FDA Accepts IND for TNFR2 Antibody

By Cecilia Brown - August 25, 2023

The US Food and Drug Administration (FDA) has approved an Investigational New Drug (IND) application for a phase I trial of an anti-TNFR2 antibody, BITT2101, in patients with relapsed or refractory non-Hodgkin lymphomas, according to an announcement from Boston Immune Technologies and Therapeutics, Inc, the manufacturer of BITT2101.

The first-in-human, multicenter trial will be an open-label study of escalating doses of BITT2101 in non-Hodgkin lymphoma subgroups including cutaneous T-cell lymphoma, primary cutaneous peripheral T-cell lymphoma, adult T-cell leukemia/lymphoma, diffuse large B-cell lymphoma, mantle cell lymphoma, and marginal zone lymphoma.

“The elevated levels of soluble TNFR2 in these lymphoma subtypes suggest that TNFR2 may play a significant role in progression and response to first-line therapy,” officials said in a statement. “As the escalation arm progresses, we are actively exploring validation of [soluble] TNFR2 in multiple cancers including solid tumors for potential expansion arms.”

Source: BusinessWire, August 2023

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