Tiny Biotechs Get Giant Results In Leukemia Treatment (NPS)—revolutionary newtreatmentfor relapsed chronic lymphocytic leukemia (CLL) may soonbe available. For decades,the only treatment for CLL was toxic chemotherapy that providedlimited benefit. However, over the last 20 years, majorstrides have been madein the quest to develop a new treatmentthatis both safe andeffective, and each new development can beattributed to efforts made bya tiny biotech company. In fact, very recently, a tiny biotech called TG Therapeutics released exciting data concerning an innovative new treat- ment, TG-1101 (ublituximab), for CLL pa- tients that builds on those past successes. So, in essence then, TG’s success re- ally begins decades ago. It was back in 1996 when researchers at a tiny company called Idec Pharmaceuticals discovered Rituxan. Rituxan wasthefirst drug to harness the immune system to treat leukemias and lymphomas, andall these yearslaterit is still hailed as one of the greatest breakthroughs in the treatment of cancer. ‘The next breakthrough occurred in 2010, when another small biotech com- pany, Pharmacyclics, developed ibrutinib. It was referred to as the magicpill for CLL. bouthalf the patients who re- lapsed after chemotherapy and Rituxan responded to ibrutinib. Unfortunately, ibrutinib alone was not the answer for all patients. “Tbrutinib has been a great addition to our CLL armamentarium. However, we have long believed that ibrutinib alone may not be enough, particularly for patients with high-risk disease,” said Dr. Kathryn Kolibaba, who is the sso- ciate Chair of the Hematology Research Committee for US Oncology and prac- tices at Compass Oncology in Vancou- ver, Washington. ‘That is why, in 2013, Dr. Kolibaba and hercolleagues at US Oncologypart- nered with TG Therapeutics to research the potential of TG-1101 as a treatment option for CLL. What intrigued them about TG’s compound wasthat it was similar to Rituxanyet it was designed to Researchers have discovered a way to encourage the body’s own immunesystem to fight off cancer. be much moreeffective due to a technique that enabled TG-1101 to better engage the immunesystem to more ef- fectively kill the cancercells. lone, TG-1101 is an exciting ad- vance, but the major breakthrough came about when TG-1101 was combined with ibrutinib. “We were excited to see if we could create a really potent combination that was safe for our patients,” stated Dr. Kolibaba. In TG’sfirst Phase 2 clinical trial evaluating the chemotherapy-free combination, published in the prestigious British Journal of Haematology, nearly all patients treated achieved great benefit and experienced a major reduction in their disease. Phase3 clinicaltrial for the same combination followed, and confirmed the impressive Phase 2 findings. Investigators again foundthatthe addition of TG-1101 to ibrutinib improved the response rate by more than 70 percent as comparedto ibrutinib alone. “These are the first Phase 3 results showing that we can dramatically in- crease the remissionrate for CLL patients taking ibrutinib without the addition of toxic chemotherapy andis truly a great advanceforpatients,” stated Dr. Kolibaba. Moreinformation about TG Therapeutics and TG-1101 (ublituximab) can be found at www.tgtherapeutics.com and www.BCellClinicalTrials.com.
