Obi Pharma, Inc. · TPEX:4174
Obi Pharma — Shareholder Meeting (June 2022)
56 slides from Obi Pharma's shareholder meeting presentation, Jun 27, 2022
Slide 1: OBI Towards Sustainability 2.0
OBI Towards Sustainability 2.0 Michael Chang PhD Chairman & CEO JUN 27, 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: OBI Pharma, Inc. (4174.TWO)
OBI Pharma, Inc. (4174.TWO) www.obipharma.com Founded: April 29, 2002 IPOon TPEx: March 23, 2015 Market Cap Jun 1, ’ 22: ~US$833M ~(NT$25B) Shanghai CHINA Fund Raised in 2013: ~US$50M (~NT$1.5B) San Diego Global HQ USA ~US$207M (~NT$6.2B) Fund Raised at IPO: Taipei Fund Raised in 2022: ~US$105M (~NT
Slide 4: Experienced Global Management Team
Experienced Global Management Team Michael Chang, PhD Kevin Poulos Chief Chairman & CEO Commercial Officer Wayne Saville, MD Frank Chen Chief Medical Officer Chief Financial Officer Ming-Tain Lai, PhD Mitch Che Chief Scientific Officer Chief Operating Officer David Hallinan, PhD VP Regulatory Affair
Slide 5: Agenda
Agenda 1 OBI Towards Sustainability 2 Product Line’s Progress 3 Affiliated Enterprises 5
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 (+), and various other potential targets Targeted Vaccine Prodrug ADC mAb BiAb CAR T mAb: monoclonal antibodies ADC: Antibody Drug Conjugates BiAb: Bi-specific ant
Slide 7: 2022 ASCO Annual Meeting
2022 ASCO Annual Meeting Poster Presentations to highlight the ongoing clinical studies Adagloxad Simolenin, OBI-999, and OBI-3424 7
Slide 8: 2022 AACR Annual Meeting
2022 AACR Annual Meeting Poster Presentations to show the synergistic antitumor efficacy in the combination of OBI-3424 with pembrolizumab (anti-PD-1) and Globo-H expression associated with poor survival of gastric cancer patients 8
Slide 9: OBI Towards Sustainability
OBI Towards Sustainability New generation Antibody Drug Cell Therapy COVID-19 vaccine Conjugate (ADC) 9
Slide 10: BCVax
Speaker: Dr. Michelle Yang BCVax Second generation Recombinant subunit protein vaccine against SARS-CoV-2 10
Slide 11: COVID-19 Global Pandemic
COVID-19 Global Pandemic New variants keeps emerging, current vaccines are not able to provide effective protection Confirmed case Death (millions) (thousands) Europe 224 2,020 Vaccination Americas started 160 2,750 2020 Dec. Western Pacific 63 230 Alpha, Delta Omicron Beta South-East Asia Gamma 58
Slide 12: BCVax
BCVax Antigen: Delta-S protein Adjuvant: ISCOM ◼ Improved from OBI-821 adjuvant ◼ Trimer, as natural form ◼ Nanoparticle format ◼ More stable for storage and transport ◼ Strong immunogenicity to induce antibody and T cell responses Induces high titer anti-S protein IgG and T cell response 12
Slide 13: Pseudovirus neutralization activity against multiple variants and T-cell responses
Pseudovirus neutralization activity against multiple variants and T-cell responses Bleeding END 13
Slide 14: Features of BCVax
Features of BCVax Protein-based vaccine is considered very safe Capable to induce immunity against multiple variants Including Alpha, Beta, Gamma, Delta, and Omicron ISCOM as adjuvant to enhance immune response ◼ High IgG titers and T cell responses were observed in vivo ◼ Expect to observe similar
Slide 15: Development status
Development status Design Phase I is planned Toxicology to conduct in TW, GMP production To file IND study mainly used as booster shots SEP~ 2022 AUG OCT DEC 15
Slide 16: OBI TROP2 ADC
Speaker: Dr. Wan-Fen Li OBI TROP2 ADC New target TROP2 ADC 16
Slide 17: TROP2 is overexpressed in a wide range of cancers
TROP2 is overexpressed in a wide range of cancers Liao et al. Drug Dev Res 2021, 82(8): 1096-1110 17
Slide 18: Success of Trodelvy proves TROP2 as a valid target
Success of Trodelvy™ proves TROP2 as a valid target ✓ FDA accelerated approval in 2020 and full approval in 2021 ✓ Indications ◼Metastatic triple negative breast cancer (mTNBC) ◼Metastatic urothelial cancer (mUC) ✓ Dose: On Days 1 and 8 in a 21-day cycle ✓ Ongoing clinical trials for additional indi
Slide 19: Trodelvy market growth forecast
Trodelvy™ market growth forcast 2020 2022 2026 Gilead Sciences, Inc. (Nasdaq: Trodelvy™ sales in Q1 Trodelvy™ Sales Forecast 2026: GILD) announced the 2022: USD 146 million ~USD 3.3 billion completion of the previously announced transaction to 3.3 2020～2026 CAGR ~ 101.1% acquire Immunomedics, Inc. (
Slide 20: ADC Success Depends on Optimization of Each Component
ADC Success Depends on Optimization of Each Component TROP2 Antibody：licensed-in from Biosion, Inc. in Dec 2021 Linker Noval Antibody ◼ Stable in plasma ◼ Internalized by cell ◼ Tumor specific ◼ Drug release inside the cell ◼ Unaltered target bindingaffinity Drug ◼ High potency payload ◼ TOP1 inhibi
Slide 21: OBI TROP2 ADC vs. Trodelvy
OBI TROP 2 ADC vs. Trodelvy™ OBI TROP2 mAb Sacituzumab Binding affinity (KD) +++ +++ Exposure (AUC) +++ ++ Pharmacokinetics Clearance +++ ++ Half-life +++ ++ OBI TROP2-ADC Trodelvy™ Linker stability +++ + Cytotoxicity of payload +++ ++ Resistance to payload ++ +++ Adverse side effects of payload ++
Slide 22: OBI TROP2 ADC Development Timeline
OBI TROP 2 ADC Development Timeline Animal IND Phase I/II Kickoff GLP GMP DS/DP PD/PK Submission Study Toxicology production studies 2022 2023 2024 22
Slide 23: Cell Therapy
Speaker: Dr. Jiann-Shiun Lai Cell Therapy 23
Slide 24: CAR-T Cell therapy
CAR-T Cell therapy https://askhematologist.com/car-t-cell-therapy/ 24
Slide 25: In vitro cytotoxicity of Globo H CAR-T
In vitro cytotoxicity of Globo H CAR-T HCC1428 cytotoxicity MCF-7 cytotoxicity 100 100 Cytotoxicity (%) Cytotoxicity (%) 80 80 60 60 40 40 20 20 0 0 1 1 1 1 1 1 1 0: 5: 1: 2: 5 : 10 : 2 0: 1 :1 1 1 1 :1 :1 0: 1: 2: 5: . 5 10 20 0 0. NCI-N87Ecytotoxicity :T SK-OV3Ecytotoxicity :T 100 100 Cytotoxicity
Slide 26: In vivo efficacy and persistence in N87 gastric cancer model
In vivo efficacy and persistence in N87 gastric cancer model 1st N87 tumor 1st N87 tumor injection cells injection 2nd N87 tumor nd Ctrl-T/ CAR-T 2 N87 ASID002_pL5w.Puro 2E6tumor T cells injection T cell injection injection cells injection Ctrl T Luminescence (Photons/sec) 10 12 2C2 CAR-T Ctrl-T CAR
Slide 27: Biodistribution and toxicity in N87 gastric cancer model
Biodistribution and toxicity in N87 gastric cancer model CAR-T cell therapy Day 0 Day 7 Day 14 Lung Spleen Tumor Tumor- Tumor Bearing B: Brain; H: Heart; Lu: Lung; Li, Liver; K: Kidney; M: Muscle; S: Spleen; T: Tumor; St: stomach; I: Intestine; Tumor- LN: Lymph node Free • Globo H CARs dominantly ta
Slide 28: Advantage of OBI Globo H CAR-T
Advantage of OBI Globo H CAR-T Unique and novel target for cancer therapy Efficacy dose close to clinical therapeutic zone Persistence for persistent tumor killing Safe for tumor specific targeting Memory for immune organ homing 28
Slide 29: CAR T Timeline for IND Application
CAR T Timeline for IND Application Laboratory Scale Tech Transfer to Process/ GMP Facility/ IND GMP Clinical Enabling Scale Production To file IND Analytical Tech Transfer Manufacturing 2022 2023 Pre-clinical Pre-IND and IND Filing 29
Slide 30: Agenda
Agenda 1 OBI Towards Sustainability 2 Product Line’s Progress 3 Affiliated Enterprises 30
Slide 31: 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-3424 Prodrug AKR1
Slide 32: Adagloxad Simolenin (OBI-822)
Adagloxad Simolenin（OBI-822） A First-in-Class Active Immunotherapy Stimulating Production of Anti-Globo H Antibodies 32
Slide 33: Adagloxad Simolenin Global Phase III Trial
Adagloxad Simolenin Global Phase III Trial Design Population ◼ Randomized ◼ Patients with high-risk, early-stage ◼ Open-label Globo H-positive triple negative ◼ Standard of care as the control breast cancer Objective Current progress ◼ Enrolling sites ： ◼ Primary endpoint: USA, Taiwan, Hong Kong, Au
Slide 34: OBI-888
OBI-888 A First-in-Class Monoclonal Antibody Targeting Globo H-Positive Cancers 34
Slide 35: OBI-888 Phase II Study, Cohort Expansion
OBI-888 Phase II Study, Cohort Expansion Design ◼ OBI-888 monotherapy at 20 mg/kg weekly ◼ Advanced cancer; no effective SOC available; measurable disease; ECOG 0-1 ◼ Patient ′s tumor sample must have an H score of Globo H ≥ 100 in an FDA IDE-approved assay (NeoGenomics) Cohort Pancreatic Cancer, Ga
Slide 36: OBI-999
OBI-999 An Antibody-Drug Conjugate (ADC) Targeting Globo H-Positive Cancers 36
Slide 37: OBI-999 Phase II Study, Cohort Expansion
OBI-999 Phase II Study, Cohort Expansion Design ◼ OBI-999 monotherapy at 1.2 mg/kg on Day 1 of a 21-day cycle ◼ Patient ′s tumor sample must have an H score of Globo H ≥ 100 in an FDA IDE-approved assay (NeoGenomics) Cohort ◼ Pancreatic Cancer, Colorectal Cancer, Basket Cohort* Sites ◼ Phase II Stud
Slide 38: OBI-3424
OBI-3424 A Small-Molecule Prodrug Targeting Cancers Expressing the AKR1C3 Enzyme 38
Slide 39: OBI-3424 Phase II Study, Cohort Expansion
OBI-3424 Phase II Study, Cohort Expansion Design ◼ OBI-3424 monotherapy at 12 mg/m2 on Day 1 of a 21-day cycle ◼ Patient ′s tumor sample must have an H score of AKR1C3 ≥135 in an IHC Assay (NeoGenomics) Cohort ◼ Pancreatic Cancer, Basket Cohort* Sites ◼ Phase II Study Centers：Up to 9 sites in the US
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: OBI-833
OBI-833 A New Generation Active Immunotherapy Stimulating Production of Anti-Globo H Antibodies 41
Slide 42: OBI-833/821 Phase II Study (Non-Small Cell Lung Cancer)
OBI-833/821 Phase II Study (Non-Small Cell Lung Cancer) Design Population ◼ Randomized ◼ Patients with Globo H-positive, ◼ Open-label inoperable, advanced or metastatic ◼ EGFR TKI therapy as the control NSCLC who have achieved PR or SD after first-line EGFR TKI therapy Objective Current progress ◼ P
Slide 43: OBI-833/821 Phase II Investigator-Initiated Trial (Esophageal Cancer)
OBI-833/821 Phase II Investigator-Initiated Trial (Esophageal Cancer) Design Population ◼ Randomized ◼ Patients with Globo H-positive, ◼ Open-label operable, locally advanced ◼ Standard of care as the control esophageal cancer who have high risk for recurrence after surgery Objective Current progres
Slide 44: Agenda
Agenda 1 OBI Towards Sustainability 2 Product Line’s Progress 3 Affiliated Enterprises 44
Slide 45: OBI Pharma Affiliated Enterprises (2022) Equity investments
OBI Pharma Affiliated Enterprises (2022) Equity investments OBI Pharma, Inc. AP Amaran Obigen Odeon OBI Pharma OBI Pharma OBI Pharma Biosciences Biotech Pharma, Inc. Therapeutics Australia USA, Inc. Limited Inc. OBI 858 (Cayman) Pty Ltd Bi-specifics CMC/CMO Botulinun Toxin A Limited 100% 100% 100% 5
Slide 46: AP Biosciences, Inc.
AP Biosciences, Inc. 46
Slide 47: APBio Bispecific Antibody Development Timeline
APBio Bispecific Antibody Development Timeline PRODUCT Format Application 2021 2022 2023 2024 2025 2026 2027 2028 Development Partner Innovent Biologics Bi-functional Fc wet AMD (macular degeneration) PII PIII IBI302 DME (Diabetic Macular Edema) (efficacy) (pivotal) (world-wide) fusion Bi-specific T
Slide 48: AP203 (PD-L1 x CD137 Bispecific Antibody)
AP203 (PD-L1 x CD137 Bispecific Antibody) - killing PD-L1-expressing cancer cells through localized activation of T cells Mechanism of Action For PD-L1-dependent activation of CD137 on cytotoxic & memory T cells in the tumor microenvironment, and to bridge the activated T cells to the cancer cells f
Slide 49: AP505 (PD-L1 x VEGF Bispecific Antibody)
AP505 (PD-L1 x VEGF Bispecific Antibody) - activates T cells while inhibiting angiogenesis with one single antibody Mechanism of Action To activate T cells through blocking of PD-1/L1, and to promote lymphocyte infiltration into the tumor through inhibition of VEGF pathway, to enhance tumor toxic ef
Slide 50: Obigen Pharma, Inc.
Obigen Pharma, Inc. 50
Slide 51: OBI-858 Product Executive Summary
OBI-858 Product Executive Summary OBI-858 : Best-in-class Botulinum Type A toxin Product Plant ◼ Drug substance and product located in Taiwan ◆ Plant design will meet CDC and cGMP Construction Hsinchu biomedical park and Tainan science park regulations ◼ A State-of-the-art PIC/s cGMP facility with h
Slide 52: OBI-858 Product Development Strategy
OBI-858 Product Development Strategy Short-Term Mid-Term Long-Term ◆ Migraine ◆ Liquid formulation ◆ Glabellar Lines ◆ Cervical dystonia ◆ Room temperature ◆ Calf Reduction storage ◆ Upper limb spasticity ◇ Frown Lines ◇ Crow ′s feet ◇ Instillation dosage form ◇ Blepharoptosis ◇ Facial Slimming ◇ Lo
Slide 53: Amaran Biotech
Amaran Biotech 53
Slide 54: Fully Automatic Robotic Aseptic Filling Line
Fully Automatic Robotic Aseptic Filling Line Gloveless Robotic Isolator Single Use Consumable Vial, Pre-filled Syringe and Cartridge Inert Air Replacement High Filling Accuracy Integrate with Lyophilizer Low Product Loss 54
Slide 55: Exhibited at Bio Asia-Taiwan CDMO Pavilion
Exhibited at Bio Asia-Taiwan CDMO Pavilion 55
Slide 56: Thank You
Thank You www.obipharma.com