Australian biotech Immutep advances phase 2 trial

Biotech News: Sydney’s Immutep, a biotechnology company developing novel immunotherapy treatments for cancer and autoimmune disease, announced the independent recommendation for its clinical trial progress to randomised, placebo-controlled portion of the study for Eftilagimod Alpha in COVID-19 disease.

Professor Matejovic, Principal Investigator for the study, stated “Sadly, hospitals and doctors in the Czech Republic are increasingly overwhelmed and are facing severe challenges treating the high volume of patients
with COVID-19. Despite this, the DSMB has prioritised the review of the safety data for the first six patients in the EAT COVID Phase II study. We are pleased with their recommendation to continue the trial and move
ahead with the randomised, placebo-controlled portion of the study.”

Dr. Frédéric Triebel, Immutep CSO and CMO, commented “There continues to be a significant need to develop therapeutics like efti to treat COVID-19 in patients with an insufficient immune response to overcome the viral spread. In the case of the EAT COVID study, efti is injected subcutaneously at close intervals, every three days. This strategy aims to quickly boost the rapidly evolving CD8 T cell responses seen in an acute infection.

“The positive recommendation from the independent Data and Safety Monitoring Board (DSMB) builds on efti’s strong safety profile reported in our clinical studies across several different indications to date. The results of the EAT COVID trial will also be valuable in providing insights into how efti could play a role in treating other acute infectious diseases that constitute a significant unmet medical need, as well as building preparedness for future epidemics and pandemics,” concluded Dr. Triebel.

The EAT COVID study is evaluating the Company’s lead product candidate eftilagimod alpha (“efti” or “IMP321”) in hospitalised patients with COVID-19. The study aims to boost a patient’s immune response to prevent development of severe COVID-19 symptoms that require intensive care and can lead to respiratory failure and death. As an antigen presenting cell (APC) activator, efti could help to control the viral load in hospitalised patients by boosting CD8 effector T cells.

The trial is being led by Principal Investigator, Professor Martin Matejovic, the Head of Medical Department at University Hospital Pilsen, Professor of Medicine at University Hospital Pilsen and Charles University Medical School.

The trial is also being conducted in collaboration with Dr. Dalibor Sedlacek, Associate Professor of Medicine and Head of the Department of Infectious Diseases, along with Dr. Marek Nalos, Associate Professor of Medicine and Head Medical ICU at Department of Intensive Care Medicine of the Nepean Hospital, Sydney.

Immutep’s current lead product candidate is eftilagimod alpha (“efti” or “IMP321”), a soluble LAG-3 fusion protein (LAG-3Ig), which is a first-in-class antigen presenting cell (APC) activator being explored in cancer and infectious disease. Immutep is also developing an agonist of LAG-3 (IMP761) for autoimmune disease.

Additional LAG-3 products, including antibodies for immune response modulation, are being developed by Immutep’s large pharmaceutical partners GlaxoSmithKline and Novartis.