CAMBRIDGE, Mass.--(BUSINESS WIRE)--Unum Therapeutics Inc., a clinical stage biopharmaceutical company developing a universal cellular immunotherapy to treat multiple cancers, today announced that an investigational new drug (IND) application is now active for ACTR087 T cells in combination with a novel antibody, SEA-BCMA, for the treatment of adult patients with relapsed/refractory multiple myeloma. The IND, which the Company 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 first novel-novel Antibody Coupled T cell receptor (ACTR)-antibody combination. It will also be the first program under Unum’s global collaboration with Seattle Genetics (Nasdaq: SGEN) to enter clinical development, and Unum’s third clinical trial with an ACTR T cell therapy.
“Despite significant advances in the multiple myeloma field over the past 15 years, there remain significant unmet medical needs in the treatment of the disease, as almost all patients eventually become refractory to therapy,” said Michael Vasconcelles, MD, Unum’s Chief Medical Officer. “B cell maturation antigen, or BCMA, is considered an attractive therapeutic target for cellular immunotherapies, due to its high and selective expression on the surface of malignant plasma cells in multiple myeloma and its potential role in survival and growth of myeloma cells. We are eager to assess the potential of ACTR087 in combination with SEA-BCMA to become an important new therapy for multiple myeloma patients.”
Site initiation activities are currently underway and the Company anticipates to initiate patient dosing in Q1 2018.
The ATTCK-17-01 trial is an open-label Phase 1 adaptive dose-escalating study of genetically modified ACTR087 T cells in combination with SEA-BCMA, a novel humanized non-fucosylated anti-BCMA antibody developed using Seattle Genetics’ sugar-engineered antibody (SEA) technology, in patients with relapsed or refractory multiple myeloma. The primary objective of this trial is to evaluate the safety and tolerability of ACTR087 in combination with SEA-BCMA in this study population and determine the recommended Phase 2 dose of the combination. Secondary objectives include patient response measured using the International Myeloma Working Group (IMWG) Response Criteria for Multiple Myeloma, and ACTR087 persistence, as well as safety and tolerability of SEA-BCMA. The trial will be conducted at several clinical sites in the U.S.
Unum and Seattle Genetics entered into a global strategic collaboration in June 2015, to develop and commercialize novel ACTR combination therapies for cancer.
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 antibodies.
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, currently in Phase I clinical testing for the treatment of adult patients with relapsed/refractory CD20-positive B cell non-Hodgkin lymphoma. ACTR707, is Unum’s second program to enter Phase I clinical testing in combination with rituximab in the same patient population. The Company anticipates that enrollment in this trial will begin in the second half of 2017. ACTR087 in combination with SEA-BCMA will be the Company’s third program to enter clinical development.
About Multiple Myeloma
Multiple myeloma (MM) is a hematologic malignancy characterized by proliferation of monoclonal plasma cells in the bone marrow and/or extramedullary sites; it accounts for 1.8% of all cancers and approximately 13% of all hematologic malignancies (SEER CSR). The American Cancer Society estimates that in 2017 alone, approximately 30,280 people will be diagnosed with this disease with a higher incidence and prevalence in the elderly. Combination regimens consisting of immunomodulatory agents, proteasome inhibitors and corticosteroids, constitute the backbone of treatment in newly diagnosed MM patients. However, almost all patients with MM who survive initial treatment will eventually relapse and require further therapy. Despite current treatment advances, MM remains largely incurable, necessitating indefinite, sequential therapies and the need for novel therapies in the setting of disease relapse or progression. BCMA (or CD269) has recently emerged as a promising candidate antigen for therapeutic targeting in MM its universal expression on MM cancer cells.
About Unum Therapeutics
Unum Therapeutics uses its proprietary Antibody-Coupled T cell Receptor (ACTR) technology in combination with tumor-targeting antibodies, to activate the body’s own immune system to fight cancer. Unum is actively building a pipeline of ACTR programs in combination with a wide range of proprietary, tumor-targeting antibodies for use in both hematologic and solid tumor indications. The Company is headquartered in Cambridge, MA. For more information, visit www.unumrx.com/.