Triumvira Submits Investigational New Drug (IND) Application to the FDA and Clinical Trial Application (CTA) to Health Canada to Evaluate TAC01-CD19, a T Cell Antigen Coupler Therapy, in Ph 1/2 TACTIC-19 Trial
- Category: DNA RNA and Cells
- Published on Wednesday, 01 May 2019 18:04
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AUSTIN, TX, USA & HAMILTON, Canada I May 01, 2019 I Triumvira Immunologics Inc. (Triumvira), a privately held biopharmaceutical company developing a novel platform for engineering T cells to attack cancers, has simultaneously submitted an IND to the U.S. Food and Drug Administration and a CTA to Health Canada to initiate a Phase 1/2, first-in-human trial of TAC01-CD19, a TAC-T cell therapy product engineered to target CD-19 in patients with Relapsed/Refractory Large B-Cell Lymphoma (TACTIC-19).
“TAC01-CD19 has the potential to be a next generation solution for cell therapy for patients with different types of cancer,” commented Paul Lammers, MD, MSc., President and CEO of Triumvira. “This filing is the result of an intensive preclinical development effort by the Triumvira team including the completion of the necessary IND-enabling studies as well as simultaneously preparing IND and CTA filings. We look forward to opening our first of five prominent clinical trial sites in the early summer of 2019.”
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 and has the potential to be a next generation solution to these challenges. TAC technology is a novel way to genetically modify T cells and redirect these T cells to target cancer antigens by co-opting the natural T cell receptor (TCR) to eradicate the tumor cells. TAC01-CD19 is the lead program in Triumvira’s pipeline of several TAC programs for both solid tumors and hematological malignancies.
TAC-01CD19 is a novel genetically engineered T cell therapy product targeting CD19 for use in B-cell malignancies. The product comprises autologous T cells that have been genetically engineered via lentiviral transduction 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.
About CD19 and 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). DLBCL is a subtype of Non-Hodgkin Lymphomas (NHLs). DLBCL is expected to impact approximately 26,000 patients in the U.S. in 2018. 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 (1).
About Triumvira Immunologics
(1) Cancer. 2017 Sep 1;123(17):3326-3334
SOURCE: Triumvira Immunologics