Triumvira Immunologics Announces Clearance of IND and CTA by U.S. FDA and Health Canada for Its First TAC T-cell Therapeutic Product Candidate, TAC01-CD19

Clinical trials of TAC01-CD19 expected to begin in third quarter 2019

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 both the U.S.
Food & Drug Administration
(FDA) and Health
Canada
have cleared Triumvira’s Investigational New Drug (IND) and
Clinical Trial Applications (CTA) for its novel T cell therapy product
TAC01-CD19 in patients with CD19-postive B-cell malignancies. The Phase
1/2 study (TACTIC-19) is expected to be initiated in the third quarter
of 2019.

Paul
Lammers,
MD, MSc., President and CEO of Triumvira commented,
“Obtaining FDA and Health Canada clearance of our first IND for this
novel approach fulfills our goal to be a clinical stage biotechnology
company and demonstrates our commitment to bringing this innovative
treatment to patients. TAC01-CD19 will be tested at five 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) technology
platform which is biologically
distinct from CAR-T. The first of our pipeline product candidates,
TAC01-CD19 is a novel T cell therapy product targeting CD19 for use in
B-cell malignancies. 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 is a subtype of Non-Hodgkin
Lymphomas (NHLs)and is expected to impact approximately 26,000 patients
annually in the U.S. 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.

About Triumvira Immunologics
Triumvira Immunologics, Inc.
(“Triumvira”) is a clinical stage 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, with our research facilities in Hamilton,
Ontario. For more information, visit www.triumvira.com or
send email inquiries to partners@triumvira.com.

Contacts

Triumvira Immunologics Inc.
via LaVoieHealthScience
Katie
Gallagher
Phone: +1-617-374-8800, Ext. 109
kgallagher@lavoiehealthscience.com
www.triumvira.com
partners@triumvira.com