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Poster display

3810 - A mechanism of action study of intra-tumoral or intravenous dosing of enadenotucirev, an oncolytic adenovirus in patients with colon, lung, bladder and renal carcinoma undergoing resection of primary tumor


09 Oct 2016


Poster display


Rocio Garcia-Carbonero


Annals of Oncology (2016) 27 (6): 359-378. 10.1093/annonc/mdw378


R. Garcia-Carbonero1, V. Boni2, I. Duran3, M. Gil4, M. Espinosa3, R. Salazar4, A. Cubillo2, M. Jurado5, B. Champion6, S. Alvis6, K. Fisher6, J. Beadle6, G. Pover6, H. McElwaine-Johnn6, C. Ellis6, C. Blanc6, E. Calvo2

Author affiliations

  • 1 Servicio De Oncología Médica, Hospital Universitario Virgen del Rocio, 41013 - Sevilla/ES
  • 2 Oncology, START-Madrid, Madrid/ES
  • 3 Oncology, Hospital Universitario Virgen del Rocio, 41013 - Sevilla/ES
  • 4 Medical Oncology, Catalan Institute of Oncology, 08907 - L´Hospitalet/ES
  • 5 Clinical Research, Pivotal, Madrid/ES
  • 6 Research & Development, PsiOxus Therapeutics Limited, OX14 4SD - Abingdon/GB


Abstract 3810


Demonstrating intravenous (IV) delivery in patients is key for the development of enadenotucirev (EnAd), a tumor selective chimeric Ad11/Ad3 group B adenovirus. Initial results from colon cancer (CC) patients receiving intra-tumoral (IT) or IV administration have been reported [ESMO 2015 Abstract 1086P]. Here we report the full study results, including an expansion to include lung (NSCLC), bladder and renal (RCC) cancer patients. The primary study objective was to describe the pattern of EnAd delivery within tumors.


Patients with histologically confirmed cancer scheduled for surgical removal of primary tumor received either 1x1012 viral particles (VP) IV over 5 min on D 1, 3 and 5; or 1011 VP/mL IT with a variable volume injected based on the tumor surface area on D 1. Immunohistochemistry (IHC) staining of formalin fixed (FFPE) sections for EnAd hexon protein (only produced late during replication), was used to visualise virus activity. A quantitative polymerase chain reaction (qPCR) specific to EnAd was used to detect virus genome. Further IHC studies were conducted with a panel of immune markers and gene expression was analysed using RNA extracted from FFPE sections (Nanostring).


The study recruited 10 CC (5 IT / 5 IV), 2 bladder, 2 NSCLC and 3 RCC (all IV) patients. Surgery was between D 8 and 51. IV and IT EnAd was well tolerated with common adverse events consistent with ‘flu like illness as previously described. Both IHC staining and qPCR confirm that IV dosing can deliver EnAd selectively to all 4 tumor types and is as reliable as IT in CC. Evidence of enhanced immune responses in tumors included high levels of CD8+ cells within tumor nests and peritumoral stroma. CD4+ cells were largely restricted to stroma. Nanostring highlighted potential treatment-responsive genes for further evaluation.


Delivery of EnAd to tumor cells following IV dosing has been confirmed by IHC and qPCR studies of surgically resected tumor samples from patients with CC, NSCLC, RCC and bladder cancer. Delivery appears to be associated with inflammatory changes within the first weeks after administration.

Clinical trial identification

EudraCT 2012-001067-79

Legal entity responsible for the study

PsiOxus Therapeutics Limited


PsiOxus Therapeutics Limited


B. Champion, S. Alvis, K. Fisher, H. McElwaine-Johnn, C. Ellis: Stock options in PsiOxus. J. Beadle: Chief Executive Officer, serves as a board member and holds stock options in PsiOxus. All other authors have declared no conflicts of interest.

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