1PD - Immunotherapy with INO-3112 (HPV16 and HPV18 plasmids + IL-12 DNA) in human papillomavirus (HPV) associated head and neck squamous cell carcinoma (H...

Date 20 November 2015
Event ESMO Symposium on Immuno-Oncology 2015
Session Poster Discussion session
Topics Immunotherapy
Head and Neck Cancers
Presenter Zane Yang
Citation Annals of Oncology (2015) 26 (suppl_8): 1-4. 10.1093/annonc/mdv513
Authors C. Aggarwal1, R. Cohen1, M. Morrow2, J. Bauml1, G. Weinstein1, J. Boyer2, J. Lee3, D. Weiner1, Z. Yang4, M. Bagarazzi3
  • 1Cancer Center, Perelman School of Medicine at the University of Pennsylvania, Philadelphia/US
  • 2Research And Development, Inovio Pharmaceuticals, Inc., Plymouth Meeting/US
  • 3Clinical Development, Inovio Pharmaceuticals, Inc., Plymouth Meeting/US
  • 4Clinical Development, Inovio Pharmaceuticals, 19462 - Plymouth Meeting/US



HNSCCa is frequently associated with HPV infection. Immunotherapy with plasmids encoding HPV16 and HPV18 E6/E7 antigens has been shown to generate robust immune responses in women with cervical dysplasia. We hypothesize that HPV-specific immunotherapy with INO-3112 in patients with HPV-associated HNSCCa will generate robust immunity.


This prospective Phase I/IIA trial enrolled adults with HPV-positive (assessed by p16) HNSCCa in 2 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 (HPV16/18 6mg + 1mg IL-12) is delivered IM followed by electroporation with the CELLECTRA® device, every 3 weeks for 4 treatments. Pts are followed for 2 years. Primary and secondary endpoints: safety and immune responses. Exploratory endpoint: anti-tumor effect. Tumor lymphocyte infiltration is studied in tumor tissue.


As of June 2015, 19 pts have been enrolled. Safety data is available for 13 pts. Cohort 1: n = 3, Cohort 2: n = 10; 12 males; median age 57.7 years; cancers at base of tongue = 6, tonsil = 6, soft palate = 1; 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). 2 subjects had Grade 3 lymphopenia at baseline without worsening during the trial. There was a Grade 2, unrelated SAE of post-surgical procedure hemorrhage. Enrollment and correlative analysis are ongoing; among evaluable samples tested to date, as compared to baseline, 4 of 5 had elevated anti HPV16 and 18 E6/E7 antibody titers. 9 of 10 exhibited increase in HPV-specific IFN-gamma ELISpot. 7 of 8 had HPV-specific CD8+ T cell activation concurrent with increased lytic proteins (granzymes and perforin). All tested pts had positive cellular immune responses in at least one test.


These interim results demonstrate that this DNA-based immunotherapy (INO-3112) can safely generate HPV-specific CD8 T cell immunity.

Clinical trial identification

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


Z. Yang, M. Morrow, J. Boyer, J. Lee, D. Weiner and M. Bagarazzi: I am employee of Inovio Pharmaceuticals.