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

On 24^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 DLBCL 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 2b UNITY-DLBCL trial (NCT02793583), which is aiming to assess the efficacy and safety of TG-1101 plus TGR-1202 compared to TGR-1202 alone in patients with treatment naïve DLBCL.

The combination TG-1101 - TGR-1202 is also being investigated in patients with treatment naïve or R/R CLL in the phase 3 UNITY-CLL trial (NCT02612311). The combination was awarded orphan drug designation for CLL by the FDA on 9^th January 2017, as previously reported by the Lymphoma Hub.