Focus on: Core Facilities
Facility Supports Development of New Immune-Based Therapies for Cancer
Immunotherapy, which harnesses the patient’s immune system to fight disease, provides a promising avenue for effective cancer treatments. However, many of these new treatments require specialized testing, as well as special expertise and facilities for manufacturing. At the University of Chicago Medicine Comprehensive Cancer Center (UCCCC), investigators interested in conducting novel immunotherapy clinical trials can take advantage of the unique services provided by the Human Immunologic Monitoring-current Good Manufacturing Practice (HIM-cGMP) Facility.
The HIM-cGMP Facility manufactures clinical-grade immunotherapy products, including cell-based cancer vaccines that boost a patient’s immune response against their tumor. These products are made in a special “clean room” environment where the air quality is regulated and staff are required to dress in sterile gowns. A major role of the Facility is to ensure compliance with U.S. Food and Drug Administration regulations known as current Good Manufacturing Practices (cGMPs) on safety, identity, purity, and strength of the manufactured products being administered to patients.
“Using cells as drugs follows similar safety requirements as pharmaceuticals, but the challenges are different,” said Amittha Wickrema, PhD, associate professor of medicine and scientific co-director of the HIM-cGMP Facility.
The Facility also helps researchers perform assays, including analyses of cytokines in serum, and gene expression analyses in tumor biopsies, to measure the immune response induced by various therapeutic interventions in patients participating in clinical trials. The specialized analyses for these studies benefit from interfacing with other UCCCC shared core facilities, such as the Genomics Core Facility, the Cytometry and Antibody Technology Facility, and Human Tissue Resource Center, to analyze and correlate the data with clinical outcomes. This information helps determine, for example, the optimal dose of a vaccine needed to elicit the appropriate immune response.
“There are a lot of questions to ask within the framework of personalized medicine,” said HIM-cGMP Facility Scientific Co-Director Thomas F. Gajewski, MD, PhD, professor of pathology and medicine. “We are always searching for biomarkers that can tell us which patients respond to which therapy and if they don’t, then why not.”
The Facility also offers customized assistance to investigators who are interested in translating their laboratory ideas into clinical research protocols.
To date, immunotherapy trials have been explored in melanoma, pancreatic cancer, leukemia, prostate cancer, and kidney cancer. Dr. Gajewski said the portfolio is expanding. He added that the recruitment of a national expert, Michael Bishop, MD, professor of medicine, to lead the University of Chicago Medicine hematopoietic stem cell transplant program will result in novel treatments for lymphoma, leukemia, and multiple myeloma. One of Dr. Bishop’s research interests is to find ways to enhance immune effects of transplanted cells against cancer.
By manufacturing therapeutic cancer vaccines and measuring biological responses, the HIM-cGMP Facility plays a central role in developing new targeted immunotherapeutics for cancer.