The FDA grants eFT508 Orphan Drug Designation for DLBCL

Last week, on 10^th March 2017, eFT508 was granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of DLBCL.

eFFECTOR Therapeutics’ eFT508 is a novel, highly selective, oral, small molecule inhibitor of MAP Kinase-Interacting Kinase 1 and 2 (MNK1/2). eFT508 activates anti-tumor immunity and also blocks several oncogenic growth and proliferation pathways.

The inhibitor is currently being assessed in patients with previously treated hematological malignancies in a phase I/II dose-escalation and cohort-expansion study (NCT02937675). Primary outcome measures are to determine the Maximum Tolerated Dose (MTD) and Overall Response Rate (ORR). The estimated primary completion date is October 2018.

A similar phase I/II trial (NCT02605083) of eFT508 is also being conducted in advanced solid tumor malignancies which have progressed after prior therapy and have no potential for cure with other therapy.