CAMBRIDGE, Mass.--(BUSINESS WIRE)--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/.
American Cancer Society. Non-Hodgkin Lymphoma. http://www.cancer.org/acs/groups/cid/documents/webcontent/003126-pdf.pdf Accessed May 20, 2016