RECEPTA biopharma. Early drug development in a start-up company. Jose Fernando Perez CEO

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1 RECEPTA biopharma Early drug development in a start-up company Jose Fernando Perez CEO 1

2 The Challenges of a Biotech in Brazil Networking for cancer drug development Why in Brazil? 2

3 Brief History Fernando Perez Odebrecht/ Mineiro April 26, 2005 Ludwig Institute for Cancer Research PR&D Biotech October 10, 2006 RECEPTA biopharma 3

4 Why in Brazil? Leveraging local advantages Highly qualified human resources: scientists and technicians: Brazil s scientific output represents circa 3% of total world production Excellent hospital facilities and qualified physicians with documented experience in the conduction of clinical trials Lower costs of operation in Brazil than in traditional research regions for required personnel at all levels. Excellent infrastructure of services: CROs & Logistics 4 Easier access to a diverse selection of informed patients and tumor samples for Phase I and II clinical trials as compared with the more traditional testing regions of the US, EU and Japan.

5 Why in Brazil?: Leveraging of local advantages Engagement of required R&D talent through research fellowships and scholarships in public educational institutions at low cost. The New Culture towards innovation: Priority in funding opportunities from several governmental sources (such as FINEP, BNDES, FAPESP) through R&D grants or low interest loans. Drug development is one the four stated priorities of the Brazilian industrial policy (PITCE) and biotechnology is also a priority as one the areas treated as carriers of the future. The Brazilian market needs new cancer drugs manufactured in the country to reduce imports 5

6 Partnership with the Ludwig Institute The Ludwig Institute for Cancer Research (LICR) has licensed four antibodies to Recepta. The agreement with the LICR creates conditions for an effective transfer of scientific and technological knowledge from the global network of scientists associated with the LICR to Recepta. The close collaboration with LICR s scientists provides an extra validation of scientific and technological procedures. The presence of LICR as a shareholder offers Recepta an immediate international insertion. 6

7 What we do? Identification of targets Generation of new mabs Development of mab Pilot scale production of mabs Pre-clinical Trials Phase I and Phase II Cancer Clinical Trials 7

8 Portfolio of Products Antibody hu3s193 Anti-Lewis Y Successful IHC, Pre-Clinical and Phase I trials carried out by LICR as an Ovarian Cancer, with potential for ALL epithelial tumors. Antibody MX-35 Successful IHC trials carried out for early Ovarian cancer by LICR and potential for other cancer remedies Antibody hu Anti-Lewis B (Leb) Successful IHC trials carried out for Breast and Colorectal cancers by LICR and potential for other cancer remedies. Antibody A-34 Successful IHC trials carried out for Gastric and Kidney cancers by LICR and potential for other cancer remedies. Four new Antibodies in development Discovery:Targets and mabs resulting from Recepta s own R&D projects 8

9 RECEPTA s Operation LICR s research programs: Antigen discovery & characterization Anti- Lewis Y New mabs generated by Recepta s research Programs: Antigen discovery and characterization MX-35 Anti- Lewis B Anti- A-34 4 new mabs Phase II trials and new high yield cell line production Cell line production, Immunohistochemical assays, Clinical trials Phase I Lab assays, Preclinicals and humanization 9

10 RECEPTA s Operational Structure MAb R&D division Oncology division Identification of new targets Generation of new antibodies High yield cell line construction Cell banks construction GMP clinical grade pilot scale Clinical Trials Management Immunohistochemistry Preclinical Trials Clinical trials Phase I (CRO, patients, hospital) Clinical trials Phase II CRO, patients, hospital) 10

11 Virtue out of Necessity: An Unique Approach through Strategic Partnerships Recepta as a Managed Virtual Biotech Partnerships: Recepta s novel model The ingredients: Experienced leadership and management with the capacity to establish mutually beneficial partnerships with leading research institutions and hospitals Excellent team of scientists both: a) Internal and, b) External: working inside labs of partner institutions Strong group of scientists affiliated to the partner institutions as PI s of the R&D projects working together with Recepta s team Last but no least: strong management! 11

12 Recepta s Scientists: Internal: 12 Recepta s Team Dr Luiz Travassos Programs Director Dr. Oren Smaletz Clinical Trials Director Dr. Keith Okamoto Scientific Director Vivian Madrigal Regulatory Affairs & Pharmacist Dr. Juçara Parra - Project Manager Dr. Igor Praskurkim - Clinical Trials External (inside partner institutions): 22 researchers Instituto Butantan: : 4 PhDs,, 2 MSc,, 1 G Medical School USP: 3 PhDs,, 2 MSc,, 2 MDs,, 3 tech Ludwig Institute São Paulo: 4 PhDs,, 1 MSc Recepta s Management: Dr. Fernando Perez, CEO Jose Barbosa Mello, COO & CFO

13 Partner Institutions Ludwig Institute for Cancer Research Global Local Branch SP (new targets, mabs generation, pre-clinical assays) 13 Dra. Anamaria Camargo Dr. Sandro de Souza Dra. Vilma R.Martins Instituto Butantan (Cell Biology) - Dr. Ana Maria Moro Medical School of the University of São Paulo Dr. Venancio A. Alves (Immunohistochemistry LIM 14) Dra. Suely Marie (new targets and mabs LIM 15) Hospitals (Clinical Trials): Sírio-Libanês, Alemão Oswaldo Cruz, Albert Einstein, National Institute of Cancer (INCA), Brazilian Institute for Cancer Control (IBCC), Baleia (BH), Institute of Cancer of Sao Paulo (ICESP) MIT s G-lab Sloan School of Administration (valuation model)

14 Recepta s 1st Clinical Trial Ovarian tumor Phase II Clinical Trial with hu3s193 anti-lewis Y mab. Protocol prepared by Dr. Oren Smaletz in close collaboration with Dr. Alberto Wainstein from Biocancer, Dr. Eric Hoffman from the LICR New York Office and Dr. Andrew Scott from the LICR Melbourne Center. Logistics: World Courier and Safe Lab CRO: EuroTrials Scientific Consultants Adverse Events Database: Medanta (UK) FDA agent: Mary Jane Walling (Don Hill & Ass.) Central Lab: Laboratórios Fleury mab cgmp production: Gala/Catalent (USA) mab vialling: University of Iowa mab production auditing: Don Hill & Associates 14

15 Clinical Trials Hospitals Recepta has established partnerships with hospitals known for their excellence in conducting clinical trials for its first Phase II clinical trial with anti-lewis Y mab. Hospital Alemão Osvaldo Cruz (SP) Instituto do Câncer Hospital das Clínicas (SP) Hospital Sírio Libanês (SP) Hospital Albert Einstein (SP) National Institute of Cancer (INCA-RJ) Hospital da Baleia (BH) Brazilian Institute for Control of Cancer (IBCC-SP) 15

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17 RECEPTA S Funding Recepta has been awarded several grants under different programs funded by the federal and Sao Paulo state government. - Federal programs: FINEP: Program to fund partnership of Companies & Research Institutions FINEP: Subvention program CNPq: Fellowships for post-docs and technicians - State Program: FAPESP: Program to fund partnership of Companies & Research Institutions 17

18 Thank you! 18