CAMBRIDGE, Mass.--(BUSINESS WIRE)--Unum Therapeutics, a company developing a universal cellular immunotherapy to treat multiple cancers, announced today that it has received unanimous approval by the National Institute of Health’s (NIH) Recombinant DNA Advisory Committee (RAC) for its first U.S.-based clinical trial. The Phase 1 trial will evaluate Unum’s Antibody-Coupled T-cell Receptor (ACTR) platform in Non-Hodgkin Lymphoma (NHL) patients who have failed to respond or relapsed following treatment with chemotherapy plus rituximab. Under the protocol, Unum will co-administer ACTR T-cells and rituximab to target and attack CD20-positive tumor cells.
“The NIH RAC’s unanimous approval of our clinical trial protocol is an important achievement for Unum, allowing us to continue to advance towards clinical testing in the U.S.,” said Chuck Wilson, Ph.D., President & CEO of Unum Therapeutics. “We appreciate the RAC’s careful review and thoughtful input.”
“The RAC’s endorsement of our protocol is a critical milestone towards testing the safety of permanently modified ACTR T-cells plus rituximab in a population of patients without other therapeutic options,” added Michael Vasconcelles, M.D., Unum Therapeutics’ Chief Medical Officer.
Unum plans to file an investigational new drug (IND) application with the U.S. Food & Drug Administration (FDA) and to begin clinical testing for viral ACTR + rituximab in 2016. An investigator-sponsored Phase 1 trial, ATTCK20, is currently underway in Singapore evaluating co-administration of mRNA ACTR and rituximab in CD20-positive Chronic Lymphocytic Leukemia (CLL) and NHL patients.
The Recombinant DNA Advisory Committee (RAC) is a federal advisory committee that provides recommendations to the NIH Director related to basic and clinical research involving recombinant or synthetic nucleic acid molecules. In the case of biological products, FDA approval is required prior to clinical testing as part of the agency’s oversight of human gene transfer research. The FDA and the NIH, through the Recombinant RAC, reviews each clinical study protocol involving a gene therapy product.
The Antibody-Coupled T-cell Receptor (ACTR) is a chimeric protein that binds to tumor-targeting antibodies. When ACTR T-cells are put back into a patient, they can be targeted to attack tumors by co-administering cancer-specific antibodies. In contrast to other approaches that are limited to a single target and treat a narrow set of tumors, Unum’s approach is not restricted by antigen and may have applications for treating many types of cancers.
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.