Advaxis has dosed the first patient in a Phase l trial of ADXS-NEO for the treatment of metastatic non-small cell lung cancer (NSCLC), metastatic microsatellite stable colon cancer and metastatic squamous head and neck cancer.
The first patient dosed with ADXS-NEO is affected by non-small cell lung cancer.
The open-label, dose-escalation, multi-centre clinical trial is currently being conducted in the US.
As part of the trial, Advaxis will conduct a biopsy of the patients and then develop an investigational personalised treatment for each patient based on an analysis of their tumour neoantigen mutations, which will be ready to be dosed within eight weeks of the initial biopsy.
Around 48 subjects are expected to be enrolled in the trial, which is expected to be completed by September 2020.
Advaxis president and CEO Kenneth Berlin said: “This programme brings our clinically validated Lm Technology to the cutting-edge area of neoantigen immuno-oncology.
“We are committed to realising the potential of ADXS-NEO to mobilise patients’ immune systems against mutations that accumulate within and contribute to the development of their cancer, and to bring the potential benefits of our technology to more patients and their families.”
ADXS-NEO is currently being investigated as a personalised Listeria monocytogenes (Lm)-based immunotherapy designed to produce an immune response against mutation-derived tumour-specific neoantigens identified through DNA sequencing of a patient’s own tumours.
Advaxis had previously partnered with Amgen in order to develop ADXS-NEO.