Clinical research, efficacy and security studies of a innovative immunobiological for immunotherapy of atopic dermatitis in dogs

• Grant number: 16/21766-0
• Support Opportunities: Research Grants - Innovative Research in Small Business - PIPE
• Start date: October 01, 2017
• End date: September 30, 2019
• Field of knowledge: Agronomical Sciences - Veterinary Medicine
• Principal Investigator: Matheus Martinez Faccioli
• Grantee: Matheus Martinez Faccioli
• Company: Farmacore Biotecnologia Ltda (FARMACORE)
• City: São Paulo
• Pesquisadores principais:( Últimos ): Aline Rocha Borges ; Jeanne Blanco de Molfetta ; Luis Felipe Buso Bortolotto
• Pesquisadores principais:( Antigos ): Matheus Martinez Faccioli
• Associated scholarship(s): 18/21908-4 - Production of Imunivax® and process control under GMP conditions, BP.TT

Abstract

Farmacore established infrastructure and technology platforms, which allow to operate throughout the complete R&D cycle of biotech products, ranging from project design and proof of concept studies to technological development and industrial production within the regulatory standards of Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP). One of biopharmaceuticals products in development by the company, Imunivax®, has immunomodulatory activity and / or immunoregulatory with proven efficacy for immunotherapy of infectious diseases, autoimmune and cancer. This product is already in the final stage of industrial development and registration phase in the Ministry of Agriculture (MAPA) for marketing in cancer immunotherapy area for PETs animals. More recently, Imunivax®, was also tested and showed immunotherapeutic activity in allergy model, both initiated by ovalbumin (OVA) or with specific allergen (Der p1). Studies equivalent to the Phase 1 program PIPE, showed that in both models, the product induced activation of the innate immune response, increased IL-10 secretion and IFN-³, decreased IL-4 and IL-5, reduction in pulmonary eosinophilia and inflammation, reduced IgE levels in serum, and decrease mucus production and hyperreactivity of the airways. These results allowed fruitful interaction between University and Company for the R&D of the product and made a patent application filing within the INPI (PI0803831-7) with entitlements between Farmacore (70%) and USP (30%). Recently, Imunivax® was also tested as a proof of concept, in the immunotherapy of atopic dermatitis (AD) in dogs. AD is an inflammatory skin disease, itchy, chronic and recurrent resulting from the complex interaction of infectious agents, environmental allergens, defects in the function of the epidermal barrier and immune hyperreactivity. It is estimated that about 25% of the dog population is affected by AD, and approximately 80% of these animals developed clinical signs which require continuous therapy. Among the therapeutic options for AD are the regular use of anti-pruritic medications topical and / or systemic, such as antihistamines, glucocorticoids and cyclosporin. Symptomatic treatment is costly, does not cure the animals, induces immunosuppression and severe side effects. The absence of an immunobiological product on the market, the high prevalence of the disease, the high cost of established treatments, along with the damage and discomfort to the owners and the animals themselves, justify the need for a new immunotherapy for the effective control of AD. The overall objective of this Phase 2 Direct project is to carry out studies to show the efficacy and safety of treatment of animals with Imunivax® for its future application and commercialization in AD immunotherapy in dogs. The Farmacore already has its own technology and industrial facilities for production and quality control Lot pilot and commercial Imunivax® able to GMP and GLP. The launch of a radical innovation immunobiological market for AD control in PETs will benefit and positive impact on the company's revenues in the generation of high-tech jobs in skilled HR training, improved health of PETs animals and comfort owners. It will also Farmacore to explore new segments and increase the competitiveness of domestic industry of biotechnology and animal health, as well as Brazil's inclusion in the new Immunobiological market with its own technology. (AU)