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news.The US Food and Drug Administration (FDA) has granted orphan drug designation for Idera Pharmaceuticals' IMO-8400, an antagonist of the endosomal Toll-like receptors (TLRs) 7, 8 and 9, to treat diffuse large B-cell lymphoma (DLBCL).
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Currently, the company is conducting a clinical trial of IMO-8400 in patients with relapsed or refractory DLBCL harboring MYD88 L265P oncogenic mutation.
The company said that 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 trial’s objectives are to evaluate the safety, tolerability and clinical activity of the three dose-escalation groups of IMO-8400 administered subcutaneously.
Idera interim chief medical officer Dr James O’Leary said: "The Orphan Drug designation granted today represents another positive milestone for our B-Cell Lymphoma clinical development program.
"We continue to advance our efforts in DLBCL, as well as our ongoing clinical trial in Waldenstrom’s macroglobulinemia (WM), which we expect to complete and have full data available in the fourth quarter of this year."
The company’s TLR antagonist drug candidates have been created using a proprietary chemistry-based drug discovery platform.
In a Phase I trial conducted in 42 healthy subjects, IMO-8400 has been well-tolerated at single and multiple escalating doses up to 0.6 mg/kg for four weeks, and has shown inhibition of immune responses mediated by TLRs 7, 8, and 9.