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)
August 7, 2015
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 W. Germantown Pike, Suite 100
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
N/A
(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)) |
Item 1.01. |
Entry into a Material Definitive Agreement. |
On August 7, 2015, we entered into a
DNA Cancer Vaccine Collaboration Agreement (the Agreement) with MedImmune, Limited (MedImmune), the global biologics research and development arm of AstraZeneca. Under the Agreement, MedImmune will acquire exclusive rights to
our INO-3112 immunotherapy, which targets cancers caused by human papillomavirus (HPV) types 16 and 18. INO-3112, which is in phase I/II clinical trials for cervical and head and neck cancers, works by generating killer T-cell responses that are
able to destroy HPV 16- and 18-driven tumors. These HPV types are responsible for more than 70 percent of cervical pre-cancers and cancers.
MedImmune intends to study INO-3112 in combination with selected immunotherapy molecules within its pipeline in HPV-driven cancers. Emerging
evidence suggests that the benefits from immuno-oncology molecules, such as those in MedImmunes portfolio, can be enhanced when they are used in combination with cancer vaccines that generate tumor-specific T-cells.
Under the terms of the Agreement, MedImmune will make an upfront payment to us of $27.5 million as well as potential future payments upon
reaching development and commercial milestones totaling up to $700 million. MedImmune will fund all development costs. We are eligible to receive up to double-digit tiered royalties on INO-3112 product sales.
Within the broader collaboration, MedImmune and we will develop up to two additional DNA-based cancer vaccine products not included in our
current product pipeline, which MedImmune will have the exclusive rights to develop and commercialize. We will receive development, regulatory and commercialization milestone payments and will be eligible to receive royalties on worldwide net sales
for these additional cancer vaccine products.
The term of the Agreement commenced on August 7, 2015 and will expire on the date when
royalty or other payment obligations are no longer due, unless the Agreement is terminated in its entirety or on a country-by-country, research program-by-research program, or product-by-product basis sooner upon the occurrence of certain events as
described in the Agreement.
On August 10, 2015, we issued a press release, which file as Exhibit 99.1 to, and incorporate by
reference in, this Form 8-K current 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 August 10, 2015 |
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: August 12, 2015
-3-
Exhibit 99.1
NEWS RELEASE
INOVIO PHARMACEUTICALS ENTERS INTO STRATEGIC CANCER VACCINE COLLABORATION AND LICENSE AGREEMENT WITH MEDIMMUNE
Agreement includes clinical-stage INO-3112 HPV cancer vaccine and preclinical collaboration to develop additional cancer vaccine
candidates
Inovio schedules conference call for 8:30am ET today;
Go to inovio.com and click on webcast tab
PLYMOUTH MEETING, Pa. August 10, 2015 Inovio Pharmaceuticals (NASDAQ: INO) today announced that it has entered into a license agreement and
collaboration with MedImmune, the global biologics research and development arm of AstraZeneca.
Under the agreement, MedImmune will acquire exclusive
rights to Inovios INO-3112 immunotherapy, which targets cancers caused by human papillomavirus (HPV) types 16 and 18. INO-3112, which is in phase I/II clinical trials for cervical and head and neck cancers, works by generating killer T-cell
responses that are able to destroy HPV 16- and 18-driven tumors. These HPV types are responsible for more than 70 percent of cervical pre-cancers and cancers.
MedImmune intends to study INO-3112 in combination with selected immunotherapy molecules within its pipeline in HPV-driven cancers. Emerging evidence suggests
that the benefits from immuno-oncology molecules, such as those in MedImmunes portfolio, can be enhanced when they are used in combination with cancer vaccines that generate tumor-specific T-cells.
Under the terms of the agreement, MedImmune will make an upfront payment of $27.5 million to Inovio as well as potential future payments upon reaching
development and commercial milestones totaling up to $700 million. MedImmune will fund all development costs. Inovio is entitled to receive up to double-digit tiered royalties on INO-3112 product sales.
Within the broader collaboration, MedImmune and Inovio will develop up to two additional DNA-based cancer vaccine products not included in Inovios
current product pipeline, which MedImmune will have the exclusive rights to develop and commercialize. Inovio will receive development, regulatory and commercialization milestone payments and will be eligible to receive royalties on worldwide net
sales for these additional cancer vaccine products.
Dr. David Berman, Senior Vice President and Head of the Oncology Innovative Medicines unit,
MedImmune, said: Todays collaboration with Inovio leverages our deep internal expertise in the use of vaccines to drive antigen-specific T-cell responses. The unique combination of our broad immuno-oncology portfolio with Inovios
T-cell-activating INO-3112, which enhances cancer specific killer T-cells, has the potential to deliver real clinical benefits for patients.
Dr. J. Joseph Kim, President and CEO, Inovio, said: Our licensing partnership with MedImmune
represents an important step in executing our immuno-oncology combination strategy and advancing Inovios cancer vaccine R&D pipeline with a leading cancer immunotherapy company. INO-3112 is progressing, with positive interim data generated
in an Inovio-initiated phase I study. We appreciate MedImmunes recognition of our ability to activate best-in-class killer T-cells in vivo and look forward to working with them on this collaboration.
Todays agreement builds on the existing partnership between Inovio and MedImmune on two research and development collaborations in the infectious
disease area. Both efforts are funded by the Defense Advanced Research Projects Agency (DARPA) and support R&D focused on Ebola, influenza, and bacterial infections. MedImmune has a strong heritage in infectious disease and vaccine innovation,
having developed the first monoclonal antibody approved by the US Food & Drug Administration for the prevention of an infectious disease and the technology that led to the creation of an HPV vaccine.
About INO-3112
Inovios SynCon® DNA-based immunotherapies help the immune system activate disease-specific killer T cells to fight a targeted disease. HPV, the most pervasive sexually transmitted virus, causes numerous
pre-cancers and cancers. Inovios HPV immunotherapy called INO-3112 targets disease associated with the high-risk HPV types 16 and 18, which are responsible for over 70% of cervical pre-cancers and cancers. INO-3112 combines Inovios
VGX-3100, its immunotherapy targeting HPV-caused diseases, with its DNA-based immune activator encoded for IL-12. INO-3112 is in three clinical studies for cervical and head and neck cancers.
Earlier this year, Inovio reported preliminary data showing that INO-3112 generated significant antigen-specific CD8+ T cell responses in 3 of 4 patients with
head and neck cancer associated with human papillomavirus (HPV) types 16 and 18. These positive results represent the first study and first report of antigen-specific T cell immune responses generated in cancer patients after treatment with a DNA
immunotherapy.
Previously in a phase II efficacy trial, treatment with VGX-3100 resulted in histopathological regression of late-stage cervical dysplasia
to early stage or no disease, meeting the studys primary endpoint. In addition, the trial demonstrated clearance of the HPV virus in conjunction with regression of cervical lesions, meeting the secondary endpoint. Robust T-cell activity was
observed in subjects who received VGX-3100 compared to those who received placebo.
About MedImmune
MedImmune is the global biologics research and development arm of AstraZeneca, a global, innovation-driven biopharmaceutical business that focuses on the
discovery, development and commercialization of small molecule and biologic prescription medicines. MedImmune is pioneering innovative research and exploring novel pathways across key therapeutic areas, including respiratory, inflammation and
autoimmunity; cardiovascular and metabolic disease; oncology; neuroscience; and infection and vaccines. The MedImmune headquarters is located in Gaithersburg, Md., one of AstraZenecas three global R&D centers. For more information, please
visit www.medimmune.com.
About AstraZeneca in Oncology
Oncology is a therapeutic area in which AstraZeneca has a deep-rooted heritage. It will be potentially transformational for the companys future, becoming
the sixth growth platform. Our vision is to help patients by redefining the cancer treatment paradigm and one day eliminate cancer as a cause of death. By 2020, we are aiming to bring six new cancer medicines to patients.
Our broad pipeline of next-generation medicines is focused on four main disease areas - ovarian, lung, breast and hematological cancers. These are being
targeted through four key platforms immuno-oncology, the genetic drivers of cancer and resistance, DNA damage repair and antibody drug conjugates.
About AstraZeneca
AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialization of prescription
medicines, primarily for the treatment of cardiovascular, metabolic, respiratory, inflammation, autoimmune, oncology, infection and neuroscience diseases. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions
of patients worldwide. For more information please visit: www.astrazeneca.com
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 MedImmune, Roche, University of Pennsylvania, DARPA, GeneOne Life Science, Drexel University, 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.
CONTACTS:
Investors: Bernie Hertel, Inovio Pharmaceuticals, 858-410-3101, bhertel@inovio.com
Media: Jeff Richardson, Inovio Pharmaceuticals, 267-440-4211, jrichardson@inovio.com
# # # #
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, our expectations regarding our research and development programs 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 and INO-3112, 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, our ability to advance our portfolio of immune-oncology products independently, the ability of our collaborators to attain development and commercial milestones for products we license and product sales that will enable us to receive
future payments and royalties, 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, our ability to enter into partnerships in conjunction with our research and development programs, 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, 2014, our Form 10-Q for the quarter ended June 30, 2015, 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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