Triumvira Immunologics, Inc. (Triumvira), a Hamilton-based private, clinical-stage biopharmaceutical company developing a novel platform for engineering T-cells to attack cancers, today announced that the U.S. Food & Drug Administration (FDA) has granted Fast Track designation for its novel T-cell therapy product TAC01-CD19 in patients with relapsed or refractory Diffuse Large B-Cell Lymphoma (DLBCL) after at least 2 prior systemic therapies. A Phase 1/2 study (TACTIC-19) conducted in patients with CD19-positive B-cell malignancies, including DLBCL, is expected to be initiated by the end of 2019.
“FDA’s decision to grant Fast Track designation to TAC01-CD19 is an important recognition of both Triumvira’s differentiated cell therapy technology and the critical need to develop new therapies to address the unmet medical need in the treatment of B-cell lymphomas,” commented Paul Lammers, MD, MSc., President and CEO of Triumvira. “With our innovative TAC technology, we hope to significantly improve upon the limitations of existing cell therapies, including the risk of cytokine release syndrome (CRS) and neurotoxicity, which would allow us to expand the number of patients eligible to receive this type of treatment.”
TAC01-CD19 will be tested at four 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.
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