Industry, academic and government
Inovio has forged partnerships with pharma companies, government agencies and leading academic institutions to support the development of synthetic vaccines delivered via Inovio’s electroporation technology in many disease areas. Our strategy is to focus on our core expertise, conducting R&D and clinical development to achieve proof of principle of SynCon® vaccine products, and engage with partners to complete late-stage clinical development and commercialization and, in some cases, advance early-stage programs. We currently have advancing discussions with funding agencies and pharma/vaccine companies with the intent of securing funding and sponsorship for R&D and early clinical studies as well as more comprehensive development and partnering relationships.
University of Pennsylvania (UPenn)
Inovio’s partnership with the University of Pennsylvania is the major source of Inovio’s synthetic vaccine research and development. The underlying technology was developed in the laboratory of Professor David B. Weiner, Ph.D., at UPenn. Dr. Weiner is a pioneer in the field of DNA vaccines and serves as chairman of Inovio’s Scientific Advisory Board.
His lab continues to design new preventive and therapeutic SynCon® vaccines for cancers and infectious diseases.
In 2007, Inovio (through VGX Pharmaceuticals, with which it merged in 2009) entered into an original research agreement with UPenn. The Company subsequently licensed from UPenn exclusive worldwide rights to develop a number of DNA plasmids and constructs with the potential to treat and/or prevent human immunodeficiency virus (HIV); hepatitis C virus (HCV); human papilloma virus (HPV), and influenza, and later an amended agreement adding novel adjuvants to enhance the effectiveness of DNA vaccines.
In 2011, Inovio expanded its existing license agreement with the University of Pennsylvania, adding exclusive worldwide licenses for technology and intellectual property for novel DNA vaccines against prostate cancer, CMV (cytomegalovirus), malaria, hepatitis B, RSV (respiratory syncytial virus), and MRSA (methicillin-resistant staphylococcus aureus). The amendment also encompassed a new optimized IL-12 cytokine gene adjuvant.
Inovio expanded its existing license agreement with the University of Pennsylvania again in 2012, adding exclusive worldwide licenses to develop DNA vaccines against C. difficile, Wilms’ tumor gene, and filoviruses Ebola and Marburg
The University of Pennsylvania has also conducted clinical studies for Inovio's PENNVAX®-B HIV DNA vaccine in a therapeutic setting.
Roche acquired an exclusive worldwide license to develop and commercialize Inovio’s hepatitis B (INO-1800) immunotherapy. Roche has exclusively licensed this DNA-based product and the use of Inovio’s CELLECTRA® electroporation technology for delivery of the product.
Under the terms of the agreement, Roche made an upfront payment of USD $10 million to Inovio, in part, for the hepatitis b rights. Roche will also provide preclinical R&D support and payments for near-term regulatory milestones as well as payments upon reaching certain development and commercial milestones. Additional development milestone payments could also be made to Inovio if Roche pursues other indications with INO-1800. In addition, Inovio is entitled to receive up to double-digit tiered royalties on product sales.
GeneOne Life Science
Since acquiring an equity interest in GeneOne in 2005, Inovio and GeneOne have entered multiple license and collaboration agreements granting GeneOne exclusive rights to certain Inovio product candidates in certain jurisdictions. GeneOne has exclusive rights in countries in Asia, including Korea, to our VGX-3400X and INO-3510 DNA vaccines delivered with electroporation for the treatment of influenza as well as our INO-8000 (VGX-6150) DNA immunotherapy delivered with electroporation for the treatment of hepatitis C. In exchange for these rights, GeneOne shares the development costs for these product candidates. Inovio and GeneOne are also co-developing an Ebola vaccine through phase I clinical trials under a $45 million grant from the Defense Advanced Research Projects Agency (DARPA) and are advancing through phase I studies Inovio’s DNA vaccine for MERS (Middle East Respiratory Syndrome). GeneOne will conduct and fund the phase I MERS study in return for milestone-based co-ownership of the vaccine.
GeneOne also has a US subsidiary, VGXI, Inc., which is a cGMP contract manufacturer of DNA plasmids. Under a supply agreement with VGXI, Inc., VGXI, Inc. produces DNA plasmids for all of Inovio’s research and early clinical trials.
Inovio is collaborating with MedImmune, the global biologics research and development arm of AstraZeneca, to develop and assess DNA-based monoclonal antibodies (mAbs) for influenza and antibiotic resistant bacteria. Funded by a $12.2 million grant from the Defense Advanced Research Projects Agency (DARPA), the goal for this project is to demonstrate that DNA plasmids encoded for disease-specific mAbs can activate sufficient quantities of specific antibodies in the body to be protective against a pathogen challenge. This collaboration also involves scientists from the Perelman School of Medicine at the University of Pennsylvania.
Inovio and MedImmune are also collaborating under a $45 million DARPA grant to develop multiple treatment and prevention approaches against Ebola, including Inovio’s therapeutic DNA-based monoclonal antibody product, MedImmune’s conventional protein-based therapeutic monoclonal antibody product, and Inovio's DNA-based vaccine. Other collaborators involved in this program include GeneOne Life Sciences and its manufacturing subsidiary, VGXI, Inc., the University of Pennsylvania, Emory University and Vanderbilt University.
Inovio entered into a license agreement with Drexel University in 2013 for a novel Clostridium difficile DNA vaccine. This technology is co-owned by the University of Pennsylvania and was developed in the lab of Dr. Michele Kutzler.
In 2013, Inovio acquired worldwide rights (excluding China) for iTreg technology with the potential to address Alzheimer's disease and multiple sclerosis from Fudan University's Shanghai Medical College. The technology is based on patent-protected and published discoveries from Dr. Bin Wang of Fudan University and his collaborator, who found a novel way to generate inducible regulatory T cells.
Defense Advanced Research Projects Agency (DARPA)
The Defense Advanced Research Projects Agency (DARPA) has awarded Inovio two grants amounting to a potential $68.2 million to develop and assess technology against multiple infectious diseases.
Under a $12.2 million grant, Inovio and MedImmune are collaborating to develop and assess DNA-based monoclonal antibodies (mAbs) for influenza and antibiotic resistant bacteria. This collaboration also involves scientists from the University of Pennsylvania.
Under a second grant, Inovio & MedImmune are developing multiple treatment and prevention approaches against Ebola, including Inovio’s therapeutic DNA-based monoclonal antibody, MedImmune’s protein-based therapeutic monoclonal antibody product, and Inovio's DNA-based vaccine. Other collaborators involved in this program include GeneOne Life Sciences and its manufacturing subsidiary, VGXI, Inc., the University of Pennsylvania, Emory University and Vanderbilt University. The funding period is over two years and covers a base award of $21 million and an option award of $24 million. A second option of $11 million would support additional product supply and clinical development activities. The options are contingent upon the successful completion of certain pre-clinical development milestones.
HIV Vaccine Trials Network
The HIV Vaccine Trials Network (HVTN) funded and conducted clinical trials of Inovio's PENNVAX®-B HIV DNA vaccine candidate. The HVTN will also assist Inovio in the clinical trial for Inovio’s PENNVAX®-GP HIV DNA vaccine candidate.
The National Institute of Allergy and Infectious Diseases of the National Institutes of Health is providing $23.5 million of funding over seven years (ending 2015), including a base period and follow-on option years, to develop Inovio's PENNVAX®-GP vaccine candidate targeting HIV clades A, C, and B and its novel intradermal electroporation (ID-EP) technology.
U.S. Military HIV Research Program
The U.S. Military HIV Research Program (MHRP) is conducting an NIAID-sponsored Phase I study, called RV262, to evaluate a combination DNA prime (PENNVAX®-G)/MVA vector boost regimen that was developed to protect against diverse subtypes of HIV-1 prevalent in North America, Europe, Africa, and South America.
National Cancer Institute
Under a 2007 co-development agreement with Inovio, the National Cancer Institute is evaluating 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.
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