# A novel immuno-oncolytic viral therapy for the treatment of non-small cell lung carcinoma

> **NIH NIH R44** · WESTERN ONCOLYTICS, LTD · 2020 · $994,294

## Abstract

Project Summary/Abstract
The goal of this project is to complete the pre-clinical and translational studies necessary to prepare a novel
oncolytic viral (OV) therapy, WO-S3, for clinical evaluation in non-small cell lung cancer (NSCLC). NSCLC is
the predominate form of lung cancer, which is the leading cause of cancer death in the United States.
Recently, immunotherapies have emerged as a potential new treatment approach in NSCLC but have been
limited by low response rates and designated primarily for use in second-line treatment. However, the ability of
OVs to exploit the immune system has been demonstrated in other solid tumor types, such as melanoma, and
so they hold great promise for use in NSCLC, especially if effective systemic delivery were possible. Oncolytic
viruses have the potential to incorporate multiple features into a single viral backbone, to target cancer cells
directly (to induce cell death), to overcome localized immune suppression within the tumor, and to boost the
anti-tumor adaptive immune response while evading anti-viral immune responses. To date, no effective OV
therapies have been developed for use in NSCLC, primarily due to the need to delivery most OVs directly into
the tumor, a delivery mechanism that is often not feasible in lung cancer. WO-S3 represents a next generation
of OV therapies, and has been engineered to contain multiple genetic modifications and expresses several
transgenes, which, collectively, overcome many of the limitations facing previous generations of OVs.
Modifications in WO-S3 allow for greatly enhanced intravenous administration, increased tumor-selective viral
replication, as well as targeting of activated STAT3, a protein that is a key driver of many of the hallmarks of
cancer. Furthermore, WO-S3 overcomes immune suppression in the tumor.
Previous pre-clinical work has demonstrated WO-S3's mechanism of action and potency against tumors,
including mouse models of lung cancer. We believe that this therapy has significant potential to advance the
treatment of NSCLC, and advancing WO-S3 to clinical testing is of importance. The work described in this
current proposal is specifically aimed at completing the studies necessary to prepare for clinical evaluation. As
such, we will demonstrate that our existing manufacture process can be used to create WO-S3 at clinical grade
and in sufficient quantities for use in clinical testing, with the ultimate goal of producing an economically viable
product. In addition, we will complete the FDA-mandated safety and toxicology testing through a series of
mouse studies. We will develop all assays necessary to confirm the clinical product (WO-S3) is as intended,
and these will be transferred to a contract manufacturing facility where a viral bank of WO-S3 will be created
for use as seed material in all future manufacturing runs for clinical testing as well as eventual commercial use.
In addition, mouse studies will be run to define the optimal treatment regimen for...

## Key facts

- **NIH application ID:** 10230812
- **Project number:** 4R44CA224737-02
- **Recipient organization:** WESTERN ONCOLYTICS, LTD
- **Principal Investigator:** Stephen H Thorne
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $994,294
- **Award type:** 4N
- **Project period:** 2019-04-08 → 2020-12-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10230812

## Citation

> US National Institutes of Health, RePORTER application 10230812, A novel immuno-oncolytic viral therapy for the treatment of non-small cell lung carcinoma (4R44CA224737-02). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10230812. Licensed CC0.

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