Other R&D Programs
Infectious Disease Research & Development
Inovio has conducted research and development to investigate the viability of DNA vaccines for multiple diseases and is conducting ongoing work on various programs. In addition, multiple organizations have obtained from Inovio research licenses to use Inovio's proprietary electroporation DNA delivery technology to conduct research in conjunction with DNA vaccines they are assessing.
The following is a description of some of these various R&D programs.
Chikungunya (CHIKV)
Chikungunya is a viral disease transmitted to humans via mosquitoes and can cause debilitating illness, most often characterized by fever, headache, fatigue, nausea, vomiting, muscle pain, rash, and joint pain. Inovio is researching a DNA vaccine, delivered via electroporation, for CHIKV.
Dengue Fever (Universal)
Dengue fever is the most important mosquito-borne viral disease affecting humans. Its global distribution is comparable to that of malaria and an estimated 2.5 billion people live in areas at risk for epidemic transmission. Symptoms are similar to those of CHIKV (above) and no dengue vaccine is currently available.
There are four dengue subtypes. People immunized against one dengue subtype are susceptible to more severe disease if subsequently infected by a second dengue subtype. A key goal in developing dengue vaccines is consequently to create vaccines that simultaneously target all four subtypes.
Inovio is researching a quadrivalent universal DNA vaccine to simultaneously target all four dengue fever subtypes. This vaccine would be delivered using Inovio's proprietary electroporation DNA delivery technology. DNA vaccine technology is particularly suitable for developing a universal dengue vaccine because DNA vaccines are easy to produce and DNA targeting different dengue subtypes can be easily combined into desirable formulations.
Hepatitis C Virus (HCV)
Hepatitis C is a liver disease caused by the hepatitis C virus (HCV) and contracted via blood transfusion. HCV infection sometimes results in acute illness, but most often becomes a chronic condition that can lead to cirrhosis of the liver and liver cancer. No vaccine is currently available.
Inovio is researching next-generation preventive and therapeutic DNA vaccines, delivered via electroporation, for HCV. Additionally, Inovio has an ongoing therapeutic HCV vaccine (Chronvac-C) clinical trial with its partner, Tripep.
HIV (Proprietary Vaccines)
Inovio is presently testing its PENNVAX™-B vaccine, which is for preventive and therapeutic treatment of HIV clade B, the prevalent HIV strain in North America and Western Europe. This vaccine is in clinical research as a stand-alone entity or in combination with electroporation delivery and/or various cytokine and chemokine adjuvants.
Inovio is also developing Synthetic Consensus (SynCon™) DNA vaccine constructs for HIV envelope clades A, C, and D for the developing regions of Africa and Asia (PENNVAX™-G, PENNVAX™-GP). This program is the focus of ongoing research and development.
Influenza (Universal)
According to the CDC, in a paper entitled, Prospects for Universal Influenza Virus Vaccine, "The current vaccination strategy against influenza A and B viruses is vulnerable to the unanticipated emergence of epidemic strains that are poorly matched by the vaccine." These vaccines may therefore provide little or no protection against the rapid spread and effects of new strains of influenza. As the paper noted, "A vaccine that is less sensitive to the antigenic evolution of the virus would be a major improvement."
Inovio is researching preventive and therapeutic DNA vaccines, delivered via electroporation, with more broadly "universal" protective capabilities. The company is developing an influenza vaccine for H1N1, which includes "swine flu" and "swine-origin influenza A/H1N1". Inovio also has a product candidate for avian influenza ("bird flu"), VGX-3400, targeting subtype H5N1. Inovio has filed an IND to initiate a clinical trial for this agent in healthy adults.
Malaria
Malaria is a mosquito-borne disease caused by a parasite that results in one of the most severe human infections. People with malaria often experience fever, chills, and flu-like illness. Left untreated, they may develop severe complications and die. Each year, 350-500 million cases of malaria occur worldwide and over one million people die, most of them young children in sub-Saharan Africa. While there are treatments and prevention methods to lower risk of infection, in general these approaches do not reach the vast majority of the at-risk population and there is increasing resistance to anti-malarial drugs. Accordingly, a vaccine to prevent malaria infection or disease is considered an important global goal.
Inovio, in collaboration with the Program for Appropriate Technology in Health (PATH), under the PATH Malaria Vaccine Initiative (MVI), is researching preventive and therapeutic DNA vaccines, delivered via electroporation, for malaria.
Bioterrorism
Inovio has been awarded contracts for research and development work being conducted by the US Army and funded by the US Department of Defense relating to DNA-based vaccines delivered via its proprietary electroporation system. The most recent project, entitled "Design and Engineering of the Elgen Gene Delivery System for Screening and Validation of Vaccine Candidates of Military Relevance," is focused on identifying DNA vaccine candidates with the potential to provide rapid, robust immunity to protect against biowarfare and bioterror attacks.
Smallpox
Inovio developed a lead DNA vaccine candidate, delivered via electroporation, for smallpox virus. The efficacy of the candidate vaccine was successfully tested in preclinical animal models including non-human primates. The research was conducted under a research grant from the Defense Threat Reduction Agency (DTRA) that included the development of the multivalent DNA vaccine as well as development of a prototype electroporation-based skin delivery system. Inovio is actively looking for government and commercial partners to further develop this promising candidate for a key biodefense target.
HIV (Third Party Research)
Inovio established an agreement with the National Cancer Institute to assess 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.
In a separate agreement, Inovio's collaboration with the International AIDS Vaccine Initiative (IAVI) is focused on optimizing HIV vaccine design in conjunction with the use of electroporation-based DNA delivery technology.
Cancer Cachexia
Inovio is developing growth hormone releasing hormone (GHRH) technology for a number of indications, including cachexia in cancer and HIV patients as well as for age-related disorders. Inovio's VGX™-3200 is a naturally occurring molecule with similar characteristics and activity in humans and animals. GHRH is a key potentiator of the growth hormone insulin-like growth factor (IGF-1) axis and studies in different animal models and humans have shown that GHRH has both direct and indirect functions in development, muscle metabolism, and maintenance of hematological and immune status under physiological and pathological conditions.
Inovio has filed an IND for VGX™-3200 delivered via electroporation.