Obi Pharma, Inc. · TPEX:4174
Obi Pharma — QIC Healthcare Forum 2022
49 slides from Obi Pharma's conference presentation, Feb 16, 2022
Slide 1: OBI Pharma, Inc.: Global Innovator in Immuno-Oncology and Targeted Cancer Therapies
OBI Pharma, Inc. Global Innovator in Immuno-Oncology and Targeted Cancer Therapies Advancing in the Clinic! Celeste Chuang, DPhil QIC Healthcare Forum 14-18 Feb 2022
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 11 Jan, ’22: ~US$ 900M (~NT$ 25B) Taipei TAIWAN San Diego Fund Raised at IPO: ~US$ 200M (~NT$ 6.2B) USA Hong Kong Net Cash on Hand: ~US$ 50M CHINA Employees: 12
Slide 5: OBI Pharma Affiliated Enterprises (2022)
OBI Pharma Affiliated Enterprises (2022) Equity investments (%) OBI Pharma, OBI Pharma Inc. Obigen USA, Inc. Pharma, Inc. 100% 62% OBI Pharma Limited 100% Amaran AP Biotech BIOSCIENCES OBI Pharma INC. 71% OBI 858 Australia Botulinun Pty Ltd 55% Toxin A OBI Pharma (Shanghai) 100% Limited 100% CMC/CMO
Slide 6: Experienced Global Management Team
Experienced Global Management Team Michael Chang, PhD Kevin Poulos Chairman & CEO Chief Commercial Officer Tillman Pearce, MD Frank Chen Chief Medical Officer Chief Financial Officer Ming-Tain Lai, PhD Mitch Che Chief Science Officer Chief Operating Officer David Hallinan, PhD VP Regulatory Affairs
Slide 7: 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 7 mAb: monoclonal antibodies ADC: Antibody Drug Conjugates BiAb: Bi-specific antibodies CAR-T: Chimeric Anti
Slide 8: 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 8
Slide 9: 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 10: 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 11: 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 12: 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 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 N = 668 O Follow-Up 3 Years for Globo H Z W R (H score ≥15) A (150 centers: 2-year recruitment) - Y T U Approx. 40% I P 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 Russia Poland, Spain EU Ukraine China Korea USA Taiwan Mexico Hong Kong Peru Brazil Australia S. Africa Enrolling sites 20 OBI data on file
Slide 21: OBI-833
OBI-833 Cancer Vaccine Targeting Tumor Expression of Globo H 21
Slide 22: OBI-833
OBI-833 OBI-833 + the saponin adjuvant OBI-821 is a therapeutic vaccine targeting Globo H ceramide in a variety of epithelial tumors Innovative Glycoprotein Saponin adjuvant OBI-821 Linker Globo H CRM-197 + OBI-833 OBI-821 Comprises a fully synthetic tumor antigen (Globo H) Induces humoral and cell-
Slide 23: Encouraging Phase 1 NSCLC cohort expansion results
Encouraging Phase 1 NSCLC cohort expansion results • OBI-833 demonstrated a favorable safety profile. • OBI-833 elicited a beneficial immune response in NSCLC patients and rendered some TKI-treated patients durable stable disease status. • The median progression-free survival was 38.1 weeks. • 11 of
Slide 24: OBI-833 P1 study published at ESMO
OBI-833 P1 study published at ESMO 24
Slide 25: OBI-888
OBI-888 First-in-Class Monoclonal Antibody Targeting Tumor Expression of Globo H 25
Slide 26: 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 27: 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 28: 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 29: OBI-999
OBI-999 Antibody-Drug Conjugate (ADC) Targeting Tumor Expression of Globo H 29
Slide 30: 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 31: 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 32: 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 33: Initiation Phase 2 portion of study November 2021
Initiation Phase 2 portion of study November 2021 ⚫ 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 cycle. ⚫ Patient tumor sample must have an H
Slide 34: 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 34
Slide 35: OBI-3424
OBI-3424 Small Molecule Prodrug Targeting Tumors Expressing the AKR1C3 Enzyme 35
Slide 36: 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 37: 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 37 Advanced Cancer, Including Hepatocellular Carcinoma (HCC) and Castrat
Slide 38: 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 39: 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 39 Advanced Cancer, Including Hepatocellular Carcinom
Slide 40: OBI-3424-001 Part 2 Cohort Expansion Initiated
OBI-3424-001 Part 2 Cohort Expansion Initiated Metastatic or OBI-3424 Part 2 Unresectable Solid OBI-3424 Part 1 COHORT EXPANSION Tumors in Dose- DOSE ESCALATION PaCa, Basket Escalation Phase w/ AKR1C3+ Initiated Measuring AKR1C3 Enzyme Expression with IDE-Approved Assay (NeoGenomics) MDACC, OSU, MSK
Slide 41: 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) 41
Slide 42: 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 43: 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 43
Slide 44: 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 44
Slide 45: Globo H scientific posters presented at 2020 AACR
Globo H scientific posters presented at 2020 AACR 45 Tzer-Min Kuo, PhD, et. al., The role of Globo H in cancer cell survival Poster 2934/8. I-Ju Chen, PhD, et. al., The prevalence of Globo H in different tumor types: Breast, pancreatic, lung, gastric, colorectal, liver, and esophageal cancers Poster
Slide 46: OBI Trial-in-Progress Posters at 2020 ASCO Congress
OBI Trial-in-Progress Posters at 2020 ASCO Congress Adagloxad Simolenin, OBI 999, OBI 3424 46
Slide 47: OBI Research Posters at 2021 AACR Conference
OBI Research Posters at 2021 AACR Conference 47
Slide 48: 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 49: Thank You
Thank You For further information please contact: THANK YOU! Celeste Chuang, DPhil Sr Manager Business Development cchuang@obipharma.com http://www.obipharma.com/ 49