87% responded to treatment, and 33% showed a complete response. Three of the complete responses occurred after eight weeks of treatment. The trial is ongoing but no longer recruiting participants.


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