Inovio Pharmaceuticals, Inc. · NASDAQ:INO
Inovio Pharmaceuticals — Investor Day (June 2020)
36 slides from Inovio Pharmaceuticals's investor day presentation, Jun 1, 2020
Slide 1: DNA Medicines: From COVID-19 to Cancer
DNA Medicines: From COVID-19 to Cancer June 1, 2020
Slide 2: Forward-Looking Statements
Forward-Looking Statements This presentation includes statements that are, or may be deemed, “forward-looking statement,” within the meaning of Section 27A of the Securities Act of 1933, as amended. All statements, other than statements of historical facts, included in this presentation regarding ou
Slide 3: Today's Agenda
Today’s Agenda In Conversation with 10:00 – DNA Medicines: From COVID-19 to Cancer David B. Weiner, Ph.D., Executive Vice President 10:25 AM ET J. Joseph Kim, Ph.D., INOVIO President, and Director, Vaccine Center, The Wistar Institute; CEO, Director Director, INOVIO 10:25 – Advantages of DNA Vaccine
Slide 4: Powering a New Decade of DNA Medicines
Powering a New Decade of DNA Medicines FIRST DNA Medicine in Phase 3 Clinical Trials Precisely Designed Plasmids Delivered (VGX-3100) for Precancerous Through Proprietary Smart Device Cervical Dysplasia FIRST to Show Clearance of Safe and Robust Immune Responses High-Risk HPV 16/18 in More Than 2,00
Slide 5: INOVIO Vision to Build the Leading DNA Medicines Company
INOVIO Vision to Build the Leading DNA Medicines Company Long-Term Strategy • Create new market in safe, effective DNA medicines Near-Term Execution • Aggressively seek partners to ensure DNA medicines reach • Rapidly bring to market patients in need precisely designed DNA Founding Vision medicines
Slide 6: Vision Built on INOVIO Proprietary Technology
Vision Built on INOVIO Proprietary Technology OPTIMIZED PLASMID DESIGN AND DELIVERY TECHNOLOGY PRECISELY PROPRIETARY IN VIVO DESIGNED PLASMIDS SMART DEVICE (SynCon®) (CELLECTRA®) 6
Slide 7: INOVIO's Technology Advantages
INOVIO’s Technology Advantages Clinical Efficacy • Demonstrated clinical efficacy in Phase 2b study • Lead candidate VGX-3100 in Phase 3 for cervical dysplasia Safety • Favorable safety profile tested in over 2,000 patients in over 6,000 administrations • Carries no potential toxicity from viral vec
Slide 8: INOVIO DNA Medicines Pipeline
INOVIO DNA Medicines Pipeline 8
Slide 9: INOVIO DNA Medicines Pipeline (Continued)
INOVIO DNA Medicines Pipeline (Continued) 9
Slide 10: DNA Medicines Featured Publications
DNA Medicines Featured Publications Safety, efficacy, and immunogenicity of VGX-3100, a therapeutic “The current trial represents a synthetic DNA vaccine targeting human papillomavirus 16 and 18 E6 and major breakthrough and proof-of- E7 proteins for cervical intraepithelial neoplasia 2/3: a randomi
Slide 11: Welcome Dr. David Weiner for a Conversation about DNA Medicines
INOVIO is Pleased to Welcome Dr. David Weiner for a Conversation about DNA Medicines David B. Weiner, Ph.D. Executive Vice President, Director Vaccine Center The Wistar Institute; Director, INOVIO 11
Slide 12: Advantages of DNA Vaccines in Response to the COVID-19 Outbreak
Advantages of DNA Vaccines in Response to the COVID-19 Outbreak Kate E. Broderick, Ph.D., Senior Vice President, R&D, Team Lead for COVID-19 Development
Slide 13: Key Characteristics of INOVIO's COVID-19 DNA Vaccine Platform
Key Characteristics of INOVIO’s COVID-19 DNA Vaccine Platform Robust Immune Responses (Neutralizing antibodies/ Rapid & B cells and Killer T cells) Scalable No Anti-Vector Manufacture Response (effective boosting) Host DNA Plasmids Room Temp (25°C) Storage >1 year; Non-replicating, SynCon® 37°C >2 m
Slide 14: Applying INOVIO's Platform to Emerging Infectious Disease
Applying INOVIO’s Platform to Emerging Infectious Disease SPEED • Design of vaccine candidate • Rapidity of manufacture 3 HOURS • Ability to harness established regulatory platform SAFETY PROFILE • Over 2,000 subjects treated in the clinic with INOVIO DNA + delivery technology • Over 6,000 doses of
Slide 15: INO-4800 Development Timeline
INOVIO’s COVID-19 DNA Vaccine INO-4800 Development Timeline 15
Slide 16: INOVIO Strategy for COVID-19 Program
INOVIO Strategy for COVID-19 Program Achieve INO-4800 licensure using dual strategy of emergency use authorization (EUA) and traditional approval pathway by: • Move rapidly into human Phase I studies to demonstrate safety, tolerability, and immunogenicity • Generating preclinical (immunogenicity & n
Slide 17: Response to COVID-19 Builds Upon Prior MERS Vaccine Experience
INOVIO Response to Novel Coronavirus COVID-19 Outbreak Builds Upon Prior Experience in Developing a MERS Vaccine We designed our COVID-19 vaccine candidate, named INO-4800, based upon studies targeting the MERS coronavirus family members. Track Record of Success with MERS DNA Vaccine – Preclinical •
Slide 18: INOVIO INO-4800 Rapid Response
INOVIO INO-4800 Rapid Response Species • Mouse • G. Pig (ID delivery) • Rabbit (full human dose) • NHP (immunogenicity/challenge) • Ferret (challenge) Published 2/02 2/09 2/16 2/23 3/01 3/08 3/15 3/22 3/29 4/06 4/10 5/20 Feb 4th Submitted ACE2/Spike blocking Biodistribution Pseudovirus In vitro neut
Slide 19: INO-4800: DNA Vaccine Targeting SARS-CoV-2 Spike Protein
INO-4800: DNA Vaccine Targeting SARS-CoV-2 Spike Protein INO-4800 instructs expression Rapid design of INO-4800 of Spike protein Isolation of virus Spike protein Zhu, N et al. 2020 NEJM Spike protein is the main target of Gene Optimization Algorithm neutralizing antibodies - Considered a key compone
Slide 20: Immune Responses After INO-4800 in Mice and Guinea Pigs
Robust Cellular and Humoral Immune Responses Measured After Immunization with INO-4800 in Mice and Guinea Pigs IFN-γ+ T cells SARS-CoV-2 S protein (RBD) serum IgG binding Single dose IM CELLECTRA® delivery ID CELLECTRA® delivery 20
Slide 21: Immune Responses Following INO-4800 in Rhesus Monkeys
Robust Cellular and Humoral Immune Responses Following Immunization of INO-4800 in Rhesus Monkeys Animal: Treatment: Group Vaccine Delivery Dose per immunization n Rhesus macaque Day 0 and 28 ID delivery of pDNA 1 pGX9501 ID, 1 site 1 mg 5 2 pGX9501 ID, 2 sites 2 mg 5 SARS-CoV-2 Spike peptides 300 P
Slide 22: Detection of Neutralizing Antibodies
Detection of Neutralizing Antibodies Naive M1 100000 Naive M2 Naive M3 10000 Naive M4 RLU Naive M5 INO-4800 M1 1000 INO-4800 M2 INO-4800 M3 100 INO-4800 M4 0.001 0.01 0.1 INO-4800 M5 sera dilution Group PRNT result (ND50) pVAX <1:10, 1:25, 1:20, 1:21, 1:14 INO-4800 >1:320, >1:320, >1:320, >1:320, >1
Slide 23: Preclinical Efficacy – SARS-CoV-2 Challenge Studies
Demonstration of Preclinical Efficacy – SARS-CoV-2 Challenge Studies Ferret Challenge at CSIRO, Australia Primate Challenge at Porton Down, PHE, UK 23
Slide 24: INO-4800 US Phase 1 Progress
INO-4800 US Phase 1 Progress • An open label study design in a small sample size – 40 healthy volunteers – to gain preliminary assessment on safety, tolerability and immunogenicity • Utilize historical experience with clinical trial sites to quickly complete start-up activities • Front load preparat
Slide 25: Thanks to Our Team and Global Coalition Supporting COVID-19 Program
Grateful Thanks to Our Team and Our Global Coalition to Date for Supporting INOVIO’s COVID-19 Program 25
Slide 26: Welcome Dr. Stanley Plotkin for a Conversation about DNA Vaccines
INOVIO is Pleased to Welcome Dr. Stanley Plotkin for a Conversation about DNA Vaccines and COVID-19 Stanley A. Plotkin, M.D. Emeritus Professor, Wistar Institute and University of Pennsylvania; Principal, Vaxconsult; Member, INOVIO Scientific Advisory Board 26
Slide 27: INOVIO DNA Immunotherapies
INOVIO DNA Immunotherapies Jeffrey Skolnik, M.D., Vice President, Clinical Development, Oncology
Slide 28: What is Glioblastoma?
What is Glioblastoma? • Glioblastoma (GBM) is an aggressive, fast-growing tumor of the supportive cells of the brain, called glial cells. Glioblastoma is also called Grade IV astrocytoma. • Patients with GBM can present with headaches, nausea and vomiting, seizures, memory loss, weakness, or other n
Slide 29: The Prognosis of GBM is Very Poor
The Prognosis of GBM is Very Poor Chemotherapy (temozolomide) plus radiation extended overall survival by approximately two months 29 Stupp R. et al. Lancet Oncol 2009; 10: 459–66
Slide 30: INO-5401 for Newly Diagnosed GBM in Phase 1/2 Study
INO-5401 for Newly Diagnosed GBM in Phase 1/2 Study in Collaboration with Regeneron TRIAL: INO-5401 (encoding tumor-associated antigens: hTERT, WT1, PSMA) Primary Endpoints: Safety, tolerability x32 x20 Phase 1b/2 open label study Combination with Cohort A: Cohort B: Regeneron’s PD-1 Secondary Endpo
Slide 31: INO-5401 Results: Six-month Progression-Free Survival
INO-5401 Results: Six-month Progression-Free Survival PREVIOUSLY REPORTED PFS6 AT SITC 2019 • MGMT Promoter Unmethylated PFS6 of 75% Cohort N Total N Event-free PFS6 (95% CI) Cohort A 32 24 75.0 (56.6-88.5) • MGMT Promoter Methylated PFS6 of 80% (MGMT Unmethylated) • Compares favorably with historic
Slide 32: INO-5401 Results: 12-Month Overall Survival Data
INO-5401 Results: Promising 12-Month Overall Survival Data; OS18 Data in 4Q2020 OVERALL SURVIVAL AT 12 MONTHS (OS12) TO BE PRESENTED AT ASCO 2020 ANNUAL MEETING WT1 PSMA hTERT • MGMT Promoter Unmethylated OS12 of 84.4% 4 2.0 7 5 %CD8+ CD38+ Prf+ GrzA+ %CD8+ CD38+ Prf+ GrzA+ %CD8+ CD38+ Prf+ GrzA+ %C
Slide 33: Welcome Dr. David Reardon for a Conversation about DNA Immunotherapy
INOVIO is Pleased to Welcome Dr. David Reardon for a Conversation about DNA Immunotherapy and GBM David Reardon, M.D. Clinical Director Center for Neuro-Oncology Dana Farber Cancer Institute; Professor of Medicine Harvard Medical School; Coordinating Principal Investigator of GBM-001/INO-5401 Phase
Slide 34: IN@GVIO
IN@GVIO
Slide 35: Closing Remarks
Closing Remarks J. Joseph Kim, Ph.D., President, Chief Executive Officer, Director 35
Slide 36: Thank You
THANK YOU IN@GVIO POWERING ONA MEDICRES™