27 Jan

Phase II study for eftilagimod alpha in COVID-19 advances

1 ASX/Media Release IMMUTEP ANNOUNCES ADVANCEMENT OF PHASE II TRIAL FOR EFTILAGIMOD ALPHA IN COVID - 19 PATIENTS TO RANDOMISED PORTION OF THE STUDY • Independent ly review ed safety run - in data prompts recommend ation to initiat e e nrolment for the randomi s ed portion of the Phase II EAT COVID study • U p to 110 COVID - 19 patients to participate in investigator - initiated study at the University Hospital Pilsen, Czech Republic SYDNEY, AUSTRALIA – 27 January 20 2 1 – 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 E ftilagimod A lpha T reatment by immune modulation in COVID - 19 disease ( EAT COVID ) , be ing conducted by the University Hospital Pilsen, Czech Republic. Following this data review, the D SMB recommended that the study advance with enrolment for the randomi s ed portion of the study . A ll 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 D SMB 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 respo nses seen in an acute infection. The positive recommendation from the D SMB builds on efti’s strong safety profil e 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 si gnificant 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 develop ment of severe COVID - 19 symptoms that require intensive 2 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. Immute p has agreed to provide efti at no cost to the University Hospital Pilsen , which is fund ing the EAT COVID study. The trial is be ing led by Principal Investigator, Professor Martin Matejovic , the Head of Medical Department at University Hospital Pilsen, Pro fessor of Medicine at University Hospital Pilsen and Charles University Medical School. The trial is also be ing 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 i nvolving 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 clinic al status at day 15 as per the WHO recommended evaluation scale. About Immutep Immutep is a globally active biotechnology company that is a leader in the development of LAG - 3 related immunotherapeutic products for the treatment of cancer and autoimmune disease. Immutep is dedicated to leveraging its technology and expertise to bring innovative treatment options to market for patients and to maximize value to shareholders. Immutep is listed on the Australian Securities Exchange (IMM), and on th e NASDAQ (IMMP) in the United States. 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. Furthe r information can be found on the Company’s website www.immutep.com or by contacting: Australian Investors/Media: Catherine Strong, Citadel - MAGNUS +61 (0)406 759 268; cstrong@citadelmagnus.com U.S. Media: Tim McCarthy, LifeSci Advisors +1 (212) 915.2564; tim@lifesciadvisors.com This announcement was authorised for release by the board of Immutep Limited.
Information on this Website is provided for general information purposes only and is not a substitute for professional advice. ASX Information (including company announcements and prices) is delayed by at least 20 minutes. JSE Information (including company announcements and prices) is delayed by at least 15 minutes. Reliance on the information you access on or from this Website is solely at your own risk. We make no representation or warranty in relation to the future performance of the companies that appear on this Website. Investment in securities involves risk and you should obtain independent professional legal, financial, investment or company advice before acting on any of the information you access on this Website. Using, browsing or otherwise accessing this Website is subject to our Terms and Conditions and our Privacy Policy.

© 2021 Listcorp. ABN 60 166 140 307

Never miss news from Immutep Limited (ASX:IMM) when you join Listcorp.