Putting IMMUNO‑INGENUITY to work in the fight against cancer and infectious diseases

Inovio is leading the way with DNA-based immunotherapy in cancer and infectious diseases, pairing a revolutionary design process with a groundbreaking delivery system to help combat two of the most pressing needs in global health.

Our unique technology is designed to be an effective and efficient platform for the development of DNA-based immunotherapies for the treatment and prevention of multiple cancers and infectious diseases. In particular, we are focusing on pathogens and tumor types with critical unmet needs.

Inovio’s approach in cancers and infectious diseases

Versatility

  • Applications across multiple therapeutic and prophylactic indications
  • We can select multiple viral antigens or tumor-associated antigens within any disease target

Rapid development

  • Rapid design and manufacturing

Practicality

  • Potential to be administered in clinic and physician office settings

Inovio is targeting a wide range of precancers and cancers

From precancerous conditions such as cervical HSIL to aggressive malignancies of the brain, prostate, and bladder, Inovio is focusing on the prevention and treatment of many types of cancer.

Cervical HSIL

Cervical HSIL facts

Cervical high-grade squamous intraepithelial lesions (HSIL), also known as cervical dysplasia, is classified as premalignant changes in cervical cells that if left untreated can advance to cervical cancer. The cause of cervical HSIL is persistent infection with one or more high-risk genotypes of human papillomavirus (HPV). HPV genotypes 16 and 18 are estimated to collectively cause approximately 70% of all cervical cancers in the United States and worldwide.1

Current standard of care for cervical HSIL is surgical excision or ablation, but surgical intervention does not treat the underlying HPV infection. 10% to 16% of women experience recurrence of lesions 9 to 16 months after loop electrosurgical excision procedure.2,3

Unmet needs in cervical HSIL

Currently, there is no treatment option that addresses the cervical HSIL and the underlying HPV infection. Existing surgical modalities are associated with serious risks such as perinatal mortality, preterm birth, and cervical HSIL recurrence.11

See Inovio’s precancer and cancer immuno-oncology pipeline

Vulvar HSIL

Vulvar HSIL facts 

Vulvar high-grade squamous intraepithelial lesions (HSIL), also known as vulvar neoplasia, is classified as premalignant changes to the vulva. Vulvar HSIL is strongly correlated with HPV infection. 

The rate of vulvar HSIL is on the rise, especially among women in their 40s. Between 1973 and 2000, there was a 4-fold increase in the rate of incidence of this condition.4  

Unmet needs in vulvar HSIL

Currently, there is no treatment that addresses vulvar HSIL and the underlying HPV infection.

See Inovio’s precancer and cancer immuno-oncology pipeline

Anal HSIL

Anal HSIL facts

Anal high-grade squamous intraepithelial lesions (HSIL), also known as anal dysplasia, is classified as premalignant changes in the squamous cells lining the anus. Anal HSIL is strongly correlated with HPV infection.

Anal HSIL or dysplasia is the precursor to anal cancer, which is estimated to cause more than 1,100 deaths in the United States in 2018.

Unmet needs in vulvar HSIL

Currently, the only treatments for anal dysplasia consist of surgical excision, electro-cautery or laser therapy, but more than 50% of those treated with these current treatments experience recurrence of the disease.

Prostate cancer

Prostate cancer facts

In 2017, over 160,000 new cases of prostate cancer will be diagnosed in the United States. Aside from skin cancer, prostate cancer is the most frequently diagnosed cancer in men. In 2017 alone, over 26,700 men in the United Sates will die from prostate cancer, making it the second leading cause of cancer death in men.5

Unmet needs in prostate cancer

Despite improved detection and screening and a wide range of targeted therapeutic options, mortality rates for prostate cancer still remain high.

See Inovio’s immuno-oncology pipeline

hTERT

Cancers with over-expression of hTERT

High levels of human telomerase reverse transcriptase (hTERT) have been reported in tumor types such as breast, lung, and pancreas. hTERT may prove to be a promising immuno-oncology target for the treatment of these cancers.

In 2017, over 530,000 new cases of breast, lung, or pancreatic cancers were reported in the United States and over 240,000 people died from these cancers.5

Unmet needs in cancers with over-expression of hTERT

Despite available treatments, mortality rates remain unacceptably high in these tumor types. In addition, many existing treatment modalities are associated with significant adverse events.

See Inovio’s immuno-oncology pipeline

Glioblastoma

Glioblastoma facts

There are an estimated 256,000 new cases of brain and nervous system tumors per year worldwide12. Glioblastoma is the most common of these tumors, accounting for 12% to 15% of all brain tumors.6

Unmet needs in glioblastoma

There is no cure for glioblastoma, and limited treatment options are currently available. Surgery, radiation, chemotherapy, and targeted therapy are current standard of care, but mortality rates remain high.6

See Inovio’s immuno-oncology pipeline

Bladder cancer

Bladder cancer facts

In 2014, there were an estimated 696,440 people in the United States living with bladder cancer. Over 79,000 new cases of bladder cancer are expected to be diagnosed in the United States in 2017, and over 16,870 people are expected to die from this cancer in that year—accounting for 2.8% of all cancer deaths.7

Unmet needs in bladder cancer

Prior to the approvals of checkpoint inhibitors, there had been no significant advances in the treatment of advanced bladder cancer for over 30 years. The prognosis for advanced bladder cancer patients is extremely poor, with a 5-year survival rate of 5%.7

See Inovio’s immuno-oncology pipeline

Head and neck cancer

Head and neck cancer facts

Head and neck cancer refers to malignancies of the sinuses, nose, mouth, throat, pharynx, larynx, and saliva glands. Approximately 70% of cancers of oropharynx (tonsils, soft palate, base of tongue) are caused by HPV infection, and approximately 85% of these are attributable to HPV types 16 and 18.8

In 2017, over 49,600 people in the United States will be diagnosed with oropharynx cancer and over 9,700 people will die that year as a result of oropharynx cancer.13

Unmet needs in head and neck cancer

Treatments for HPV-related head and neck cancers vary based on size and location of the tumor, but current standard of care includes surgery, radiation, chemotherapy, and targeted therapy. All of these modalities are associated with significant adverse events and even when successful can prove challenging for patients.

References

  1. Bruni L, Barrionuevo-Rosas L, Albero G, et al. ICO Information Centre on HPV and Cancer (HPV Information Centre). Human Papillomavirus and Related Diseases in the world. Summary Report 30 June 2017. http://www.hpvcentre.net/statistics/reports/XWX.pdf. Accessed July 3, 2017.
  2. Xi LF, Kiviat NB, Wheeler CM, et al. Risk of cervical intraepithelial neoplasia grade 2 or 3 after loop electrosurgical excision procedure associated with human papillomavirus type 16 variants. J Infect Dis. 2007;195(9):1340-1344.
  3. Nobbenhuis MA, Meijer CJ, van den Brule AJ, et al. Addition of high-risk HPV testing improves the current guidelines on follow-up after treatment for cervical intraepithelial neoplasia. Br J Cancer. 2001;84(6):796-801.
  4. Judson PL, Habermann EB, Baxter NN, et al. Trends in the incidence of invasive and in situ vulvar carcinoma. Obstet Gynecol. 2006;107(5):1018-1022.
  5. Cancer facts and figures 2016. American Cancer Society. https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2016/cancer-facts-and-figures-2016.pdf. Accessed July 3, 2017.
  6. Kumar G, Kawatra N, Sharma P, et al. A review on glioblastoma multiforme (brain tumor)-grade IV glioma. Am J Pharm Health Res. 2014;2(7):21-28.
  7. Cancer stat facts: bladder cancer. Surveillance, epidemiology, and end results program. National Cancer Institute. https://seer.cancer.gov/statfacts/html/urinb.html. Accessed July 7, 2017.
  8. Head and neck cancers. Division of Cancer Prevention and Control, Centers for Disease Control and Prevention. https://www.cdc.gov/cancer/headneck/index.htm. Updated June 2017. Accessed July 3, 2017.
  9. Human papillomavirus (HPV) and cervical cancer Fact Sheet. World Health Organization website http://www.who.int/mediacentre/factsheets/fs380/en/. Updated June 2016. Accessed July 3, 2017.
  10. Anantharaman D, Gheit T, Waterboer T, et al. Human papillomavirus infections and upper aero-digestive tract cancers: the ARCAGE study. J Natl Cancer Inst. 2013;105(8):536-545.
  11. Kyrgiou M, Athanasiou A, Paraskevaidi M, Mitra A, Kallaiala I, Martin-Hirsch P, Arbyn M, Bennett P, Paraskevaidis E. Adverse obstetric outcomes after local treatment for cervical preinvasive and early invasive disease according to cone depth: systematic review and meta-analysis. BMJ. 2016 Jul 28;354:i3633.
  12. Ferlay J, Soerjomataram I, Ervik M, Dikshit R, Eser S, Mathers C, Rebelo M, Parkin DM, Forman D, Bray, F. GLOBOCAN 2012 v1.0, Cancer Incidence and Mortality Worldwide: IARC CancerBase No. 11 [Internet]. Lyon, France: International Agency for Research on Cancer; 2013. Available from: http://globocan.iarc.fr, accessed on 27 October 2017.
  13. US National Cancer Institute. Survival, Epidemiology, and End Results (SEER) Program. Cancer Stat Facts: Oral Cavity and Pharynx Cancer. https://seer.cancer.gov/statfacts/html/oralcav.html (accessed Oct. 27, 2017).
  14. Alemany L, Saunier M, Alvarado-Cabrero I, Quiros B, Salmeron J, Shin HR, et al. Human papillomavirus DNA prevalence and type distribution in anal carcinomas worldwide. Int J Cancer 2015,136:98-107.
  15. Bruni L, Barrionuevo-Rosas L, Alberto G, Serrano B, Mena M, Gomez D, et al. Human Papillomavirus and Related Diseases Report in USA. In: ICO Information Centre on HPV and Cancer (HPV Information Centre); 2017.
  16. Sahasrabuddhe VV, Castle PE, Follansbee S, Borgonovo S, Tokugawa D, Schwartz LM, et al. Human papillomavirus genotype attribution and estimation of preventable fraction of anal intraepithelial neoplasia cases among HIV-infected men who have sex with men. J Infect Dis 2013,207:392-401.
  17. Saraiya M, Unger ER, Thompson TD, Lynch CF, Hernandez BY, Lyu CW, Steinau M, Watson M, Wilkinson EJ, Hopenhayn C, Copeland G, Cozen W, Peters ES, Huang Y, Saber MS, Altekruse S, Goodman MT; HPV Typing of Cancers Workgroup. US assessment of HPV types in cancers: implications for current and 9-valent HPV vaccines. J Natl Cancer Inst. 2015 Apr 29;107(6):djv086.
  18. Surveillance, Epidemiology, and End Results Program (SEER), US National Cancer Institute.  Cancer Stat Facts:  Anal Cancer.  https://seer.cancer.gov/statfacts/html/anus.html (accessed July 2, 2018).

Inovio is targeting a wide range of infectious diseases

From well-established pathogens with significant unmet needs to new and emerging threats around the world, Inovio's focus is on the prevention and treatment of multiple infectious diseases.

Hepatitis B

Hepatitis B facts

Hepatitis B is a life-threatening infection of the liver caused by the hepatitis B virus (HBV). It is transmitted through blood and bodily fluids. In some, HBV can cause chronic liver infection, eventually resulting in cirrhosis and cancer of the liver.1

It is estimated that over 257 million people are chronically infected with HBV around the world. In 2015, over 887,000 people died due to complications from HBV.1

Unmet needs in hepatitis B

A vaccine against hepatitis B has been available since 1992 and is 95% effective in preventing infection. However, there is no specific curative treatment for chronic HBV infection. Post-infection treatment to address symptoms and chronic disease can be costly and is associated with long-term adverse events.1

See Inovio’s infectious diseases product pipeline

HIV

HIV facts

Human immunodeficiency virus (HIV) is a retrovirus that targets and weakens the immune system. HIV is classified into two distinct types: HIV-1 and HIV-2. In addition, there are six HIV-1 subtypes, or clades: A, B, C, D, E, and AE.

In 2015, there were approximately 36.7 million people worldwide living with HIV. Over 2.1 million new infections were reported, and 1.1 million died from HIV-related complications.3

Unmet needs in HIV

Despite significant slowing in the rate of infection from 2000 to 2015, HIV remains a pressing global threat. Currently, there is no vaccine to prevent infection and no cure once infected. Effective antiretroviral treatments are available, but these are associated with potentially severe side effects and may lose effectiveness over time.3

See Inovio’s infectious diseases product pipeline

Ebola

Ebola facts

Infection with ebola virus is always a life-threatening and often fatal condition. Ebola virus is transmitted to humans through wild animals and spreads through human-to-human contact with blood, secretions, organs, or bodily fluids of infected people, and with contaminated surfaces and materials such as clothing and linens.4 

Unmet needs in ebola

There is no approved vaccine to prevent ebola and no effective curative treatment post-infection. The average case fatality rate of ebola virus disease is 50%, but this varies from 25% to 90%.4

See Inovio’s infectious diseases product pipeline

MERS

MERS facts

Middle East respiratory syndrome (MERS) is caused by infection by the MERS coronavirus. This coronavirus was first identified in Saudi Arabia in 2012. The transmission from animals to humans is not well defined, though dromedary camels are known to be a host of the MERS coronavirus. The virus does not pass easily from human to human, and is usually transmitted through the unprotected care of an infected patient in healthcare facilities.5

As of June 2017, MERS has been reported in 27 countries around the world. Although approximately 80% of cases occur in Saudi Arabia, significant outbreaks have been reported in countries as far as South Korea. Most cases that are reported outside of the Middle East are the result of people who were infected while travelling in the region.5

Unmet needs in MERS

There is no vaccine to prevent infection with the MERS virus, and there is no cure once infected. In previous outbreaks, up to 35% of people ill with MERS virus have died.5

See Inovio’s infectious diseases product pipeline

Zika

Zika facts

Zika is a flavivirus that is transmitted by the Aedes mosquito. It was first identified in 1952, and outbreaks have been observed around the world—most recently in the Americas in 2015. Zika is transmitted through the bite of an infected mosquito, and human-to-human transmission via unprotected sexual intercourse has been reported.6

Symptoms of Zika infection are generally mild and last for 2 to 7 days. However, infection during pregnancy can lead to significant fetal brain abnormalities such as microcephaly and Guillain-Barré syndrome. 

Unmet needs in Zika

There is no vaccine to prevent infection with Zika. Though symptoms are generally moderate and abate over a few weeks, there is a significant risk to the fetus if the mother is infected while pregnant.

Recent reports of persistent Zika infection has caused alarm due to the impact on testicular development and potential for reproductive health issues over time—long after primary Zika infection has occured.

See Inovio’s infectious diseases product pipeline

References

  1. Hepatitis B Fact Sheet. World Health Organization website. http://www.who.int/mediacentre/factsheets/fs204/en/. Updated April 2017. Accessed July 3, 2017.
  2. Hepatitis C Fact Sheet. World Health Organization website. http://www.who.int/mediacentre/factsheets/fs164/en/. Updated April 2017. Accessed July 3, 2017.
  3. HIV/AIDS Fact Sheet. World Health Organization website. http://www.who.int/mediacentre/factsheets/fs360/en/. Updated April 2016. Accessed July 3, 2017.
  4. Ebola Virus Disease Fact Sheet. World Health Organization website. http://www.who.int/mediacentre/factsheets/fs103/en/. Updated June 2017. Accessed July 3, 2017.
  5. Middle East Respiratory Syndrome Coronavirus (MERS-CoV) Fact Sheet. World Health Organization website. http://www.who.int/mediacentre/factsheets/mers-cov/en/. Updated May 2017. Accessed July 3, 2017.
  6. Zika Virus Fact Sheet. World Health Organization website. http://www.who.int/mediacentre/factsheets/zika/en/. Updated September 2016. Accessed July 3, 2017.