Oncoxx Biotech. Saverio Alberti. Anti-Trop-2 monoclonal antibodies for cancer therapy and target diagnosis

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1 Oncoxx Biotech Saverio Alberti Anti-Trop-2 monoclonal antibodies for cancer therapy and target diagnosis

2 INTRODUCTION Oncoxx Biotech S.r.l. is a Cancer Biotech Company as partnership between Chieti University Research Center and private entrepreneurs DEPARTMENT OF NEUROSCIENCE & IMAGING 1

3 INTRODUCTION Business: antibody development Synergy: Unique know-how on Trop-2 Academic research collaborators Health care centers Business professionals Venture capital 2

4 INTRODUCTION Monoclonal antibodies successful against cancer Novel targets needed: Trop-2 100% 80% 60% 76% 58% 70% 88% 62% 66% 80% 83% 91% 40% 29% 20% 0% Liver Breast Colon-rectum Stomach Endometrium Lung Ovary Prostate Pancreas Cervix Success in obtaining anti-trop-2 monoclonal antibodies Applications: therapy & target diagnosis Kidney 3

5 BUSINESS MODEL Generate Identify target Tests Humanization antibodies We are here Exit 4

6 PRODUCT OVERVIEW Anti-Trop-2 antibodies for therapy of big killers: Lung tumors and metastases Liver metastases of colon cancer Ovarian cancer untreated Efficacy in vivo Colon cancer volume antibody Time 5

7 MARKET OPPORTUNITY Western nations Lung, colon, ovarian cancers new cases per year: 700,000 Trop-2 expressing: 500,000 tumors National health care reimbursements (30,000 $ per patient): 10,000 patients Planned production capacity: 5,000 patients Gross sales: 150 m / year Success example: Herceptin 3.8 billion / year 6

8 MARKET ENTRY Phase First year Second year Third year Collaboration with international scientists & big players Humanization Positive conclusion of humanization Efficacy & toxicity tests Patenting and scientific publications Collaboration with opinion leaders Big company presentations Market entry 7

9 COLLABORATORS Long-standing collaboration with Ulrich Weidle, Head Oncology Dept, Roche Long-standing collaboration with Rita de Santis, Head Immunology Dept, Sigma-Tau Major academic & translational network Trop-2 function Trop-2 target Università di Genova Antibodies Kinexus 8

10 COMPETITION Arius Biotech has been bought by Roche. Oncoxx antibodies shown superior to Arius antibodies in preclinical models. Roche has dropped efficacy tests on Arius anti- Trop-2 antibodies because of inadequate performance Livtech: later filing date (priority date 17may2010; european patent filed on the 17th may 2011; Oncoxx Biotech PCT filed on the 5th feb. 2009). No anti-cancer antibody synergy Unsuitable antibodies (mixed light chains): T16 Patent WO 98/12227 RS7 Patents WO03/074566, US2004/001825, US2007/ e US2008/ Public 9

11 BARRIERS TO COMPETITION Leadership in the field of Trop-2 research Unique know-how on the molecule Proprietary anti-trop-2 antibodies Major collaborators network Two pending PCT; two PCT undergoing filing Key PCT: antibodies & hybridoma lines generation strategy synergy Efficacy in preclinical models Advanced stage of research Regulatory activity planning 10

12 RESEARCH MANAGEMENT TEAM Saverio Alberti (President) Co-Director, Unit of Cancer Pathology, University of Chieti Patents & Spin-off Commission, University of Chieti J. Yun Tso (Chief Scientific Advisor) Founder, Protein Design Laboratories CEO, Antibody engineering company Key player in humanization of leading antibodies on the market 11

13 BOARD MEMBERS Saverio Alberti (President) Lorenzo Spatocco (Mentor & council member) Antonella Bompensa (Chief financial officer) 12

14 FINANCIALS Generate Identify target Tests Humanization antibodies 5 4 ROUND 1: 2.25 million Expenses 3 90 Value st Y 2nd Y 3rd Y 4th Y + Pre-money (PCT, hybridomas, labs) At sale 123 million 13

15 USE OF FUNDS 2nd year 1st year Efficacy Humanization Pharma tests Toxicity M To reach key milestones To produce antibodies for tests (pending) Investments only at milestones achievements 14

16 EXIT STRATEGY Assets sale to a Pharma Company after humanization Comparable exits: Company Buyer Phase Sale date R e s e a r c h Arius Roche Posthumanization field 2008 Anti-cancer antibodies 2004 Metabolic Xenon Novartis Target ID & validation diseases Plexxikon Wyeth Pre-clinical 2004 Metabolic diseases Nastech Merck Clinical phase I 2004 Metabolic U3 Pharma AG Daiichi Sankyo Pre-clinical Clinical phase I diseases 2008 Anti-cancer antibodies T r a n s a c t i o n value 191 million canadian $ 157 million US $ 372 million US $ 346 million US $ 150 million 15

17 KEY UPDATES Key target knowledge acquired signaling targeting drugs major scientific articles Proof of synergy of two antibodies Chimeric antibodies One humanized antibody Second humanization ongoing Licensing agreement with Millipore-Merck for laboratory use 1st Prize Innova Day Start-Up Program (investors choice) Intesa Sanpaolo Start-Up Initiative - 3/11/11 Frankfurt 13 Declarations of interest Major Grant applications IPA Adriatic Strategic Project 2013 Smart Cities South Two Smart Cities National Made in Italy

18 Oncoxx Biotech Saverio Alberti New immunotherapeutic approaches against Trop-2 need to be developed and tested Qizhi Yao, Baylor College of Medicine, Houston, TX

19 ANNEX - Gantt diagram 1st Year 2nd Year 3rd Year FASE 1: T E ST SU T OPI IMMUNOSOPPRE SSI - anticorpi chim erici M3 - anticorpi umanizzati (2G10 + 2EF) M6 FASE 2: T E ST SU SCIMMIE E GROSSI RODIT ORI - test bersaglio anticorpi originali M2 - test bersaglio anticorpi chimerici M4 - test bersaglio anticorpi umanizzati M5 - test PK e tossicità anticorpi originali M7 - test PK e tossicità anticorpi chimerici M8 - test PK e tossicità anticorpi umanizzati M9 FASE 3: UMANIZZAZIONE (2EF) M1 FASE 4: PRODUZ IONE ANT ICORPI PE R USO SPE RIME NT ALE FASE 5: PRODUZ IONE ANT ICORPI PE R USO CLINICO FASE 6: PROT E Z IONE PROPRIE T A' INT E LLE T T UALE M1 0 M1 0 18

Oncoxx Biotech. Saverio Alberti. Anti-Trop-2 monoclonal antibodies for cancer therapy and target diagnosis

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