Unum Therapeutics Announces Active Investigational New Drug (IND) Application for ACTR707 in Combination with Rituximab in Pa...
June 19 2017 - 7:30AM
Business Wire
- Company Plans to Initiate Multi-center, Phase
1 Trial in Second Half of 2017 -
- ACTR707 is Optimized for Development in Both
Hematologic and Solid Tumors -
Unum 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
No. NCT02776813).
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.
This trial 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/.
1
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