June 18, 2019 07:00 AM Eastern Daylight Time
AUSTIN, Texas & HAMILTON, Ontario–(BUSINESS WIRE)–Triumvira Immunologics, Inc. (Triumvira), a private, clinical-stage biopharmaceutical company developing a novel platform for engineering T cells to attack cancers, today announced that both the U.S. Food & Drug Administration (FDA) and Health Canada have cleared Triumvira’s Investigational New Drug (IND) and Clinical Trial Applications (CTA) for its novel T cell therapy product TAC01-CD19 in patients with CD19-postive B-cell malignancies. The Phase 1/2 study (TACTIC-19) is expected to be initiated in the third quarter of 2019.
Paul Lammers, MD, MSc., President and CEO of Triumvira commented, “Obtaining FDA and Health Canada clearance of our first IND for this novel approach fulfills our goal to be a clinical stage biotechnology company and demonstrates our commitment to bringing this innovative treatment to patients. TAC01-CD19 will be tested at five leading lymphoma clinical study centers in the U.S. and Canada. Based on its preclinical profile, TAC01-CD19 has the potential to represent a significant advancement in T cell therapy.”
About TAC01-CD19
Despite transformational efficacy with existing approved Chimeric Antigen Receptor T Cells (CAR-T), a significant unmet need remains due to substantial CAR-T toxicities and limited tumor types where CAR-T is effective. Triumvira is developing a proprietary T Cell Antigen Coupler (TAC) technology platform which is biologically distinct from CAR-T. The first of our pipeline product candidates, TAC01-CD19 is a novel T cell therapy product targeting CD19 for use in B-cell malignancies. The product comprises patient-derived T cells that have been genetically engineered to express the CD19 T cell Antigen Coupler (TAC). Preclinical data suggest that TAC01-CD19 has the potential for being highly efficacious with minimal side effects in hematological malignancies.
About CD19 and Diffuse Large B Cell Lymphoma (DLBCL)
CD19 is a B cell marker and is expressed on the surface of B cell malignancies such as Diffuse Large B Cell Lymphoma. DLBCL is a subtype of Non-Hodgkin Lymphomas (NHLs)and is expected to impact approximately 26,000 patients annually in the U.S. Even though significant improvements in therapies have occurred in the past years, about 45% of patients with DLBCL die of either their disease or of non-cancerous causes.