| Grant number: | 18/08502-9 |
| Support Opportunities: | Research Grants - Innovative Research in Small Business - PIPE |
| Start date: | December 01, 2018 |
| End date: | January 31, 2021 |
| Field of knowledge: | Biological Sciences - Microbiology - Applied Microbiology |
| Agreement: | FINEP - PIPE/PAPPE Grant |
| Principal Investigator: | Luana Raposo de Melo Moraes Aps |
| Grantee: | Luana Raposo de Melo Moraes Aps |
| Company: | Imunotera Soluções Terapêuticas Ltda. - EPP |
| CNAE: |
Pesquisa e desenvolvimento experimental em ciências físicas e naturais |
| City: | São Paulo |
| Associated researchers: | Bruna Felício Milazzotto Maldonado Porchia Ribeiro ; Luis Carlos de Souza Ferreira |
| Associated scholarship(s): | 19/00831-6 - Translational development and preclinical validation of an immunotherapy against tumors induced by Human Papillomavirus (HPV), BP.PIPE |
Abstract
Human papillomavirus (HPV) infection is considered the most common sexually transmitted disease and eight out of ten people have ever come into contact with it at some point in their lives. Most HPV infections are asymptomatic and are controlled by the immune system without intervention. However, persistent infections caused by this virus can lead to the onset of both uterine cervix lesions and different cancers, including in men. In this case, the treatment is based on surgery, chemotherapy and radiotherapy, invasive methods that generate discomfort, complications and, often, severe side effects, without necessarily having significant efficacy. In this context, ImmunoTera has developed alternative and innovative therapies capable of reprogramming the immune system to combat lesions and tumors caused by HPV. The immunotherapy presented in this project is based on a recombinant hybrid protein that promotes permanent healing in 100% of treated animals. The treatment also allows the reduction of doses of chemotherapy in the treatment of advanced tumors, with superior results to other therapeutic strategies developed against HPV. In this scenario, the present proposal aims at the development of a product that can be used in humans in a phase I clinical study. For this, one of the central objectives of the project is to obtain the GMP (Good Manufacturing Practices) and its pre-clinical validation of efficacy and safety. The protein will be obtained from transfected eukaryotic cells and will be evaluated for their sterility, functionality and biological activity in vitro and in vivo in the experimental model of HPV-16-associated tumors. The product will then undergo pre-clinical tests to assess the safety of rodents in one of the reference centers in non-clinical trials in the country. Once qualified, the product can be used for a pilot study in cancer patients (initially cases induced by HPV-16) and, once confirmed its therapeutic potential, may represent a case of clinical translation success, placing Brazil in a new level of innovation in the health area. (AU)
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