Unum Therapeutics Announces Active Investigational New Drug (IND) Application for ACTR087 in Patients with Relapsed/Refractory B-cell Lymphoma
Company Focused on Initiating Multi-center, Phase 1 Trial in Second Half of 2016 –
CAMBRIDGE, MA, June 20, 2016 – a clinical stage biopharmaceutical company developing a universal cellular immunotherapy to treat multiple cancers, today announced that the investigational new drug (IND) application for ACTR087 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 to evaluate the use of ACTR087 in combination with rituximab in this patient population. This trial will be the first U.S.-based clinical program for Unum Therapeutics.
?“This is an important milestone in our strategy to identify and develop ACTR T-cell immunotherapies to combat a broad range of cancers,” said Michael Vasconcelles, MD, Unum’s Chief Medical Officer. “We are eager to explore the potential of ACTR087 to become an important new treatment option for underserved patients with relapsed/refractory B-cell non-Hodgkin lymphoma. We’re excited to be working with experienced clinical investigators at several leading U.S. academic medical centers in this trial.”
Site initiation activities are currently underway and the Company anticipates that study enrollment will begin in the second half of 2016. ACTR087, Unum’s most advanced product candidate, combines the Company’s proprietary Antibody-Coupled T-cell Receptor (ACTR), with rituximab, an anti-CD20 antibody. By binding to tumor cells, rituximab effectively targets the tumor for destruction by the genetically modified ACTR087 T-cells.
“ACTR087 is Unum’s first product candidate with an active IND. This marks an important step as we advance our clinical efforts and continue developing a broad pipeline of novel product candidates based on our universal ACTR technology,” said Charles Wilson, PhD, Unum’s President and Chief Executive Officer.
This trial will be an open label Phase 1 dose-escalating study using three doses of genetically modified ACTR 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 ACTR087 in patients with relapsed or refractory CD20-positive B-cell lymphoma. Secondary objectives will include the assessment of efficacy of ACTR087 and measurements of durability and persistence of ACTR087 in the blood. The study will be conducted at several clinical sites in the U.S. and is planned to enroll approximately 45 patients.
?About Antibody-Coupled T-cell Receptor (ACTR) Technology and ACTR087
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 cancer cell killing activity. 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, Unum’s most advanced product candidate, combines Unum’s proprietary ACTR, with rituximab, an anti-CD20 antibody. The ACTR087 study will be the first clinical trial using a viral vector to permanently insert the ACTR gene into the genome of patient T-cells.
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.[i] 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.
Unum uses proprietary T-cell engineering technology in combination with tumor-targeting antibodies to activate the body’s own immune system to fight cancer. The Company’s lead program, based on its Antibody-Coupled T-cell Receptor (ACTR) technology, is in Phase 1 clinical testing to assess its safety and efficacy. The company is headquartered in Cambridge, MA. For more information, visit www.unumrx.com.
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