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COVID-19: targeted treatment trial launched in Vienna

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(Vienna/Heidelberg/Cologne/London, 22 December 2020) A phase II clinical trial of a treatment for COVID-19 patients is currently starting at the Medical University of Vienna as a sub-study of the Austrian CoronaVirus Adaptive Clinical Trial (ACOVACT). The trial was initiated as an academia-industry collaboration (investigator Initiated trial) between Apogenix AG, a biotech company based in Heidelberg, and their scientific consultant Henning Walczak and his teams at the University of Cologne and University College London (UCL).

Patients with severe to critical COVID-19 are now being treated with an immunotherapeutic drug, the Fas ligand blocker asunercept, from Apogenix within the framework of the Austrian CoronaVirus Adaptive Clinical Trial (ACOVACT). ACOVACT is a randomised, controlled, multi-centre, open-label clinical trial sponsored by MedUni Vienna. Within ACOVACT, different treatments for COVID-19 are compared to one another.

The sub-study of ACOVACT was initiated by Henning Walczak, Michael Bergmann and Apogenix. Walczak is an expert in the role of cell death and inflammation in inflammatory disease and cancer. He is Alexander von Humboldt Professor of Biochemistry at the Cluster of Excellence for Ageing Research (CECAD) at the University of Cologne and Professor of Cancer Biology at the UCL Cancer Institute. Bergmann is a surgeon at MedUni Vienna and an expert on oncolytic viruses and cancer immunotherapies. Apogenix develops innovative immunotherapeutic agents for the treatment of cancer and viral diseases such as Covid-19.

Novel approach in the treatment of COVID-19
The study is based on a scientific concept developed by Walczak and Bergmann together with Apogenix. In conjunction with results published by other researchers, they hypothesised that tissue damage and lung failure in patients with severe COVID-19 may in fact be the result of the overactivity of so-called death ligands rather than the viral infection itself.

Death ligands are proteins normally produced by our own body in the course of immune defence. The immunotherapeutic that is now being trialled intercepts the death ligand known as Fas ligand or CD95 ligand.

"It appears that SARS-CoV-2 infection induces an overreaction of our immune system, resulting in overproduction of Fas ligand. This killer protein can then kill healthy, uninfected cells in the lungs of COVID-19 patients, thus causing lung damage," explains Walczak. "The concept of blocking cell death in the treatment of COVID-19 is a completely novel one. We are excited to see the outcome of this clinical trial," adds Bergmann. Hitherto, the search for effective treatments for COVID-19 has mainly focused on drugs that aim to interfere either with the virus itself or with the effects of the cytokine storm. "However, by the time doctors get to see patients, the viral load has normally already dropped substantially and the systemic cytokine storm was shown to be quite low in COVID-19 patients when compared to diseases such as septic shock, for example," says Bergmann.

"Blocking the Fas ligand offers the opportunity to interfere with the cause of severe COVID-19. By blocking cell death, we are preventing the fuel from feeding the fire rather than trying to put out a fire that is constantly fed," says Christian Schörgenhofer, who is coordinating the trial together with Bernd Jilma (both from MedUni Vienna's Department of Clinical Pharmacology).

Thomas Höger, Chief Executive Officer of Apogenix, comments: "It has been an exciting endeavour to team up with Henning Walczak, a co-founder of our company, and the team from MedUni Vienna in a joint effort to ascertain whether this novel treatment is effective. We hope that our new therapeutic can help improve the treatment of severe COVID-19 and also see the therapeutic potential of such a treatment for other viral diseases such as Influenza."

This phase II clinical trial complements another stand-alone phase II clinical trial by Apogenix with the same therapeutic in patients with severe COVID-19 being conducted in Spain and Russia.