Development of Cancer Immunoprevention Agents

Fast-Track proposals will be accepted. Direct-to-Phase II proposals will be accepted. Number of anticipated awards: 2-4 Budget (total costs, per award): Phase I: up to $400,000 for up to 12 months Phase II: up to $2,250,000 for up to 2 years PROPOSALS THAT EXCEED THE BUDGET OR PROJECT DURATION LISTED ABOVE MAY NOT BE FUNDED. Summary While therapeutic cancer vaccines and immunomodulatory drugs have been actively developed for many cancer indications, there is a significant unmet medical need to develop such agents for cancer prevention and interception. Effective prophylactic vaccines are available for virus-induced cancers (e.g., human papillomavirus (HPV) vaccines and Hepatitis B vaccines that reduce the incidence of cervical and liver cancers respectively). However, most cancers are not caused by viruses. There are specific high-risk human populations that have predictable and measurable risks of developing certain cancers (i.e., individuals with high-penetrance germline mutations, individuals diagnosed with precancers, or individuals exposed to environmental carcinogens). These populations would greatly benefit from the development of specific vaccinations or immunomodulatory drugs. Ongoing research on the role of immune mechanisms during tumor initiation and progression is rapidly evolving. Recent proof-of-principle preclinical studies have demonstrated that vaccines and other immunological interventions can induce host immune responses and provide immunoprevention efficacy by controlling tumor onset and progression in animal models of several cancers. These studies suggest that immunoprevention could be effectively translated to the clinic. Since most immunopreventive strategies aimed against non-viral cancers currently are at the preclinical or early clinical research stages, there is a need to stimulate small business development and commercialization of these products.