UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant
to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported) July 23, 2014
INOVIO PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
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Delaware |
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001-14888 |
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33-0969592 |
(State or other jurisdiction
of incorporation) |
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(Commission
File Number) |
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(I.R.S. Employer
Identification No.) |
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660 West Germantown Pike, Suite 110
Plymouth Meeting, Pennsylvania |
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19462 |
(Address of principal executive offices) |
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(Zip Code) |
Registrants telephone number, including area code: (267) 440-4200
1787 Sentry Parkway West, Building 18, Suite 400, Blue Bell, Pennsylvania 19422
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the
following provisions:
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
On July 23, 2014, the Company issued a press release to announce
successful results from the Companys randomized, double-blind, placebo-controlled phase II trial of VGX-3100 in women with biopsy-proven cervical intraepithelial neoplasia, 2/3 (CIN2/3) associated with the human papillomavirus (HPV) types 16
or 18.
The Companys press release is filed as Exhibit 99.1 to this Form 8-K current report and is incorporated by reference into
this Form 8-K report.
Item 9.01. |
Financial Statements and Exhibits. |
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Exhibit No. |
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Exhibit Description |
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99.1 |
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Press Release dated July 23, 2014. |
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned hereunto duly authorized.
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INOVIO PHARMACEUTICALS, INC. |
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By: |
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/s/ Peter Kies |
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Peter Kies, |
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Chief Financial Officer |
Date: July 23, 2014
-3-
Exhibit 99.1
NEWS RELEASE
Immediate Release
CONTACTS:
Investors: Bernie Hertel, Inovio Pharmaceuticals, 858-410-3101, bhertel@inovio.com
Media: Jeff Richardson, Inovio Pharmaceuticals, 267-440-4211, jrichardson@inovio.com
Inovio Pharmaceuticals HPV Immunotherapy Achieves
Primary Efficacy Endpoint in Randomized Phase II
Cervical Dysplasia Trial
Treatment with VGX-3100 induces regression of precancerous cervical disease and clears HPV infection with robust T cell responses
PLYMOUTH MEETING, Pa., July 23, 2014 Inovio Pharmaceuticals, Inc. (NYSE MKT: INO) today announced successful results from its randomized,
double-blind, placebo-controlled phase II trial of VGX-3100 in women with biopsy-proven cervical intraepithelial neoplasia 2/3 (CIN2/3) associated with human papillomavirus (HPV) types 16 or 18. Treatment with VGX-3100, Inovios
HPV16/18-specific immunotherapy, resulted in histopathological regression of CIN2/3 to CIN1 or no disease, meeting the studys primary endpoint. In addition, the trial demonstrated clearance of HPV in conjunction with regression of cervical
lesions. Robust T-cell activity was detected in subjects who received VGX-3100 compared to those who received placebo.
This is a significant step
toward providing women and their physicians a non-surgical approach to the treatment of precancerous lesions by stimulating their immune system to eliminate high risk HPV infection and induce regression of a cervical intraepithelial neoplastic
process, said Mark Bagarazzi, MD, Chief Medical Officer, Inovio Pharmaceuticals. This proof of concept trial will guide the advancement of VGX-3100 for precancerous dysplasias as well as HPV-associated cervical, head and neck, and
anogenital cancers.
Treatment was randomized 3:1 between the VGX-3100 and placebo groups, and was stratified by age and severity of CIN. The
primary endpoint, histologic regression, was evaluated 36 weeks after the first treatment. In the per protocol analysis, CIN2/3 resolved to CIN1 or no disease in 53 of 107 (49.5%) women treated with VGX-3100 compared to 11 of 36
(30.6%) who received placebo. This difference was statistically significant (p<0.025).
Virological clearance of HPV 16 or 18 from the cervix in
conjunction with histopathological regression of cervical dysplasia to CIN1 or no disease, a secondary endpoint of the trial, was observed in 43 of 107 (40.2%) VGX-3100 recipients compared to 5 of 35 (14.3%) placebo recipients
(p<0.025).
As in the phase I study, VGX-3100 elicited robust HPV-specific T cell responses in the majority of treated subjects. A comprehensive
analysis of T cell responses is ongoing.
The treatment was generally well-tolerated, with only administration site redness occurring significantly more
frequently in the VGX-3100 group compared to the placebo group in the 7- and 28-day periods following treatment.
Beyond the direct clinical implications of this phase II study, these results are a breakthrough for the
field of immunotherapies. This efficacy and T cell data provide evidence that our SynCon® immunotherapy technology can activate the immune system to fight chronic infections, pre-cancers
and ultimately, cancers, said Dr. J. Joseph Kim, Inovios President and CEO. These results significantly de-risk our product and business development strategy for VGX-3100 and our broad pipeline of SynCon® active immune therapy and vaccine products.
We thank the women who participated and the
clinical investigators who provided patient care and made this trial possible.
Topline results will be presented at the 2014 International Society
of DNA Vaccines Conference in San Diego, on July 23, 2014. Detailed study findings will be submitted for publication in a peer-reviewed scientific journal.
About VGX-3100
Inovios VGX-3100 is an
immunotherapy containing two DNA plasmids targeting the E6 and E7 oncogenes of HPV types 16 and 18. The treatment is administered to patients by injection into muscle (typically in the arm), followed by electroporation using Inovios CELLECTRA® device. VGX-3100 has been shown to induce a robust immune response against the E6 and E7 oncogenes associated with HPV types 16 and 18. These oncogenes are responsible for transforming
HPV-infected cells into pre-cancerous and cancerous cells. Apart from this cervical dysplasia study, Inovio is also conducting studies using this immunotherapy against cervical as well as head and neck cancers caused by these HPV types.
About HPV-003 (ClinicalTrials.gov: NCT01304524; EudraCT: 2012-001334-33)
This phase II trial is a randomized, placebo-controlled, double-blind study of women with CIN2 or CIN3 who were randomized 3:1 to the active and placebo
groups. Women in the active group received three 6 mg doses of VGX-3100 in a 1 mL intramuscular injection followed by electroporation with Inovios CELLECTRA® device at weeks 0, 4, and
12. Cervical tissue was examined before starting blinded treatment and 9 months later.
Cornelia Trimble, MD, Associate Professor of Gynecology and
Obstetrics, Oncology, and Pathology, Johns Hopkins School of Medicine, is the principal investigator for the study.
About HPV and Cervical Dysplasia
Human papillomavirus (HPV) is the most common sexually transmitted disease. At any given time, approximately 11% percent of the world population is
infected with HPV. Roughly 90% of HPV infections are cleared by naturally occurring immune responses within two years.
Persistent HPV infection can lead
to dysplasia, or premalignant changes, in cervical cells. HPV types 16 and 18 cause 70% of cervical dysplasia and cervical cancer cases. Each year in the United States, 1.4 million women are diagnosed with CIN1 and 300,000-400,000 women are
diagnosed with CIN 2/3. All cervical cancers arise from untreated CIN2/3.
About Inovio Pharmaceuticals, Inc.
Inovio is revolutionizing the fight against cancer and infectious diseases. Our immunotherapies uniquely activate best-in-class immune responses to prevent and
treat disease, and have shown clinically significant efficacy with a favorable safety profile. With an expanding portfolio of immune therapies, the company is advancing a growing preclinical and clinical stage product pipeline. Partners and
collaborators include Roche, University of Pennsylvania, NIH, HIV Vaccines Trial Network, National Cancer Institute, U.S. Military HIV Research Program, and University of Manitoba. For more information, visit
www.inovio.com.
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This press release contains certain forward-looking statements relating to our business, including our plans to develop electroporation-based drug and gene
delivery technologies and DNA vaccines and our capital resources. Actual events or results may differ from the expectations set forth herein as a result of a number of factors, including uncertainties inherent in pre-clinical studies, clinical
trials and product development programs (including, but not limited to, the fact that pre-clinical and clinical results referenced in this release may not be indicative of results achievable in other trials or for other indications, that the studies
or trials may not be successful or achieve the results desired, including safety and efficacy for VGX-3100, that pre-clinical studies and clinical trials may not commence or be completed in the time periods anticipated, that results from one study
may not necessarily be reflected or supported by the results of other similar studies and that results from an animal study may not be indicative of results achievable in human studies), the availability of funding to support continuing research and
studies in an effort to prove safety and efficacy of electroporation technology as a delivery mechanism or develop viable DNA vaccines, our ability to support our broad pipeline of SynCon®
active immune therapy and vaccine products, the adequacy of our capital resources, the availability or potential availability of alternative therapies or treatments for the conditions targeted by the company or its collaborators, including
alternatives that may be more efficacious or cost-effective than any therapy or treatment that the company and its collaborators hope to develop, evaluation of potential opportunities, issues involving product liability, issues involving patents and
whether they or licenses to them will provide the company with meaningful protection from others using the covered technologies, whether such proprietary rights are enforceable or defensible or infringe or allegedly infringe on rights of others or
can withstand claims of invalidity and whether the company can finance or devote other significant resources that may be necessary to prosecute, protect or defend them, the level of corporate expenditures, assessments of the companys
technology by potential corporate or other partners or collaborators, capital market conditions, the impact of government healthcare proposals and other factors 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 March 31, 2014, and other regulatory filings from time to time. There can be no assurance that any product in Inovios pipeline will be successfully developed or manufactured, that final results of
clinical studies will be supportive of regulatory approvals required to market licensed products, or that any of the forward-looking information provided herein will be proven accurate.
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