New immunotherapeutic approach against HPV-induced tumors

Abstract

The difficulty in developing new biopharmaceuticals in Brazil led researchers from USP to found a company to enable the progress of an immunotherapeutic strategy against HPV-induced tumors. The company aims the optimization of the formulation, the conduction of clinical trials and later, the product commercialization. The immunotherapy in question, created in the Vaccine Development Laboratory of the ICB/USP, consists of a new vaccine therapeutic strategy against tumors caused by HPV-16, which currently causes more than 5,000 deaths among women in Brazil (at least 270,000 deaths/year worldwide) and an indefinite number of deaths associated with head and neck and anal cancer. The immunotherapeutic strategy to be developed is based on recombinant DNA and is capable of controlling the growth of tumors expressing the HPV-16 oncoproteins under experimental conditions. This therapeutic vaccine proved to be superior in mice, than the vaccines currently being evaluated in clinical trials against the same target. The product is protected by a patent deposited by USP in the PCT on 05/03/2012 (BR 11 2012 004928-3). The group has attempted to form partnerships with local companies to carry out the production of pilot batches of the vaccine in conditions of Good Manufacturing Practices (GMP) and conducting pre-clinical trials, but such partnerships did not result in the progress of the development of the biopharmaceutical. Thus, it was decided to found a company dedicated exclusively to transform the vaccine in an effective product, by conducting research of commercial interest, in order to obtain improvements in the vaccine efficiency and, thus, increasing its chances to succeed in clinical trials. Facing the potential of the results and the need to enable the pharmaceutical composition as a treatment for cervical cancer, this project proposes the construction of a more comprehensive therapeutic vaccine formulation by inserting the HPV-18 E6 and E7 genes in the current vaccine composition, expanding the use of this formulation to be employed against tumors associated with the two HPV types most commonly associated with cancers in Brazil and worldwide. Furthermore, we aim to test the stability and efficacy of a pilot batch of the vaccine generated in GMP conditions. Throughout the project, a business plan will be outlined for the drug development process as a product, including the financial viability of processes involved in large-scale production, pre-clinical testing and clinical trial. The proposal is of great importance for it proposes a new product, secured by patent protection, with great potential for prevention and, above all, treatment of cervical cancer as well as other forms of cancer associated with HPV. The proposed methodology represents a step ahead of passive immunotherapy based on monoclonal antibodies, now in vogue to treat different types of tumors, and could change the landscape of innovation in Biomedicine in São Paulo and in the country. (AU)