Inovio’s Product Pipeline

We are advancing products across multiple tumor types and infectious diseases

Light Blue
Internally Funded
Dark Blue
Partner Funded

VGX-3100

  • Cervical HSIL

    P3

    Product

    VGX-3100

    Antigen

    E6,E7

    Trial Stage

    Phase III

    Partner

    None

    Product information

    VGX-3100 is an investigational immunotherapy designed to treat precancers and cancers caused by human papillomavirus (HPV). VGX-3100 includes DNA plasmids targeting the E6 and E7 proteins of HPV types 16 and 18. VGX-3100 is delivered intramuscularly using the CELLECTRA® 5PSP delivery device.

    Disease state

    Persistent HPV infection can lead to high-grade squamous intraepithelial lesions (HSIL) in cervical cells. HPV types 16 and 18 cause 70% of cervical cancer cases. In the US and EU5 countries, there are approximately 3.4 million incidences of low-grade and high-grade cervical precancers.1

    Development status

    A randomized, double-blind, placebo-controlled Phase 2b trial was completed in July 2015. In this trial involving 167 patients, VGX-3100 was the first therapeutic vaccine to demonstrate efficacy against cervical HSIL associated with HPV-16 and HPV-18. [Trimble 2015]

    A Phase 3 trial (REVEAL 1) was initiated in June 2017.

    See the REVEAL 1 website
  • Vulvar HSIL

    P2

    Product

    VGX-3100

    Antigen

    E6, E7

    Trial Stage

    Phase II

    Partner

    None

    Product information

    VGX-3100 is an investigational immunotherapy designed to treat precancers and cancers caused by human papillomavirus (HPV). VGX-3100 includes DNA plasmids targeting the E6 and E7 proteins of HPV types 16 and 18. VGX-3100 is delivered intramuscularly using the CELLECTRA® delivery device.

    Disease state

    Persistent infection with HPV can lead to development of high-grade squamous intraepithelial lesions (HSIL) in vulvar cells.  In the past 3 decades, there has been a 4-fold increase in the rate of vulvar HSIL in the United States.2

    Development status

    Based on promising results in treating cervical HSIL, VGX-3100 is being used to treat patients with vulvar HSIL in an ongoing Phase 2 trial. This is a randomized, open-label study of VGX-3100 alone or in combination with imiquimod in patients with HPV-16 and/or HPV-18 related vulvar HSIL.

    See study design
  • Anal HSIL

    P2

    Product

    VGX-3100

    Antigen

    E6, E7

    Trial Stage

    Phase II

    Partner

    None

    Product information

    VGX-3100 is an investigational immunotherapy designed to treat precancers and cancers caused by human papillomavirus (HPV). VGX-3100 includes DNA plasmids targeting the E6 and E7 proteins of HPV types 16 and 18. VGX-3100 is delivered intramuscularly using the CELLECTRA® delivery device.

    Disease state

    Persistent infection with HPV can lead to development of high-grade squamous intraepithelial lesions (HSIL) in anal and/or peri-anal cells.  These lesions can lead to anal cancer, for which about 8,580 new cases per year are diagnosed in the United States. In the past 3 decades, the incidence rate of this cancer has increased by nearly 60% [SEER, NCI (2018)].  The vast majority (about 80%) of anal cancers in the U.S. are attributed to HPV-16 and/or HPV-18 (and most to HPV-16) [Saraiya et al J Natl Cancer Instit (2015)].  In the US, about 55% to 80% of anal HSIL cases are associated with HPV-16 and/or HPV-18, and worldwide about 80% of anal HSIL cases are associated with HPV-16/18 [Alemany et al Cancer (2015); Bruni et al HPV Info. Centre (2017); Sahasrabuddhe et al J Infect Dis (2013)].

    Development status

    Based on promising results in treating cervical HSIL, VGX-3100 is being used to treat patients with anal HSIL in an ongoing Phase 2 trial. This is an open-label efficacy study of VGX-3100 administered by intramuscular (IM) injection followed by electroporation (EP) in adult men and women who are HIV negative with histologically confirmed anal or anal/peri-anal high-grade squamous intraepithelial lesion (HSIL) associated with human papilloma virus (HPV)-16 and/or HPV-18.

    See study design

INO-5401

  • Glioblastoma

    P2

    Product

    INO-5401 + cemiplimab

    Antigen

    WT1, PSMA, hTERT

    Trial Stage

    Phase II

    Partner

    Regeneron

    Product information

    INO-5401 is a highly optimized synthetic DNA immunotherapy and has the potential to be a foundational treatment in combination with checkpoint inhibitors. INO-5401 targets WT1, hTERT, and PSMA antigens. INO-5401 is delivered intramuscularly using the CELLECTRA® delivery device.

    Disease state

    Glioblastoma is the most common brain tumor, and is among those tumors with the worst prognosis/worst overall survival, accounting for 12% to 15% of all brain tumors.4

    Development status

    Inovio and Regeneron Pharmaceuticals, Inc. are currently in development of a clinical program to evaluate the efficacy and safety of Inovio’s INO-5401 with Regeneron’s PD-1 inhibitor, cemiplimab, in combination with chemoradiotherapy in patients with glioblastoma.

    See study design
  • Bladder cancer

    P2

    Product

    INO-5401 + atezolizumab

    Antigen

    WT1, PSMA, hTERT

    Trial Stage

    Phase II

    Partner

    Genentech

    Product information

    INO-5401 is a highly optimized synthetic DNA immunotherapy and has the potential to be a foundational treatment in combination with checkpoint inhibitors. INO-5401 targets WT1, hTERT, and PSMA antigens. INO-5401 is delivered intramuscularly using the CELLECTRA® delivery device.

    Disease state

    79,000 new cases of bladder cancer are expected to be diagnosed in 2017. Advanced bladder cancer is associated with an extremely poor prognosis, with an expected survival of less than 12 months.5

    Development status

    In June of 2017, Inovio initiated a clinical collaboration with Genentech to evaluate the safety and efficacy of Inovio’s INO-5401 in combination with Genentech’s atezolizumab in the treatment of advanced bladder cancer.

    See study design

MEDI0457

  • Head and neck cancer

    P2

    Product

    MEDI0457 + durvalumab

    Antigen

    E6, E7

    Trial Stage

    Phase II

    Partner

    MedImmune

    Product information

    INO-3112 is a combination of Inovio’s VGX-3100 immunotherapy and a DNA-based immune activator encoded for IL-12. INO-3112 targets the E6 and E7 oncogenes of human papillomavirus (HPV) types 16 and 18. INO-3112 enables the body to produce E6 and E7 antigens to induce a targeted immune response. INO-3112 is delivered intramuscularly using the CELLECTRA® delivery device.

    Disease state

    Persistent HPV infection can cause a wide range of cancers, including oropharyngeal, head, neck, oral cavity, oropharynx, nose/nasal passage, and neck. Over 49,670 new cases of HPV-caused oropharyngeal cancers are diagnosed each year in the United States13. Approximately 70% oropharyngeal cancers are caused by HPV, mostly by types 16 and 18.7

    Development status

    Inovio advanced INO-3112 into Phase I/IIa head and neck cancer clinical studies in 2014. MedImmune acquired the rights to develop INO-3112. This study will be part of MedImmune’s development plans.

    See study design
Light Blue
Internally Funded
Dark Blue
Partner Funded

VGX-3100

Disease
Antigen
Preclinical
Phase I
Phase II
Phase III
Partner
Cervical HSILE6,E7
Phase 3 - Middle
None

Product

VGX-3100

Product information

VGX-3100 is an investigational immunotherapy designed to treat precancers and cancers caused by human papillomavirus (HPV). VGX-3100 includes DNA plasmids targeting the E6 and E7 proteins of HPV types 16 and 18. VGX-3100 is delivered intramuscularly using the CELLECTRA® 5PSP delivery device.

Disease state

Persistent HPV infection can lead to high-grade squamous intraepithelial lesions (HSIL) in cervical cells. HPV types 16 and 18 cause 70% of cervical cancer cases. In the US and EU5 countries, there are approximately 3.4 million incidences of low-grade and high-grade cervical precancers.1

Development status

A randomized, double-blind, placebo-controlled Phase 2b trial was completed in July 2015. In this trial involving 167 patients, VGX-3100 was the first therapeutic vaccine to demonstrate efficacy against cervical HSIL associated with HPV-16 and HPV-18. [Trimble 2015]

A Phase 3 trial (REVEAL 1) was initiated in June 2017.

See the REVEAL 1 website
Vulvar HSILE6, E7
Phase 2 - Middle
None

Product

VGX-3100

Product information

VGX-3100 is an investigational immunotherapy designed to treat precancers and cancers caused by human papillomavirus (HPV). VGX-3100 includes DNA plasmids targeting the E6 and E7 proteins of HPV types 16 and 18. VGX-3100 is delivered intramuscularly using the CELLECTRA® delivery device.

Disease state

Persistent infection with HPV can lead to development of high-grade squamous intraepithelial lesions (HSIL) in vulvar cells.  In the past 3 decades, there has been a 4-fold increase in the rate of vulvar HSIL in the United States.2

Development status

Based on promising results in treating cervical HSIL, VGX-3100 is being used to treat patients with vulvar HSIL in an ongoing Phase 2 trial. This is a randomized, open-label study of VGX-3100 alone or in combination with imiquimod in patients with HPV-16 and/or HPV-18 related vulvar HSIL.

See study design
Anal HSILE6, E7
Phase 2 - Middle
None

Product

VGX-3100

Product information

VGX-3100 is an investigational immunotherapy designed to treat precancers and cancers caused by human papillomavirus (HPV). VGX-3100 includes DNA plasmids targeting the E6 and E7 proteins of HPV types 16 and 18. VGX-3100 is delivered intramuscularly using the CELLECTRA® delivery device.

Disease state

Persistent infection with HPV can lead to development of high-grade squamous intraepithelial lesions (HSIL) in anal and/or peri-anal cells.  These lesions can lead to anal cancer, for which about 8,580 new cases per year are diagnosed in the United States. In the past 3 decades, the incidence rate of this cancer has increased by nearly 60% [SEER, NCI (2018)].  The vast majority (about 80%) of anal cancers in the U.S. are attributed to HPV-16 and/or HPV-18 (and most to HPV-16) [Saraiya et al J Natl Cancer Instit (2015)].  In the US, about 55% to 80% of anal HSIL cases are associated with HPV-16 and/or HPV-18, and worldwide about 80% of anal HSIL cases are associated with HPV-16/18 [Alemany et al Cancer (2015); Bruni et al HPV Info. Centre (2017); Sahasrabuddhe et al J Infect Dis (2013)].

Development status

Based on promising results in treating cervical HSIL, VGX-3100 is being used to treat patients with anal HSIL in an ongoing Phase 2 trial. This is an open-label efficacy study of VGX-3100 administered by intramuscular (IM) injection followed by electroporation (EP) in adult men and women who are HIV negative with histologically confirmed anal or anal/peri-anal high-grade squamous intraepithelial lesion (HSIL) associated with human papilloma virus (HPV)-16 and/or HPV-18.

See study design

INO-5401

Disease
Antigen
Preclinical
Phase I
Phase II
Phase III
Partner
GlioblastomaWT1, PSMA, hTERT
Phase 2 - Middle
Regeneron

Product

INO-5401 + cemiplimab

Product information

INO-5401 is a highly optimized synthetic DNA immunotherapy and has the potential to be a foundational treatment in combination with checkpoint inhibitors. INO-5401 targets WT1, hTERT, and PSMA antigens. INO-5401 is delivered intramuscularly using the CELLECTRA® delivery device.

Disease state

Glioblastoma is the most common brain tumor, and is among those tumors with the worst prognosis/worst overall survival, accounting for 12% to 15% of all brain tumors.4

Development status

Inovio and Regeneron Pharmaceuticals, Inc. are currently in development of a clinical program to evaluate the efficacy and safety of Inovio’s INO-5401 with Regeneron’s PD-1 inhibitor, cemiplimab, in combination with chemoradiotherapy in patients with glioblastoma.

See study design
Bladder cancerWT1, PSMA, hTERT
Phase 2 - Middle
Genentech

Product

INO-5401 + atezolizumab

Product information

INO-5401 is a highly optimized synthetic DNA immunotherapy and has the potential to be a foundational treatment in combination with checkpoint inhibitors. INO-5401 targets WT1, hTERT, and PSMA antigens. INO-5401 is delivered intramuscularly using the CELLECTRA® delivery device.

Disease state

79,000 new cases of bladder cancer are expected to be diagnosed in 2017. Advanced bladder cancer is associated with an extremely poor prognosis, with an expected survival of less than 12 months.5

Development status

In June of 2017, Inovio initiated a clinical collaboration with Genentech to evaluate the safety and efficacy of Inovio’s INO-5401 in combination with Genentech’s atezolizumab in the treatment of advanced bladder cancer.

See study design

MEDI0457

Disease
Antigen
Preclinical
Phase I
Phase II
Phase III
Partner
Head and neck cancerE6, E7
Phase 2 - Middle
MedImmune

Product

MEDI0457 + durvalumab

Product information

INO-3112 is a combination of Inovio’s VGX-3100 immunotherapy and a DNA-based immune activator encoded for IL-12. INO-3112 targets the E6 and E7 oncogenes of human papillomavirus (HPV) types 16 and 18. INO-3112 enables the body to produce E6 and E7 antigens to induce a targeted immune response. INO-3112 is delivered intramuscularly using the CELLECTRA® delivery device.

Disease state

Persistent HPV infection can cause a wide range of cancers, including oropharyngeal, head, neck, oral cavity, oropharynx, nose/nasal passage, and neck. Over 49,670 new cases of HPV-caused oropharyngeal cancers are diagnosed each year in the United States13. Approximately 70% oropharyngeal cancers are caused by HPV, mostly by types 16 and 18.7

Development status

Inovio advanced INO-3112 into Phase I/IIa head and neck cancer clinical studies in 2014. MedImmune acquired the rights to develop INO-3112. This study will be part of MedImmune’s development plans.

See study design
Light Blue
Internally Funded
Dark Blue
Partner Funded
  • Cervical HSIL

    P3

    Product

    VGX-3100

    Antigen

    E6,E7

    Trial Stage

    Phase III

    Partner

    None

    Product information

    VGX-3100 is an investigational immunotherapy designed to treat precancers and cancers caused by human papillomavirus (HPV). VGX-3100 includes DNA plasmids targeting the E6 and E7 proteins of HPV types 16 and 18. VGX-3100 is delivered intramuscularly using the CELLECTRA® 5PSP delivery device.

    Disease state

    Persistent HPV infection can lead to high-grade squamous intraepithelial lesions (HSIL) in cervical cells. HPV types 16 and 18 cause 70% of cervical cancer cases. In the US and EU5 countries, there are approximately 3.4 million incidences of low-grade and high-grade cervical precancers.1

    Development status

    A randomized, double-blind, placebo-controlled Phase 2b trial was completed in July 2015. In this trial involving 167 patients, VGX-3100 was the first therapeutic vaccine to demonstrate efficacy against cervical HSIL associated with HPV-16 and HPV-18. [Trimble 2015]

    A Phase 3 trial (REVEAL 1) was initiated in June 2017.

    See the REVEAL 1 website
  • Glioblastoma

    P2

    Product

    INO-5401 + cemiplimab

    Antigen

    WT1, PSMA, hTERT

    Trial Stage

    Phase II

    Partner

    Regeneron

    Product information

    INO-5401 is a highly optimized synthetic DNA immunotherapy and has the potential to be a foundational treatment in combination with checkpoint inhibitors. INO-5401 targets WT1, hTERT, and PSMA antigens. INO-5401 is delivered intramuscularly using the CELLECTRA® delivery device.

    Disease state

    Glioblastoma is the most common brain tumor, and is among those tumors with the worst prognosis/worst overall survival, accounting for 12% to 15% of all brain tumors.4

    Development status

    Inovio and Regeneron Pharmaceuticals, Inc. are currently in development of a clinical program to evaluate the efficacy and safety of Inovio’s INO-5401 with Regeneron’s PD-1 inhibitor, cemiplimab, in combination with chemoradiotherapy in patients with glioblastoma.

    See study design
  • Head and neck cancer

    P2

    Product

    MEDI0457 + durvalumab

    Antigen

    E6, E7

    Trial Stage

    Phase II

    Partner

    MedImmune

    Product information

    INO-3112 is a combination of Inovio’s VGX-3100 immunotherapy and a DNA-based immune activator encoded for IL-12. INO-3112 targets the E6 and E7 oncogenes of human papillomavirus (HPV) types 16 and 18. INO-3112 enables the body to produce E6 and E7 antigens to induce a targeted immune response. INO-3112 is delivered intramuscularly using the CELLECTRA® delivery device.

    Disease state

    Persistent HPV infection can cause a wide range of cancers, including oropharyngeal, head, neck, oral cavity, oropharynx, nose/nasal passage, and neck. Over 49,670 new cases of HPV-caused oropharyngeal cancers are diagnosed each year in the United States13. Approximately 70% oropharyngeal cancers are caused by HPV, mostly by types 16 and 18.7

    Development status

    Inovio advanced INO-3112 into Phase I/IIa head and neck cancer clinical studies in 2014. MedImmune acquired the rights to develop INO-3112. This study will be part of MedImmune’s development plans.

    See study design
  • Vulvar HSIL

    P2

    Product

    VGX-3100

    Antigen

    E6, E7

    Trial Stage

    Phase II

    Partner

    None

    Product information

    VGX-3100 is an investigational immunotherapy designed to treat precancers and cancers caused by human papillomavirus (HPV). VGX-3100 includes DNA plasmids targeting the E6 and E7 proteins of HPV types 16 and 18. VGX-3100 is delivered intramuscularly using the CELLECTRA® delivery device.

    Disease state

    Persistent infection with HPV can lead to development of high-grade squamous intraepithelial lesions (HSIL) in vulvar cells.  In the past 3 decades, there has been a 4-fold increase in the rate of vulvar HSIL in the United States.2

    Development status

    Based on promising results in treating cervical HSIL, VGX-3100 is being used to treat patients with vulvar HSIL in an ongoing Phase 2 trial. This is a randomized, open-label study of VGX-3100 alone or in combination with imiquimod in patients with HPV-16 and/or HPV-18 related vulvar HSIL.

    See study design
  • Anal HSIL

    P2

    Product

    VGX-3100

    Antigen

    E6, E7

    Trial Stage

    Phase II

    Partner

    None

    Product information

    VGX-3100 is an investigational immunotherapy designed to treat precancers and cancers caused by human papillomavirus (HPV). VGX-3100 includes DNA plasmids targeting the E6 and E7 proteins of HPV types 16 and 18. VGX-3100 is delivered intramuscularly using the CELLECTRA® delivery device.

    Disease state

    Persistent infection with HPV can lead to development of high-grade squamous intraepithelial lesions (HSIL) in anal and/or peri-anal cells.  These lesions can lead to anal cancer, for which about 8,580 new cases per year are diagnosed in the United States. In the past 3 decades, the incidence rate of this cancer has increased by nearly 60% [SEER, NCI (2018)].  The vast majority (about 80%) of anal cancers in the U.S. are attributed to HPV-16 and/or HPV-18 (and most to HPV-16) [Saraiya et al J Natl Cancer Instit (2015)].  In the US, about 55% to 80% of anal HSIL cases are associated with HPV-16 and/or HPV-18, and worldwide about 80% of anal HSIL cases are associated with HPV-16/18 [Alemany et al Cancer (2015); Bruni et al HPV Info. Centre (2017); Sahasrabuddhe et al J Infect Dis (2013)].

    Development status

    Based on promising results in treating cervical HSIL, VGX-3100 is being used to treat patients with anal HSIL in an ongoing Phase 2 trial. This is an open-label efficacy study of VGX-3100 administered by intramuscular (IM) injection followed by electroporation (EP) in adult men and women who are HIV negative with histologically confirmed anal or anal/peri-anal high-grade squamous intraepithelial lesion (HSIL) associated with human papilloma virus (HPV)-16 and/or HPV-18.

    See study design
  • Bladder cancer

    P2

    Product

    INO-5401 + atezolizumab

    Antigen

    WT1, PSMA, hTERT

    Trial Stage

    Phase II

    Partner

    Genentech

    Product information

    INO-5401 is a highly optimized synthetic DNA immunotherapy and has the potential to be a foundational treatment in combination with checkpoint inhibitors. INO-5401 targets WT1, hTERT, and PSMA antigens. INO-5401 is delivered intramuscularly using the CELLECTRA® delivery device.

    Disease state

    79,000 new cases of bladder cancer are expected to be diagnosed in 2017. Advanced bladder cancer is associated with an extremely poor prognosis, with an expected survival of less than 12 months.5

    Development status

    In June of 2017, Inovio initiated a clinical collaboration with Genentech to evaluate the safety and efficacy of Inovio’s INO-5401 in combination with Genentech’s atezolizumab in the treatment of advanced bladder cancer.

    See study design
Light Blue
Internally Funded
Dark Blue
Partner Funded
Disease
Product
Antigen
Preclinical
Phase I
Phase II
Phase III
Partner
Cervical HSILVGX-3100E6,E7
Phase 3 - Middle
None

Product information

VGX-3100 is an investigational immunotherapy designed to treat precancers and cancers caused by human papillomavirus (HPV). VGX-3100 includes DNA plasmids targeting the E6 and E7 proteins of HPV types 16 and 18. VGX-3100 is delivered intramuscularly using the CELLECTRA® 5PSP delivery device.

Disease state

Persistent HPV infection can lead to high-grade squamous intraepithelial lesions (HSIL) in cervical cells. HPV types 16 and 18 cause 70% of cervical cancer cases. In the US and EU5 countries, there are approximately 3.4 million incidences of low-grade and high-grade cervical precancers.1

Development status

A randomized, double-blind, placebo-controlled Phase 2b trial was completed in July 2015. In this trial involving 167 patients, VGX-3100 was the first therapeutic vaccine to demonstrate efficacy against cervical HSIL associated with HPV-16 and HPV-18. [Trimble 2015]

A Phase 3 trial (REVEAL 1) was initiated in June 2017.

See the REVEAL 1 website
GlioblastomaINO-5401 + cemiplimabWT1, PSMA, hTERT
Phase 2 - Middle
Regeneron

Product information

INO-5401 is a highly optimized synthetic DNA immunotherapy and has the potential to be a foundational treatment in combination with checkpoint inhibitors. INO-5401 targets WT1, hTERT, and PSMA antigens. INO-5401 is delivered intramuscularly using the CELLECTRA® delivery device.

Disease state

Glioblastoma is the most common brain tumor, and is among those tumors with the worst prognosis/worst overall survival, accounting for 12% to 15% of all brain tumors.4

Development status

Inovio and Regeneron Pharmaceuticals, Inc. are currently in development of a clinical program to evaluate the efficacy and safety of Inovio’s INO-5401 with Regeneron’s PD-1 inhibitor, cemiplimab, in combination with chemoradiotherapy in patients with glioblastoma.

See study design
Head and neck cancerMEDI0457 + durvalumabE6, E7
Phase 2 - Middle
MedImmune

Product information

INO-3112 is a combination of Inovio’s VGX-3100 immunotherapy and a DNA-based immune activator encoded for IL-12. INO-3112 targets the E6 and E7 oncogenes of human papillomavirus (HPV) types 16 and 18. INO-3112 enables the body to produce E6 and E7 antigens to induce a targeted immune response. INO-3112 is delivered intramuscularly using the CELLECTRA® delivery device.

Disease state

Persistent HPV infection can cause a wide range of cancers, including oropharyngeal, head, neck, oral cavity, oropharynx, nose/nasal passage, and neck. Over 49,670 new cases of HPV-caused oropharyngeal cancers are diagnosed each year in the United States13. Approximately 70% oropharyngeal cancers are caused by HPV, mostly by types 16 and 18.7

Development status

Inovio advanced INO-3112 into Phase I/IIa head and neck cancer clinical studies in 2014. MedImmune acquired the rights to develop INO-3112. This study will be part of MedImmune’s development plans.

See study design
Vulvar HSILVGX-3100E6, E7
Phase 2 - Middle
None

Product information

VGX-3100 is an investigational immunotherapy designed to treat precancers and cancers caused by human papillomavirus (HPV). VGX-3100 includes DNA plasmids targeting the E6 and E7 proteins of HPV types 16 and 18. VGX-3100 is delivered intramuscularly using the CELLECTRA® delivery device.

Disease state

Persistent infection with HPV can lead to development of high-grade squamous intraepithelial lesions (HSIL) in vulvar cells.  In the past 3 decades, there has been a 4-fold increase in the rate of vulvar HSIL in the United States.2

Development status

Based on promising results in treating cervical HSIL, VGX-3100 is being used to treat patients with vulvar HSIL in an ongoing Phase 2 trial. This is a randomized, open-label study of VGX-3100 alone or in combination with imiquimod in patients with HPV-16 and/or HPV-18 related vulvar HSIL.

See study design
Anal HSILVGX-3100E6, E7
Phase 2 - Middle
None

Product information

VGX-3100 is an investigational immunotherapy designed to treat precancers and cancers caused by human papillomavirus (HPV). VGX-3100 includes DNA plasmids targeting the E6 and E7 proteins of HPV types 16 and 18. VGX-3100 is delivered intramuscularly using the CELLECTRA® delivery device.

Disease state

Persistent infection with HPV can lead to development of high-grade squamous intraepithelial lesions (HSIL) in anal and/or peri-anal cells.  These lesions can lead to anal cancer, for which about 8,580 new cases per year are diagnosed in the United States. In the past 3 decades, the incidence rate of this cancer has increased by nearly 60% [SEER, NCI (2018)].  The vast majority (about 80%) of anal cancers in the U.S. are attributed to HPV-16 and/or HPV-18 (and most to HPV-16) [Saraiya et al J Natl Cancer Instit (2015)].  In the US, about 55% to 80% of anal HSIL cases are associated with HPV-16 and/or HPV-18, and worldwide about 80% of anal HSIL cases are associated with HPV-16/18 [Alemany et al Cancer (2015); Bruni et al HPV Info. Centre (2017); Sahasrabuddhe et al J Infect Dis (2013)].

Development status

Based on promising results in treating cervical HSIL, VGX-3100 is being used to treat patients with anal HSIL in an ongoing Phase 2 trial. This is an open-label efficacy study of VGX-3100 administered by intramuscular (IM) injection followed by electroporation (EP) in adult men and women who are HIV negative with histologically confirmed anal or anal/peri-anal high-grade squamous intraepithelial lesion (HSIL) associated with human papilloma virus (HPV)-16 and/or HPV-18.

See study design
Bladder cancerINO-5401 + atezolizumabWT1, PSMA, hTERT
Phase 2 - Middle
Genentech

Product information

INO-5401 is a highly optimized synthetic DNA immunotherapy and has the potential to be a foundational treatment in combination with checkpoint inhibitors. INO-5401 targets WT1, hTERT, and PSMA antigens. INO-5401 is delivered intramuscularly using the CELLECTRA® delivery device.

Disease state

79,000 new cases of bladder cancer are expected to be diagnosed in 2017. Advanced bladder cancer is associated with an extremely poor prognosis, with an expected survival of less than 12 months.5

Development status

In June of 2017, Inovio initiated a clinical collaboration with Genentech to evaluate the safety and efficacy of Inovio’s INO-5401 in combination with Genentech’s atezolizumab in the treatment of advanced bladder cancer.

See study design

References

  1. 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.
  2. 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.
  3. 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.
  4. 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.
  5. 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.
  6. 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.
  7. 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.
  8. Hepatitis B Fact Sheet. World Health Organization website. http://www.who.int/mediacentre/factsheets/fs204/en/. Updated April 2017. Accessed July 3, 2017.
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