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Poster display session: Biomarkers, Gynaecological cancers, Haematological malignancies, Immunotherapy of cancer, New diagnostic tools, NSCLC - early stage, locally advanced & metastatic, SCLC, Thoracic malignancies, Translational research

2255 - Tracking VSV-IFN_-NIS oncolytic virus (OV) activity in patients (pts) with advanced solid tumors: the iodide symporter gene (NIS) as a pharmacodynamic (PD) marker using SPECT/CT imaging of OV therapy


20 Oct 2018


Poster display session: Biomarkers, Gynaecological cancers, Haematological malignancies, Immunotherapy of cancer, New diagnostic tools, NSCLC - early stage, locally advanced & metastatic, SCLC, Thoracic malignancies, Translational research


Staging and Imaging;  Tumour Immunology

Tumour Site


Jaime Merchan


Annals of Oncology (2018) 29 (suppl_8): viii479-viii482. 10.1093/annonc/mdy294


J. Merchan1, M.R. Patel2, S.F. Powell3, J. Strauss4, T.P. Cripe5, M.O. Old6, R.M. Diaz7, S.J. Russell8, A.S. Bexon9, L. Suksanpaisan10, M.K. O'Connor11, K.W. Peng12

Author affiliations

  • 1 Oncology, U Miami School of Medicine, 33136 - Miami/US
  • 2 Hematology, Oncology And Transplantation, U Minnesota Medical School, 55455 - Minneapolis/US
  • 3 Hematology And Oncology, Sanford Health, 57104 - Sioux Falls/US
  • 4 Oncology, Mary Crowley Medical Research Center, 75230 - Dallas/US
  • 5 Hematology/oncology/bmt, Nationwide Children's Hospital, 43205 - Columbus/US
  • 6 Arthur James Cancer Hospital, The Ohio State University, 43210 - Columbus/US
  • 7 Regulatory And Clinical Affairs, Vyriad, 55905 - Rochester/US
  • 8 -, Vyriad, 55905 - Rochester/US
  • 9 Cmo, Vyriad, 55905 - Rochester/US
  • 10 Diagnostics, Imanis Life Sciences, 55905 - Rochester/US
  • 11 Nuclear Medicine, Mayo Clinic, Rochester/US
  • 12 Cto, Vyriad, 55905 - Rochester/US


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Abstract 2255


VSV-IFNβ-NIS (Voyager V1; VV1) is a VSV-derived OV with low human seroprevalence. In addition to its tumor-selective and immune-stimulatory properties, VV1 encodes the human thyroidal sodium iodide symporter NIS to allow imaging of virus-infected tumors with IV 99mTc pertechnetate. Preclinical studies show increasing 99mTc uptake correlates with virus dose and allows spatial and temporal tracking of virus.


Single-photon emission computerized tomography (SPECT/CT) is used to assess virus replication and spread. In a phase 1 study, VV1 is given intratumorally into 1 target lesion on Day 1 (D1). SPECT/CT imaging is performed 45 minutes after 20 mCi IV 99mTc at baseline and D3. If there is uptake in injected tumor on D3, SPECT/CTs are also done D8 and D15. Imaging requirements include: gamma camera, low energy high resolution collimators with standard acquisition protocols and iterative image reconstruction. All images are read locally and centrally.


SPECT/CT has been performed on 12 patients at 4 VV1 dose levels (DL). 99mTc uptake was not detected at the first 2 DLs but was seen in injected lesions of 2/4 pts at DL 3 (3e7 TCID50) in pts with metastatic colorectal and pancreas cancer, and 1/2 to date at DL 4. PD analysis revealed SPECT/CT-positive pts had peak uptake in injected lesions between D3 and D8. Tumor biopsy samples are being analyzed to correlate SPECT/CT with viral RNA. Spread to uninjected lesions was not yet visualized, but viral RNA was recovered in cystic fluid from the lesion with the strongest signal in a pancreas cancer pt.


This novel therapeutic and diagnostic approach allows PD visualization of the investigational oncolytic virotherapy, VV1, replicating within the injected lesion. Positive images at dose levels 3-4 indicate we have reached a viral dose that allows sufficient viral replication for potential clinical activity. Further objectives include correlation of SPECT/CT positivity with clinical response, viremia, immune infiltrates, and genetic markers of susceptibility to OV therapy.

Clinical trial identification


Legal entity responsible for the study




Editorial Acknowledgement


R.M. Diaz: Paid consultant running the trial: Vyriad. S.J. Russell: CEO and own equity: Vyriad. A.S. Bexon: Paid consultant and CMO: Vyriad. K.W. Peng: CTO and own equity: Vyriad. All other authors have declared no conflicts of interest.

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