TG Therapeutics Inc (NASDAQ:TGTX) announced the publication of clinical data from a Phase 2 study of TG-1101 (ublituximab), the Company’s novel glycoengineered anti-CD20 monoclonal antibody, in combination with ibrutinib, the oral BTK inhibitor, in patients with Chronic Lymphocytic Leukemia (CLL). The data, which was presented at the 2015 International Conference on Malignant Lymphoma (ICML) in Lugano, Switzerland, demonstrates the combination to be well tolerated with limited grade 3/4 adverse events observed.
An 88% overall response rate (ORR) was reported at month 6 for all patients treated, with a 95% ORR observed in patients with high risk CLL (presence of a 17p or 11q deletion or a TP53 mutation). These data are described further in the manuscript titled, “Ublituximab (TG-1101), a novel, glycoengineered anti-CD20 antibody, in combination with ibrutinib is safe and highly active in patients with relapsed and/or refractory chronic lymphocytic leukemia: results of a phase 2 trial,” which was published online today in the British Journal of Haematology.
“We want to thank Dr. Jeff Sharman and the team at the US Oncology Network for their work on this important Phase 2 study and congratulate them on this peer-reviewed publication. We believe the chemo-free combination of TG-1101 and ibrutinib is an effective and much needed treatment option for patients with high-risk CLL who continue to exhibit a poor prognosis, and the data in this publication underscores our belief. The results from this study support the GENUINE Phase 3 study, and given the dramatic and rapid responses seen in this Phase 2, we are confident in the success of GENUINE. We recently announced the completion of enrollment in the revised GENUINE trial and look forward to announcing top line data in the first half of 2017,” stated Michael S. Weiss, the Company’s Executive Chairman and Interim Chief Executive Officer.
“While ibrutinib is effective in patients with CLL, it is not the only answer. In this study, the addition of ublituximab to ibrutinib not only produced high response rates, but also allowed patients to achieve deeper responses with complete responses and minimal residual disease (MRD) negativity seen, which is rare with ibrutinib alone. We look forward to exploring how the increased depth of response may affect the sequence of treatments given to patients,” stated Dr. Jeff Sharman, Medical Director of Hematology Research for the US Oncology Network. (Original Source)
Shares of TG Therapeutics are currently trading at $5.00. TGTX has a 1-year high of $12.22 and a 1-year low of $4.80. The stock’s 50-day moving average is $5.49 and its 200-day moving average is $6.40.
On the ratings front, TG Therapeutics has been the subject of a number of recent research reports. In a report issued on December 7, Roth Capital analyst Joseph Pantginis reiterated a Buy rating on TGTX, with a price target of $33, which implies an upside of 560% from current levels. Separately, on December 6, FBR’s Edward White reiterated a Buy rating on the stock and has a price target of $24.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Joseph Pantginis and Edward White have a yearly average loss of -15.6% and -11.4% respectively. Pantginis has a success rate of 31% and is ranked #4200 out of 4279 analysts, while White has a success rate of 20% and is ranked #4166.
Sentiment on the street is mostly bullish on TGTX stock. Out of 4 analysts who cover the stock, 4 suggest a Buy rating . The 12-month average price target assigned to the stock is $28.00, which implies an upside of 460% from current levels.
TG Therapeutics, Inc. is a biopharmaceutical company. It is focused on the acquisition, development and commercialization of novel treatments for B-cell malignancies and autoimmune diseases. The company develops two therapies targeting hematological malignancies: TG-1101 and TGR-1202.