- A novel cancer immunotherapy developed by biotech company Immutep (IMM) will be tested in an investigator-initiated clinical trial against COVID-19
- The phase two study will evaluate eftilagimod alpha (efti) in up to 110 COVID-19 patients at University Hospital Pilsen in the Czech Republic
- Efti is an antigen-presenting cell (APC) activator, which acts to stimulate the body’s immune response by boosting CD8 effector T cells
- It is hoped it will serve as an early intervention tool to prevent disease progression in COVID-19 patients
- All necessary approvals have been received and recruitment will start immediately
- Immutep is trading 6 per cent higher for 26.5 cents
A novel cancer immunotherapy developed by Immutep (IMM) will be tested in an investigator-initiated clinical trial against COVID-19.
The study
The placebo-controlled and randomised phase two study will evaluate eftilagimod alpha (efti) in up to 110 COVID-19 patients.
The trial will be led by Principal Investigator, Professor Martin Matejovic, who is the Head of the Medical Department at University Hospital Pilsen in the Czech Republic.
The study will test efti in patients hospitalised with COVID-19.
Subjects will be given three injections over a week, and their progress will be mapped against World Health Organisation standards.
The primary endpoint is the patient’s clinical status at day 15.
Efti is an antigen-presenting cell (APC) activator, which was developed as an immunotherapy for cancer.
It works to stimulate the body’s immune response by boosting CD8 effector T cells.
It’s hoped the “Eftilagimod Alpha Treatment by immune modulation in COVID-19 disease”, or EAT COVID, study will demonstrate efti can prevent disease progression in COVID-19 patients.
Under the agreement, Immutep will provide efti at no cost to the University Hospital Pilsen, while the hospital will fund the study.
All necessary approvals from the Czech Republic’s State Institute for Drug Control and ethics committee have been received, so the hospital can start immediate recruitment.
Immutep CEO Marc Voigt said while efti wasn’t designed to fight COVID-19, the study will provide an even better understanding of how it works on the immune system.
“It is highly encouraging that efti, with its broad mechanism of action, attracts keen interest from clinicians who are willing and able to fund the research and commit their time to further exploring efti’s potential to fight diseases,” Marc said.
“While Immutep’s focus remains on cancer and autoimmune disease, this new trial gives us the opportunity to contribute to the global efforts to beat COVID-19.”
Immutep CEO, Marc Voigt
“We believe efti is currently the only APC activator of its kind being evaluated against COVID-19 in a randomised phase two trial and that the study will contribute to our further understanding of its potential in infectious diseases in general,” he added.
Next steps
Recruitment will start with an open label safety run-in of six patients, followed by a first cohort of 26 randomised patients.
Successive cohorts will be recruited following positive recommendations from the Data Monitoring Committee (DMC), which will evaluate safety and efficacy of the treatment.
University Hospital Pilsen Principal Investigator Professor Martin Matejovic says the treatment could provide a valuable early intervention in COVID-19 patients.
“Some hospital patients are developing severe COVID-19 disease after seven to 10 days which requires intensive care and can be fatal,” Professor Matejovic said.
“Efti’s safety profile to date and its proven efficacy as an APC activator gives us the confidence to initiate a phase two study for our patients as soon as they are hospitalised and before their condition deteriorates,” he concluded.
Immutep is trading 6 per cent higher for 26.5 cents at 10:55am AEDT.