Boston Immune Technologies and Therapeutics, Inc. (BITT), a biotechnology company in the clinical stage, has announced that its Investigational New Drug application (IND) for BITT2101 (anti-TNFR2), a novel tumor necrosis factor superfamily receptor (TNFSR) antagonist antibody, has been cleared by the Food and Drug Administration (FDA). This marks a significant step forward for BITT as they receive approval for a Phase I trial targeting patients with relapsed or refractory Non-Hodgkin’s lymphomas.

Russell LaMontagne, the Co-Founder and Chief Executive Officer of BITT, expressed enthusiasm about the development, stating, "We are excited to have approval to bring our lead antibody into clinical trials. 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."

The Phase I trial, set to be a multi-center open-label study, will involve escalating doses of BITT2101 and will focus on different 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).

LaMontagne further noted, "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."

BITT, based in Boston, Massachusetts, focuses on the development of antagonist antibodies targeting TNF superfamily receptors using their DOMab platform. Their lead candidate, BIR2101, is a monoclonal antibody directed at tumor necrosis factor receptor 2 (TNFR2). The company is also working on other antibodies targeting TNF superfamily receptors for applications in inflammation, oncology, and infectious diseases. Their dedication to innovation and advancement in the field of biotechnology is reflected in their ongoing clinical trials and development efforts.

For more information about Boston Immune Technologies and Therapeutics, please visit their website: www.bostonimmunetech.com.

Contacts: Karl Schmieder karl@messaginglab.com (646) 515-3392
 

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