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

    HPV16 E6,E7 / HPV18 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]

    The Phase 3 program consists of two studies in parallel. The primary trial (REVEAL 1) has completed enrollment. The confirmatory trial (REVEAL 2) is currently enrolling.

    See the REVEAL 2 website
  • Vulvar HSIL

    P2

    Product

    VGX-3100

    Antigen

    HPV16 E6,E7 / HPV18 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

    HPV16 E6,E7 / HPV18 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 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 evaluating the efficacy and safety of Inovio’s INO-5401 with Regeneron’s PD-1 inhibitor, cemiplimab, in combination with chemoradiotherapy in patients with glioblastoma in a Phase 1/2 trial.

    See study design

INO-5151

  • Prostate cancer

    P2

    Product

    INO-5151

    Antigen

    PSA, PSMA

    Trial Stage

    Phase II

    Partner

    PICI, CRI

    Product information

    INO-5151 is a combined formulation of INO-5150 and INO-9012. INO-5150 encodes for prostate-specific membrane antigen (PSMA) and prostate-specific antigen (PSA). INO-5150 was generated by the creation of PSA and PSMA synthetic consensus antigens based on human and other mammalian sequences. INO-9012 encodes for interleukin 12. INO-5151 is delivered intramuscularly using the CELLECTRA® delivery device.

    Disease state

    In 2016, over 180,000 new cases of prostate cancer were diagnosed, and over 26,000 men died from prostate cancer, making it the second leading cause of cancer death in men.3

    Development status

    In a clinical collaboration agreement with Parker Institute for Cancer Immunotherapy (PICI) and the Cancer Research Institute (CRI), Inovio’s prostate cancer immunotherapy INO-5151 is being combined with an immune modulator (CDX-301, FLT3 ligand, a dendritic cell mobilizer) and a PD-1 checkpoint inhibitor (nivolumab) targeting metastatic castration resistant prostate cancer (mCRPC) in a PICI-sponsored platform study.

    This trial is an open-label, non-randomized, exploratory platform study designed to assess the safety and antitumor activity of multiple immunotherapy based combinations in participants with mCRPC who have received prior secondary androgen inhibition. Evaluating biomarkers of immune activity and clinical outcomes using a multi-omic, multi-parameter approach is an important aspect of the study. Inovio’s immunotherapy is one arm (Cohort C) of this broad PICI-supported study which is a multi-arm, multi-stage platform design.

    Under the agreement, PICI will design and execute the clinical study, working in collaboration with its established network of the most pre-eminent clinical academic and industry cancer centers, and with funding support from CRI. Based on PICI's novel approach to accelerating studies of cancer immunotherapies, Inovio will provide financial contributions if Inovio's product(s) studied under the collaboration reaches the initiation of a Phase 3 study.

    See study design

MEDI0457

  • Head and neck cancer

    P2

    Product

    MEDI0457 + durvalumab

    Antigen

    HPV16 E6,E7 / HPV18 E6,E7

    Trial Stage

    Phase II

    Partner

    AstraZeneca

    Product information

    MEDI0457 is a combination of Inovio’s VGX-3100 immunotherapy and a DNA-based immune activator encoded for IL-12. MEDI0457 targets the E6 and E7 oncogenes of human papillomavirus (HPV) types 16 and 18. MEDI0457 enables the body to produce E6 and E7 antigens to induce a targeted immune response. MEDI0457 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

    AstraZeneca acquired the rights to develop MEDI0457. 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 HSILHPV16 E6,E7 / HPV18 E6,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]

The Phase 3 program consists of two studies in parallel. The primary trial (REVEAL 1) has completed enrollment. The confirmatory trial (REVEAL 2) is currently enrolling.

See the REVEAL 2 website
Vulvar HSILHPV16 E6,E7 / HPV18 E6,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 HSILHPV16 E6,E7 / HPV18 E6,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 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 evaluating the efficacy and safety of Inovio’s INO-5401 with Regeneron’s PD-1 inhibitor, cemiplimab, in combination with chemoradiotherapy in patients with glioblastoma in a Phase 1/2 trial.

See study design

INO-5151

Disease
Antigen
Preclinical
Phase I
Phase II
Phase III
Partner
Prostate cancerPSA, PSMA
Phase 2 - Middle
PICI, CRI

Product

INO-5151

Product information

INO-5151 is a combined formulation of INO-5150 and INO-9012. INO-5150 encodes for prostate-specific membrane antigen (PSMA) and prostate-specific antigen (PSA). INO-5150 was generated by the creation of PSA and PSMA synthetic consensus antigens based on human and other mammalian sequences. INO-9012 encodes for interleukin 12. INO-5151 is delivered intramuscularly using the CELLECTRA® delivery device.

Disease state

In 2016, over 180,000 new cases of prostate cancer were diagnosed, and over 26,000 men died from prostate cancer, making it the second leading cause of cancer death in men.3

Development status

In a clinical collaboration agreement with Parker Institute for Cancer Immunotherapy (PICI) and the Cancer Research Institute (CRI), Inovio’s prostate cancer immunotherapy INO-5151 is being combined with an immune modulator (CDX-301, FLT3 ligand, a dendritic cell mobilizer) and a PD-1 checkpoint inhibitor (nivolumab) targeting metastatic castration resistant prostate cancer (mCRPC) in a PICI-sponsored platform study.

This trial is an open-label, non-randomized, exploratory platform study designed to assess the safety and antitumor activity of multiple immunotherapy based combinations in participants with mCRPC who have received prior secondary androgen inhibition. Evaluating biomarkers of immune activity and clinical outcomes using a multi-omic, multi-parameter approach is an important aspect of the study. Inovio’s immunotherapy is one arm (Cohort C) of this broad PICI-supported study which is a multi-arm, multi-stage platform design.

Under the agreement, PICI will design and execute the clinical study, working in collaboration with its established network of the most pre-eminent clinical academic and industry cancer centers, and with funding support from CRI. Based on PICI's novel approach to accelerating studies of cancer immunotherapies, Inovio will provide financial contributions if Inovio's product(s) studied under the collaboration reaches the initiation of a Phase 3 study.

See study design

MEDI0457

Disease
Antigen
Preclinical
Phase I
Phase II
Phase III
Partner
Head and neck cancerHPV16 E6,E7 / HPV18 E6,E7
Phase 2 - Middle
AstraZeneca

Product

MEDI0457 + durvalumab

Product information

MEDI0457 is a combination of Inovio’s VGX-3100 immunotherapy and a DNA-based immune activator encoded for IL-12. MEDI0457 targets the E6 and E7 oncogenes of human papillomavirus (HPV) types 16 and 18. MEDI0457 enables the body to produce E6 and E7 antigens to induce a targeted immune response. MEDI0457 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

AstraZeneca acquired the rights to develop MEDI0457. 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

    HPV16 E6,E7 / HPV18 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]

    The Phase 3 program consists of two studies in parallel. The primary trial (REVEAL 1) has completed enrollment. The confirmatory trial (REVEAL 2) is currently enrolling.

    See the REVEAL 2 website
  • Prostate cancer

    P2

    Product

    INO-5151

    Antigen

    PSA, PSMA

    Trial Stage

    Phase II

    Partner

    PICI, CRI

    Product information

    INO-5151 is a combined formulation of INO-5150 and INO-9012. INO-5150 encodes for prostate-specific membrane antigen (PSMA) and prostate-specific antigen (PSA). INO-5150 was generated by the creation of PSA and PSMA synthetic consensus antigens based on human and other mammalian sequences. INO-9012 encodes for interleukin 12. INO-5151 is delivered intramuscularly using the CELLECTRA® delivery device.

    Disease state

    In 2016, over 180,000 new cases of prostate cancer were diagnosed, and over 26,000 men died from prostate cancer, making it the second leading cause of cancer death in men.3

    Development status

    In a clinical collaboration agreement with Parker Institute for Cancer Immunotherapy (PICI) and the Cancer Research Institute (CRI), Inovio’s prostate cancer immunotherapy INO-5151 is being combined with an immune modulator (CDX-301, FLT3 ligand, a dendritic cell mobilizer) and a PD-1 checkpoint inhibitor (nivolumab) targeting metastatic castration resistant prostate cancer (mCRPC) in a PICI-sponsored platform study.

    This trial is an open-label, non-randomized, exploratory platform study designed to assess the safety and antitumor activity of multiple immunotherapy based combinations in participants with mCRPC who have received prior secondary androgen inhibition. Evaluating biomarkers of immune activity and clinical outcomes using a multi-omic, multi-parameter approach is an important aspect of the study. Inovio’s immunotherapy is one arm (Cohort C) of this broad PICI-supported study which is a multi-arm, multi-stage platform design.

    Under the agreement, PICI will design and execute the clinical study, working in collaboration with its established network of the most pre-eminent clinical academic and industry cancer centers, and with funding support from CRI. Based on PICI's novel approach to accelerating studies of cancer immunotherapies, Inovio will provide financial contributions if Inovio's product(s) studied under the collaboration reaches the initiation of a Phase 3 study.

    See study design
  • 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 evaluating the efficacy and safety of Inovio’s INO-5401 with Regeneron’s PD-1 inhibitor, cemiplimab, in combination with chemoradiotherapy in patients with glioblastoma in a Phase 1/2 trial.

    See study design
  • Head and neck cancer

    P2

    Product

    MEDI0457 + durvalumab

    Antigen

    HPV16 E6,E7 / HPV18 E6,E7

    Trial Stage

    Phase II

    Partner

    AstraZeneca

    Product information

    MEDI0457 is a combination of Inovio’s VGX-3100 immunotherapy and a DNA-based immune activator encoded for IL-12. MEDI0457 targets the E6 and E7 oncogenes of human papillomavirus (HPV) types 16 and 18. MEDI0457 enables the body to produce E6 and E7 antigens to induce a targeted immune response. MEDI0457 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

    AstraZeneca acquired the rights to develop MEDI0457. This study will be part of MedImmune’s development plans.

    See study design
  • Vulvar HSIL

    P2

    Product

    VGX-3100

    Antigen

    HPV16 E6,E7 / HPV18 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

    HPV16 E6,E7 / HPV18 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 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
Light Blue
Internally Funded
Dark Blue
Partner Funded
Disease
Product
Antigen
Preclinical
Phase I
Phase II
Phase III
Partner
Cervical HSILVGX-3100HPV16 E6,E7 / HPV18 E6,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]

The Phase 3 program consists of two studies in parallel. The primary trial (REVEAL 1) has completed enrollment. The confirmatory trial (REVEAL 2) is currently enrolling.

See the REVEAL 2 website
Prostate cancerINO-5151PSA, PSMA
Phase 2 - Middle
PICI, CRI

Product information

INO-5151 is a combined formulation of INO-5150 and INO-9012. INO-5150 encodes for prostate-specific membrane antigen (PSMA) and prostate-specific antigen (PSA). INO-5150 was generated by the creation of PSA and PSMA synthetic consensus antigens based on human and other mammalian sequences. INO-9012 encodes for interleukin 12. INO-5151 is delivered intramuscularly using the CELLECTRA® delivery device.

Disease state

In 2016, over 180,000 new cases of prostate cancer were diagnosed, and over 26,000 men died from prostate cancer, making it the second leading cause of cancer death in men.3

Development status

In a clinical collaboration agreement with Parker Institute for Cancer Immunotherapy (PICI) and the Cancer Research Institute (CRI), Inovio’s prostate cancer immunotherapy INO-5151 is being combined with an immune modulator (CDX-301, FLT3 ligand, a dendritic cell mobilizer) and a PD-1 checkpoint inhibitor (nivolumab) targeting metastatic castration resistant prostate cancer (mCRPC) in a PICI-sponsored platform study.

This trial is an open-label, non-randomized, exploratory platform study designed to assess the safety and antitumor activity of multiple immunotherapy based combinations in participants with mCRPC who have received prior secondary androgen inhibition. Evaluating biomarkers of immune activity and clinical outcomes using a multi-omic, multi-parameter approach is an important aspect of the study. Inovio’s immunotherapy is one arm (Cohort C) of this broad PICI-supported study which is a multi-arm, multi-stage platform design.

Under the agreement, PICI will design and execute the clinical study, working in collaboration with its established network of the most pre-eminent clinical academic and industry cancer centers, and with funding support from CRI. Based on PICI's novel approach to accelerating studies of cancer immunotherapies, Inovio will provide financial contributions if Inovio's product(s) studied under the collaboration reaches the initiation of a Phase 3 study.

See study design
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 evaluating the efficacy and safety of Inovio’s INO-5401 with Regeneron’s PD-1 inhibitor, cemiplimab, in combination with chemoradiotherapy in patients with glioblastoma in a Phase 1/2 trial.

See study design
Head and neck cancerMEDI0457 + durvalumabHPV16 E6,E7 / HPV18 E6,E7
Phase 2 - Middle
AstraZeneca

Product information

MEDI0457 is a combination of Inovio’s VGX-3100 immunotherapy and a DNA-based immune activator encoded for IL-12. MEDI0457 targets the E6 and E7 oncogenes of human papillomavirus (HPV) types 16 and 18. MEDI0457 enables the body to produce E6 and E7 antigens to induce a targeted immune response. MEDI0457 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

AstraZeneca acquired the rights to develop MEDI0457. This study will be part of MedImmune’s development plans.

See study design
Vulvar HSILVGX-3100HPV16 E6,E7 / HPV18 E6,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-3100HPV16 E6,E7 / HPV18 E6,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 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

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.
  9. HIV/AIDS Fact Sheet. World Health Organization website. http://www.who.int/mediacentre/factsheets/fs360/en/. Updated April 2016. Accessed July 3, 2017.
  10. Ebola Virus Disease Fact Sheet. World Health Organization website. http://www.who.int/mediacentre/factsheets/fs103/en/. Updated June 2017. Accessed July 3, 2017.
  11. 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.
  12. Zika Virus Fact Sheet. World Health Organization website. http://www.who.int/mediacentre/factsheets/zika/en/. Updated September 2016. Accessed July 3, 2017.
  13. 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.
  14. 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.
  15. 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.
  16. 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.
  17. 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).