Vaccines help educate the immune system to recognize and eliminate harmful antigens and cells. There are prophylactic vaccines that prevent people from getting sick and therapeutic vaccines that treat people who already have a disease or sickness. To treat cancer both prophylactic and therapeutic vaccines are in development. The concept of using the immune system to help prevent and treat cancer is not a new idea. There have been more than 700 completed clinical studies and there are more than 450 active clinical trials involving cancer vaccines.
The Hepatitis B Vaccine (HBV) approved in 1981 could be considered the first cancer vaccine because prolonged HBV infection can lead to liver cancer. The human papillomavirus (HPV) vaccine, approved by the FDA in 2008, is another prophylactic cancer vaccine. It can prevent cervical as well as head and neck cancers caused by HPV.
Prophylactic vaccines are limited in the fight against cancer because there are only a handful of viruses known to cause cancer, therefore there is a major need for therapeutic cancer vaccines. Despite significant challenges like overcoming immune suppression and differentiating tumor cells from healthy cells, therapeutic cancer vaccines have recently gained interest from investors, scientists, and doctors around the globe. Innovative technologies and recent approvals are fueling this interest, such as oncolytic virus vaccines, which use viruses that are engineered to infect and kill cancer cells. Another interesting cancer vaccine approach involves removing a tumor, processing it, and presenting it back to the body with an adjuvant to help stimulate the immune system to attack tumor cells. Recent advances in our ability to block or reduce immune suppression with molecules like anti-PD-L1 antibodies have caused combination therapeutic cancer vaccine strategies to gain momentum. One of the biggest drivers of interest to the cancer immunotherapy field is chimeric antigen receptor T cell therapy (CAR T cell therapy), with two recent FDA approvals. The first was developed by University of Pennsylvania, Children’s Hospital of Philadelphia, and Novartis and approved by the FDA in August 2017 for certain children and young adults with a form of acute lymphoblastic leukemia (ALL). The second was developed by Kite, a Gilead Company and approved by the FDA in October 2017 for treatment of adults with relapsed or refractory Large B-Cell Lymphoma. (see New Modalities blog)
Anyone developing a cancer vaccine needs to characterize immune responses to help determine if their vaccine is working and to possibly identify a population of people or patients who will respond positively to their vaccine. KCAS Bioanalytical and Biomarker Services can help with this immune response characterization by running Flow Cytometry and Biomarker Assays. Our Flow Cytometry and Cell Culture team can perform 10 color cell analysis and collectively has over 55 years of flow cytometry experience. We solve flow problems for our clients in many ways including identification of tumor infiltrating lymphocytes (TILs), intracellular cytokine analysis, in vitro stimulation drug assessments and exploratory biomarker development, ex vivo stimulation for biomarker analysis, data analysis assistance, flow cytometry design (including validation of flow protocols), processing/storage and proper handling of samples (fluids and tissues). We currently offer 15 qualified flow panels covering a wide range of diseases. (See KCAS Flow Panels)
KCAS has more than 50 qualified assays for human biomarkers (see list of biomarkers). Most applicable to characterizing immune responses are the proinflammatory panel (IFN-g, IL-10, IL-12p70, IL-13, IL-1b, IL-2, IL-4, IL-6, IL-8, TNF) and cytokine panel (GM-CSF, IL-12/IL-23p40, IL-15, IL-16, IL-17A, IL-1a, IL-5, IL-7, TNF-b, VEGF). Each panel consists of multi-plexed assays which are analyzed from a single sample. There are similar panels qualified in other species for those looking at immune responses in animal models and preclinical studies.
Many academic institutions, such as universities and hospitals, have core flow cytometry labs and biomarker analysis capabilities. However, many small- to medium-sized biotechnology companies attracted to these academic labs often find their projects are not a priority and the quality systems are not adequate for drug development. Contract Research Organizations like KCAS have a long and positive history with the FDA and are dedicated to making your cancer vaccine projects a priority.
Schedule a call today with KCAS’s senior scientific advisor to see if our services are a fit for your immune response characterization needs.