Industry, academic and government
Inovio has forged partnerships with pharma companies, government agencies and leading academic institutions to support the development of DNA-based immunotherapies 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 our SynCon® immunotherapy 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 pharmaceutical 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.
In 2015, MedImmune exclusively licensed Inovio’s INO-3112 immunotherapy for the treatment of cancers caused by human papillomavirus. MedImmune expects to evaluate INO-3112 in combination with multiple checkpoint inhibitors. MedImmune paid Inovio $27.5 million upfront, is paying for all development costs, and could pay development and commercial milestones amounting to $700 million. Inovio is entitled to receive up to double-digit tiered royalties on INO-3112 product sales.
Under the agreement MedImmune and Inovio will also jointly research two DNA-based cancer vaccine products, which MedImmune will have the rights to develop and commercialize.
Inovio and MedImmune are also collaborating under two separate grants from the Defense Advanced Research Projects Agency focused on developing DNA-based monoclonal antibodies targeting influenza, antibiotic resistant bacteria, and Ebola.
Roche acquired an exclusive worldwide license to develop and commercialize Inovio’s hepatitis B (INO-1800) immunotherapy. Roche exclusively licensed this DNA-based product and was granted the right to use Inovio’s CELLECTRA® electroporation technology to deliver INO-1800.
Roche paid US $10 million upfront, in part for the hepatitis B rights. Roche paid for all preclinical R&D and paid a $3 million milestone payment in early 2015 for the launch of a phase I study of INO-1800. Roche is paying all clinical development costs and will make payments upon reaching certain development and commercial milestones. Inovio is entitled to receive up to double-digit tiered royalties on product sales.
University of Pennsylvania
Inovio has a license agreement with the University of Pennsylvania (UPenn), which is the center of core synthetic immunotherapy research for Inovio. The underlying technology was developed in the laboratory of Professor David B. Weiner, Ph.D. 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 DNA-based immunotherapy applications and products for cancers and infectious diseases.
Inovio has licensed from UPenn exclusive worldwide rights to develop numerous DNA constructs with the potential to treat a broad spectrum of cancers including breast, lung, pancreatic, prostate, and HPV-associated precancers and cancers, as well as treat and/or prevent human immunodeficiency virus, hepatitis C virus, hepatitis B virus, human papilloma virus, influenza, cytomegalovirus, malaria, respiratory syncytial virus, methicillin-resistant staphylococcus aureus, C. difficile, filoviruses Ebola and Marburg, and novel adjuvants to enhance the effectiveness of DNA vaccines, such as optimized IL-12 cytokine gene adjuvant.
UPenn has also conducted clinical studies for Inovio's PENNVAX®-B HIV DNA vaccine in a therapeutic setting.
Defense Advanced Research Projects Agency (DARPA)
The Defense Advanced Research Projects Agency (DARPA) has awarded Inovio two grants amounting to a potential $57 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 for influenza and antibiotic resistant bacteria. This collaboration also involves scientists from the University of Pennsylvania.
Under a $45 million grant, Inovio and 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.
GeneOne Life Science
Inovio has entered into multiple license and collaboration agreements granting GeneOne Life Science exclusive rights to certain Inovio product candidates in certain jurisdictions in exchange for GeneOne funding and conducting various clinical studies. GeneOne has exclusive rights in countries in Asia, including Korea, to our VGX-3400X and INO-3510 influenza DNA vaccines as well as our INO-8000 (VGX-6150) hepatitis C DNA immunotherapy. Inovio and GeneOne are also planning a phase I study of Inovio’s MERS (Middle East Respiratory Syndrome) DNA vaccine. Inovio has an equity interest in GeneOne. Inovio also uses the DNA plasmid contract manufacturing services of VGXI, Inc., a Texas-based subsidiary of GeneOne.
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 and C 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 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.
Plumbline Life Sciences
Inovio and its 90%-owned subsidiary, VGX Animal Health, Inc., sold its animal health assets to Plumbline Life Sciences, Inc. The assets transferred include an exclusive license with Inovio for animal applications of its growth hormone-releasing hormone (GHRH) technology and animal DNA vaccines plus a non-exclusive license to Inovio electroporation delivery systems. VGX Animal Health is receiving cash in multiple payments and 20% of the outstanding shares of Plumbline.
Inovio entered into a license agreement with Drexel University 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.
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.
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