True North Presents Additional Data from an Ongoing Clinical Study Showing Normalization of Hemoglobin Levels with TNT009 in ...
December 03 2016 - 12:30PM
Business Wire
Oral and Poster Presentations at the 2016
American Society of Hematology Annual Meeting
True North Therapeutics, a clinical stage biotechnology company
developing novel product candidates that selectively inhibit the
Complement system, presented updated clinical data today from an
ongoing Phase 1b trial of TNT009 for the treatment of Cold
Agglutinin Disease (CAD), a rare form of autoimmune hemolytic
anemia. These interim clinical results further support TNT009 as a
promising treatment for CAD, given the normalization of hemoglobin
levels seen in severely anemic CAD patients. The data are described
in oral and poster presentations by True North researchers and
collaborators at the American Society of Hematology (ASH) annual
meeting on December 3 - 6, 2016 in San Diego.
“We are highly encouraged by the growing body of efficacy and
safety data of TNT009, enabling us to address an underserved CAD
patient population,” said Nancy Stagliano, PhD, Chief Executive
Officer of True North Therapeutics. “Based on these results, we are
actively working with the treatment community to rapidly advance
the clinical program for TNT009 as a potential new therapeutic for
CAD patients.”
The additional data from the ongoing clinical study demonstrated
robust activity of TNT009 in patients with CAD, as described in the
oral presentation titled “TNT009 Prevents Erythrocyte C3 Fragment
Opsonization and Rescues Reticulocytes from Destruction in Patients
with Cold Agglutinin Disease” and the poster presentation titled
“Chronic Inhibition of Complement C1s by TNT009 Produces Sustained,
Complete Remission in Patients with Severe, Transfusion-Dependent
Cold Agglutinin Disease (CAD).”
The clinical data were reported on six CAD patients. All
patients were dosed with TNT009 in the Phase 1b trial, followed by
treatment under a named patient provision for some patients. The
named patient provision was requested by the treating physicians
and allowed for continued access to TNT009, treating some patients
for over 3 months. Among the six patients in the Phase 1b trial,
one patient had an active malignancy, a lymphoma with 70% bone
marrow infiltration. Highlights from the presentations at ASH
include:
- All five CAD patients without an active
malignancy had a sustained response with improvements in hemoglobin
of approximately 4-5 g/dL, reaching hemoglobin levels of >
12g/dL.
- Patients that required transfusions
immediately prior to dosing in the Phase 1b trial became
transfusion-free during treatment with TNT009.
- TNT009 was safe and well-tolerated in
the study, with no serious or severe drug-related adverse
events.
- The clinical data support TNT009’s
mechanism of inhibition of the Classical Complement pathway, by
showing reductions of C3 opsonized red blood cells concurrent with
improvement in hemoglobin levels.
TNT009 is a first-in-class monoclonal antibody that selectively
inhibits the Classical Complement pathway by targeting C1s, a
serine protease within the C1-complex in the Complement pathway of
the immune system. Positive interim results from the ongoing Phase
1b study in patients with CAD were initially presented in June 2016
at the 21st Congress of the European Hematology Association (EHA).
True North received Orphan Drug Designation for TNT009 from the
U.S. Food and Drug Administration (FDA) and the European Medicines
Agency (EMA).
About Cold Agglutinin Disease (CAD)CAD is an autoimmune
hemolytic anemia in which autoantibodies target and destroy red
blood cells, causing anemia, fatigue and potentially fatal
thrombotic events. The prevalence of primary CAD is approximately
sixteen per million. There are limited treatment options available
and many of these patients, despite therapy, have moderate to
severe anemia. True North sponsors a patient registry for CAD and
other autoimmune hemolytic anemias, called the COMPASS Registry
(https://www.compassregistry.org/), dedicated to advancing a deeper
understanding of these diseases, engaging with patients, and
supporting clinical trial recruitment.
About TNT009TNT009 is a first-in-class monoclonal
antibody that selectively inhibits the Classical Complement pathway
by targeting C1s, a serine protease within the C1-complex in the
Complement pathway of the immune system. TNT009 thereby prevents
downstream disease processes involving phagocytosis, inflammation,
and cell lysis. With a unique mechanism of action and high target
specificity, TNT009 selectively inhibits disease processes in the
Classical Complement pathway while maintaining the important immune
surveillance provided by the Alternative Complement Pathway and
Lectin Complement Pathway. TNT009 is currently in clinical
development for the treatment of Cold Agglutinin Disease (CAD), a
rare hematological disease. Because numerous other diseases are
known to share the basic underlying pathological mechanism
addressed by TNT009, the potential for other indications is
clear.
About True North TherapeuticsTrue North Therapeutics is a
clinical stage biopharmaceutical company focused on the discovery,
development, and commercialization of first-in-class product
candidates for Complement-mediated diseases. The company’s lead
product candidate, TNT009, is designed to selectively inhibit a
target in the Classical Complement pathway. True North’s antibody
drug development is focused on the treatment of certain rare
diseases mediated by the Complement system in hematology,
transplantation, and dermatology. True North Therapeutics is
located in South San Francisco, California. For more information,
please visit www.truenorthrx.com.
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The Yates NetworkKathryn Morris,
845-635-9828kathryn@theyatesnetwork.com