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.
Under a 2013 agreement, Roche acquired an exclusive worldwide license to develop and commercialize Inovio’s prostate cancer (INO-5150) and hepatitis B (INO-1800) immunotherapies and further therapeutic vaccine candidates resulting from the collaboration in these disease areas. Roche has exclusively licensed these DNA-based products and the use of Inovio’s CELLECTRA® electroporation technology for delivery of the products.
Under the terms of the agreement, Roche will make an upfront payment of USD $10 million to Inovio. 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 potentially up to USD $412.5 million. Additional development milestone payments could also be made to Inovio if Roche pursues other indications with INO-5150 or INO-1800. In addition, Inovio is entitled to receive up to double-digit tiered royalties on product sales.
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.
Merck & Co.
Under a 2004 license agreement, Merck & Co. holds worldwide non-exclusive rights to use Inovio's electroporation technology for intramuscular delivery of certain proprietary DNA vaccines. Inovio received an upfront payment and has received $4 million in milestone payments. Inovio is eligible to receive milestone payments, development fees, and royalties on products commercialized under the agreement, which also includes a supply agreement. To date, Merck has filed two Investigational New Drug Applications (INDs) for product candidates targeting various cancers using Inovio’s electroporation technology.
University of Southampton
The University of Southampton (UK) is advancing an investigator-sponsored clinical study of its leukemia DNA vaccine using Inovio's electroporation delivery technology.
The university previously completed an investigator-sponsored clinical study using Inovio's electroporation delivery technology in conjunction with a DNA-based vaccine against prostate cancer. Significant antibody and T-cell responses in humans were reported reported in a scientific paper published in Nature Reviews Cancer.
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.
PATH Malaria Vaccine Initiative
The PATH Malaria Vaccine Initiative (MVI), established in 1999 through a grant from the Bill & Melinda Gates Foundation, is funding preclinical development of Inovio's SynCon® synthetic vaccine with respect to malaria.
U.S. Department of Homeland Security
Inovio entered into a Cooperative Research and Development Agreement with the US Department of Homeland Security Science and Technology Directorate Plum Island Animal Disease Center. This collaboration is evaluating the efficacy of Inovio's SynCon® vaccines for foot & mouth disease in important animal models including cattle, sheep, and pigs.
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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