Pharma Focus Europe

BITT Granted FDA Acceptance of IND Application for TNFR2 Antibody

Saturday, August 19, 2023

Boston Immune Technologies and Therapeutics, Inc. (BITT), a clinical-stage biotechnology firm specializing in novel treatments, has received the green light from the Food and Drug Administration (FDA) for its Investigational New Drug application (IND) for BITT2101, an anti-TNFR2 antibody. This development paves the way for a Phase I clinical trial for BITT2101, aimed at patients grappling with relapsed or refractory Non-Hodgkin’s lymphomas.

Russell LaMontagne, CEO and Co-Founder of BITT, expressed his excitement about the FDA clearance: "We are delighted that we've been granted approval to kickstart clinical trials with our flagship antibody. This marks a significant milestone as it introduces an antibody from BITT’s TNF Superfamily platform into the realm of clinical research, offering a unique opportunity to demonstrate the innovation and effectiveness of our dominant antagonist antibodies."

The Phase I trial is set to be an open-label study conducted across multiple medical centers. It will focus on administering increasing doses of BITT2101 and will encompass various subgroups of Non-Hodgkin’s lymphomas, including cutaneous T cell lymphoma (CTCL), primary cutaneous peripheral T cell lymphoma (PTCL), adult T cell leukemia/lymphoma (ATLL), diffuse large B cell lymphoma (DLBCL), mantle cell lymphoma (MCL), and marginal zone lymphoma (MZL).

LaMontagne underscored the significance of elevated soluble TNFR2 (sTNFR2) levels within these lymphoma subtypes, indicating the possible role of TNFR2 in disease progression and response to initial therapies. As the trial progresses through its escalation phase, BITT is proactively investigating the validation of sTNFR2 in various cancers, including solid tumors. This exploration could potentially lead to expansion arms of the study.

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