INO-3106 SynCon® immunotherapy for aerodigestive cancer
Inovio is developing a DNA immune therapy candidate designed to treat aerodigestive cancers caused by human papillomavirus (HPV) type 6. This DNA immune therapy includes plasmids targeting the E6 and E7 proteins of HPV type 6. It will be delivered intramuscularly followed by electroporation using our CELLECTRA® delivery device.
Following positive phase II results with VGX-3100, Inovio’s immunotherapy designed to treat HPV-caused precancers and cancers, Inovio broadly expanded clinical development of its DNA-based immune therapy products to treat different HPV types and the many diseases they cause. Inovio advanced INO-3106 into a phase I clinical study to treat HPV-caused aerodigestive cancers in the third quarter of 2014. Successful results of this trial could open a path to pursuing an FDA orphan designation for aerodigestive cancers.
Aerodigestive cancers affect the lips, mouth, tongue, nose, throat, vocal cords, larynx, and parts of the esophagus and windpipe.
INO-3106 aerodigestive cancer immunotherapy
In 3Q 2014, Inovio initiated a clinical trial to evaluate the safety, tolerability, and immunogenicity of Inovio’s DNA immunotherapy, INO-3106, alone or in combination with DNA-based IL-12, Inovio's proprietary immune activator, in subjects with HPV-6 associated aerodigestive malignancies. This study is a phase I, open label compassionate study enrolling patients with invasive cancer who have exhausted all other treatment options (chemotherapy, radiation, and surgery).
Subjects (up to 6) in this study will be split into two cohorts. Subjects in the first cohort will receive 3 mg of INO-3106 on day 0, 6 mg of INO-3106 at week 3, and 6 mg of INO-3106 + 1 mg of IL-12 at weeks 6 and 9 if no grade 2 or higher systemic adverse events are observed after each dosing regimen. Subjects in cohort two will receive 6 mg of INO-3106 in combination with 1 mg of IL-12, or the maximum tolerated dose observed in cohort 1, at weeks 0, 3, 6, and 9.
The primary endpoint of this study is to measure and grade potential adverse events in accordance with "Common Terminology Criteria for Adverse Events (CTCAE)." We will also observe potential injection site reactions including skin erythema, induration pain and tenderness at the administration site.
The secondary outcomes of this study are to assess HPV-6 specific Ig levels, look at the number of antigen-specific IFN-γ-secreting cells in response to stimulation with HPV-6 by antigen-specific IFN-γ ELISpot assays, and measure cytotoxic T cells in response to HPV-6 specific immunotherapy by flow cytometry.
Successful results could open a path to pursuing an FDA orphan designation (special status granted for therapies for rare diseases) for aerodigestive cancers.
INO-3106 SynCon® aerodigestive cancer immunotherapy
There is no study data for INO-3106 at this time.
Aerodigestive cancer caused by HPV
Historically, HPV-6 has been considered a low-risk HPV strain due to its association with benign genital warts that generally do not progress to cancer. HPV-6 has recently attracted more attention, however, because a number of recent studies have linked HPV-6 (and HPV-11) with lung, tonsil, and larynx cancers and other malignant transformations of otherwise benign neoplasms and dysplasia of the head and neck.
Gardasil®, one of two current prophylactic vaccines, provides protection against HPV-6 (as well as types 11, 16, and 18), however, there is no therapeutic treatment once a person is infected with HPV-6. Current treatment for HPV-associated aerodigestive cancers includes chemotherapy, radiation, and surgery, all of which have negative side effects.
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