Lung immunity in the elderly will be the subject of a controlled clinical trial after receiving clearance to go ahead from Health Canada.
Qu Biologics will receive additional funding to launch the trial for the restoration of innate immune function – the defense system humans are born with.
Qu, a private clinical stage biopharmaceuticals company that develops site specific immunomodulators (SSIs) – a novel platform of immunotherapies – announced it received the clearance this week (July 20) with no objection letter.
The trial of QBKPN, an innate immune modulator for enhancing lung immunity in the elderly (immunosenescence [IS]-01 trial), is designed to assess QBKPN’s effectiveness in restoring innate immunity, the prevention of serious morbidity and mortality from respiratory infections including Covid-19 and its variants and a reduction in all-cause mortality.
With the receipt of Health Canada’s No Objection Letter, the National Research Council of Canada Industrial Research Assistance Program (NRC IRAP) has committed additional advisory services and conditional funding to support the study.
The company notes that while people over the age of 65 represent about 16 per cent of the population in Canada, 90 per cent of COVID-19 deaths in the country have been in this age group. Decline in innate immunity with ageing contributes to this vulnerability.
Hal Gunn, CEO of Qu Biologics, said: “We are very grateful for this additional support from NRC IRAP which has significantly expedited the clinical development of QBKPN to prevent the disproportionate morbidity and mortality of severe respiratory infections borne by the elderly.”
QBKPN SSI is designed to restore and enhance innate immune function, the body’s first line of defense against all infections and other diseases such as cancer. By restoring innate immunity, QBKPN is positioned to contain and clear viral and bacterial infections before they have had an opportunity to spread.
QBKPN has a broad innate immune protective effect, and it is anticipated its therapeutic effects will be retained as new mutations of SARS-CoV-2 arise, and it is also anticipated to provide protection against future viral pandemics, seasonal influenza, and a wide range of other viral and bacterial infections. Additionally, given the role of innate immunity in protecting against cancer and other chronic diseases, the study is also designed to assess the effect of QBKPN on all-cause mortality.
Immunologist Shirin Kalyan, Qu’s vice president of scientific innovation, said: “We have shown that QBKPN treatment can improve the innate immune dysfunction that is present in the context of aging, inflammatory lung diseases, and lung cancer. These same conditions increase the risk of serious COVID-19 and other respiratory infections. We anticipate that QBKPN treatment will address these underlying vulnerabilities in innate immune competency in people who are at high risk of serious respiratory infections, like COVID-19, and other critical lung diseases rooted in immune dysfunction.”
Qu Biologics is developing immunotherapies designed to stimulate an innate immune response in targeted organs to reverse the immune dysregulation in important diseases including cancer, inflammatory bowel disease, infection, and inflammatory lung diseases.
Qu has completed four phase 2 studies in lung cancer, Crohn’s disease, and ulcerative colitis. Qu’s 5th phase 2 study is under way in early-stage colon cancer, with two additional upcoming phase 2 randomized placebo-controlled studies in late-stage colon cancer and immunosenescence.