Triumvira’s T-cell candidate for B-cell malignanciesAugust 6, 2019
The US 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-positive B-cell malignancies.
The phase 1/2 study (TACTIC-19) is expected to be initiated in the third quarter of 2019.
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 haematological 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 (NHLs).
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, according to a company statement.