In June, the Butantan Institute in São Paulo and a company called Recepta Biopharma opened the Monoclonal Antibodies Laboratory, where a project will be developed to master the technology for generating monoclonal antibodies of cell strains for use in anti-cancer therapies. This initiative is certainly unprecedented in Brazil and few companies around the world have mastered the technology for producing monoclonal antibodies on a commercial scale.
Therapy using monoclonal antibodies has been consolidating its position as an important therapeutic option in the treatment of cancer, either used on its own or together with chemotherapy. Currently there are just nine of them in the market for the treatment of cancer and a further one hundred under development. Monoclonal antibodies recognize and bond in a selective way to specific antigens found in tumor cells, and in doing so activate the immune system to destroy these cells. Antibodies have produced good results in the control and prevention of metastases because they have the same antigens as the original tumor.
Finding antibodies that are truly efficient against a certain tumor is an arduous task. The Ludwig Cancer Research Institute has focused on the subject for several years and has identified some very promising antibodies. Recepta closed a deal with the institute to obtain the exclusive international rights for researching, developing, carrying out clinical trials and marketing four of them. These first monoclonal antibodies have shown their potential effectiveness for treating ovarian, colon, bladder and gastric tumors, among others.
“We have a long way to go before we find an effective drug,” says Professor José Fernando Perez, President of Recepta and former scientific director of FAPESP. “We’ll have to build a technology platform that’s highly reproductive, something that is difficult and still very restricted in the world,” adds researcher Ana Maria Moro, director of Butantan’s Monoclonal Antibodies Laboratory. In the 600 sq. m laboratory, 200 of which are a bio-clean area, cell strains of monoclonal antibodies will be produced, which will be humanized. In other words, the strains are generated from mice, but can only be used in human beings after the genes producing the antibodies have been altered to make them more like the antibodies produced by man, thereby reducing immune reactions. “Maintaining the affinity between antibodies and antigens after altering them and managing to produce them in large numbers and of good quality are our major challenges,” says Ana Maria.
Among the four antibodies licensed by Ludwig, one is especially promising. The anti-LeY, with the potential for treating ovarian cancer, has undergone clinical trial phase 1 – with human beings – in Australia and the United States. Phase 1 trials are to check the product’s safety level on people. Recepta and its partners are now working with LeY on phase 2, to measure its effectiveness. “It will be the first clinical trial of this type planned and carried out by a Brazilian company for the treatment of cancer. It is important to begin with a product that already has a part of its development ready, because we’ll save time,” notes Perez. The three other antibodies are at an earlier stage of development and will be submitted to immunohistochemical studies and preclinical and clinical trials. So far, monoclonal antibodies have been produced in Brazil only for use in diagnosis kits.
Partnerships
Another aspect that draws particular attention to this initiative is how the current degree of co-operation among the parties involved in this work was achieved. Recepta Biopharma has two private individual investors, businessmen Jovelino Mineiro and Emílio Odebrecht, but the company became a viable concern as a result of its partnerships. Only the company’s President, Perez, its Finance Director, José Barbosa Mello and its Scientific Director, Oswaldo Keith Okamoto (half-day only) are based permanently at the company’s headquarters. Keith is responsible for coordinating and integrating the network of 43 researchers that includes Ph.Ds, M.Scs and physicians, who work on the project via partnerships with universities, hospitals and research institutes.
The main partner is the Ludwig Institute from New York, which became a shareholder in the company when it became a licensee for the four monoclonal antibodies. Ludwig provides full support for the exchange of technology and guarantees a constant interchange of researchers between the two countries. The Brazilian arm of the institute is also participating in research work in São Paulo, where it identifies new targets and generates new antibodies for subsequent development by Recepta and its partners.
Butantan is the other partner and it is fundamental for the project. This is where the newly opened laboratory is installed and where the monoclonal antibodies will be generated to carry out the clinical trials and the feasibility of their commercial production demonstrated. Recepta has also formed an association with the Medical School of the University of São Paulo (FMUSP) for carrying out immunohistochemical trials and USP’s School of Veterinary Medicine for the pre-clinical trials. A further seven public and private hospitals from São Paulo, Rio and Belo Horizonte will take part in the phase 2 clinical trials.
A total investment of R$8 million has been planned for building and maintaining the Monoclonal Antibodies Laboratory, carrying out the immunohistochemical trials and conducting the phase 2 clinical trial. Recepta has put up R$2 million and the Studies and Projects Funding Agency (FINEP) the other R$6 million, via its Therapeutic and Diagnostic Products Innovation program.
“This public-private partnership has all the characteristics of something that is going to work out well,” states Isaias Raw, President of the Butantan Foundation. “This is not just public research that has been appropriated by private initiative, but an opportunity to try and solve one of society’s serious health problems, which is cancer, at a realistic cost.” Perez is emphatic when he says that everybody will come out of this a winner, and not just his company: “This is a win-win partnership. The associated institutions that will do the research at the cutting-edge of knowledge will publish the results and gain strong technological know-how in something that is totally new.”
The Minister of Science and Technology, Sérgio Rezende, has been enthusiastic about the venture. “Venture capital is growing and science and technology has matured a lot,” was his assessment. “Today, circumstance are much more favorable for researchers who wish to set up their own business.” The state Secretary of Health, Luiz Roberto Barradas Barata, celebrated this gathering of researchers from institutions and universities in the pursuit of a common goal. “This means bringing knowledge together to benefit Brazilians’ health,” commented Barradas.
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