The FDA has granted Orphan Drug Designation to eFT508 for the treatment of diffuse large B-cell lymphoma, an aggressive form of non-Hodgkin lymphoma. eFT508 is a potent, highly-selective inhibitor of MNK1 and MNK2, two enzymes critical for the growth and survival of tumors.
The first subject in a phase I/II clinical trial of eFT508 in patients with B-cell hematological malignancies has been dosed. The recently-initiated trial is an open-label, sequential-group, dose-escalation, and cohort-expansion study evaluating the safety, pharmacokinetics, pharmacodynamics, and antitumor activity of eFT508. The primary goals will be to establish a maximum tolerated dose and recommended dose for further evaluation and to assess preliminary efficacy of the compound. A phase I/II dose escalation trial of eFT508 in patients with solid tumors is also being conducted.