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Updated: Jun 12, 2026

Paramyxoviruses for Tumor-targeted Immunomodulation: Design and Evaluation Ex Vivo
Published on: January 7, 2019
Herpes simplex virus oncolytic vaccine therapy in melanoma
Shanthi Sivendran1, Michael Pan, Howard L Kaufman
1The Mount Sinai School of Medicine, The Tisch Cancer Institute, Division of Hematology/Oncology, Department of Medicine, New York, NY 10029, USA.
Importance Of The Field:
Advanced melanoma is a devastating disease with a five year survival for Stage IV disease of 10 - 20% and a median survival of 6 - 18 months depending on sub-stage. Current FDA approved therapies demonstrate limited response rates, few complete remissions and no proven survival benefit. New therapies are clearly needed. JSI/34.5-/47-/GM-CSF is a herpes simplex virus-1 (OncoVEX(GM-CSF)) oncolytic vaccine therapy designed to induce local and systemic anti-tumor immune responses.
Areas Covered In This Review:
Evolution of current herpes simplex virus oncolytic vaccines from preclinical to clinical studies from 1994 to 2010.
What The Reader Will Gain:
Preclinical studies have shown that herpes simplex virus-1 oncolytic vaccines generate local tumor destruction through the lytic action of the virus and local and systemic immune responses. Phase I studies demonstrated limited toxicities with no neurotoxicty. Phase II studies demonstrated durable regressions in patients with metastatic melanoma. A Phase III trial in melanoma is ongoing to determine clinical effectiveness, and a Phase III trial in head and neck cancer will initiate during 2010.
Take Home Message:
JSI/34.5-/47-/GM-CSF is a new generation herpes simplex virus-1 oncolytic vaccine that demonstrates direct tumor lysis and systemic immune responses. Early clinical studies have yielded preliminary evidence of activity.
Insights
A novel herpes simplex virus-1 oncolytic vaccine, JSI/34.5-/47-/GM-CSF, shows promise in treating advanced melanoma by inducing both local tumor destruction and systemic immune responses. Early clinical trials indicate durable regressions and limited toxicity, suggesting a new therapeutic avenue.
Area of Science:
- Oncolytic virotherapy
- Cancer immunotherapy
- Melanoma treatment
Background:
- Advanced melanoma has poor prognosis with current therapies offering limited efficacy.
- There is a critical need for novel therapeutic strategies to improve survival rates.
- JSI/34.5-/47-/GM-CSF is an oncolytic vaccine designed to elicit anti-tumor immune responses.
Purpose of the Study:
- To review the development of herpes simplex virus oncolytic vaccines.
- To evaluate the preclinical and clinical data of JSI/34.5-/47-/GM-CSF.
- To assess the potential of this therapy in advanced cancers.
Main Methods:
- Review of preclinical studies on herpes simplex virus-1 (HSV-1) oncolytic vaccines.
- Analysis of Phase I and II clinical trial data for JSI/34.5-/47-/GM-CSF.
- Overview of ongoing Phase III trials in melanoma and head and neck cancer.
Main Results:
- Preclinical studies confirm HSV-1 oncolytic vaccines induce tumor lysis and immune responses.
- Phase I trials showed minimal toxicity, with no neurotoxicity observed.
- Phase II trials demonstrated durable regressions in metastatic melanoma patients.
- Ongoing Phase III trials aim to confirm clinical effectiveness.
Conclusions:
- JSI/34.5-/47-/GM-CSF represents a new generation of HSV-1 oncolytic vaccine.
- This therapy combines direct tumor cell killing with the induction of systemic anti-tumor immunity.
- Early clinical data suggest promising therapeutic activity for advanced cancers.
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