TG Therapeutics Announces Orphan Drug Designation
TG Therapeutics, Inc. recently announced that the US FDA has granted orphan drug designation covering the combination of TG-1101 (ublituximab), the company’s novel, glycoengineered anti-CD20 monoclonal antibody, and TGR-1202 the company’s oral, next-generation PI3K delta inhibitor, for the treatment of patients with diffuse large B-cell lymphoma (DLBCL).
The combination of TG-1101 and TGR-1202 is currently being evaluated in the UNITY-DLBCL Phase IIb Trial for patients with relapsed or refractory DLBCL as well as the UNITY-CLL Phase III Trial for patients with both frontline and previously treated chronic lymphocytic leukemia (CLL).
“We are pleased to receive orphan drug designation for our proprietary combination of TG-1101 and TGR-1202 in diffuse large B-cell lymphoma. This status complements our already strong proprietary protection portfolio, which includes composition of matter patents issued for both TG-1101 and TGR-1202, as well as orphan drug designation already granted for the combination in CLL,” said Michael S. Weiss, Executive Chairman and Chief Executive Officer of TG Therapeutics. DLBCL is an area of significant unmet medical need, and we are highly encouraged by the early clinical data we have seen in DLBCL patients treated with 1101 plus 1202 and look forward to evaluating this further in our ongoing Phase IIb registration directed trial.”
According to the American Cancer Society, diffuse large B-cell lymphoma (DLBCL) is an aggressive (fast growing) type of non-Hodgkin lymphoma (NHL), a cancer that starts in cells called lymphocytes, which are part of the body’s immune system. Diffuse large B-cell lymphoma is the most common type of NHL in the US, accounting for about 30% of newly diagnosed cases of NHL. DLBCL occurs in both men and women and can affect any age group, although its prevalence increases with age, with the average age of diagnosis being in the mid-60s.
TG Therapeutics is a biopharmaceutical company focused on the acquisition, development, and commercialization of novel treatments for B-cell malignancies and autoimmune diseases. Currently, the company is developing two therapies targeting hematological malignancies and autoimmune diseases. TG-1101 (ublituximab) is a novel, glycol-engineered monoclonal antibody that targets a specific and unique epitope on the CD20 antigen found on mature B-lymphocytes. TG Therapeutics is also developing TGR-1202, an orally available PI3K delta inhibitor. The delta isoform of PI3K is strongly expressed in cells of hematopoietic origin and is believed to be important in the proliferation and survival of B‐lymphocytes. Both TG-1101 and TGR-1202 are in clinical development for patients with hematologic malignancies, with TG-1101 recently entering clinical development for autoimmune disorders. The company also has preclinical programs to develop IRAK4 inhibitors, BET inhibitors, and anti-PD-L1 and anti-GITR antibodies. TG Therapeutics is headquartered in New York City. For more information, visit www.tgtherapeutics.com.
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