Comercialización: Transferencia de Conocimiento. María S. Soengas (Spin Off)

Transcription

1 Comercialización: Transferencia de Conocimiento María S. Soengas (Spin Off)

2 Comercialización: Transferencia de Conocimiento (Spin Off)

3 The Starting Point: Malignant Melanoma 1. Unmet Clinical Need Frequent Life time risk: 1/53 Incidence up >600% since 1950 Aggressive Metastasis: Average survival 6 10 months Resistant to standard radio, immuno and chemotherapy 2. Market Opportunity $ 800 Million Market is Estimated to Triple in Size by 2015 Melanoma (8650) Other (2940) Skin Cancer Deaths (US)

4 The Objective: Novel and Improved Anti-Melanoma Drugs Effective (killing resistant cells) Selective (no secondary effects) Synthetic dsrna Carrier BO 110 (dsrna nanocomplexes) Bioavailable (+ new mode of action) Autophagy (MDA 5, LC3 ) Apoptosis (NOXA, Caspases ) Innate Immunity (IFN, Cytokines )

5 Validation of the Therapeutic Efficacy of BO-110 in vivo Melanoma Lung Metastases Control BO 110 Anticancer activity in tumor models Control Cutaneous Melanoma BO 110 Damià Tormo Tyr::NRAS Q61K ; INK4a/ARF / PET CT Tormo D. et al. (Cancer Cell, 2009) Alonso Curbelo D. et al. (Autophagy, 2009) Tormo D. et al. (Clinical & Translat Oncology, 2009) Poeck H. et al. (Nature Medicine, 2008) Besch R. et al. (Journal Clinical Investigation, 2009)

6 The Process: Constitution of Bioncotech Therapeutics Melanoma Bladder, pancreas, glioblastoma Orphan Diseases Patentability (Elzaburu) Publication Valorization (BioSerentia) M. Soengas Illescas y Bueno (OEPM) D. Tormo D. Tormo Patent Filing Product Method

7 Targeted RNA therapy for cancer

8 Transfer of Knowledge/Technology from Academia to Industry Fundación University Transfer IP to the company Participation in the social capital Technology Transfer Contract Partnership Contract Ignasi Costas

9 Exclusive Patent License Agreement Kalonia Legal (J. Merino) Intellectual Property, Know How Confidentiality Conflict of Interests (publication rights ) Royalties + Collaboration Agreements for the use of CNIO infraestructure

10 Finding the RigthTeam of Partners Buyout Vesting Provisions Shareholder's Agreement Expertise Funding Networking Deadlock Capitalization Table Buy-sell Agreement Tag along Drag along Dilution

11 Bioncotech Team April 2010 Damià Tormo, Ph.D., MBA Founder and CEO of Bioncotech Researcher at CNIO, University Michigan, Uniklinik Bonn Founder KR2, Biocapital Advisors July 2010 María Soengas, Ph.D. Founder and CSO of Bioncotech Director Molecular Pathology Programme, CNIO Professor University of Michigan, Investigator Cold Spring Harbor Laboratory Javier Fernández, MBA Business Developer of Bioncotech Director at Bioavance, Vivia Biotech, Pevesa, Halotech Founder Suanfarma VC fund and IE Business School professor Neil Collen, MBA (Livingstone Partners) Jorge Garcia del Moral, MD (Founder and CEO of several companies in the health sector) Jose Luis de Miguel, MBA (CEO at Onofre de Miguel Group) Alejandro Portilla, MBA (General Excellence Manager ABBOT Europe) Aug new partners

12 Collaboration Agreement CNIO-Bioncotech Clinical Development of BO-110 GLP production of BO Carbogen, Polyplus Formulation. Azurebio Preclinical Studies (PK, PD). Innoqua/BASi Phase I/II..Hosp 12 Oct, La Paz Gregorio Marañón, La Fe Research & Development Biomarkers of Response Normal vs Tumor Cells Uptake, selectivity Improvement of Efficacy Pipeline InnoMelanoma

13 Collaboration Agreement CNIO-Bioncotech: Funding NIH (USA) AICR (UK) Consolider INNOCASH Neotech IMPIVA INNPACTO MICINN AECC Miguel Servet Juan de la Cierva FPU La Caixa Genoma España Inncorpora Expande Torres Quevedo

14 S. Ortega (GEM Unit) PB. Fisher M. McMahon D. Mejias (Confocal Microscopy) P. Barral F. Mulero (ImagingUnit) L. Larrue F. Beermann

15 Parque Científico Univ.Valencia

16 Comercialización: Transferencia de Conocimiento María S. Soengas (Spin Off)

17 20 Julio Feb 2011

18 Therapeutics Research Technicians Univ. Valencia Inncorpora Mercedes Pozuelo (Project Manager) Dr. Biochemistry (Univ. Córdoba) Ramón y Cajal Senior Investigator (CABIMER, Sevilla) Postdoctoral Fellow (Univ. Dandee, Scotland, UK) Predoctoral Fellow (Albert Ludwigs Universitat, Freigburg, Germany) Andrés Gagete (R&D, Innovation) Dr. Molecular Biology and Genetics (Univ. Valencia) Postdoctoral Assistant (Centro Investigación Príncipe Felipe, Valencia) Predoctoral Fellow (Univ. Valencia) Estela Cañón (Lab Manager, CNIO) Dr. Molecular Biology and Genetics (Univ. Valencia) Drug Discovery Specialist (Experimental Therapeutics Program, CNIO) Association for International Cancer Research Fellow (Univ. Cantabria) Predoctoral Fellow (Instituto Investigaciones Biomédicas, Madrid)

19 Value of Indications Real options valuation PoS Melanoma PhII 400 M 52% Glioblastoma PhI 82 M Bladder PhI 153 M 21% Pancreas PhI 53 M Total 688 M EBITDA (M) Pancreas Bladder Glioblastoma Melanoma YEAR 5 Years

20 Exit strategy year 5 Real options valuation PoS Melanoma 127 M 21% Glioblastoma 82 M Pancreas 53 M Bladder 153 M Year 5 Exit Strategy Options 1 Licensing / M&A 2 Alliance with a pharma (co devlp.) 3 IPO or Round C Pancreas NPV (M) Bladder Glioblastoma Melanoma License deals in Phase I/II Product Value ($) PX4032 (Plexxikon) 708 M MDX 010 (Medacare) 530 M Elesclomol (Syntia) 585 M Genasense (Genta Inc) Years 480 M

21 Min. we need (5 years) 7,000,000 Exit Strategy Year 5 Round A Year 0 2M 24 Months Year 2 2M 12 Months IND Submission Round B Year 3 1M 12 Months End Phase I Year 4 2M 12 Months First patient Phase II Company Valuation Multiplier A Multiplier B PHASE 3/4 End Phase II What we expect: 400M > 20 times > 10 times Milestones

22 Programa Cooperación Farma-Biotech 3. Availability for cooperation Co-development of BO-110 (for one or more indications) License in more advanced stage (Phase I/II)