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Poster Discussion session - Developmental therapeutics / investigational immunotherapy

4827 - Final Results from a Phase I Clinical Trial Evaluating the Safety, Immunogenicity, and Anti-Tumor Activity of SNS-301 in Men with Biochemically Relapsed Prostate Cancer


20 Oct 2018


Poster Discussion session - Developmental therapeutics / investigational immunotherapy


Clinical Research;  Immunotherapy

Tumour Site

Prostate Cancer


Luke Nordquist


Annals of Oncology (2018) 29 (suppl_8): viii133-viii148. 10.1093/annonc/mdy279


L.T. Nordquist1, H. Ghanbari2, J.J. Elist3, J.C. Oliver4, W. Gannon5, A. Shahlaee2, S. Fuller2, N. Shore6

Author affiliations

  • 1 Medical Oncology, Urology Cancer Center and GU Research Network, 68130-5606 - Omaha/US
  • 2 Clinical Development, Sensei Biotherapeutics, 20879 - Gaithersberg/US
  • 3 Private Medical Practice, Dr. James J. Elist, 90211 - Beverley Hills/US
  • 4 Oncology Development, Accelovance, 27612-5311 - Raleigh/US
  • 5 Oncology Development, Capital City Technical Consulting, 20013 - Washington/US
  • 6 Gu Oncology, Carolina Urologic Research Center, 29572 - Myrtle Beach/US


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Abstract 4827


SNS-301 (formerly PAN-301) is a first-in-class therapeutic vaccine candidate targeting human aspartyl (asparaginyl) β-hydroxylase (ASPH). ASPH is differentially over-expressed in multiple human cancers but not in healthy adult tissue and is associated with tumor cell growth, motility and invasiveness. SNS-301 is engineered to express an ASPH fusion product within an inactivated λ-bacteriophage viral vector. Previously presented pre-clinical data demonstrate the vaccine’s ability to overcome tumor self-tolerance and provide anti-tumor immuno-stimulatory effect.


SNS-301 was administered intradermally every 21 days to men with biochemically (PSA) relapsed prostate cancer with evidence of ASPH over-expression. A 3 + 3 dose-escalation design evaluated dose levels of 2X1010, 1X1011, and 3X1011 particles with the primary objectives of defining safety and identifying a recommended phase 2 dose (R2PD). Secondary endpoints included immunogenicity parameters and an assessment of anti-tumor activity.


Twelve patients (pts.) with detectable levels of ASPH received 3-18 doses of SNS-301 (median = 10 doses). The vaccine was well tolerated with only 3 pts. experiencing an adverse event (AE) considered at least possibly related to study drug. All AEs were ≤ grade 3 and no dose-limiting toxicity was observed. All pts. experienced dose-dependent ASPH-specific immune responses incl. T-cell and antibody parameters. Specifically, post-treatment anti-ASPH antibody titers increased in a dose-dependent fashion from 3.0 (Day 1) to 4.6 (Day 2) to 12.0 (Day 3) units/ml. Anti-tumor activity was observed in 6/8 eligible pts. (75%) with declines noted in both overall PSA level and PSA doubling rate.


SNS-301 appears safe and well tolerated when administered intradermally at doses up to the RP2D of 3X1011 particles. The vaccine induces vibrant antigen-specific immune responses and demonstrates provocative signals of anti-tumor activity. Based on these results, a multi-site phase 2 efficacy clinical trial will commence enrollment in the 2nd half of 2018.

Clinical trial identification


Legal entity responsible for the study

Sensei Biotherapeutics, Inc. 620 Professional Drive Gaithersburg, MD 20879 USA.


Sensei Biotherapeutics, Inc. 620 Professional Drive Gaithersburg, MD 20879.

Editorial Acknowledgement


H. Ghanbari: Founder and employee: Drug sponsor and owns equity in the company. J.C. Oliver: Employee: Contract research organization who managed operational aspects of the clinical trial; Funding: Drug sponsor. A. Shahlaee: Employee: Drug sponsor. S. Fuller: Employee: Drug sponsor; Owns equity in the company. All other authors have declared no conflicts of interest.

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