TG Therapeutics Inc (NASDAQ:TGTX) announced the initiation of a Phase 1/2 clinical study that will investigate the use of TGR-1202, the Company’s oral PI3K delta inhibitor and TG-1101 (ublituximab), the Company’s glycoengineered anti-CD20 monoclonal antibody in combination with pembrolizumab the anti-PD-1 immune checkpoint inhibitor, in patients with relapsed or refractory CLL. This will be the first clinical trial evaluating the safety, tolerability and effectiveness of the triple combination of a PI3K delta inhibitor with an anti-CD20 mAb and an anti-PD-1 checkpoint inhibitor.
“We are very excited about the launch of this combination study and its potential in treating patients with CLL. To date, engaging T-cells to fight CLL has been promising but has yet to produce the dramatic effects seen in other settings. We believe our proprietary TG-1101 plus TGR-1202 regimen in combination with T-cell enhancing therapies, like anti-PD-1, could significantly improve the outcomes for patients with CLL,” stated Michael S. Weiss, the Company’s Executive Chairman and Interim Chief Executive Officer. Mr. Weiss continued, “Additionally, with our own anti-PD-L1 antibody expected to enter clinical trials next year, this trial will give us a nice head start in designing our proprietary combination clinical program.”
Dr. Anthony Mato, an assistant professor in the Perelman School of Medicine at the University of Pennsylvania, Director of the Center for CLL at Penn’sAbramson Cancer Center and Study Chair of the Phase 1/2 study added, “We look forward to collaborating with TG Therapeutics on this novel combination clinical trial. Our center has been intimately involved with T-cell therapies for hematologic diseases and we are firm believers in the promise they hold broadly for cancer patients. The combination of TG-1101 and TGR-1202 has demonstrated unique tolerability and activity which we believe represents a strong backbone on which to add additional novel therapies. We believe the novel approach utilized in this study, where we will induce a response with TG-1101 and TGR-1202, followed by consolidation with anti-PD-1 therapy, could maximize the potential benefit of T-cell therapy in CLL. We are thrilled to have moved this study from concept to first patient enrolled in just a few months, and look forward to offering patients with advanced CLL new options with this novel triple combination.”
The Phase 1 part of the study will evaluate the safety, tolerability, and appropriate dose of pembrolizumab when combined with TGR-1202 and TG-1101 in patients with advanced CLL. The Phase 2 part of the study will further evaluate the safety and effectiveness of the triple combination at the recommended Phase 2 dose. (Original Source)
Shares of TG Therapeutics closed yesterday at $11.45. TGTX has a 1-year high of $20 and a 1-year low of $9.03. The stock’s 50-day moving average is $15.25 and its 200-day moving average is $15.91.
On the ratings front, TG Therapeutics has been the subject of a number of recent research reports. In a report issued on August 12, H.C. Wainwright analyst Andrew Fein assigned a Buy rating on TGTX, with a price target of $22, which implies an upside of 92.1% from current levels. Separately, on August 10, Brean Murray Carret’s Jonathan Aschoff reiterated a Buy rating on the stock and has a price target of $28.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Andrew Fein and Jonathan Aschoff have a total average return of 16.1% and 8.5% respectively. Fein has a success rate of 52.6% and is ranked #263 out of 3752 analysts, while Aschoff has a success rate of 46.4% and is ranked #316.
Overall, 4 research analysts have given a Buy rating to the stock. When considering if perhaps the stock is under or overvalued, the average price target is $25.00 which is 118% above where the stock closed yesterday.
TG Therapeutics Inc is a biopharmaceutical company. It is engaged in the acquisition, development & commercialization of medically important pharmaceutical products for the treatment of cancer & other underserved therapeutic needs.