What: Shares of TG Therapeutics (NASDAQ:TGTX), a clinical-stage biopharmaceutical company focused on the development of therapies to treat blood cancers and autoimmune diseases, surged higher by as much as 20% during Thursday's trading session after announcing updated results from its phase 2 study involving TG-1101.
So what: In TG Therapeutics' midstage trial, TG-1101, also known as ublituximab, is being combined with FDA-approved blood cancer drug Imbruvica as a potential treatment for patients with previously treated, high-risk chronic lymphocytic leukemia (CLL). In total, the trial enrolled 44 patients, of which 40 were evaluable.
Out of the 20 patients in the "high-risk" category, 19 demonstrated an objective response, with four achieving a complete response and/or minimum residual disease negativity by the end of the six month study. A bone marrow confirmation is still needed to confirm a complete response or minimum residual disease in select "unconfirmed" complete response patients. There was also a marked response in nodal reduction for high-risk CLL patients. A median nodal reduction of 64% was noted by month three, while it improved to 85% by the end of the study at month six.
Additionally, across all evaluable patients, the combo therapy proved quite tolerable with only three grade 3 or grade 4 adverse events and only two patients dropping out of the trial. The implication here is that patients should be able to stay on the therapy for a longer period of time (and thus provide ample revenue to TG Therapeutics).
Now what: This is just more gravy on the top for TG Therapeutics which has been enrolling previously treated, high-risk CLL patients in the phase 3 GENUINE trial. GENUINE is expected to enroll some 330 patients, with TG Therapeutics using the overall response rate from the first two-thirds of patients in the study to submit a rolling new drug application. All patients will be monitored for progression-free survival, which, if the results are positive, is designed to support the full approval of the combo therapy.
The great thing about this combo therapy is Imbruvica is already approved by the Food and Drug Administration, and it was streamlined through as a breakthrough therapy drug. Wall Street has been estimating peak annual sales for Imbruvica of anywhere from $3 billion to $9 billion, depending on its ability to gain new indications. Thus, if TG Therapeutics can latch ublituximab onto a projected blockbuster drug, then I suspect it would validate TG Therapeutics' drug development platform as successful, and give it a chance at profitability by the end of the decade. That doesn't mean I'd exactly run out to buy TG Therapeutics today considering that profitability is a long way off, but a more risk-tolerant investor could certainly make a buy thesis.