Inovio Pharmaceuticals Inc (INO)

[$tockfather]

INO RESEARCH / DD SUMMARY!!!

by The $tockfather






Inovio Pharmaceuticals, Inc., formerly Inovio Biomedical Corporation, is engaged in the discovery, development, and delivery of vaccines, called deoxyribonucleic acid (DNA) vaccines, focused on cancers and infectious diseases. The Company's SynCon technology enables the design of universal DNA-based vaccines capable of providing cross-protection against new, unmatched strains of pathogens, such as influenza. Its electroporation DNA delivery technology uses brief, controlled electrical pulses to increase cellular DNA vaccine uptake. Inovio's clinical programs include human papillomavirus (HPV)/cervical cancer (therapeutic), avian influenza (preventative), hepatitis C virus (HCV) and human immunodeficiency virus (HIV) vaccines. It is advancing preclinical research for a universal seasonal/pandemic influenza vaccine. The Company's HIV vaccines consist of candidates for HIV prevention as well as therapy or treatment.



Management

J. Joseph Kim, Ph.D.
President, Chief Executive Officer, Director

Mark L. Bagarazzi
Chief Medical Officer

Peter Kies
Chief Financial Officer

Niranjan Y. Sardesai, Ph.D.
Chief Operating Officer



Revenue 10.52m
Net income -16.07m
Founded 1983
Employees 41
Average volume 528.10k
Shares outstanding 127.27m
Free float 114.81m
P/E (TTM) --
Market cap 55.07m USD
EPS (TTM) -0.1386 USD
Short Interest 568,281
Total assets 56
Total liabilities 9.56


FINANCIALS

http://markets.ft.com/research/Markets/Tearsheets/Financials?s=INO:ASQ&subview=BalanceSheet


SEC Filings

http://ir.inovio.com/secfilings


PRESS RELEASES

http://ir.inovio.com/index.php?year=2011&s=43


INSIDER TRADING

http://www.nasdaq.com/symbol/ino/insider-trades/sells


Inovio Product Pipeline

Inovio is focused on the discovery, development and delivery of an important new generation of vaccines, called DNA vaccines. The ability of DNA vaccines to induce not only a strong antibody response but also a strong T-cell response creates the potential to prevent and treat cancers and chronic infectious diseases. Furthermore, the capabilities of genomic engineering enables the design of optimized vaccines that may protect against a broad spectrum of evolving strains of a pathogen, such as influenza, that is not specifically matched to the genetic make-up of the vaccine.

Inovio's novel SynCon® DNA vaccine construct technology and electroporation DNA delivery technology have enabled the development of an active pipeline of proprietary preclinical and clinical DNA vaccines, as shown below. Multiple partners and collaborators are also using Inovio's electroporation technology under license to facilitate their DNA vaccine research. These programs are described in the following sections under the categories of cancers and infectious diseases.

Inovio has conducted early research to assess the potential utility of electroporation-delivered DNA vaccines for a range of diseases. These programs help to characterize the potential applicability and importance of DNA vaccines and may be the focus of additional future R&D effort. Various collaborators are also funding and conducting research using Inovio's electroporation-based DNA delivery systems in conjunction with experimental vaccines for different diseases.

Inovio has a non-vaccine, small molecule drug under development that is focused on inflammatory diseases including rheumatoid arthritis (RA), Type 1 diabetes (T1D), uveitis, and colitis.

The company owns a majority interest in VGX Animal Health, Inc., which markets LifeTide™ animal growth hormone for swine. LifeTide™ is one of only four DNA-based treatments approved for use in animals and is the only DNA-based agent delivered using electroporation that has been granted marketing approval (Australia).





Inovio Clinical Trials: Cancer

Inovio Pharmaceuticals or its partners/collaborators are conducting the following ongoing clinical trials for the treatment of cancers. Patients are being recruited for these trials, with details available by following the links below.

Indications: Cervical dysplasia / cancer caused by human papillomavirus (HPV)

Treatment: VGX-3100

Study title: Phase II Placebo Controlled Study of VGX-3100, (HPV16 E6/E7, HPV18 E6/E7 DNA Vaccine) Delivered IM Followed by Electroporation with CELLECTRA®-5P for the Treatment of Biopsy-proven CIN 2/3 or CIN 3 with Documented HPV 16 or 18

Trial Stage: Phase II

http://www.clinicaltrials.gov/ct2/show/NCT01304524?term=NCT01304524&rank=1

Indications: Acute and chronic myeloid leukemia (Partner/Sponsor: University of Southampton)

Treatment: DNA vaccine encoding for Wilms' tumor gene 1 (WT1)

Study title: WT1 Immunity via DNA Fusion Gene Vaccination in Haematological Malignancies by Intramuscular Injection Followed by Intramuscular Electroporation (WIN)

Trial Stage: Phase II

http://clinicaltrials.gov/ct2/show/NCT01334060?term=leukemia+southampton&rank=1

Indications: Breast, lung, prostate & other cancers

Treatment: V934/V935

Study title: A Phase I Investigation of the Safety, Tolerability and Immunogenicity of V934/V935 hTERT Vaccination in Cancer Patients With Selected Solid Tumors

Trial Stage: Phase I
http://clinicaltrials.gov/ct2/show/NCT00753415?term=v934&rank=1



Inovio Product Pipeline: Infectious Disease DNA Vaccines

DNA vaccine technology has created the potential for a new generation of infectious disease vaccines with not only preventive but therapeutic capabilities. Inovio has a proprietary DNA vaccine candidate for HIV in Phase I clinical studies, an avian influenza candidate awaiting IND approval, and multiple R&D programs for different infectious diseases. Many of these programs are being conducted and/or funded in collaboration with respected research organizations.

License partners and other collaborators are also using Inovio's electroporation DNA delivery technology to facilitate their vaccine research.

Multiple clinical studies are progressing and are described in the following sections.



Partners

Merck



In May 2004, Merck & Co. licensed Inovio's electroporation-based DNA delivery technology to use in conjunction with proprietary DNA vaccine candidates. The agreement granted Merck worldwide non-exclusive rights to use Inovio's electroporation technology for intramuscular delivery of certain proprietary DNA vaccines. The deal involves upfront and milestone payments, development fees, royalties, and a supply agreement.

Merck files first Investigational New Drug application, triggering a $2M milestone payment.
Merck's first clinical program.
Merck's files IND for a second DNA vaccine, triggering another $2M milestone payment.
Merck's second clinical program.

University of Southampton



The University of Southampton (UK) is advancing an investigator-sponsored clinical study using Inovio's technology in conjunction with a DNA-based vaccine against prostate cancer.

Southampton's clinical program.
Significant antibody response in humans reported at international vaccine conference.
Significant T-cell response in humans reported in scientific paper published in Nature Reviews Cancer.

Tripep



Tripep AS is advancing a Phase I/II clinical study for a hepatic C virus DNA vaccine using Inovio's DNA delivery technology.

Tripep clinical study.
Tripep announces pre-clinical results for hepatic C virus DNA vaccine.

HIV Vaccine Trials Network (HVTN)



The HIV Vaccine Trials Network (HVTN) is an international collaboration of scientists and educators searching for an effective and safe HIV vaccine. The HVTN's mission is to facilitate the process of testing preventive vaccines against HIV/AIDS. Our organization conducts all phases of clinical trials, from evaluating experimental vaccines for safety and the ability to stimulate immune responses, to testing vaccine efficacy.

HVTN is currently funding and conducting clinical trials of Inovio's PENNVAX™-B HIV DNA vaccine candidate.
The University of Pennsylvania




Inovio (through VGX Pharmaceuticals, with which it merged on June 1, 2009) entered into an original research agreement with the University of Pennsylvania on December 22, 2005. It entered into a subsequent license for exclusive worldwide rights to develop a number of DNA plasmids and constructs with the potential to treat and/or prevent HIV, HCV, HPV and influenza, and an amended agreement adding novel adjuvants to enhance the effectiveness of DNA vaccines. The underlying technology was developed in the laboratory of Professor David B. Weiner at the University of Pennsylvania. Professor Weiner is a pioneer in the field of DNA vaccines.

The University of Pennsylvania is conducting a clinical trial of Inovio's PENNVAX™-B HIV DNA vaccine, without electroporation, in a therapeutic setting.
The National Institute of Allergy and Infectious Diseases



The National Institute of Allergy and Infectious Diseases of the National Institutes of Health is supporting HIV DNA vaccine research being conducted by Inovio. The NIAID contract, announced October 1, 2008, provides $23.5 million of funding over seven years, including a base period and follow-on option years, to Inovio's PENNVAX™-G vaccine candidate targeting HIV clades A, C, and D, and its novel intradermal electroporation (ID-EP) technology.
PATH Malaria Vaccine Initiative (MVI)




The PATH Malaria Vaccine Initiative (MVI) is a global program of the international nonprofit organization PATH. MVI was established in 1999 through a grant from the Bill & Melinda Gates Foundation.

PATH MVI is assessing Inovio's SynCon® DNA vaccine development platform with respect to malaria.



USAMRIID, located at Fort Detrick, Maryland, is the lead medical research laboratory for the U.S. Biological Defense Research Program, and plays a key role in national defense and infectious disease research. The Institute's mission is to conduct basic and applied research on biological threats resulting in medical solutions (such as vaccines, drugs and diagnostics) to protect the warfighter. USAMRIID is conducting research using Inovio's electroporation technology.

US Army demonstrates protection from possible biological warfare agent in pre-clinical research.
Inovio receives third appropriation of US Dept. of Defense funding for US Army research.

National Cancer Institute



Inovio established an agreement with the National Cancer Institute to assess novel HIV constructs in non-human primates, cytokine genes as vaccine adjuvants (immune system stimulants), and possibly anticancer therapies delivered using Inovio's electroporation-mediated DNA delivery technology.


Inovio milestones

1996: First data in small animals using electroporation and gene therapy

2004: First industry license agreement of electroporation technology with a Big Pharma (Merck) relating to a DNA vaccine

2004: First-in-man clinical study using a DNA-based immunotherapy delivered with electroporation (with partner, Moffitt Cancer Center)

2007: First human data from a DNA-based immunotherapy delivered using electroporation (with partner, Moffitt Cancer Center)

2008: First DNA-based product delivered using electroporation approved for use in an animal (growth hormone replacement hormone (GHRH) for swine).




Analyst Coverage

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Analyst David S. Moskowitz, RPh.
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Industry Biotechnology & Drugs

Location

Inovio Pharmaceuticals Inc
11494 Sorrento Valley Road
San Diego92121
United States
USA