Rare Disease Report

Phase 2 Trial Initiates Dosing of Selective Translation Regulator in Non-GCB DLBCL Patients

JUNE 06, 2018
Krista Rossi
This morning, eFFECTOR Therapeutics, Inc announced the first patient has been dosed in the phase 2 expansion portion of its monotherapy trial of eFT508, an oral, small molecule inhibitor of MNK1/2, for the treatment of relapsed, refractory non-germinal center B cell (non-GCB) diffuse large B cell lymphoma (DLBCL). 

Non-GCB DLBCL is an aggressive form of non-Hodgkin’s lymphoma. It is partly catalyzed by the activation of nuclear factor kappa-light-chain-enhancer of activated B cells (NFkB). Poor responses to standard treatments are frequently experienced by non-GCB DLBCL patients.

“This phase 2 expansion cohort builds on our Phase 1 results, where we observed a confirmed partial response in 1 of 2 non-GCB DLBCL patients enrolled during dose escalation,” commented Steve Worland, PhD, president and chief executive officer of eFFECTOR in a recent statement.   

“Patients with non-GCB DLBCL who have failed other available treatment options face a devastating disease,” he added. “We are hopeful that our approach of regulating translation by inhibiting MNK1/2, which lies downstream of NFkB signaling, will be effective in treating these patients in great need of new therapeutic approaches.”

Part of an ongoing phase 1/2, the phase 2 expansion serves as an open-label, sequential-group, dose-escalation and cohort-expansion study to assess the safety, pharmacokinetics, pharmacodynamics, and antitumor activity of eFT508 in patients with hematological malignancies [NCT02937675]. An objective response rate (ORR) of eFT508 in non-GCB DLBCL patients is serving as the primary endpoint in the expansion cohort. As established in the phase 1 dose-escalation portion of the trial, 200 mg of eFT508 will be taken twice daily as the dose for the phase 2 expansion.

 “This phase 2 expansion cohort builds on our phase 1 results, where we observed a confirmed partial response in one of two non-GCB DLBCL patients enrolled during dose escalation,” added Dr Worland. “Patients with non-GCB DLBCL who have failed other available treatment options face a devastating disease. We are hopeful that our approach of regulating translation by inhibiting MNK1/2, which lies downstream of NFkB signaling, will be effective in treating these patients in great need of new therapeutic approaches.

Previously, eFT508 received orphan drug designation from the US Food and Drug Administration (FDA) for the treatment of DLBCL. The expected completion date for the phase 2 expansion study is October 2018.

 

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