21 June 2019 - - Both the US Food and Drug Administration (FDA) and Health Canada have cleared US- and Canada-based biopharmaceutical company Triumvira Immunologics, Inc.'s Investigational New Drug and Clinical Trial Applications 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 3Q19, the company said.
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 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.
Preclinical data suggest that TAC01-CD19 has the potential for being highly efficacious with minimal side effects in hematological malignancies.
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 and is expected to impact approximately 26,000 patients annually in the US 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.
Triumvira Immunologics is a clinical stage immunotherapy company co-founded in 2015 by Dr. Jonathan Bramson at McMaster University and Bloom Burton and Co., with the vision of developing novel T cell therapies that are safer and more efficacious than current gene therapy cancer treatments, including chimeric antigen receptor and engineered T cell receptor therapies.
Its proprietary T cell Antigen Coupler technology recruits the entire natural T cell receptor and is independent of the Major Histocompatibility Complex, allowing for the development of better therapies for a broader range of patients with solid or liquid malignancies and with diseases other than cancer.
With operations spanning North America, the company's corporate offices are in Austin, Texas, with research facilities in Hamilton, Ontario.