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Genitourinary tumours, prostate

3950 - Safety and Immunogenicity of a DNA-vaccine Immunotherapy in Men with Biochemically (PSA) Relapsed Prostate Cancer


10 Sep 2017


Genitourinary tumours, prostate


Immunotherapy;  Prostate Cancer


Neal Shore


Annals of Oncology (2017) 28 (suppl_5): v269-v294. 10.1093/annonc/mdx370


N.D. Shore1, E. Heath2, L. Nordquist3, H. Cheng4, K. Bhatt5, M. Morrow6, T. McMullan7, K. Kraynyak6, J. Lee5, B. Sacchetta5, L. Liu6, S. Rosencranz5, S.T. Tagawa8, R.A. Parikh9, R. Tutrone10, J. Garcia11, Y. Whang12, W. Kelly13, I. Csiki5, M. Bagarazzi5

Author affiliations

  • 1 Urology, Atlantic Urology Clinics, 29579 - Myrtle Beach/US
  • 2 Prinicipal Investigator, Karmanos Cancer Institute, 48201 - Detroit/US
  • 3 Principal Invesitgator, GU Research Network LLC/Urologoy Cancer Center, 68130 - Omaha/US
  • 4 Principal Investigator, University of Washington School of Medicine, 98109 - Seattle/US
  • 5 Clinical Development, Inovio Pharmaceuticals, 19464 - Plymouth Meeting/US
  • 6 R&d, Inovio Pharmaceuticals, 19464 - Plymouth Meeting/US
  • 7 Biostatistics, Inovio Pharmaceuticals, 19464 - Plymouth Meeting/US
  • 8 Hematology And Medical Oncology, Weill Cornell Medical College, 10065 - New York/US
  • 9 Principal Investigator, University of Pittsburgh Medical Center, 15232 - Pittsburg/US
  • 10 Principal Investigator, Greater Baltimore Medical Center (GBMC) - Chesapeake Urology Associates (CUA) P, 21204 - Towson/US
  • 11 Principal Investigator, Cleveland Clinic, 44195 - Cleveland/US
  • 12 Medical Oncology/lineberger Comprehensive Cancer Center, University of Norht Carolina at Chapel Hill, 27599 - Chapel Hill/US
  • 13 Principlal Investigator, Sidney Kimmel Cancer Center - Thomas Jefferson University, 19107 - Philadelphia/US


Abstract 3950


DNA vaccines INO-5150 (PSA and PSMA) +/- INO-9012 (IL-12) were administered to biochemically recurrent prostate cancer patients (pts) to demonstrate breaking tolerance, assessing antigen-specific humoral and cellular immune responses with the potential for stabilization of disease progression.


Phase I, open-label, multi-center study in pts post-definitive therapy with a rising PSA after surgery and/or RT and PSA doubling time (DT)> 3 months (mos), testosterone > 150 ng/dL, no concomitant ADT and no evidence of metastases. Safety, immunogenicity and efficacy were evaluated in 4 treatment arms in 60 planned pts (A: 16, 2mg INO-5150; B: 15, 8.5 mg INO-5150; C: 15, 2mg INO-5150 + 1mg INO-9012; D: 16, 8.5mg INO-5150 + 1mg INO-9012) treated with 4 IM doses followed by electroporation on day 0, wks 3, 12 and 24 who were followed for a total of 72 Wks.


Median age, Gleason score and time since diagnosis were 69.5 yrs (range: 55.4-87.7), 7 (5-10) and 8.4 yrs (0.4-23.8) respectively. Of 61 evaluable pts, 38 (62%) had PSADT ≤ 12 mos and 23 (38%) had DT > 12 mos at Day 0. For pts with DT ≤ 12 mos, Day 0 and week 27 median DT were 6.0 (1.5, 11.6) mos and 8.1 (2.2, 100.0) mos respectively. Flow cytometry analysis revealed antigen specific upregulation of CD38 and Perforin on CD8+ T cells in 19/50 (38%) pts across the trial, with the greatest proportion in arm A, 8/14 (57%). Additional analysis for this cell subset showed a high PD-1 expression of 68.6% in this arm at week 27. Of note, in 8/15 (53%) arm A pts with DT ≤ 12 mos, their median DT at Day 0 was 6.2 (2.9, 10.2) mos and 19.2 (6.6, 100.0) mos at Wk 27. Safety: 7 Grade (Gr) 3 SAEs in 5 pts and 0 Gr 4-5 SAEs reported. Most AEs were Gr 1-3 in 51/62 (82%) pts and majority of those were associated with injection site reactions.


INO-5150 +/- INO-9012 was safe at dosages examined. Data demonstrated both PSA and PSMA are immunogenic and INO-5150 induced cellular immune responses. Higher proportion of arm A pts showed immunological responses as well as improvements in PSA DT, specifically pts with DT ≤ 12 mos suggesting correlation of immunological efficacy and clinical benefit. Continued analyses are planned as patient follow-up is ongoing. (NCT02514213)

Clinical trial identification

NCT02514213; July 29, 2015

Legal entity responsible for the study

Inovio Pharmaceuticals


Inovio Pharmaceuticals


K. Bhatt: Inovio (study sponsor employee), own stocks M. Morrow, T. McMullan, K. Kraynyak, J. Lee, B. Sacchetta, L. Liu, S. Rosencranz: Inovio (study sponsor) employee, own stocks in company. Y. Whang: Research funding from Janssen, Astellas, Tokai, Inovio. I. Csiki, M. Bagarazzi: Employed by Inovio Pharmaceuticals. All other authors have declared no conflicts of interest.

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