Cancer Vaccine Development
Supported By CIBR CORE Services
The University of Maryland School of Medicine’s (UMSOM) Center for Innovative Biomedical Resources (CIBR) serves as a center of excellence for state-of-the-art technologies, high-tech instrumentation, and expertise that supports biomedical research, clinical practice, and health care in the state of Maryland and the region. This regular feature of SOMNews highlights UMSOM faculty who are seeing significant results from using CIBR Cores.
A major challenge in using a patient’s own cells as a therapy for cancer is that those cells must be handled through special processes called “GMP” (Good Manufacturing Practice). A GMP lab is required to ensure than the production of any medicine meets the Federal Drug Administration (FDA) requirements for consistency and quality. Aaron P. Rapoport, MD, the Gary Jobson Professor in Medical Oncology, Professor of Medicine, and the Director of the Blood and Marrow Transplant Program at the UM Marlene and Stewart Greenebaum Comprehensive Cancer Center, needed such a facility for his Phase II clinical trial that is testing a type of cell-based therapy for multiple melanoma.
The therapy being tested requires isolating both tumor cells (myeloma cells) and immune cells (dendritic cells) from the patient. These two types of cells are then cultured in a GMP lab under conditions that cause them to fuse together, forming dendritic cell-myeloma cell (DC/MM) fusions. The DC/MM cells are then injected back into the patient with the goal that the patient’s immune system will see these cells as foreign, leading it to attack myeloma cells. This kind of an anti-tumor immune response is similar to the response to a vaccine; thus, the DC/MM therapy is called DC/MM fusion vaccine or simply a myeloma vaccine. These are completely personalized therapies, because the cells used to make the DC/MM fusion vaccine come from the patient and are perfectly tailored to match the patient’s tumor.
“Not only was it a challenge to have a GMP lab to produce this cell-based vaccine, but it was also a challenge making the DC/MM fused cells for the vaccine,” Dr. Rapport notes.
Making this type of cell-based vaccine had never been done in any location other than at Beth Israel Deaconess Hospital in Boston, Mass., where the vaccine was initially developed. In order for the UMSOM to effectively participate in this multi-site clinical trial, the project needed strong support and coordination from multiple facilities, core labs, and the clinical research division.
This project involved the following CIBR Core services:
Offering pre-clinical and clinical experimental support to UMSOM researchers and physicians, including cell culture assays, mouse models, and patient sample isolation
Providing pathology, histology, and histotechnology services to assist with procurement, analyses, and clinicopathologic correlations of human tissue specimens.
According to Dr. Rapoport, the core lab staff were essential to producing the personalized vaccines used in the research and to developing the stringent manufacturing and quality environment to support the clinical trial. Staff members include Rena Lapidus, PhD, Associate Professor of Medicine; Olga Ioffe, MD, Professor of Pathology; Brandon Carter Cooper, MS; Ashley Cellini, PA (ASCP); Kim Hankey, PhD, Associate Professor of Radiation Oncology and Cell Processing Facility Director; Nancy Hardy, MD FACP, Associate Professor of Medicine and Collection/ Processing Facility Medical Director; and Quality Manager Clarissa Saba.