- Company Plans to Initiate Multi-center, Phase 1 Trial in Second
Half of 2017 -
- ACTR707 is Optimized for Development in Both Hematologic and Solid
Therapeutics, a clinical stage biopharmaceutical company developing
a universal cellular immunotherapy to treat multiple cancers, today
announced that an investigational new drug (IND) application for ACTR707
in combination with rituximab for the treatment of adult patients with
relapsed/refractory CD20-positive B cell non-Hodgkin lymphoma, is now
active. The IND, which the Company had filed in the United States with
the Food and Drug Administration, enables Unum to initiate a
multi-center Phase 1 trial. This will be the second clinical trial for
Unum Therapeutics. The Company has an ongoing clinical trial evaluating
ACTR087, Unum’s most advanced product candidate, in combination with
rituximab, in the same patient population (ClinicalTrials.gov
ACTR707 incorporates the costimulatory domain of CD28 and additional
changes relative to ACTR087 to increase cytokine secretion and
proliferation. The new variant shows increased activity against a number
of different tumor cell types and the ability to persist through
repeated rounds of antigen stimulation.
“Given ACTR’s universal cellular immunotherapy potential, Unum has
undertaken a comprehensive screening effort to identify ACTR variants
with a range of biological activities, selecting the most promising for
development in hematologic and solid tumors”, said Charles
Wilson, PhD, Unum’s President and Chief Executive Officer. “ACTR707
is an optimized ACTR construct, selected on the basis of its strong
performance in preclinical tests to assess activity not only in
hematologic cancers, but also in solid tumor settings. This represents
an important step as we continue to develop a broad pipeline of novel
product candidates based on our universal ACTR technology”.
“In pre-clinical testing, ACTR707 has demonstrated potent activity in
combination with a broad range of tumor-targeting antibodies for use in
a variety of cancer indications”, said Michael
Vasconcelles, MD, Unum’s Chief Medical Officer. “As a first step, we
are eager to explore the potential of ACTR707 in combination with
rituximab, as a new treatment option for underserved patients with
relapsed/refractory B cell non-Hodgkin lymphoma. This will enable rapid
assessment of ACTR707 in the clinic and a comparison with ACTR087 in the
same patient population.”
Site initiation activities are currently underway and the Company
anticipates that enrollment will begin in the second half of 2017.
is an open label Phase 1 dose-escalating study of genetically modified
ACTR707 T cells in combination with rituximab in patients with relapsed
or refractory CD20-positive B cell non-Hodgkin lymphoma. The primary
objective of this trial is to evaluate the safety and tolerability of
ACTR707 in this study population. Secondary objectives will include the
assessment of anti-tumor activity of ACTR707 and measurements of
durability and persistence of ACTR707 in the blood. The trial will be
conducted at several clinical sites in the U.S. and is planned to enroll
up to 38 patients.
About Antibody-Coupled T-cell Receptor (ACTR) Technology
Unum’s proprietary ACTR is a chimeric protein that combines components
from receptors normally found on two different human immune cell types –
natural killer (NK) cells and T cells – to create a novel approach to
cancer cell killing. T cells bearing the ACTR receptor protein can be
directed to attack a tumor by combining with a monoclonal antibody that
binds antigens on the cancer cell surface.
In contrast to other T cell therapy approaches for cancer that are
limited to a single cancer cell surface target and, therefore, treat a
narrow set of tumors, Unum’s approach is not restricted by a specific
tumor cell antigen and, thus, may have applications for treating many
different types of cancers when combined with the right antibody.
Unum is developing ACTR in combination with a range of tumor-targeting
antibodies for use in both hematologic and solid tumor indications.
ACTR087 in combination with rituximab, an anti-CD20 antibody, is Unum’s
most advanced product candidate. ACTR707 in combination with rituximab,
will be Unum’s second clinical-stage product candidate.
About B-cell non-Hodgkin Lymphoma
B-cell non-Hodgkin lymphoma, a collection of many distinct forms of
cancer arising from specific immune cells called B lymphocytes, is one
of the most common cancers in the United States. The American Cancer
Society estimates that in 2016 alone, approximately 72,000 people will
be diagnosed with this disease.1 Though B-cell non-Hodgkin
lymphoma is treatable with a variety of available cancer medicines, and
some forms of the disease may be curable with initial chemotherapy-based
treatment, patients whose disease relapses after treatment or is
refractory to available therapies face limited treatment options, and
historically their outcomes are poor.
About Unum Therapeutics
Unum Therapeutics uses its proprietary Antibody-Coupled T cell Receptor
(ACTR) technology in combination with tumor-targeting antibodies, which
is designed to activate the body’s own immune system to fight cancer.
Unum is actively building a pipeline of ACTR programs in which
proprietary, tumor-targeting antibodies are armed to improve their
therapeutic potential. The Company is headquartered in Cambridge, MA.
For more information, visit www.unumrx.com/.
American Cancer Society. Non-Hodgkin Lymphoma. http://www.cancer.org/acs/groups/cid/documents/webcontent/003126-pdf.pdf
Accessed May 20, 2016
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Unum Therapeutics Inc.Jeff Michaels, +1-617-843-3820Corporate_Communications@unumrx.com