The Food and Drug Administration has granted Orphan Drug designation to IMO-8400, an antagonist of the endosomal Toll-like receptors (TLRs) 7, 8 and 9, to treat patients with diffuse large B-cell lymphoma (DLBCL).
A news release from the manufacturer, Idera Pharmaceuticals, notes that the company is conducting a clinical trial of IMO-8400 in patients with relapsed or refractory DLBCL harboring MYD88 L265P oncogenic mutation.
Preclinical trials have shown that in B-cell lymphomas characterized by the MYD88 L265P oncogenic mutation, including DLBCL, TLR signaling is over-activated, allowing tumor cell survival and proliferation.
The new trial's objectives are to evaluate the safety, tolerability, and clinical activity of the three dose-escalation groups of IMO-8400 administered subcutaneously.
"We continue to advance our efforts in DLBCL, as well as our ongoing clinical trial in Waldenstrom's macroglobulinemia, which we expect to complete and have full data available in the fourth quarter of this year," said Idera's Interim Chief Medical Officer, James J. O'Leary, MD.