Promising results in the use of genetically engineered immune cells to combat cancer has led to the creation of a first-of-its-kind clinical trials unit (CTU) dedicated to immuno-oncology.

Seattle-based Juno Therapeutics, a biopharmaceutical company focused on re-engaging the body’s immune system to fight cancer, and the Fred Hutchinson Cancer Research Center, which pioneered work in bone marrow transplantation, are joined in the CTU venture by the University of Washington and the Seattle Cancer Care Alliance (SCCA). Juno also is providing research funds to Fred Hutch in support of preclinical and clinical research focused on cancer immunotherapies.

“Establishing this clinical trials unit is vital to accelerating our lifesaving research,” Fred Hutchinson President and Director Gary Gilliland, M.D., Ph.D., said. “We are on the precipice of multiple curative therapies, and the investment of Juno and the SCCA in our science will be catalytic in moving our discoveries into patients.”

“Immuno-oncology and T-cell therapies in particular 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. Our ongoing CAR T-cell trials have highlighted the opportunity for strong translational medicine to improve our therapies and for dedicated clinical scientists to improve patient outcomes.”

Fred Appelbaum, M.D., executive vice president and deputy director of Fred Hutch, who also serves as SCCA’s executive director and president, said the new CTU is designed to specifically support the complex science and patient care involved in removing, genetically engineering and returning T-cells to cancer patients.

“In order to make these therapies better, it requires that patients be studied very carefully and in depth,” Appelbaum explained. “We believe patients can be treated most safely, and studied most effectively, in a specialized unit where physicians, nurses, data managers and others are familiar with the technology and the complications, and how to treat them. We’re very excited about it.”

In a recent experimental T-cell immunotherapy trial with lymphoblastic leukemia patients who had failed all other therapies, the complete response rate at Fred Hutch was 94%. “We hadn’t seen anything that dramatic in many, many years of clinical investigation,” Appelbaum said, crediting the work of scientists that include Drs. David Maloney, Cameron Turtle and Stan Riddell. “The results have been jaw-dropping.”

Appelbaum, who has been working in cancer therapeutics for four decades, compares immuno-oncology advances to some of the greatest breakthroughs in the field. “Marrow transplantation was the first revolutionary therapy I witnessed that changed how we treat patients. The second was monoclonal antibodies, and again that had a profound effect. I would have to say that this is at least as revolutionary, and potentially more so, than those therapies.”

The approach taken to develop this new CTU was out of the ordinary. Nurses, researchers, clinicians and patients were assembled as an advisory group. Fred Hutch rented a warehouse and built a life-sized cardboard model of the ward. Group members moved the pieces around to determine the best approach for efficiency, traffic flow, patient comfort, aesthetics and more.

“It was a fun process,” Appelbaum recalls. “You’d walk through the first time, then you came back two days later and it looked entirely different.”

The CTU is expected to be operational in mid-2016 and will be available for studies supported by Juno and other drugmakers.

Appelbaum anticipates similar immunotherapy success in treating other types of cancer. “The results are so astounding that we are very eager to see this pursued in settings other than leukemia and lymphoma where it seems to be working so dramatically well,” he said.

The extent to which genetically engineered immune cells can be adapted to common solid tumors, such as breast, pancreatic, lung and prostate cancers, is yet to be seen.  “Those studies are now being initiated,” Appelbaum said. “In some settings we are seeing encouraging responses, but it’s really in the early days. But I would be both disappointed and surprised if it doesn’t find a role in the treatment of a number of solid tumors in a very profound way.” 

Lisa Catanese, ELS, has been a medical writer and editor since 1986, covering clinical trials, medical research, newly approved drugs and devices, consumer health education, continuing medical education and more. She is a member of the American Medical Writers Association and is certified by the Board of Editors in the Life Sciences. Email Lisa@BlueBlazeCommunications.com.

This article was reprinted from Volume 20, Issue 10, of CWWeekly, a leading clinical research industry newsletter providing expanded analysis on breaking news, study leads, trial results and more. Subscribe »