- Dr. Joseph Kim presented on Inovio's DNA immunotherapy technologies and clinical pipeline.
- Their lead product, VGX-3100, met primary and secondary efficacy endpoints in a Phase II trial for treating HPV-related cervical dysplasia.
- Inovio is developing immunotherapies targeting HPV-related cancers and diseases, as well as cancers related to hTERT and prostate cancer, using their DNA plasmid vaccine approach coupled with electroporation delivery.
In this section of the coronavirus pandemic series, we discuss the current capacity of local healthcare systems and the need for effective treatment options as well as the pathogenesis of the coronavirus. Current treatment options include RNA, monoclonal antibodies (mAb), antibodies, convalescent plasma, and others. Critical stage implications such as cytokine storm and the need for immunomodulatory agents would also be discussed. Therapeutic pathways would are also compared.
In this section of the coronavirus pandemic series, we discuss the current capacity of local healthcare systems and the need for effective treatment options as well as the pathogenesis of the coronavirus. Current treatment options include RNA, monoclonal antibodies (mAb), antibodies, convalescent plasma, and others. Critical stage implications such as cytokine storm and the need for immunomodulatory agents would also be discussed. Therapeutic pathways would are also compared.
5-minute lightning talk describing "personal story" with open access. To be delivered at Ontario Open Access: Accelerating Science symposium organized by the Ontario Ministry of Research and Innovation on 18 March 2016.
The comparison between effects of free curcumin and curcumin loaded PLGA-PEG ...Innspub Net
lung cancer is the most common cancer in men still now. Telomerase is responsible for cancerous cells immortality and is a suitable target for cancer therapy. TRF1 is a modulator for telomerase activity. It is necessary to find more efficient and safer anticancer drugs. Curcumin is a natural polyphenol which has many anticancer effects but it has hydrophobic structure and low solubility in water. PLGA-PEG nanoparticles was used to comprise effects of free curcumin and curcumin loaded PLGAPEG on telomerase and TRF1 expressions in lung cancer cell line. 1H NMR, FT-IR and SEM confirmed PLGA-PEG structure and curcumin loading on it.Then, cytotoxic effects of free curcumin and curcumin loaded PLGA-PEG determined by MTT assay. mRNA expression levels of hTERT and TRF1 was determined by Real-time PCR. MTT assay data analysis indicated that curcumin cytotoxicity is dose and time-dependent. Curcumin loaded nanoparticles showed IC50 values in lower concentration in comparison to free curcumin. Curcumin loaded PLGA-PEG decreased hTERT expression and increased TRF1 expression more than pure curcumin. Our study demonstrates curcumin loaded PLGA-PEG promises a natural and efficient system for
anticancer drug delivery to fight lung cancer. Get the full articles at: http://www.innspub.net/volume-4-number-10-may-2014/
Telomerase Activation: Is it a key to unlocking the aging puzzle?Phil Micans
The length of our telomeres has a direct correlation to our healthspan. In this slideshow we take you through the importance of telomere length for health and longevity and the details of the clinical evidence showing TA65 extending telomeres in humans.
Identified the likelihood of success for treatment of five cancers of interest by comparing novel drug combinations treated cell line gene signatures (predicted by bioinformatic analysis), with disease gene signatures (calculated by fitting linear model on gene expression data).
Lustrumlezing paul stoffels de rol van innovatie voor de gezondheidszorg van ...Michiel Stoffels
Ter gelegenheid van het 40 jarig bestaan van de Universiteit werd een reeks lustrumlezingen georganiseerd. Voor de faculteit Gezondheid en Levenswetenschappen hadden we de eer Dr. Paul Stoffels - Worldwide Chairman , Janssen Pharmaceutical Chief Scientific Officer, Johnson & Johnson - te mogen ontvangen.
Viral Challenge Studies: An Innovative Way to Speed Up Vaccine Development; A...SGS
In order to effectively fight influenza, the development of new, higher performing and universal vaccines is essential. However, clinical development is a lengthy and very expensive process, making it difficult for researchers to design vaccines for rapidly mutating viruses such as influenza. Assessing efficacy of a new influenza vaccine as early as possible in the development, to make a first selection and an early ‘go – no go’ decision, is key. Viral Challenge studies are an important tool to aid in the swift development of effective influenza vaccines particularly for potential pandemics like the avian influenza (bird flu).
Osisko Development - Investor Presentation - June 24
Inovio - Revolutionizing the Fight Against Cancers and Infectious Diseases
1. Revolutionizing the Fight Against Cancers and Infectious Diseases
Dr. Joseph Kim
President & CEO
NASDAQ: INO
2. Forward Looking Statement
Our commentary and responses to your questions may contain forward-looking statements, including comments concerning clinical trials and product development programs, evaluation of potential opportunities, the level of corporate expenditures, the assessment of Inovio’s technology by potential corporate partners, capital market conditions, timing of events, cash consumption and other subjects. Information concerning factors that could cause actual results to differ materially from those set forth in our Annual Report on Form 10-K for the year ended December 31, 2013, our Form 10-Q for the quarter ended June 30, 2014, and other regulatory filings from time to time. 2
3. 3
Inovio: creating the path to an active immunotherapy with broad clinical utility
•
Lead DNA immunotherapy product, VGX- 3100, meets phase II efficacy endpoints; technology breakthrough for active immunotherapy field
•
First clinically meaningful efficacy from T cells generated EXCLUSIVELY in vivo
•
De-risking of pipeline products
•
Best T cell responses in published clinical studies
•
Favorable safety profile
•
Validating partnerships
First-in-Class Efficacy from an Active Immunotherapy
4. Human Papillomavirus
Low Grade Cervical Pre-cancer (CIN 1)
High Grade Cervical Pre-cancer (CIN 2/3)
VGX-3100 Phase II Data: Building New Market Opportunity
•
Treat HPV-associated pre-cancers and cancers
•
Phase II controlled trial regressed high grade cervical pre-cancer and cleared HPV
•
Fulfill unmet need, providing non-surgical alternative for pre-cancerous lesions
•
Potential elimination of residual HPV in untreated tissue
•
Advance into phase III for cervical pre-cancer (CIN 2/3) in 2016
•
Dominate post-HPV infection therapeutic markets
•
Advance other HPV-associated pre-cancers (vulvar, vaginal and anogenital neoplasias) and cancers (cervical, head and neck, and anogenital) 4
Disease Progression
Cervical Cancer
5. VGX-3100 Phase II Study Design
•
Placebo-controlled, randomized, double blind
o
148+ subjects: females 18-55
o
Histologically confirmed HPV16 or 18- associated CIN 2/3 or CIN3
o
Randomized 3:1: VGX-3100 vs. placebo; both with electroporation
o
Two plasmids: HPV Types 16 and 18; encoded for E6/E7 antigens
o
Treatment at months 0, 1, 3
•
Primary endpoint month 9
o
Regress CIN 2/3 to CIN 1 or no disease
•
Secondary endpoints
o
Clearance of HPV 16 or 18 AND CIN 2/3 regression
o
Immunogenicity
o
Safety 5
6. Phase II Data: Clinical Efficacy With Robust T Cells
•
Efficacy data meets primary and secondary efficacy endpoints
•
High level of complete CIN 2/3 clearance
•
Robust HPV-specific T cell responses in majority of treated subjects, as in phase I
•
Treatment well-tolerated with only administration site redness
•
Data being published
•
Expect to initiate phase III trial in 2016 6
VGX-3100
Placebo
P Value
CIN 2/3 regression to CIN 1 or no disease
49.5%
53 of 107
30.6%
11 of 36
<0.025
HPV clearance AND CIN 2/3 regression to CIN 1 or no disease
40.2%
43 of 107
14.3%
5 of 35
<0.025
8. T cell Antigen-specific killer T cell
Target cell 8
It’s All About the T Cells
•
Inovio immunotherapies display best-in-class T cells in HIV and HPV human studies:
o
Magnitude
o
Durability (memory)
o
“Killing tools”: granzyme and perforin
o
Functional killing effect
•
A new paradigm for generating clinically relevant immune responses and efficacy
•
Safe and well tolerated
9. 9
Sources: CDC, www.hpvcentre.net;
WHO IARC
Incidence rates in the U.S. + EU5
HPV-Caused Pre-Cancers & Cancers: VGX-3100
10. HPV-Associated Cancer Treatments Already Enrolling
Phase I/IIa’s: INO-3112 (VGX-3100 + IL-12 DNA immune activator); HPV 16/ 18 related disease Cervical Cancer
•
20 women with cervical carcinoma
•
Safety, tolerability, immunogenicity
•
Cervical histology
•
Treated after chemoradiation Head & Neck Squamous Cell Carcinoma
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20 men/women
•
Safety, tolerability, immunogenicity
•
Anti-tumor effects & progression free survival
•
Arm #1: treated before/after tumor resection
•
Arm #2: treated after chemoradiation 10
11. hTERT-Associated Cancers: INO-1400
•
Antigen: human telomerase reverse transcriptase (hTERT), an enzyme associated with cancer cell survival; overexpressed in 85% of cancers - potential “universal” cancer therapy
•
(+/- IL-12 DNA immune activator)
•
Phase I/IIa: 54 patients with breast, lung, or pancreatic cancers
•
Safety, tolerability, immunogenicity
•
Anti-tumor effects and progression free survival
•
Trial launch: 4Q 2014 11
12. Prostate Cancer: INO-5150
•
Antigens: PSA + PSMA
•
Phase Ia/Ib: multi-arm study design
•
Targeting castrate resistant prostate cancer
•
Additional prostate cancer antigens being developed with Roche
•
Roche immuno-modulatory drugs including checkpoint inhibitors
•
Trial launch: 2015 12
13. 13
Checkpoint Inhibitors: Potent Combination Potential
Active immunotherapies:
•
Inovio immunotherapies greatly increase T cells
•
Potential to overwhelm cancer cells as monotherapy
•
Potential to combine with checkpoint inhibitors to increase efficacy
Checkpoint inhibitors:
•
Unprecedented efficacy
o
Melanoma, lung cancer
•
Validate potential to enhance T cell capabilities
•
Evidence suggests non-responders do not have sufficient pre-existing T cells
1 + 1 = ?
14. anthrax
Louis Pasteur
Peter Kies
CFO
• Ernst & Young
• Experience with growth companies
Mark L. Bagarazzi, MD CMO • Clinical research experience incl. Merck • Led clinical/regulatory for shingles and rotavirus vaccines; DNA vaccine expert 14
J.Joseph Kim, PhD President & CEO • Decades of biotechnology/ pharma management • Merck: hepatitis A and B vaccines manufacturing; HIV vaccine (Ad5) R&D
Niranjan Y. Sardesai, PhD COO • Extensive biotech management and product development experience • Led diagnostics development for mesothelioma, bladder cancer, and ovarian cancer for Fujirebio Diagnostics
Management
15. anthrax
Louis Pasteur
J.Joseph Kim, PhD
• President & CEO, Inovio
Adel Mahmoud, PhD • Professor, Princeton University • Former President, Merck Vaccines • Responsible for Gardasil®, Zostavax®, Proquad® and Rotateq®
Morton Collins, PhD • General Partner, Battelle Ventures and Innovations Valley Partners 15
Simon X. Benito • Former Senior Vice President, Merck Vaccine Division
Angel Cabrera, PhD • President, George Mason University • Former President, Thunderbird School of Global Management
Avtar Dhillon, MD Chairman, BOD • Former President & CEO, Inovio Biomedical
Board of Directors
16. anthrax
Louis Pasteur
Stanley A. Plotkin, MD • Developed rubella and rabies vaccines • Oversaw Sanofi flu vaccine • Emeritus Professor, Wistar Institute & University of Pennsylvania
Philip Greenberg, MD • Expert in T cell immunology • Head, Immunology Program, Fred Hutchinson Cancer Research Center 16
Thomas S. Edgington, MD • Founded multiple biotech companies; extensively published • Emeritus Professor, Scripps Research Institute
Anthony W. Ford-Hutchinson, PhD • Former SVP, Vaccines R&D, Merck • Oversaw development: Singulair®, Januvia®, Gardasil®, Zostavax®, Proquad® and Rotateq®
David B. Weiner, PhD Chairman •“Father of DNA vaccines” • Dept. of Pathology & Laboratory Medicine, University of Pennsylvania
Scientific Advisory Board
17. Financial Information
Cash, cash equivalents & short-term investments2
$ 109.0 M
Debt2
0 M
Cash runway
4Q 2017
Shares outstanding2
60.3 M
Recent share price1
$10.67
Market cap1
$ 643.4 M
NASDAQ: INO
1Sept 12, 2014 2Jun 30, 2014 17
Recent insider buying
$2.75M
18. INTERNALLY FUNDED
EXTERNALLY FUNDED
Ino-5150
2015 Initiate phase Ia/Ib
Prostate cancer
Vgx-3100
2016 Initiate phase III
Cervical dysplasia
INO-3112
2Q 2014
Initiated phase I/IIa
Head & Neck Cancer 18
Value Drivers
INO-3112
2Q 2014 Initiated phase I/IIa
Cervical Cancer
Ino-1400
2H 2014
Initiate phase I/IIa
Breast/lung/ Pancreatic Cancer
PennVAX®
4Q 2014 Initiate PENNVAX-GP phase I
HIV
Ino-8000
2015 Report phase I data
Hepatitis C
Ino-1800
2015 Initiate phase I/IIa
Hepatitis B
19. •
Phase II data shows clinically significant efficacy
•
Breakthrough active immune therapy technology with potential to save lives and maximize shareholder value
•
Best-in-class T cells to prevent, treat & cure cancers and infectious diseases
•
Targeting broad range of diseases and numerous billion dollar markets
•
Validating partnership with Roche; working toward more deals
Investor Highlights
19
21. Strain 1
Strain X
Strain 2
Antigen Y
Antigen Y
Antigen Y
T Cells by Design: Antigen-Specific, Optimized, Best-in-Class 21
Identify gene sequence of selected antigen(s) from chosen strains/variants of the virus/cancer
Synthetically create optimal consensus gene sequence for the selected antigen – PATENTABLE
22. Insert SynCon® gene sequence for selected antigen into DNA plasmid.
SYNCON® DNA
Antigen
consensus
sequence
DNA Plasmid
Designed to Break Tolerance or Provide Universal Protection 22
SynCon DNA plasmid ready to manufacture.
25. PENNVAX®: Highest CD8+ T Cell Responses for HIV Vaccine
Ref: Kalams et al JID 2013
25
A: 3X vaccination without EP B: 4X vaccination without EP C: 2x vaccination with EP (month 2) D: 3x vaccination with EP (month 4) E: Memory response (month 9)
A B C D E
•
Best CD8+ T cell response in HIV clinical studies
•
Durable T cell memory responses
•
Safe and well tolerated
0 1 2 3 4 5 6 7 8 9
Dosing Schedule (Months)
26. Inovio Beats Previous Gold Standard for T Cell Generation DNA/Electroporation vs Merck Ad5 Viral Vector (Non-Human Primates)
SIV Model: UPenn/Merck/Inovio Assay: Data Co-Published
T Cell ELISpot Assay
T Cell Proliferation Assay
DNA + EP Ad5 DNA + EP Ad5
Ref: Hirao et al. Molecular Therapy, August 2010 Flow Cytometry Assay
26
Ad5 DNA + EP
Ad5 DNA + EP
27. Combined Cohorts
Individual Dose Cohorts
VGX-3100 Induces Robust and Durable T Cell Responses
Bagarazzi, Yan, Morrow et al. Sci Transl Med 4, 155ra138 (2012)
•
14/18 (78%) subjects responded to at least one antigen
•
13/18 (72%) responded to at least two antigens
•
9/18 (50%) responded to all four antigens 27
ELISpot Assay
0 1 2 3 4 5 6 7 8 9
Dosing Schedule (Months)
30. VGX-3100 Flow Cytometry – Functional Killing Assays
Inovio Confidential
Bagarazzi, Yan, Morrow et al. Sci Transl Med 4, 155ra138 (2012)
Quantitative Assay
Qualitative Assay
•
Patient pre-VGX-3100 PBMC are targets, post-VGX-3100 PBMC are effectors
•
Quantitative - PBMC added irrespective of Ag-specific CD8 frequency
•
Qualitative - PBMC normalized to account for Ag-specific CD8 frequency
•
Measure granzyme B delivery to targets 30
31. INO-1400: Potential Universal Cancer Therapy Targeting hTERT (overexpressed in 85% of cancers)
Yan J et al., Cancer Immunol Res. (2013) 31
Dharmapuri et al., Mol Ther. (2009)
T-cell generation: older generation DNA vaccine and electroporation device
SynCon® T-cell generation with CELLECTRA® electroporation device
