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A trial of biotechnology company Immutep's (ASX: IMM) experimental cancer drug on COVID-19 patients will go ahead, after a preliminary test found the immune boosting drug was safe for use.
As a result Immutep will see the trial progress to Phase II where a randomised population of 110 COVID patients will receive eftilagimod alpha ('efti').
According to an independent data and safety monitoring board (DSMB), the "Eftilagimod Alpha Treatment by immune modulation in COVID-19 disease" study (dubbed 'EAT COVID') proved efti was safe in Phase I.
During the previous phase, six patients in the Czech Republic between the ages of 50 and 83 received the experimental treatment, all with three planned 10mg injections of Immutep's efti. They have since been discharged from hospital with no adverse events reported.
Ultimately, the researchers behind EAT COVID will hope to prove the cancer treatment will boost the body's immune response while fighting off a COVID-19 infection.
"The aim of efti is to "push the gas" on the body's innate and adaptive immune systems making it a suitable candidate to evaluate not only for the treatment of cancer, but also for the treatment of infectious diseases such as COVID-19," Immutep said back in October.
For the company, which has offices in Sydney, Paris, Leipzig and Berlin, the development represents a significant step toward boosting the immune response in COVID-infected patients.
"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," says Immutep CSO and CMO Dr Frédéric Triebel.
"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."
Immutep was formed in 2001 after listed mining company Prime Resources acquired the rights to develop technologies from the Austin Research Institute (now the Burnet Institute) in Melbourne, including the immunotherapeutic product candidate CVac.
In 2014 the company acquired Immutep SA, a private French biotechnology company, transforming it from a single product cancer vaccine developer to a multi-product developer and leader in immunotherapy.
While the company is still continuing trials of its products for the treatment of cancers and autoimmune diseases, it announced in October 2020 that it would assist in the global fight against COVID-19.
According to Triebel, today's news is "positive" for the future of Immutep's efti treatment, not only in COVID-19 patients, but other infectious diseases too.
"The positive recommendation from the DSMB builds on efti's strong safety profile reported in our clinical studies across different indications to date," says Triebel.
"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."
The trial of EAT COVID is being conducted in the Czech Republic, a country that is in the midst of a deadly second wave of the coronavirus.
Just yesterday the country reported 84 deaths from COVID-19, and 2,387 new cases.
Principal Investigator for the EAT COVID study Professor Matejovic says despite hospitals being overwhelmed in the Czech Republic, Phase II of the study has been prioritised.
"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," says Matejovic.
"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."
Shares in Immutep are up 4.82 per cent to $0.44 per share at 11.21am AEDT.
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