Obi Pharma, Inc. · TPEX:4174
Obi Pharma — 39th Annual J.P. Morgan Healthcare Virtual Conference (January 2021)
45 slides from Obi Pharma's conference presentation, Jan 11, 2021
Slide 1: OBI Pharma, Inc.
OBI Pharma, Inc. Global Innovator in Immuno-Oncology and Targeted Cancer Therapies Advancing in the Clinic! Tillman Pearce, MD. Chief Medical Officer 39th Annual J.P. Morgan Healthcare Virtual Conference January 11th, 2021
Slide 2: Safe Harbor Statement
Safe Harbor Statement This presentation contains certain forward-looking statements. These forward-looking statements may be identified by words such as ‘believes,’ ‘expects,’ ‘anticipates,’ ‘projects,’ ‘intends,’ ‘should,’ ‘seeks,’ ‘estimates,’ ‘future,’ or similar expressions or by discussion of,
Slide 3: Agenda
Agenda 1 2 3 4 Company Globo Series AKR1C3 Key Introduction Science Science Milestones Leadership Leadership and Inflection Globo H Points Novel I-O Novel Pipeline Pro-drug 3
Slide 4: OBI Pharma, Inc. (TPEx: 4174.TWO)
OBI Pharma, Inc. (TPEx: 4174.TWO) www.obipharma.com Founded: April 29, 2002 Shanghai CHINA IPO on TPEx: March 23, 2015 Global HQ Market Cap Jan. 8, ’21: ~US$910M (~NT$25.5 B) Taipei TAIWAN San Diego Fund Raised at IPO: ~US$200M (~NT$6.2B) USA Hong Kong Net Cash on Hand: ~US$100M CHINA Employees: 115
Slide 5: Experienced Global Management Team
Experienced Global Management Team Michael Chang, PhD Kevin Poulos Chairman & CEO Chief Commercial Officer Amy Huang Frank Chen CEO OBI Pharma China Chief Financial Officer Tillman Pearce, MD Mitch Che Chief Medical Officer Chief Operating Officer Ming-Tain Lai, PhD David Hallinan, PhD Chief Science
Slide 6: OBI Pharma Has Evolved Into an Oncology Company With a Diversified Portfolio of Novel Therapies
OBI Pharma Has Evolved Into an Oncology Company With a Diversified Portfolio of Novel Therapies TARGETS: Globo H (+), SSEA-4 (+), AKR1C3 (+) Tumors Vaccine mAb ADC Targeted BiAb Prodrug CAR T 6 mAb: monoclonal antibodies ADC: Antibody Drug Conjugates BiAb: Bi-specific antibodies CAR-T: Chimeric Anti
Slide 7: Agenda
Agenda 1 2 3 4 Company Globo Series AKR1C3 Key Introduction Science Science Milestones Leadership Leadership and Inflection Globo H Points Novel I-O Novel Pipeline Pro-drug 7
Slide 8: Functions of Glycosphingolipids (GSLs)
Functions of Glycosphingolipids (GSLs) A B C D Including and Several receptors Crosslinking of Interacting with glycans excluding can be directly several GSLs can or with proteins on other proteins from regulated by GSLs induce signaling cells, contributing to cell- microdomains present in the cell
Slide 9: Glycans, Glycosphingolipids and Cancer
Glycans, Glycosphingolipids and Cancer • Glycans and glycosphingolipids (GSLs) play a crucial role in tumor progression Globo Series GSLs β3 • Aberrant glycosylation is a hallmark of Ceramide cancer cells SSEA-3 • GSLs are glycans conjugated to a lipid α2 (ceramide) core Ceramide Globo H • Globo ser
Slide 10: Potential Roles of Globo H in Immunosuppression, Angiogenesis, and Cancer Cell Survival Signaling
Potential Roles of Globo H in Immunosuppression, Angiogenesis, and Cancer Cell Survival Signaling Lymphocytes Promotes Promotes Angiogenesis2 Immunosuppression1 Notch 1 Ub Endothelial Cells Ub Ca2+ TRAX Degradation Promotes Tumor Tumor Shedding of Survival Signaling3 Globo H Ceramide Kinase Kinase
Slide 11: High Globo H Expression in Common Cancers
High Globo H Expression in Common Cancers Globo H IHC H-score of various tumor tissues # Prevalence # Evaluable Cancer H-score at H-score 300 Specimens ≥100 ≥100 250 Pancreatic 72 36 50.0% 200 Esophageal 64 11 17.2% H score 150 Gastric 73 18 24.7% 100 Breast 131 17 13.0% 50 Lung 77 8 10.4% Colon 75
Slide 12: Globo H scientific posters presented at 2020 AACR
Globo H scientific posters presented at 2020 AACR Globo H Ceramide enhances cancer cell survival Tzer -M in Kuo 1 , Yi-Chien Tsai 1 , Chin-Chan Lee1 , and Jiann-Shiun Lai 1 1 2934 OBI Phar ma, Inc., Taipei, Taiwan INTRODUCTION Enhanced colony formation activity in GHCer-treated lung cancer cells wit
Slide 13: OBI Pharma's First-in-Class Cancer Pipeline
OBI Pharma’s First-in-Class Cancer Pipeline Stage of Development PRODUCT TYPE TARGET CANCER PRE-CLINICAL PHASE 1 PHASE 2 PHASE 3 Adagloxad Vaccine Globo H Breast (TNBC) Global Phase 3 TNBC Study Simolenin OBI-888 mAb Globo H Multiple Cancers OBI-999 ADC Globo H Multiple Cancers OBI-833 Vaccine Globo
Slide 14: Adagloxad Simolenin
Adagloxad Simolenin First-in-Class Active Immunotherapy Stimulating anti-Globo H Antibodies 14 14
Slide 15: Adagloxad Simolenin (OBI-822) + OBI-821
Adagolaxad Simolenin (OBI-822) + OBI-821 Adagloxad Simolenin (OBI-822) + the saponin adjuvant OBI-821 is a therapeutic vaccine targeting Globo H ceramide in a variety of epithelial tumors + Adagloxad Simolenin (OBI-822) Potent Adjuvant (OBI-821) Saponin-based adjuvant Comprises a fully synthetic tum
Slide 16: Phase 3, Randomized, Open-Label Study of Adagloxad Simolenin in TNBC
Phase 3, Randomized, Open-Label Study of the Anti-Globo H Vaccine Adagloxad Simolenin (OBI-822)/OBI-821 in the Adjuvant Treatment of Patients with High-Risk, Early-Stage Globo H-Positive Triple-Negative Breast Cancer Clinicaltrials.gov. Study of Adagloxad Simolenin (OBI-822)/OBI-821 in the Adjuvant
Slide 17: Globo H Expression in Triple Negative Breast Cancer
Globo H Expression in Triple Negative Breast Cancer GH+ tumor Stroma Capillary GH+ tumor GH+ TILs Fat GH- tumor White 57-year-old female with infiltrating ductal carcinoma White 59-year-old female with papillary carcinoma H-score = 300 H-score = 185 GH expression level was assessed, and results are
Slide 18: Phase 3 TNBC Study Design
Phase 3 TNBC Study Design R A OBI-822/OBI-821 + SOC N S D F U Tissue Globo H O O L R M 1:1 G submission 2 weeks analysis I Treatment Period 2 Years L E Z N = 668 O Follow-Up 3 Years R for Globo H (150 centers: 2-year recruitment) W (H score A - Y T U ≥15) I P Approx. 40% O N SOC Key Eligibility Crit
Slide 19: Phase 3 TNBC Study Objectives
Phase 3 TNBC Study Objectives Primary Objective Exploratory Objectives • To determine the effect of adagloxad simolenin • To explore the association between the (AS) treatment on improving IDFS in the study anti-Globo H antibody response to AS and IDFS population and OS Secondary Objectives • To eva
Slide 20: Adagloxad Simolenin Global Phase 3 Trial Investigator Site Locations
Adagloxad Simolenin Global Phase 3 Trial Investigator Site Locations France, Germany, Russia Poland, Spain. EU Ukraine China Korea USA Taiwan Mexico Hong Kong Peru Brazil Australia S. Africa Argentina Enrolling sites Pending sites 20 OBI data on file
Slide 21: OBI-888
OBI-888 First-in-Class Monoclonal Antibody Targeting Tumor Expression of Globo H 21
Slide 22: OBI-888 Inhibits Tumor Growth in Cancer Xenograft Models
OBI-888 Inhibits Tumor Growth in 5 Cancer Xenograft Models CANCER TUMOR DOSES TREATMENT TGI AT TOP DOSE TYPE MODEL (mg/kg) DURATION TESTED, % Breast MCF7 1, 3, 10 Q2W x 6 85% Breast HCC-1428 3, 10, 30 Q2W x 6 55% Pancreatic HPAC 5, 20, 80 Q2W x 5 47% Colorectal SW480 100 Q2W x 4 49% Lung NCI-H526 10
Slide 23: OBI 888-001 Two-Part Phase 1 Study
OBI 888-001 Two-Part Phase 1 Study Part 1: Dose Escalation Dose Escalation (3+3) 20 mg/kg (N = 3*) Results • No drug-related SAEs 10 mg/kg • No DLTs at 20 mg/kg (N = 3*) • OBI-888 was well tolerated 5 mg/kg (N = 3*) Endpoints: Safety, efficacy, PK/ADA, Tumor and CTC exploratory biomarkers * Number o
Slide 24: Recruiting the Cohort Expansion Portion of the OBI-888-001 Phase 1/2 Study
Recruiting the Cohort Expansion Portion of the OBI-888-001 Phase 1/2 Study Pancreatic Gastric Esophageal Colorectal Basket Cancer Cancer Cancer Cancer Cohort* • OBI-888 monotherapy at 20 mg/kg weekly • Advanced cancer; no effective SOC available; measurable disease; PS 0-1 • Patient tumor sample mus
Slide 25: OBI-999
OBI-999 Antibody-Drug Conjugate (ADC) Targeting Tumor Expression of Globo H 25
Slide 26: OBI-999 Targeting Tumor-Specific Globo H
OBI-999 Targeting Tumor-Specific Globo H Proprietary Novel Site-Specific Improved Homogeneity vs Adcetris Linker Technology ThioBridge® OBI-999 Adcetris 100 100 80 80 60 60 % % 40 40 20 20 0 0 0 1 2 3 4 5 6 7 8 0 1 2 3 4 5 6 7 8 DAR Species DAR Species Maintains the stability of the antibody and a c
Slide 27: OBI-999 Strong Anti-Tumor Effects in Cancer Models
OBI-999 Strong Anti-Tumor Effects in 4 Cancer Models CANCER TUMOR MODEL TREATMENT ANTI-TUMOR EFFECT AT TYPE DURATION TOP DOSE Pancreatic HPAC QW x 4 Tumor Free Tumor Free Gastric NCI-N87 QW x 4 (achieved at both 3 and 10 mg/kg) Lung PDX LU-01-0266 QW x 4 Tumor Free Breast MCF7 QW x 6 or Q3W x 2 Tumo
Slide 28: OBI-999 Strong tumor growth inhibition in HPAC pancreatic cancer xenograft model
100 OBI-999 Strong tumor growth inhibition in -7 1 HPAC pancreatic cancer xenograft model 6 Days 9 12 16 HPAC xenograft (OBI-20180927) 3000 Globo H expression: 97%. Vehicle OBI-999 1mpk, IV, QWKx4 2500 OBI-999 3mpk, IV, QWKx4 Tumor volume (mm3) OBI-999 10mpk, IV, QWKx4 OBI-999 at 3 mg/kg: 2000 TGI 3
Slide 29: OBI-999 Strong tumor growth inhibition in NCI-N87 Gastric carcinoma xenograft
OBI-999 Strong tumor growth inhibition in NCI-N87 Gastric carcinoma xenograft N C I- N 8 7 x e n o g r a f t ( A B 6 7 8 3 5 ) Globo H expression: 57%. 2000 V e h ic le ( Q W X 4 ,IP + IV ) O B I- 9 9 9 , 1 m g /k g ( Q W x 4 , IV ) O B I- 9 9 9 , 3 m g /k g ( Q W x 4 , IV ) 1500 O B I- 9 9 9 , 1 0
Slide 30: Nearing End of Recruitment to the Dose Escalation Portion of the Phase 1/2 OBI-999-001 Study
Nearing End of Recruitment to the Dose Escalation Portion of the Phase 1/2 OBI-999-001 Study ⚫ Subject number: 3+3 design, up to 30 (sequential enrollment); ⚫ Treatment cycle: 21-day cycle up to 35 cycles (approximately 2 years); ⚫ SRC: review safety and PK data after each cohort completes the 1st c
Slide 31: Agenda
Agenda 1 2 3 4 Company Globo Series AKR1C3 Key Introduction Science Science Milestones Leadership Leadership and Inflection Globo H Points Novel I-O Novel Pipeline Pro-drug 31
Slide 32: OBI-3424
OBI-3424 Small Molecule Prodrug Targeting Tumors Expressing the AKR1C3 Enzyme 32
Slide 33: OBI Pharma's First-in-Class Cancer Pipeline
OBI Pharma’s First-in-Class Cancer Pipeline Stage of Development PRODUCT TYPE TARGET CANCER PRE-CLINICAL PHASE 1 PHASE 2 PHASE 3 Adagloxad Vaccine Globo H Breast (TNBC) Global Phase 3 TNBC Study Simolenin OBI-888 mAb Globo H OBI-999 ADC Globo H Multiple Cancers OBI-833 Vaccine Globo H Multiple Cance
Slide 34: The Prodrug OBI-3424 Is Converted to Active Drug in AKR1C3 Expressing Tumor Cells
The Prodrug OBI-3424 Is Converted to Active Drug in AKR1C3 Expressing Tumor Cells Apostolia Maria Tsimberidou et al. A First-In-Man Phase 1/2 Study of OBI-3424, an AKR1C3-Selective Bis-Alkylating Agent Prodrug, in Subjects With 34 Advanced Cancer, Including Hepatocellular Carcinoma (HCC) and Castrat
Slide 35: AKR1C3 Prevalence in Cancer Types
AKR1C3 Prevalence in 10 Cancer Types Prevalence of H-score ≥135 400 AKR1C3 IHC H-score 300 200 135 100 0 ng r al ca r nx r G ac C m cC A P nC A A er r C on r c r as r A A ng A C so gu C ea A or Ov ary o C B ic C A e L u ce e Li ive e e v en m HC TM or ri TM N olo TM Lu M al ia TM TM ag TM C ha SC C
Slide 36: OBI-3424 Tumor Inhibition in Orthotopic Xenograft Liver Cancer Animal Model
OBI-3424 Tumor Inhibition in Orthotopic Xenograft Liver Cancer Animal Model (1.25mg/kg and 2.5mg/kg) Apostolia Maria Tsimberidou et al. A First-In-Man Phase 1/2 Study of OBI-3424, an AKR1C3-Selective Bis-Alkylating Agent Prodrug, in Subjects With 36 Advanced Cancer, Including Hepatocellular Carcinom
Slide 37: Nearing End of Recruitment to the Dose Escalation Portion of the Phase 1/2 OBI-3424-001 Study
Nearing End of Recruitment to the Dose Escalation Portion of the Phase 1/2 OBI-3424-001 Study Metastatic or OBI-3424 Part 2 Unresectable Solid OBI-3424 Part 1 COHORT EXPANSION Tumors in Dose- DOSE ESCALATION (HCC, Gastric, Escalation Phase Pancreas, Basket) Ongoing – Completed 8 Cohorts Measuring AK
Slide 38: OBI-3424 Potential Therapeutic Value in T-cell Acute Lymphoblastic Leukemia (T-ALL)
OBI-3424 Potential Therapeutic Value in T-cell Acute Lymphoblastic Leukemia (T-ALL) 38
Slide 39: Significant Reduction in Leukemia Bone Marrow Infiltration With OBI-3424 in PDX Model
Significant Reduction in Leukemia Bone Marrow Infiltration With OBI-3424 in PDX Model (T-ALL 31) Control OBI-3424 “OBI-3424 is one of the most Group Group effective drugs we have ever %huCD45+ in the PB tested against T-ALL in over 12 years of evaluating drugs at Significant the Children’s Cancer In
Slide 40: OBI-3424 Phase 2 T-ALL Study sponsored by SWOG ongoing
OBI-3424 Phase 2 T-ALL Study sponsored by SWOG ongoing Clinicaltrials.gov A Phase II Study of AKR1C3-Activated Prodrug OBI-3424 (OBI-3424) in Patients With Relapsed/Refractory T-Cell Acute Lymphoblastic Leukemia (T-ALL) NCT04315324 40
Slide 41: Agenda
Agenda 1 2 3 4 Company Globo Series AKR1C3 Key Introduction Science Science Milestones Leadership Leadership and Inflection Globo H Points Novel I-O Novel Pipeline Pro-drug 41
Slide 42: OBI Trial-in-Progress Posters at 2020 ASCO Congress
OBI Trial-in-Progress Posters at 2020 ASCO Congress Adagloxad Simolenin, OBI 999, OBI 3424 42
Slide 43: Projected Phase 1-2 Clinical Data in 2021-22
Projected Phase 1-2 Clinical Data in 2021-22 1st-in-class Oncology products Adagloxad Enrollment Simolenin Global Phase 3 TNBC Study Ends Globo H Vx OBI-888 Phase 1 Phase 2 Phase 2 Globo H mAb (Stage 1) (Stage 2) 2020 2021 2022 2023 2024 OBI-999 Phase 2 Phase 2 Phase 1 Globo H ADC (Stage 1) (Stage 2
Slide 44: OBI Pharma Affiliated Enterprises (2021)
OBI Pharma Affiliated Enterprises (2021) Equity investments (%) Delos OBI Pharma, Odeon* OBI Pharma Inc. Therapeutics USA, Inc. (Cayman) Limited 100% 60% OBI Pharma Obigen* Limited Pharma, Inc. 100% OBI Pharma Amaran 75% Australia Odeon AP Biotech * Pty Ltd BIOSCIENCES Hong Kong 100% INC. 67% 100% 5
Slide 45: Thank You
Thank You For further information please contact: THANK YOU! Kevin Poulos Chief Commercial Officer kpoulos@obipharmausa.com http://www.obipharma.com/ 45
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