Home / FDA News / FDA Grants Fast Track Designation to Triumvira’s TAC01-CD19 for Treatment of Relapsed or Refractory DLBCL

FDA Grants Fast Track Designation to Triumvira’s TAC01-CD19 for Treatment of Relapsed or Refractory DLBCL

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 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.

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) receptor which is structurally and biologically distinct from CAR-T. The first of our pipeline product candidates, TAC01-CD19 is a novel T-cell therapy product targeting CD19, a validated target in lymphomas and leukemias. 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). DLBCL is a subtype of Non-Hodgkin Lymphomas (NHLs). DLBCL impacted approximately 26,000 patients in the U.S. in 2018. While the objective response rates of 50 – 70% observed for treatment of large B-cell lymphomas with currently marketed patient-derived T-cell products are good, there still exists a significant percentage of patients who either do not benefit from treatment or who are not able to tolerate the serious toxicities associated with these products.

About U.S. FDA’s Fast Track Designation Program

The FDA’s Fast Track program was established to facilitate the development and expedite the review of drugs with the potential to treat serious conditions and address an unmet medical need. Companies that receive Fast Track designation are provided the opportunity for more frequent interactions with FDA during clinical development and are eligible for accelerated approval and/or priority review, if relevant criteria are met. Additionally, companies that receive Fast Track designation are allowed to submit completed sections of their New Drug Application (NDA) or Biologics License Application (BLA) for the drug on a rolling basis, resulting in the potential for an expedited FDA review process.

About Triumvira Immunologics

Triumvira Immunologics, Inc. (“Triumvira”) is a clinical stage immunotherapy company with the vision of developing novel T-cell therapies that are safer and more efficacious than current cell therapy cancer treatments, including chimeric antigen receptor (CAR) and engineered T-cell receptor (TCR) therapies. Our proprietary T-cell Antigen Coupler (TAC) technology recruits the entire natural T-cell receptor and functions independent of the Major Histocompatibility Complex (MHC), 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, our corporate offices are in Austin, Texas, with our research facilities in Hamilton, Ontario. For more information, visit www.triumvira.com or send email inquiries to partners@triumvira.com.

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