Shares of TG Therapeutics (NASDAQ:TGTX) gained as much as 36.7% after the company announced an update for two triple-combination therapies it's developing as treatments for relapsed/refractory chronic lymphocytic leukemia (CLL) and non-Hodgkin's lymphoma (NHL). The clinical-stage company presented the data at the Annual Meeting of the American Society of Hematology (ASH).
Both triple combinations provoked robust responses in the difficult-to-treat cancers. In fact, one achieved an objective response rate (ORR) of 100%, which means all patients responded to treatment. The results are early and from a small number of patients, but they sure are promising.
As of 1:38 p.m. EST, the pharma stock had settled to a 24% gain.
The first triple-combination therapy includes ublituximab (an experimental monoclonal antibody), umbralisib (an experimental small-molecule inhibitor of PI3K delta and CK1 epsilon, two proteins involved in cellular growth), and venetoclax (an approved treatment for CLL). TG Therapeutics owns the first two assets and refers to the duo as U2.
The triple-combination therapy achieved an ORR of 100% in 13 patients with CLL. Of the nine patients available for evaluation at the 12-month cutoff date, all achieved undetectable levels of minimal residual disease (MRD) in their blood, and seven (78%) had undetectable levels of MRD in their bone marrow. All have stopped treatment.
The second triple-combination therapy includes U2 and TG-1701, a once-daily BTK inhibitor. All three molecules are owned by TG Therapeutics. The proprietary triple combo achieved an ORR of 86% in seven patients with either relapsed/refractory CLL and NHL. While that sounds a little less impressive after reading about the perfect ORR above, the results are from the lowest dose of the BTK inhibitor that will be studied. However, BTK inhibitors can trigger mutations that make tumors resistant to treatment.
TG Therapeutics ended September with only $72.4 million in cash, which means investors might expect the company to wisely take advantage of a soaring stock price with a public stock offering. That would raise much-needed cash to support research and development efforts that include 10 clinical programs. Given the promising results from the two triple-combination therapies being developed, investors might not mind the dilution if the pipeline keeps delivering.