Immutep Limited announced that an independent Data and Safety Monitoring Board (DSMB) has completed a safety run-in data review of the first six patients from the Phase II clinical trial of Eftilagimod Alpha Treatment by immune modulation in COVID-19 disease (EAT COVID), being conducted by the University Hospital Pilsen, Czech Republic. Following this data review, the DSMB recommended that the study advance with enrolment for the randomised portion of the study. All six patients (age range, 50-83 years; 2 women) received the three planned 10 mg efti injections and have since been discharged from hospital. No adverse events have been reported. The positive recommendation from the DSMB builds on efti’s strong safety profile reported in 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. About EAT COVID: The EAT COVID study (EudraCT n° 2020-002009-25) 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 hospitalized patients by boosting CD8 effector T cells. Immutep has agreed to provide efti at no cost to the University Hospital Pilsen, which is funding the EAT COVID study. 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. The study is a placebo controlled, 1:1 randomised, double blinded Phase II clinical trial involving up to 110 adult patients hospitalised with COVID-19 at University Hospital Pilsen. Patients will receive subcutaneous injections of efti (10 mg) on days 1, 3 and 7, in addition to standard care. The study’s primary endpoint is the patient’s clinical status at day 15 as per the WHO recommended evaluation scale.