On February 21, 2017 TG Therapeutics, Inc. (NASDAQ:TGTX) reported the publication of clinical data from a Phase 1/2 trial of TG-1101 (ublituximab), the Company’s novel glycoengineered anti-CD20 monoclonal antibody, in patients with B-cell non-Hodgkin Lymphoma (NHL) or Chronic Lymphocytic Leukemia (CLL) previously exposed to rituximab (Press release, TG Therapeutics, FEB 21, 2017, View Source [SID1234517775]). The data demonstrates single agent TG-1101 to be well tolerated with the most common adverse event observed being grade 1/2 infusion related reactions (IRR), with no grade 3/4 IRRs. TG-1101 monotherapy was active, with a 45% overall response rate (ORR) observed among heavily pretreated patients with NHL and CLL, including those who were refractory to prior anti-CD20 based therapy. These data are described further in the manuscript titled, "A phase 1/2 trial of ublituximab, a novel, glycoengineered anti-CD20 monoclonal antibody, in patients with B-cell non-Hodgkin lymphoma or chronic lymphocytic leukaemia previously exposed to rituximab," which was published online today in the British Journal of Haematology. The online version of the article can be accessed at View Source Schedule your 30 min Free 1stOncology Demo! "We want to thank Dr. Owen O’Connor, and the team from Columbia Presbyterian Medical Center and the Center for Lymphoid Malignancies for their work on this Phase 1/2 trial of single agent TG-1101 and congratulate them on the publication of these data. Since the inception of our Company, we have been focused on developing best-in-class agents with the goal of building novel combination therapies. This single agent data illustrates that TG-1101 is a safe and highly-active anti-CD20 monoclonal antibody on top of which additional treatments can be layered. The safety profile, speed of infusion, and response rates observed, with single agent TG-1101, especially in rituximab-refractory patients, serve as a foundation for our belief that TG-1101 is a best-in-class anti-CD20 monoclonal antibody," stated Michael S. Weiss, Executive Chairman and Chief Executive Officer of TG Therapeutics. Mr. Weiss continued, "These Phase 1/2 data, as well as the combination data of TG-1101 plus ibrutinib published in the British Journal of Haematology late last year, further support our Phase 3 GENUINE trial of TG-1101 in combination with ibrutinib and we look forward to presenting top-line data from this study in the first half of this year."
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"The addition of an anti-CD20 monoclonal antibody to other treatments, whether chemo-based or novel targeted therapies, has demonstrated to be an impactful way to enhance responses for patients with NHL and CLL. Acquired resistance to rituximab is a significant clinical issue for which many patients need an alternative effective agent to overcome the resistance. We are highly encouraged by the results we have seen in the clinic with ublituximab and believe the drug’s safety profile, as well as shortened infusion times as compared to other anti-CD20s, can provide meaningful benefit to patients," stated Dr. Owen A. O’Connor, Professor of Medicine and Experimental Therapeutics, Director Lymphoid Malignancies at Columbia Presbyterian Medical Center.