The LVR was formed by Dr. Diamond in 2000 to address priorities in vaccine research that will potentially impact patient outcomes at City of Hope (COH) and other cancer centers worldwide. In 2008, Dr. Diamond formed the TVR to expand the work started in the LVR towards additional tumor types and to accelerate clinical development of promising vaccine strategies. The foundation of the research priorities of the program grew out of the extensive collaboration with the Hematopoietic Stem Cell Transplant Program at COH, and the need for an effective therapeutic strategy for infections post-transplant (Tx). The infection that has historically played a major role in reducing Tx success rate is the herpes virus called cytomegalovirus (CMV). In 1993 an immunologic approach was developed for controlling this virus, and this work has continued. The TVR has a two pronged attack on virus infection using two different but allied approaches for therapy. The first approach relies on a non-living synthetic portion of the virus called a peptide that has cleared its safety hurdle after a successful clinical trial in healthy volunteers. The peptide is now undergoing preliminary efficacy testing in stem cell transplant recipients at COH. The goal of this trial is to measure if it is immunologically recognized. In cooperation with physicians at the University of Minnesota, we are expanding the evaluation to cover all types of stem cell transplant including cord blood. The goal is to discover if it is protective against CMV infection and substitutes for toxic anti-viral drugs that hamper recovery. The 2nd approach is nearing submission to the FDA for review and permission to conduct a 1st in humans safety trial. While the peptide applies to about 40% of transplant recipients, the newer approach would be universal in coverage. It is designed to protect both stem cell and solid organ transplant recipients. We anticipate the 1st safety trial to begin in late 2013.
Based on work initiated 2 decades ago with former COH surgical oncologist and clinical researcher, Dr. Joshua D.I. Ellenhorn, a Phase 1 safety trial of a cancer vaccine was started in early 2012. Gastro-intestinal patients with inoperable disease are receiving the vaccine, and TVR personnel are monitoring its immunologic recognition, while Dr. Vincent Chung, a COH medical oncologist is assessing clinical responses based on CT-scans. Using a different vector system based on an attenuated Salmonella strain, TVR investigators have developed a therapeutic strategy that applies to a large panel of solid tumors and melanoma. The strategy depends on using RNAi to deplete immunosuppressive molecules to allow anti-tumor immunity to flourish. We are also trying to adopt this therapy to brain cancer, where immunosuppression is strong and standard approaches have largely failed.
Continuing the theme of brain injury, we are pursuing a vaccine strategy to prevent birth defects that strongly impact lifelong cognitive abilities. Interestingly, the culprit is still CMV, but in this case it infects women of child-bearing years who were never previously exposed, and causes harm to over 4000 neonates annually in the USA. We are in the process of developing a more effective vaccine than one already investigated and found only to be 50% effective at controlling CMV infection in neonates.
We welcome inquiries about our ongoing programs which can be found as a sidebar together with the TVR investigators and outside collaborators who are leading the research effort.