It was opening day at the new Translational and Clinical Research Centers (TCRC) at Massachusetts General Hospital and Michael Bamber was reclining comfortably in a chair receiving a new drug he hoped would stop his kidney disease in its tracks.
Surrounded by his wife, doctor and nurse, the retired university professor from Georgia felt the drug flow into his arm as he became one of the first 15 patients in the world to receive the therapy for his autoimmune condition.
The TCRC, where he sat, is part of Mass General’s new effort to encourage innovation and collaboration between industry and Mass General’s preeminent clinical researchers. The TCRC houses both the Clinical Research Center (CRC), founded at Mass General in 1925, and the hospital’s new Translational Research Center (TRC).
Equipped with the latest technology and a highly skilled staff, the TCRC connects Mass General’s world-renowned doctors and patients, like Mr. Bamber, with biotech and pharmaceutical companies anxious to study new medical therapies.
Innovation in Clinical Research
The 18-bed TCRC paves the way for an unprecedented level of clinical research collaboration, says Mason Freeman, MD, director of Mass General’s Translational Research Center. Drug and medical device companies need access to expert doctors and their patients to do all-important early clinical trials, he explains. And the hospital’s clinical researchers, as part of the Mass General Research Institute, need new drugs to test, funding for studies, and a chance to bring new treatments to their patients.
The new TCRC has the added benefit of helping Mass General attract and retain outstanding clinical researchers by giving them an in-house opportunity to run clinical trials.
The new TCRC has the added benefit of helping Mass General attract and retain outstanding clinical researchers by giving them an in-house opportunity to run clinical trials. But at the end of the day, it is the patients who benefit, Dr. Freeman says.
“We’re not just here to be partners with industry,” he says, “If we don’t do this, drugs do not get made in the United States for the patients who need them.”
New Bridge to Industry
The mandate is strong, says Harry Orf, PhD, senior vice president for Research at Mass General. “Hospital leadership understands how critical such innovation is to the hospital mission of providing the best healthcare possible and improving medicine for all,” he says. With this in mind, the hospital dedicated $11 million to build the new space, which opened in October.
A major goal of the TCRC is to bridge the long-standing gulf between industry and hospital-based research. Mass General has the largest hospital-based research program in the U.S.
“I broker these partnerships,” Dr. Freeman says. “We have 1,500 disease experts across pretty much every human disease at Mass General.” Even the biggest pharmaceutical companies need these medical experts to help them understand the diseases they’re trying to treat with their new drugs.
New Drug for a New Disease
Mr. Bamber’s new treatment is a drug developed by Xencor, a biopharmaceutical company that makes drugs known as monoclonal antibodies. Such drugs treat autoimmune diseases, asthma, allergies and cancer.
The drug is so new it is known as XmAb5871. In the TCRC study, it is intended to halt the progress of a newly identified disease called IgG4-related disease. The disease threatens Mr. Bamber’s kidneys and, without proper diagnosis and treatment, his life, says John Stone, MD, MPH, chief of Clinical Rheumatology in the Department of Medicine at Mass General.
Steroid drugs have helped some patients, but they can cause harmful side effects. A drug called rituximab provides some relief but it has become difficult to obtain.
When Xencor approached Dr. Stone, a world leader in IgG4-related disease, he recognized an opportunity to target this condition with a treatment seemingly made with IgG4-related disease in mind. He and Dr. Freeman went to work, developing a budget, setting up the collaboration with Xencor, and arranging to meet the many demanding protocols of a “first-in-patient” study. Xencor is funding the trial and also helping patients cover some travel expenses.
Promising Early Results
For Mr. Bamber, the news that Dr. Stone was launching a clinical trial of a new drug was exciting. He called Mass General, seeking to be included in the study.
Working in close collaboration with Xencor, Dr. Stone has tested the new drug in 15 patients. Preliminary results from the first 11 patients show that nine, including Mr. Bamber, have seen major improvements under the new regimen.
“I feel totally fine now,” Mr. Bamber said recently while sitting with his wife at the TCRC receiving one of his last few infusions. Dr. Stone says the drug has stopped the progression of his disease.
“You have plenty of good kidney function now to last for as long as you need it,” Dr. Stone told him, “and with careful monitoring, we will keep it that way.”
The promising early results with XmAb5871, Dr. Stone says, are prompting Xencor to consider a worldwide trial that would involve sites in North America, Asia, and Europe – with roots at Mass General.
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