eFFECTOR Therapeutics has started dosing patients in the Phase ll expansion portion of its ongoing Phase l/ll study of eFT508 for the treatment of relapsed, refractory, non-germinal centre B cell (non-GCB) diffuse large B-cell lymphoma (DLBCL).
In this portion, patients will be given a 200mg dose of eFT508 twice daily, which was established in the Phase l dose-escalation portion of the trial.
The Phase l/ll trial is an open-label, sequential-group, dose-escalation and cohort-expansion study designed to analyse the safety, pharmacokinetics, pharmacodynamics and anti-tumour activity of eFT508 in patients with haematological malignancies.
The primary objective of the expansion cohort is the objective response rate (ORR) of eFT508 in non-GCB DLBCL patients.
eFFECTOR Therapeutics president and CEO Steve Worland said: “This Phase ll expansion cohort builds on our Phase l results, where we observed a confirmed partial response in one of two non-GCB DLBCL patients enrolled during dose escalation.
“Patients with non-GCB DLBCL who have failed other available treatment options face a devastating disease.”
Non-GCB DLBCL is an aggressive form of non-Hodgkin’s lymphoma (NHL) that is partly caused by the activation of nuclear factor kappa-light-chain-enhancer of activated B-cells (NFkB) and frequently responds poorly to standard treatments.
According to the Lymphoma Research Foundation, DLBCL is estimated to account for 30% of the newly diagnosed NHL cases each year.
eFT508, an oral, small molecule inhibitor of MNK1/2, has previously secured orphan drug designation from the US Food and Drug Administration (FDA) for the treatment of DLBCL.