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GMO dealings

DIR 208

Clinical trial of GM vaccinia virus for the treatment of solid tumours

Licence details

Licence number:
DIR 208
Licence status:
Current
Category:
Medical
Release:
Limited and controlled
Organisation:

Novotech Australia Pty Ltd

Parent organism:

Vaccinia virus

Modified trait:
  • Three separate genes related to immune function of human origin, which enhance anti-tumour immune responses.
  • The deletion of 3 VACV genes, which improves the efficacy and safety of the GMO.
Licence issue date:
Description:

This licence allows Novotech (Australia) Pty Ltd to conduct a clinical trial, under limited and controlled conditions, of a genetically modified (GM) vaccinia virus for treatment of solid tumours in Australia.

The GM treatment is based on vaccinia virus, the principal agent of the smallpox vaccine. The GM treatment has been modified by deletion of genes to improve its safety and enrich its replication in cancer cells, and addition of genes which will allow the immune system to rapidly target it and clear cells it replicates in.

The GMO will be manufactured overseas and imported into Australia. Up to 40 patients with refractory tumours will receive the GM treatment at clinical trial sites and hospitals in Australia, over a period of 5 years.

The RARMP concluded that the clinical trial poses negligible risks to people or the environment. However, as this is a clinical trial under limited and controlled conditions, licence conditions have been imposed to:

  • restrict when and where the trial can take place
  • limit the size of the trial
  • restrict the spread and persistence of the GM vaccine.

The risk analysis for this application was carried out in accordance with the Regulator’s Risk Analysis Framework.

Date application received:
RARMP open for public consultation:
RARMP closed for public consultation:

Documents

Licence decision - notification

Outlines the Regulator’s decision to issue a licence following the assessment of this application.

Licence decision - Q&A

FAQs on the licence application and the Regulator’s decision to issue a licence for this application.

Risk assessment and risk management plan - summary

A summary of the Risk Assessment and Risk Management Plan prepared as part of the assessment of this application. It provides a brief description of the licence application, the risk assessment and risk management plan.

Risk assessment and risk management plan - full version

The final risk assessment and management plan prepared to support the Regulator's decision. It describes the GMO(s) and proposed work with the GMO(s) and provides an assessment of potential risks posed by the GMO(s). It also includes a summary of submissions received during the public consultation process.

Licence conditions

Sets out the licence conditions imposed by the Regulator, including the licence holder’s general and specific obligations and reporting requirements.

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