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Infectious Diseases

(Non-HPV Associated)

Many public health authorities believe that DNA medicines may be the best modern approach to addressing potential infectious disease pandemics due to their rapid design and manufacture.

INOVIO has multiple programs in clinical studies to address infectious diseases, including COVID-19, Ebola, Lassa fever, and MERS (both COVID-19 and MERS are caused by coronaviruses). These programs are all externally funded by leading government agencies and global public health organizations, including the Coalition for Epidemic Preparedness Innovations (CEPI), the National Institutes of Health (NIH), the Bill & Melinda Gates Foundation, the U.S. Department of Defense, and the International Vaccine Institute (IVI). INOVIO also has the first-ever DNA-encoded monoclonal antibody (dMAb™), which is in clinical trials targeting the Zika virus.

Ebola Facts

The Ebola virus has been described as one of the most virulent viral diseases, with lethality rates up to 90%. Ebola can spread through human-to-human transmission by direct contact with the blood, secretions, organs or bodily fluids of an infected individual and with surfaces or materials that contain the contaminated fluids of an infected person, such as bedding and clothing. It is capable of causing death within two to twenty-one days of exposure.1

Advancements on the Horizon for Ebola

INOVIO is taking a multi-faceted approach to develop products to prevent and treat Ebola infection. These programs include development and early clinical testing of:

  • a therapeutic DNA-encoded monoclonal antibody product against the Ebola virus infection, which we believe has properties that best fit a response to the outbreak in that they could be designed and manufactured expediently on a large scale using common fermentation technology, are thermal-stable, and may provide more rapid therapeutic benefit;
  • a highly potent conventional protein-based therapeutic monoclonal antibody (mAb) product against Ebola virus infection; and
  • a DNA vaccine against Ebola.

In March 2019, Phase 1 clinical data of Ebola vaccine candidate INO-4201 was published in The Journal of Infectious Diseases, in the article entitled, “Intradermal SynCon® Ebola GP DNA Vaccine is Temperature Stable and Safely Demonstrates Cellular and Humoral Immunogenicity Advantages in Healthy Volunteers.” The study, which is being fully funded by U.S. Defense Advanced Research Projects Agency (DARPA), further supports the advancement of the intradermal delivery platform for emerging infectious diseases.

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References:

  1. World Health Organization (WHO). Ebola virus disease. Available at: who.int. Accessed April 3, 2020.

Middle East Respiratory Syndrome Facts

Middle East Respiratory Syndrome Facts (MERS) is a viral respiratory illness and all cases are linked to the Arabian Peninsula. MERS appears to have been transmitted from an animal reservoir to humans, but human-to-human transmission has been confirmed. This communicable virus has not been shown to spread in a sustained way in communities, but rapid spread in the nosocomial setting, such as emergency rooms and/or hospitals without adherence to state-of-the-art infection control practices, can result in outbreaks with many cases, including superspreading events.1 Like the severe acute respiratory syndrome (SARS) outbreak in 2003, which made approximately 8,000 people ill and was fatal in nearly 10% of those cases,2 MERS is caused by a coronavirus and appears to cause a severe lung infection.1 Despite the continuing threat of MERS outbreaks, there are no licensed vaccines or treatments for MERS.1

Advancements on the Horizon for MERS

In November 2013, INOVIO announced that preclinical testing of our MERS DNA vaccine candidate, INO-4700 (formerly known as GLS-5300), had induced robust and durable immune responses, demonstrating the potential for such a vaccine to prevent and treat this deadly virus. DNA vaccine constructs targeting multiple MERS antigens were designed with the goal to universally protect against multiple strains of MERS, which has been shown to have diverse genetic variants.

INO-4700 is currently in Phase 1/2a development for the treatment and prevention of MERS. INOVIO and GeneOne Life Science are co-developing INO-4700 in collaboration with the Walter Reed Army Institute of Research.

View INOVIO’s DNA Medicines Pipeline

References:

  1. World Health Organization (WHO). Middle East respiratory syndrome coronavirus (MERS-CoV). Available at: who.int. Accessed April 3, 2020.

  2. Centers for Disease Control and Prevention (CDC). CDC SARS Response Timeline – SARS: Key Events. Available at: cdc.gov. Accessed April 3, 2020.

Lassa Fever Facts

Discovered in 1969, Lassa fever is an animal-borne acute viral illness. Humans usually become infected with Lassa virus through exposure to food or household items contaminated with urine or feces of infected Mastomys rats. The disease is endemic in the rodent population in parts of West Africa. An estimated 100,000 to 300,000 infections of Lassa fever occur annually, with approximately 5,000 deaths.1

Advancements on the Horizon for Lassa Fever

INOVIO is conducting a Phase 1, first-in-human clinical trial to evaluate INO-4500, a DNA candidate vaccine to prevent infection from the Lassa virus. This trial is the first Lassa fever candidate vaccine to enter the clinic. The INO-4500 program is fully funded through a global partnership with CEPI – the Coalition for Epidemic Preparedness Innovations. INOVIO is also planning to advance INO-4500 to a Phase 1b trial in Africa in 2020.

View INOVIO’s DNA Medicines Pipeline

References:

  1. Centers for Disease Control and Prevention (CDC). Lassa Fever. Available at: cdc.gov. Accessed April 3, 2020.

COVID-19 Facts

Coronavirus disease 2019 (COVID-19) is a respiratory illness that can spread from person to person.1 The virus that causes COVID-19 is a novel coronavirus that was first identified in December 2019.

Advancements on the Horizon for COVID-19

To help in the fight for the coronavirus (SARS-CoV-2) that causes COVID-19, INOVIO created an optimized plasmid in about three hours based on the virus’s genetic sequence. The company began small-scale manufacturing of the DNA vaccine – INO-4800 – in the lab, followed by preclinical testing to assess its safety and immunogenicity. On April 6, less than three months after creating INO-4800, INOVIO announced the U.S. Food and Drug Administration authorized its Investigational New Drug (IND) application and the company began Phase 1 clinical trials in humans.

View INOVIO’s DNA Medicines Pipeline

References:

  1. Centers for Disease Control and Prevention (CDC). 2019 Novel Coronavirus. Available at: cdc.gov. Accessed February 12, 2020.