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

Transcription

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

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

3 INTRODUCTION Business: antibody development Manufacturing partner: 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 Efficacy in vivo Colon cancer volume untreated 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 Patenting and scientific publication Workshops Collaboration with opinion leaders Big company presentations Market entry 7

9 PARTNERS Dr. Lorenzo Spatocco (mentor) Dr. Pier Luigi Balietti (CEO) Dr. Antonella Bompensa (business plan) Founding members 8

10 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 9

11 COMPETITION Arius Biotech has been recently bought by Roche, becoming Roche Toronto, part of Roche Canada Oncoxx antibodies shown superior to Arius antibodies in preclinical models Roche has dropped efficacy tests on Arius anti-trop-2 antibodies because of inadequate efficacy parameters Unsuitable antibodies (mixed light chains): T16 Patent WO 98/12227 RS7 Patents WO03/074566, US2004/001825, US2007/ e US2008/ Public 10

12 KEY ASSETS OF ONCOXX 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; one PCT undergoing filing Key PCT: antibodies & hybridoma lines generation strategy synergy Efficacy in preclinical models Regulatory activity planning 11

13 RESEARCH MANAGEMENT TEAM Saverio Alberti (President Incoming) Co-Director, Unit of Cancer Pathology, University of Chieti Scientific Board, ABO Foundation, Venice, Italy Patents & Spin-off Commission, University of Chieti J. Yun Tso (Scientific Consultant) CEO, JN Biosciences (Mountain View, CA) Key player in humanization of Trastuzumab (Herceptin) and Bevacizumab (Avastin) 12

14 FINANCIALS Generate Identify target Tests Humanization antibodies 5 4 ROUND 1: 3.12 million Expenses 3 90 Value PCT = 0.5 M 3 hybridomas = 0.45 M CESI research partnership = 0.75 M 1 1st Y 2nd Y 3rd Y 4th Y 30 Pre-money 1.7 million At sale 123 million 13

15 USE OF FUNDS 2nd year 1st year Toxicity in Efficacy in mice Tests Humanization monkeys M To reach key milestones To produce antibodies for tests 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 Xenon Novartis Target ID & 2004 Metabolic 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 Oncoxx Biotech Saverio Alberti New immunotherapeutic approaches against Trop-2 need to be developed and tested Qizhi Yao, Baylor College of Medicine, Houston, TX

18 ANNEX - Gantt diagram 17

19 ANNEX - Financial recalls 18