DIR 222 Clinical trial of genetically modified adenovirus for treatment of locally advanced rectal cancer

Between 21 January and 05 March 2026, we sought your feedback on the consultation version of the Risk Assessment and Risk Management Plan (RARMP) prepared for the DIR 222 licence application (Clinical trial of genetically modified (GM) adenovirus from Novotech (Australia) Pty Ltd).

During the 6-week consultation period, we received advice from prescribed Government agencies, the Gene Technology Technical Advisory Committee, and the public.

We heard support for:

• the overall conclusions of the RARMP
• the licence conditions for DIR 222

We also heard concerns for exposure of people following shedding of the genetically modified adenovirus from clinical trial participants into the sewerage.

We analysed the feedback provided during the public consultation process in finalising the RARMP. The issues raised and how they were addressed can be found in Appendices A and B of the final RARMP.

The Gene Technology Regulator issued a licence to Novotech (Australia) Pty Ltd for the clinical trial of GM adenovirus on 14 April 2026. More details, including the final version of the RARMP and the licence, are available at DIR 222 | Office of the Gene Technology Regulator.

We appreciate all those who provided input to the consultation – your feedback will help to ensure that any risks posed by gene technology to people and the environment continue to be managed.