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Immunotherapy with VGX-3100 (HPV16 and HPV18 plasmids) + INO-9012 (DNA encoding IL-12) in human papillomavirus (HPV) associated head and neck squamous cell carcinoma (HNSCCa): interim safety and immunogenicity results
  1. Charu Aggarwal1,
  2. Roger Cohen1,
  3. Matthew P Morrow2,
  4. Joshua Bauml1,
  5. Gregory Weinstein1,
  6. Jean Boyer3,
  7. Xuefei Shen3,
  8. Jian Yan2,
  9. Jessica Goldenberg2,
  10. Drishty Nashit4,
  11. Sandra Oyola5,
  12. Jessica Lee4,
  13. Laurent M Humeau3,
  14. David B Weiner1,
  15. Zane Yang5,
  16. Mark L Bagarazzi4 and
  17. David Weiner1
  1. Aff1 grid.25879.310000000419368972University of Pennsylvania Philadelphia PA USA
  2. Aff2 grid.421774.30000 0004 0417 098XInovio Pharmaceuticals, Plymouth Meeting PA USA
  3. Aff3 grid.421774.30000 0004 0417 098XInovio Pharmaceuticals San Diego CA USA
  4. Aff4 grid.421774.30000 0004 0417 098XInovio Philadelphia PA USA
  5. Aff5 grid.421774.30000 0004 0417 098XInovio Pharmaceuticals, Inc., Plymouth Meeting PA USA

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Meeting abstracts


Oropharyngeal HNSCCa is frequently associated with HPV infection. DNA-based Immunotherapy with plasmids encoding HPV16 and HPV18 E6/E7 antigens has been shown to generate robust immune responses in women with HPV-driven high-grade cervical dysplasia. We hypothesize that HPV-specific immunotherapy with INO-3112 (VGX-3100 + INO-9012) in patients with HPV-associated HNSCCa will generate robust immunity which may contribute to disease stabilization or regression.


Eligibility for this prospective Phase I/IIa trial included adults with HPV-positive (assessed by p16) HNSCCa, ECOG PS 0-1, and adequate organ function. Patients (pts) are enrolled into two cohorts. In Cohort 1, pts receive INO-3112 pre and post-surgery. In Cohort 2, pts receive INO-3112 after completion of cisplatin based chemoradiation. INO-3112 (6mg of VGX-3100 plus 1mg of INO-9012) is delivered IM followed by electroporation with the CELLECTRA® device, once every 3 weeks for a total of 4 doses. Pts are followed for 2 years. Primary and secondary endpoints are safety and immune responses. Exploratory endpoints include: anti-tumor effect and progression-free-survival. Assessment of post-immunotherapy surgical specimens is being done to evaluate vaccine-induced lymphocyte infiltration in tumor.


As of June 2015, 19 pts have been enrolled. Complete safety data is available for 13 pts. Cohort 1: n=3, Cohort 2: n=10; 12 males; median age 57.7 years (range 39-76); cancers at base of tongue=6, tonsil=6, soft palate=1; never smoker=5, median follow-up is 104 days. INO-3112 was well tolerated with no Grade 3 or higher AEs. The most common AEs were injection site pain (n=11), local erythema (n=4) and hematoma/swelling (n=2, each). Two subjects had Grade 3 lymphopenia at baseline and no worsening during the trial. There was a Grade 2, unrelated SAE of post-surgical procedure hemorrhage. Enrollment and correlative analysis are ongoing; among samples tested to date, as compared to baseline, 4 of 5 evaluable pts showed elevated anti HPV16 and 18 E6/E7 antibody titers. Nine of 10 evaluable pts exhibited increased HPV-specific cellular responses by IFN-gamma ELISpot. Seven of 8 evaluable pts had HPV-specific CD8+ T cell activation concurrent with increased lytic proteins (granzymes and perforin) by flow cytometric analysis.


These interim results demonstrate that this DNA-based immunotherapy (INO-3112) can safely generate HPV-specific CD8 T cell immunity in patients with HPV-related HNSSCa. All tested pts had positive cellular immune responses in at least one assay.

This study (NCT02163057) is co-sponsored by Inovio and the Abramson Cancer Center at the University of Pennsylvania (5P30CA016520-39).

Trial Registration identifier NCT02163057.