BITR2101 / BeOne Medicines, Boston Immune Tech - LARVOL DELTA

A Clinical Trial in Adults With Non-Hodgkin Lymphoma (NHL), With a Particular Emphasis on Cutaneous T Cell Lymphoma (CTCL), Testing the Safety and Activity of a Novel Drug to Inhibit a Protein Called Tumor Necrosis Factor Receptor 2 That Drives Both Lymphoma Growth and Escape of the Immune System (clinicaltrials.gov) - P1 | N=37 | Not yet recruiting | Sponsor: Boston Immune Technologies and Therapeutics | Trial primary completion date: Feb 2027 ➔ Jun 2026

Trial primary completion date • Cutaneous T-cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma

A Clinical Trial in Adults With Non-Hodgkin Lymphoma (NHL), With a Particular Emphasis on Cutaneous T Cell Lymphoma (CTCL), Testing the Safety and Activity of a Novel Drug to Inhibit a Protein Called Tumor Necrosis Factor Receptor 2 That Drives Both Lymphoma Growth and Escape of the Immune System (clinicaltrials.gov) - P1 | N=37 | Not yet recruiting | Sponsor: Boston Immune Technologies and Therapeutics

New P1 trial • Cutaneous T-cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma

BITT Announces FDA Acceptance of IND for TNFR2 Antibody (Businesswire) - "Boston Immune Technologies and Therapeutics...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....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)."

IND • New P1 trial • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Marginal Zone Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma

Selexis and Boston Immune Technologies and Therapeutics (BITT) Enter Service Agreement to Advance BITT’s Lead TNFR2 Oncology Candidate (Businesswire) - "Selexis SA and Boston Immune Technologies and Therapeutics (BITT) have entered into a service agreement to develop the cell line for BITR2101, BITT’s lead tumor necrosis factor receptor 2 (TNFR2) antagonist antibody for the treatment of cancers and infectious diseases. Under the agreement, BITT will leverage Selexis’ SUREtechnology Platform™, a suite of proprietary modular technologies designed to overcome the complex challenges of protein-expression and deliver the high performance research cell banks necessary to pursue clinical development."

Licensing / partnership • Oncology

Boston Immune Technologies and Therapeutics and BeiGene Enter into an Exclusive Option and License Agreement to Develop Novel TNFR2 Antagonistsb (BeiGene Press Release) - "Boston Immune Technologies and Therapeutics...announced that they have entered into an option and license agreement aimed...to develop, manufacture, and commercialize BITT’s proprietary TNFR2 antagonist antibodies in Asia (excluding Japan), Australia, and New Zealand. The companies plan to conduct Phase 1 clinical trials of BITR2101...including planned combination studies with tislelizumab...Under the terms of the agreement, BITT will receive an upfront payment and potential near-term milestone payments totaling $16.6 million..."

Licensing / partnership • Oncology