Boston Immune Technologies & Therapeutics, Inc.

BOSTON, MA, USA I August 16, 2024 I Boston Immune Technologies and Therapeutics, Inc. (BITT), a clinical stage developer of novel tumor necrosis factor superfamily receptor (TNFSR) antagonist antibodies, announced today a sponsored research and exclusivity agreement with the McQuade Center for Strategic Research and Development, LLC (MSRD), a member of the global Otsuka family of pharmaceutical companies. MSRD will finance key non-human primate studies for the pre-clinical development of BITT’s CD40 antagonist in exchange for an exclusive right to negotiate an acquisition, license or collaboration agreement related to the asset. BITT is also announcing that it has also been awarded a $4M National Institute of Health/National Cancer Institute to support the ongoing Phase I clinical trial of BITT’s lead TNFR2 antagonist. “Our agreement with Otsuka will provide significant resources in furtherance of our goal of filing an IND related to our CD40 antagonist program in 2025,” said Russell LaMontagne, Co-Founder and Chief Executive Officer of BITT. “This is our second NIH/NCI grant to support our TNFR2 oncology program and confirmation of the novelty of our antibody and the potential of TNFR2 as a therapeutic target.” About Boston Immune Technologies and Therapeutics Boston Immune Technologies and Therapeutics, Inc. (BITT) is a Boston, MA-based company 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 has begun 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. Learn more at: www.bostonimmunetech.com . SOURCE: BITT

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 the award of funding from the National Institutes of Health (NIH) to support the preclinical development of BITT’s CD40 antagonist antibody. The award for Advancing BITT-101: A Novel Dominant CD40 Antagonist for Use in the Treatment of Sjögren’s Syndrome will help support steps toward an IND filing in 2024. “The NIH award will accelerate our path to the clinic,” said Russell LaMontagne, Co-Founder and Chief Executive Officer of BITT. “We believe our anti-CD40 antibody has novel properties that differentiate it from prior CD40 antagonists, and we anticipate it could have uses in multiple autoimmune indications beyond Sjögren’s syndrome.” In preclinical studies, BITT antibodies exhibited the ability to deplete B cells and inhibit IgG levels – including a unique ability to selectively deplete activated (CD86+) and younger B cells making early IgM antibodies. This selective action could result in more potent immunosuppressive function at the site of inflammation and reduce the risk of side effects that have limited the clinical development of earlier CD40 antagonists. About CD40 CD40 is co-stimulatory protein on antigen presenting cells (CD154+). The CD40-CD40 ligand (CD40L) pathway is a key co-stimulatory pathway for driving T cell-dependent B cell activation and humoral immune responses. This pathway has been implicated in the pathogenesis of several autoimmune diseases, including autoimmune thyroiditis, type 1 diabetes, Crohn’s disease, inflammatory bowel disease, psoriasis, multiple sclerosis, rheumatoid arthritis, systemic lupus erythematosus and Sjögren’s syndrome. About Boston Immune Technologies and Therapeutics, Inc. 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: .

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: .