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

AUSTIN, Texas & HAMILTON, Ontario–(BUSINESS WIRE)–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 [email protected].

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

Contacts

Triumvira Immunologics Inc.
LaVoieHealthScience
Katie
Gallagher
Phone: +1-617-374-8800, Ext. 109
[email protected]
www.triumvira.com
[email protected]