Immutep Announces Advancement Of Phase II Trial For Eftilagimod Alpha In Covid-19 Patients To Randomised Portion Of The Study

• Independently reviewed safety run-in data prompts recommendation to initiate enrolment for the randomised portion of the Phase II EAT COVID study
• Up to 110 COVID-19 patients to participate in investigator-initiated study at the University Hospital Pilsen, Czech Republic

Sydney, AUSTRALIA , Jan. 27, 2021 (GLOBE NEWSWIRE) --  Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep” or “the Company”), a biotechnology company developing novel immunotherapy treatments for cancer and autoimmune disease, 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.

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 prioritized 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 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.