{"id":199110,"date":"2015-08-13T12:30:15","date_gmt":"2015-08-13T15:30:15","guid":{"rendered":"http:\/\/revistapesquisa.fapesp.br\/?p=199110"},"modified":"2017-07-24T13:39:26","modified_gmt":"2017-07-24T16:39:26","slug":"antibody-milestone","status":"publish","type":"post","link":"https:\/\/revistapesquisa.fapesp.br\/en\/antibody-milestone\/","title":{"rendered":"Antibody milestone"},"content":{"rendered":"

\"VidrariaL\u00c9O RAMOS<\/span>Recepta Biopharma, a Brazilian company based in S\u00e3o Paulo, recently signed an agreement with Mersana Therapeutics of the U.S. to license a monoclonal antibody that could be used in cancer treatments. Under the terms of the partnership, Recepta will cede the rights to the antibody outside of Brazil to Mersana, which the company will use to develop an immunoconjugate compound against several tumor targets. Recepta will retain the rights in Brazil. Mersana owns a technology known as Fleximer, which is able to create a so-called ADC (antibody-drug conjugate). \u201cThey use a binder to join the antibody to a toxin. This immunoconjugate delivers the toxin to the tumor cells in a very targeted way,\u201d says Jos\u00e9 Fernando Perez, a physicist and the president of Recepta. \u201cWe are excited about developing this new immunoconjugate to address the unmet needs of cancer patients,\u201d said Anna Protopapas, the president of Mersana, in a press release.<\/p>\n

The terms of the agreement provide that Recepta will be entitled to cash payments, provided that predetermined milestones are achieved in development, as well as in regulatory approval and marketing of the drug. It is estimated that these payments could reach $86 million. The agreement is unprecedented in Brazil. \u201cIt’s the first time a Brazilian biotech company has licensed intellectual property for the development of a potential cancer drug,\u201d says Perez, who was the scientific director of FAPESP from 1993 to 2005. \u201cIt shows that bolder things can be done despite the difficulties of conducting drug research in Brazil.\u201d<\/p>\n

An antibody is an organism’s defense molecule that specifically binds to its target. A monoclonal antibody is derived from a cell clone and hence all molecules are identical and directed toward the same target. Recepta is working on the development of various monoclonal antibodies, most of them discovered by the Ludwig Institute for Cancer Research, a non-profit organization based in New York, with which the company has partnered. The name of the antibody licensed to Mersana will not be released until the end of the year.<\/p>\n

\u201cRecepta showed that it is possible to move ahead in expanding radical innovation such as developing new molecules,\u201d says Carlos Gadelha, an economist and the Secretary of Production Development of the Ministry of Development, Industry and Foreign Trade (MDIC). He believes that Brazilian biotechnology companies mostly invest in innovation incrementally, merely improving upon known methods and technologies. \u201cThe fact that Recepta has transferred knowledge to a U.S. company represents a milestone in Brazil,\u201d says Gadelha, who between 2011 and 2014 was Secretary of Science, Technology and Strategic Inputs of the Ministry of Health.<\/p>\n

Perez says that Recepta\u2019s work was facilitated by an environment favorable to providing government resources. FAPESP and the Brazilian Innovation Agency (FINEP) assisted in equipment purchases and supported the work of institutional research groups. The Brazilian Development Bank (BNDES), which has been one of its partners since 2012, also invested in the company. \u201cThis is an example of how a long-term strategic alliance between the private sector and federal and state governments can be consolidated,\u201d says Gadelha. Jos\u00e9 Gomes Temper\u00e3o, former health minister and current director of the South American Institute of Government in Health\u00a0(ISAGS) of the Union of South American Nations (Unasur), believes Recepta\u2019s development of monoclonal antibodies may also represent a breakthrough for Brazil\u2019s industrial health complex. \u201cGetting this product to market will take a long time. But once this is achieved, the focus will be on making this new technology available to all Brazilians, without limitation, through the Unified Health System,\u201d he says.<\/p>\n

Ruy de Quadros Carvalho, a researcher at the Department of Science and Technological Policy of the Institute of Geosciences at the University of Campinas (Unicamp), says that Recepta\u2019s example demonstrates the feasibility of distributing the innovation process over an external network of partners, where there is room for universities and partners, whether nearby or with other countries, to help each other according to their expertise. \u201cBy licensing the use of monoclonal antibodies, Recepta is enabling another company to accelerate the development of a new drug, since Mersana has mastered a technology required for this process,\u201d says Quadros.<\/p>\n

Lines<\/strong>
\nAn association with research organizations in the state of S\u00e3o Paulo has been decisive when it comes to the monoclonal antibodies developed by Recepta (see Pesquisa FAPESP <\/em>Issue n\u00ba 223<\/a>). With support from FAPESP, Recepta mobilized institutions such as the Butantan Institute and the University of S\u00e3o Paulo School of Medicine (FMUSP), which participated collaboratively at various stages of these studies. Thus, among other advances, it was possible to master one of the monoclonal antibody production stages: obtaining cell lines capable of producing antibodies in large amounts and with the same standard of quality and stability for use in humans. \u201cWe have been producing monoclonal antibodies for therapeutic use for over 20 years. We have already developed, for example, a treatment for the rejection of transplanted organs,\u201d says Jorge Kalil, director of the Butantan Institute. He says the partnership with Recepta has been very beneficial to the research institution. \u201cWe intend to use the human monoclonal antibody technique in other areas, such as antibodies for tetanus or against some spider venoms,\u201d says Kalil.<\/p>\n

Perez, of Recepta, also points out the importance of the company\u2019s translational research activity in collaboration with research groups, such as clinical pathology led by Ven\u00e2ncio Alves and experimental oncology coordinated by Roger Chammas, both professors at FM-USP. \u201cBesides the technological fruits, scientific publications in reference journals in the field were also generated,\u201d he says.<\/p>\n

Projects
\n1.<\/strong> Cell lines with high productivity and stability for humanized monoclonal antibodies for cancer therapy (n\u00ba 2005\/60816-8<\/a>); Grant Mechanism: <\/strong>Research Partnership for Technological Innovation (PITE); Principal Investigator:<\/strong> Ana Maria Moro (Butantan Institute); Investment: <\/strong>R$377,708.00 and $810,616.85 (FAPESP), R$1,793,198.00 (Recepta).
\n2.<\/strong> Monoclonal antibodies for treating tumors of the central nervous system (n\u00ba 2008\/57914-6<\/a> and 2011\/50526-3<\/a>); Grant Mechanism:<\/strong> Innovative Research in Small Businesses Program (PIPE); Principal Investigator:<\/strong> Maria Carolina Braga Tuma (Recepta); Investment:<\/strong> R$124,788.20 (Phase 1) and R$456,631.34 (Phase 2).<\/p>\n","protected":false},"excerpt":{"rendered":"Brazilian company licenses molecule with potential to treat cancer","protected":false},"author":421,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_exactmetrics_skip_tracking":false,"_exactmetrics_sitenote_active":false,"_exactmetrics_sitenote_note":"","_exactmetrics_sitenote_category":0,"footnotes":""},"categories":[166,1560],"tags":[229,243,247,232],"coauthors":[740],"class_list":["post-199110","post","type-post","status-publish","format-standard","hentry","category-policies-st-en","category-innovative-research-in-small-business-pipe-en","tag-epidemiology","tag-innovation","tag-medicine","tag-pharmacology"],"acf":[],"_links":{"self":[{"href":"https:\/\/revistapesquisa.fapesp.br\/en\/wp-json\/wp\/v2\/posts\/199110","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/revistapesquisa.fapesp.br\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/revistapesquisa.fapesp.br\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/revistapesquisa.fapesp.br\/en\/wp-json\/wp\/v2\/users\/421"}],"replies":[{"embeddable":true,"href":"https:\/\/revistapesquisa.fapesp.br\/en\/wp-json\/wp\/v2\/comments?post=199110"}],"version-history":[{"count":0,"href":"https:\/\/revistapesquisa.fapesp.br\/en\/wp-json\/wp\/v2\/posts\/199110\/revisions"}],"wp:attachment":[{"href":"https:\/\/revistapesquisa.fapesp.br\/en\/wp-json\/wp\/v2\/media?parent=199110"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/revistapesquisa.fapesp.br\/en\/wp-json\/wp\/v2\/categories?post=199110"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/revistapesquisa.fapesp.br\/en\/wp-json\/wp\/v2\/tags?post=199110"},{"taxonomy":"author","embeddable":true,"href":"https:\/\/revistapesquisa.fapesp.br\/en\/wp-json\/wp\/v2\/coauthors?post=199110"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}