Citi s 2017 Global Healthcare Conference 6~7 December 2017, New York

Transcription

1 Citi s 2017 Global Healthcare Conference 6~7 December 2017, New York

2 Safe Harbor Statement forward-looking statements. These forward-looking statements may be identified by words sthis presentation contains certain uch as believes, expects, anticipates, projects, intends, should, seeks, estimates, future or similar expressions or by discussion of, among other things, strategy, goals, plans or intentions. Various factors may cause actual results to differ materially in the future from those reflected in forward-looking statements contained in this presentation, among others: 1 pricing and product initiatives of competitors; 2 legislative and regulatory developments and economic conditions; 3 delay or inability in obtaining regulatory approvals or bringing products to market; 4 fluctuations in currency exchange rates and general financial market conditions; 5 uncertainties in the discovery, development or marketing of new products or new uses of existing products, including without limitation negative results of clinical trials or research projects, unexpected side-effects of pipeline or marketed products; 6 increased government pricing pressures; 7 interruptions in production 8 loss of or inability to obtain adequate protection for intellectual property rights; 9 litigation; 10 loss of key executives or other employees; and 11 adverse publicity and news coverage. OBI Pharma cautions that this foregoing list of factors is not exhaustive. There may also be other risks that management is unable to predict at this time that may cause actual results to differ materially from those in forward-looking statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date on which they are made. OBI undertakes no obligation to update publicly or revise any forward-looking statements. Any statements regarding earnings growth is not a profit forecast and should not be interpreted to mean that OBI s earnings or earnings per share for this year or any subsequent period will necessarily match or exceed published earnings or earnings per share forecasts of OBI Pharma, Inc. 2

3 Re inventing OBI as a Global Oncology Company 3 with an innovative and balanced portfolio

4 Key Highlights Making progress towards Global P3 (Adagloxad Simolenin) Constructive EOP2 Meetings with FDA and EMA CTA approval by CFDA Expanding the product portfolio Advancing from Active to Passive Immunotherapy Introducing a non-carbohydrate asset (OBI-3424) into the pipeline Raising visibility at international conferences ASCO Presentation, ESMO Symposium 4 Restructuring for tomorrow Stronger worldwide IP estate Recruiting global talent and expertise

5 Latest Update on Adagloxad Simolenin 5

6 Key Learnings from the Adagloxad Simolenin 001 Study PFS by Immune Response for Metastatic Patients treated with Adagloxad Simolenin Probability of Progression Free Survival IgG <1:160 Months since randomized IgG >=1:160 Well tolerated Can induce significant number of Globo series antibodies

7 Clinical Insight from the 001 Study Global Phase III trial patient selection More doses will maintain an immune response Potential uses Combination therapy Adjuvant therapy

8 Constructive End of Phase 2 (EOP2) Regulatory Meetings for Adagloxad Simolenin US China EU FDA EOP2 Jan 2017 CTA Approval Jan 2017 EMA EOP2 Apr 2017

9 Adagloxad Simolenin FDA/EMA EOP2 feedback Patient Population IHC Test / Companion Diagnostic Treatment Duration Primary & Secondary Endpoints

10 Proposed Adagloxad Simolenin Global Phase 3 TNBC Trial Residual Disease Post Neo Adjuvant Chemo EXPERIMENTAL ARM Adagloxad Simolenin PLACEBO ARM Placebo Primary End Point Secondary End Points Exploratory End Points Disease Free Survival Overall Survival Correlating Tumor Globo H Expression to clinical outcomes 10

11 Extending to Passive Immunotherapy 11 OBI 888 OBI 999

12 Beyond Cancer Vaccines: mabs and ADCs Globo H Immunotherapies Adagloxad Simolenin 1st in Class Cancer Vaccine OBI 888 Globo H Monoclonal Antibody (mab) OBI 999 Globo H Antibody Drug Conjugate (ADC) Innovative oncology portfolio focusing on 1st-in-class novel Globo H immunotherapies 12

13 MECHANISMS OF ACTION OBI 888 a Novel Humanized Globo H Antibody with Promising Pre clinical Results Antigen & Epitope Globo H confirmed by glycan screening and competitive ELISA Globo H GalNAc Gal Glc Fuc 13

14 OBI 888 Inhibits Breast Cancer in Human Xenograft Model Globo H Over expression 1 mg/kg MCF7 Xenograft 3 mg/kg 10 mg/kg 27% 400X Globo H Antigen Cell Nuclei 70% 14 82%

15 OBI 888 High Potential Globo H mab Therapy Unique therapeutic approach Anti angiogenesis Anti immune suppression Plan to file IND by YE 2017 Global Cancer market dominated by mabs Enhances and strengthens OBI Global Cancer Portfolio In a range of human tumor xenografts: Breast, Pancreas, Stomach, Lung, Colon 15

16 Synergy of APBio and OBI Antibody Screening and Antibody Engineering Human antibody screening Antibody humanization and optimization Bispecific antibody Will speed OBI antibody development and strengthen the pipeline Antibody Engineering Lower immunogenicity Better expression Higher affinity

17 OBI 999 Novel Target portfolio Antibody Drug Conjugates (ADC) 17

18 ADC Success Depends on Optimization of Each Component Target Tumor specific Highly expressed in tumor cells Linker Stable in plasma Internalized by cell 18 Antibody Specificity Unaltered target binding affinity Drug Potency Linked drug is set free

19 ADCs Target the Delivery of Potent Cytotoxic Drugs via Tumor Specific Antigens Toxicity Toxicity Less exposure to normal tissues Drug Dose Efficacy Efficacy Therapeutic Window is greater 0% Inefficacy Free Drug Inefficacy ADC More drug reaches the tumor 19

20 OBI 999 Represents an Exciting Market Opportunity ADC Market Large Potential Growth US$18.1B in ADC Market: Dublin, Feb. 22, 2017 (GLOBE NEWSWIRE) Projected value: Evaluate Pharma worldwide review 2017

21 Introducing OBI 3424 Globo Series Immunotherapies AKR1C3 Targeted Therapy Adagloxad Simolenin 1st in Class Cancer Vaccine OBI 888 Globo H Monoclonal Antibody OBI 999 Antibody Drug Conjugates Globo H Antibody OBI 3424 Potent Small Molecule targeting AKR1C3 Enzyme Formerly TH

22 OBI 3424 Highly Tumor Selective and First in Class Pro drug Activated by AKR1C3 Enzyme Adequate Pre Clinical Safety Margin Overcomes Resistance Multiple Indications Planned IND 1Q2018 Blockbuster Potential Impressive in vivo anti-tumor activity in mice at a non-toxic dose in monkeys Effective vs sorafenib-resistant liver cancer model 2 Target expressed by several human cancers 1, including: Liver, Gastric Kidney, Bladder Prostate, Leukemia Potential for 1st line or 2nd usage 22 1.Guise et al., Cancer Res 70: 1573, 2010; AACR Annual Meeting 2016, Abstract #1369; Threshold in-house data

23 OBI 3424 Activation by AKR1C3 Enzyme Releases Cytotoxic Agent Directly at the Tumor OBI 3424 AKR1C3 enzyme present Tumor Cell Prodrug AKR1C3 Active drug Tumor cells (killed) 23

24 OBI 3424: Impressive Preclinical Data in a Orthotopic Xenograft Liver Cancer Animal Model Tumor Area (mm 2 ) Saline Sorafenib Significant separation observed 2 OBI Days 24 NOTE: Doses in mg/kg SOURCE: Duan et al., Broad In Vitro and In Vivo Antitumor Activity of TH-3424: Preclinical Rationale for a Highly Selective AKR1C3 Prodrug for Treating Cancer AACR Annual Meeting 2016, Abstract #1369 OBI

25 Significant Reduction in Leukemia Bone Marrow Infiltration with OBI 3424 PDX Model (T ALL 31) %hucd45+ in the PB Control Group Significant Differences in EFS (Event Free Survival) distribution between Control and OBI-3424-Treated groups OBI 3424 Treated Group Welltolerated Days post treatment initiation A novel treatment for aggressive and chemoresistant T-ALL in an AKR1C3 biomarker-driven clinical trial

26 Results of a Patient Derived Xenograft (PDX) Study of OBI 3424 in T cell Acute Lymphoblastic Leukemia (T ALL) Presented at the AACR OBI 3424 is one of the most effective drugs we have ever tested against T-ALL in over 12 years of evaluating drugs at the Children's Cancer Institute in Australia using preclinical models of aggressive childhood ALL. We are incredibly excited about the potential for OBI 3424 to improve the treatment and quality of life for patients with this aggressive type of cancer and look forward to having this potential evaluated in clinical trials. Professor Richard B. Lock Head of the Leukemia Biology Program Children's Cancer Institute in Australia

27 Current Status of OBI s Novel First in Class Oncology Pipeline by Stage of Development Program Indication Pre-Clinical P1 P2 P3 Adagloxad Simolenin TNBC OBI 888 mab Epithelial cancers OBI 3424 Target Therapy Multiple cancers OBI 999 ADC Epithelial cancers 27

28 Key Portfolio Milestones Q Q H H 2019 OBI 888 IND OBI 3424 IND Adagloxad Simolenin FPFV OBI 999 IND 28

29 Enhance International Visibility 29

30 Adagloxad Simolenin Results Unveiled at Prestigious Cancer Meetings 3 7 JUNE OCTOBER 2016 Advisory Board Meeting Breast Cancer Symposium 1 on 1 Meetings 30 Dr Rugo presents Clinical Data at ASCO Clinical Professor Hope S Rugo of the Helen Diller Family Comprehensive Cancer Center at UCSF Dr Johnston chairs 1st Adagloxad Simolenin Symposium Professor Stephen Johnston of the The Royal Marsden NHS Foundation Trust

31 14 Experts from Around the World Gathered in ASCO 2017 to Discuss our Clinical Trials Key Opinion Leader Meeting at ASCO

32 Robust Intellectual Assets 32

33 Robust Worldwide IP Estate for OBI Portfolio Canada Russia China Korea United States Europe Israel Malaysia Japan 63* Approved Global Patents 107* Patents in Review Brazil Chile Mexico Argentina South Africa Taiwan India Philippines Singapore Thailand Australia New Zealand * Including licensor s patents

34 Recruiting International Experts 34

35 New Members on Our Advisory Boards Russell Greig, PhD Global Biotech Big Pharma R&D VC/PE Perspective Chi huey Wong, PhD Global Pioneer in Glycan Science Taiwan Biotech Thought leader Tillman Pierce, MD Global Clinical Trials Protocol Design Biotech R&D 35

36 Michael Chang, PhD Founder & Chairman Amy Huang General Manager Highly Experienced Global Management Tony Yu CSO Kevin Poulos CCO Max Chan COO Mitch Che COO OBI USA Cristina Chang VP Global Medical & Clinical Development David Hallinan VP Regulatory Affairs Sophia Lee VP Biostatistics 36

37 Strategic Direction Key Drivers of Long term Development Vx, mabs, ADCs, Target Therapies Retooling R&D and Pipeline Priorities Recruiting global talent and expertise 37 IP and Corporate Governance Co development and Licensing partners

38 Thank you San Diego Green Flash