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BITT Announces FDA Acceptance of IND for TNFR2 Antibody

2023-08-18

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Phase I trial in patients with relapsed or refractory Non-Hodgkin’s lymphomas BOSTON--(BUSINESS WIRE)-- Boston Immune Technologies and Therapeutics, Inc. (BITT), a clinical stage biotechnology company developing novel tumor necrosis factor superfamily receptor (TNFSR) antagonist antibodies, announced today that the Food and Drug Administration (FDA) has cleared BITT’s Investigational New Drug application (IND) for a Phase I trial of BITT2101 (anti-TNFR2) in patients with relapsed or refractory Non-Hodgkin’s lymphomas. “We are excited to have approval to bring our lead antibody into clinical trials,” said Russell LaMontagne, Co-Founder and Chief Executive Officer of BITT. “This is the first antibody from BITT’s TNF Superfamily platform to enter the clinic and the first opportunity to demonstrate the novelty and utility of our proprietary dominant antagonist antibodies.” BITT’s Phase I, first-in-human, multi-center trial will be an open-label study of escalating doses of BITT2101 in Non-Hodgkin’s lymphoma subgroups 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). “The elevated levels of soluble TNFR2 (sTNFR2) in these lymphoma subtypes suggest that TNFR2 may play a significant role in progression and response to first line therapy. As the escalation arm progresses, we are actively exploring validation of sTNFR2 in multiple cancers including solid tumors for potential expansion arms,” added LaMontagne. About Boston Immune Technologies and Therapeutics Boston Immune Technologies and Therapeutics, Inc. (BITT) is a clinical stage biotechnology company based in Boston, MA. BITT is developing a novel class of antagonist antibodies targeting TNF superfamily receptors for applications in oncology, inflammation, autoimmunity, and infectious disease based on the company’s DOMab platform. BITT is initiating clinical trials for BIR2101, its lead candidate, which is a monoclonal antibody that targets tumor necrosis factor receptor 2 (TNFR2). BITT is also developing additional antibodies targeting TNF superfamily receptors for indications in inflammation, oncology and infectious disease including a CD40 antagonist that recently completed developability studies and is progressing toward an IND filing. Learn more at: .

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