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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

May 1, 2019

AUSTIN, Texas & HAMILTON, Ontario--(BUSINESS WIRE)--May 1, 2019--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.

About TAC01-CD19

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

Triumvira Immunologics, Inc. (Triumvira) is an immunotherapy company co-founded in 2015 by Dr. Jonathan Bramson at McMaster University and Bloom Burton & 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 (CAR) and engineered T cell receptor (TCR) therapies. Our proprietary T cell Antigen Coupler (TAC) technology recruits the entire natural T cell receptor and is 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, and our research facilities in Hamilton, Ontario. For more information, visit www.triumvira.com  or send email inquiries to  partners@triumvira.com.

(1) Cancer. 2017 Sep 1;123(17):3326-3334

View source version on businesswire.com:https://www.businesswire.com/news/home/20190501005171/en/

CONTACT: Triumvira Immunologics Inc.

LaVoieHealthScience

Katie Gallagher

Phone: +1-617-374-8800, Ext. 109

kgallagher@lavoiehealthscience.com

www.triumvira.com

partners@triumvira.com

KEYWORD: UNITED STATES NORTH AMERICA CANADA TEXAS

INDUSTRY KEYWORD: HEALTH BIOTECHNOLOGY ONCOLOGY PHARMACEUTICAL FDA

SOURCE: Triumvira Immunologics Inc.

Copyright Business Wire 2019.

PUB: 05/01/2019 07:00 AM/DISC: 05/01/2019 07:01 AM

http://www.businesswire.com/news/home/20190501005171/en

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