Juno will provide research funds to Fred Hutch for pre-clinical and clinical research focused on developing improved cancer immunotherapies. The CTU will consolidate trial participants’ care into one location and will also feature a dedicated space for research teams to handle specimens and collect trial data.
"This new Clinical Trials Unit will allow us to study patients undergoing these new therapies carefully and safely, bringing experts in immunotherapy together with specialists in surgery, radiology, pathology, and nursing," Fred Appelbaum, M.D., executive vice president and deputy director of Fred Hutch, told Outsourcing-Pharma.com.
"Progress in the fight against cancer requires carefully performed clinical studies, and we believe this is the best structure in which to perform those studies." he added.
In addition to June and Fred Hutch, The University of Washington and the Seattle Cancer Care Alliance (SCCA), are also investing in the CTU.
“The new unit is, as far as we know, the first of its kind dedicated to the study and treatment of patients undergoing a new and very exciting form of cancer therapy involving the use of genetically engineered immune cells,” explained Appelbaum.
The announcement follows encouraging preliminary results from an ongoing Juno-funded Phase I/II trial (NCT01865617) of an experimental T cell immunotherapy.
“This form of therapy consists of taking a patient’s own immune cells, and manipulating them so that they react against the patient’s tumor,” explained Appelbaum.
Fred Hutch announced that 27 of 29 patients with acute lymphoblastic leukemia showed no trace of cancer in their bone marrow following infusion with the therapy. Additionally, 19 of 30 non-Hodgkin's lymphoma patients experienced partial or complete responses.
“Early results … have been amazing, with over a 93% complete response rate in patients who have failed every other form of therapy,” added Appelbaum.
“Immuno-oncology, and in particular, T cell therapies are advancing at a rapid pace, and translational medicine and clinical care of patients need to move as quickly as the basic science,” said Mark J. Gilbert, M.D., Juno’s Chief Medical Officer. “We are pleased to work with these world-leading institutions to accelerate the pace of learning for the field and the standard of care for patients.”
The CTU is expected to begin operations in mid-2016 and will be available for studies supported by the company and other drug developers.