The Phase 1/2 clinical trial evaluating eFT508 for the treatment of relapsed or refractory non-germinal center B-cell (non-GCB) diffuse large B-cell lymphoma (DLBCL) has dosed the first patient in its Phase 2 part, eFFECTOR Therapeutics announced.
DLBCL is an aggressive form of non-Hodgkin’s lymphoma (NHL) that begins in lymph nodes and areas of the body outside of the lymphatic system. DLBCL is the most common form of NHL, making up 30 percent of newly-diagnosed NHL cases each year, according to the Lymphoma Research Foundation.
The candidate eFT508 is a kind of immunotherapy that harnesses the body’s own immune system to fight cancer. The therapy is a highly potent and selective oral inhibitor of MNK1 and MNK2 terminal kinases, known to play roles in multiple tumor-promoting pathways and to regulate many disease-driving proteins.
eFT508 has a double mechanism. It not only targets and kills tumor cells directly, it also prevents tumor cells from tricking the immune system into failing to recognize them as foreign cells and eliminating them.
eFT508 is currently in development for the treatment of patients with solid tumors and lymphoma.
The recently-initiated Phase 2 expansion is part of an ongoing Phase 1/2 clinical trial (NCT02937675) designed to evaluate the safety and preliminary signs of effectiveness of eFT508 in patients with lymphoma. It also will determine how the drug is absorbed, metabolized, and eliminated from the body. About 95 patients will be enrolled and eFFECTOR is still recruiting.
After the Phase 1 portion of the trial, the company selected 200 mg of eFT508 taken twice daily to be further tested in the Phase 2 part. The primary goal of the expansion group is to determine the number of patients who respond to the therapy.
“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,” Steve Worland, PhD, president and CEO of eFFECTOR, said in a press release. “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,” Worland said.
In March 2017, eFT508 received orphan drug status from the U.S. Food and Drug Administration (FDA) for the treatment of DLBCL, based on preliminary findings of the Phase 1/2 clinical trial.
eFFECTOR also was conducting an additional Phase 1/2 trial in patients with solid tumors (NCT02605083). However, the study was terminated after determination of the recommended Phase 2 dose, and prior to opening the expansion group of patients.