In short
NG-641 is an experimental gene therapy being studied for metastatic or advanced epithelial tumours. It is a modified virus designed to attack cancer cells and activate the immune system. One completed Phase 1 trial (NCT05043714) tested NG-641 in combination with nivolumab in 220 patients. The trial aimed to assess safety and find a recommended dose for further development.
Key points
- NG-641 is an experimental gene therapy, a modified adenovirus carrying four added genes.
- It was studied in a Phase 1 trial together with the immunotherapy nivolumab.
- The trial enrolled 220 patients with metastatic or advanced epithelial tumours.
- The trial is completed and focused on safety, tolerability and finding a recommended dose.
- NG-641 is designed to multiply only in cancer cells and to help the immune system attack the tumour.
What is NG-641?
NG-641 is an experimental gene therapy medicinal product. It is a virus with four additional genes inserted. A gene is information in the form of DNA required for making proteins or other molecules. The virus used in NG-641 is described as a tumour-selective and transgene-expressing adenoviral vector. NG-641 is not an authorised medicine; it is still an investigational substance being studied in clinical trials.
How does NG-641 work?
NG-641 is designed to multiply only in cancer cells and is not expected to have an effect on normal cells. The products of the four added genes help to activate a type of white blood cell called T cells, which help the immune system to kill a specific type of cell in the immune system called fibroblasts. Fibroblasts are not cancer cells, but it is thought they can help cancer cells grow. As well as killing fibroblasts within tumours, the additional genes in the virus are also thought to help the immune system to locate and kill the cancer cells more effectively. In the clinical trial, NG-641 was combined with nivolumab, a monoclonal antibody that works by changing the action of the immune system and directing it to attack cancer cells.
Which conditions is NG-641 studied for?
- Metastatic cancer — cancer that has spread from where it first started to other parts of the body.
- Epithelial tumours — cancers that begin in the cells that line the inside and outside surfaces of the body.
The Phase 1 trial enrolled patients with metastatic or advanced epithelial tumours.
How is NG-641 given?
NG-641 is given by intravenous use, meaning it is delivered directly into a vein. In the clinical trial, NG-641 was given as a solution for infusion in a volume of 3 millilitres. Nivolumab was also given by intravenous infusion in the same trial.
What do the clinical trials show?
One completed Phase 1 trial tested NG-641 in combination with nivolumab or another standard-of-care PD-1 inhibitor in patients with metastatic or advanced epithelial tumours. The trial enrolled 220 participants and was designed as a multicentre, open-label, non-randomized Phase 1a/1b study.
The main measures in the trial were the incidence of adverse events, serious adverse events, adverse events leading to discontinuation and adverse events resulting in death. The trial also measured adverse events meeting protocol-defined dose-limiting toxicity criteria. The study aimed to characterise the safety and tolerability of NG-641 in combination with nivolumab and to determine the recommended dose for further development.
The trial is recorded as completed. The sponsor organisation is Akamis Bio, formerly PsiOxus Therapeutics Limited.
What side effects are known?
The published sources for this page do not provide a detailed list of side effects for NG-641. The clinical trial measured adverse events, serious adverse events and dose-limiting toxicities as its primary outcomes, but the specific side effects observed are not reported in the available registry data.