FDA greenlights BITT’s Phase I trial of BITT2101 for Non-Hodgkin’s lymphomas

Boston Immune Technologies and Therapeutics, Inc. (BITT), a pioneering clinical-stage biotech company, has announced the US Food and Drug Administration’s (FDA) clearance for the Investigational New Drug (IND) application of its BITT2101 anti-TNFR2 antibody. The approval marks the commencement of a Phase I trial, targeted at patients with relapsed or refractory Non-Hodgkin’s lymphomas, as the company embarks on testing the first antibody developed from its tumor necrosis factor superfamily receptor (TNFSR) platform.

Russell LaMontagne, the Co-Founder and CEO of BITT, expressed his enthusiasm about the recent development, stating that the clearance represents a crucial step in bringing BITT’s lead antibody into clinical trials. The Phase I trial is set to showcase the novel and unique capabilities of BITT’s proprietary dominant antagonist antibodies, as the first antibody from the TNF Superfamily platform moves into the clinic.

The Phase I trial, a first-in-human, multi-center study, will be open-label, exploring escalating doses of BITT2101 in various Non-Hodgkin’s lymphoma subgroups. These will include 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).

Russell LaMontagne further explained the significance of the trial, emphasizing the potential role of soluble TNFR2 (sTNFR2) in the progression and response to first-line therapy in these lymphoma subtypes. As the escalation arm of the trial progresses, BITT is actively investigating the validation of sTNFR2 in various cancers, including solid tumors, exploring possibilities for potential expansion arms.

The FDA’s clearance of BITT2101’s IND application marks a significant step towards addressing the needs of patients with relapsed or refractory Non-Hodgkin’s lymphomas, potentially paving the way for more advanced and targeted therapies.