The FDA grants TG-1101 and TGR-1202 combination Orphan Drug Designation for CLL

On 9^th January 2017, the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation covering the combination of TG-1101 (ublituximab) and TGR-1202 for treating CLL patients.

TG Therapeutics’ TG-1101 is a novel, chimeric Monoclonal Antibody (mAb) specific for a unique epitope of the CD20 antigen and glycoengineered to increase affinity for all FCγRIIIa receptors. This results in more efficient Antibody-Dependent Cellular Cytotoxicity (ADCC) activity compared to ofatumumab and rituximab in vitro, especially directed against cells with low surface expression of CD20. TGR-1202 (previously referred to as RP5264) is also owned by TG Therapeutics, and is a next generation, oral PI3Kδ inhibitor.

Currently, this combination is being explored in the phase 3 UNITY-CLL trial (NCT02612311), which is recruiting treatment naïve and previously treated CLL patients who have an ECOG score of 0–2. The aim of the study is to compare the efficacy and safety of the combination against obinutuzumab plus chlorambucil. The estimated primary completion date for this study is September 2018.

The combination TG-1101 - TGR-1202 is also being investigated in patients with R/R DLBCL in the UNITY-DLBCL (NCT02793583) phase 2b trial, which is aiming to assess the efficacy and safety of the combination compared to TGR-1202 alone.

Due to the promising rate of enrollment on the UNITY-CLL trial, TG Therapeutics are expecting to initiate regulatory filing for the combination in CLL in 2018.