Burnaby, British Columbia – July 20, 2022 – Qu Biologics Inc., a private clinical stage biopharmaceutical company developing Site Specific Immunomodulators (SSIs), a novel platform of immunotherapies designed to restore innate immune function, is pleased to announce it received clearance (No Objection Letter) from Health Canada to proceed with a randomized placebo-controlled clinical trial of QBKPN, a first-in-class innate immune modulator that enhances lung immunity, in the elderly (Immunosenescence [IS]-01 trial). The clinical 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 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 this important clinical study.
Even though people over the age of 65 represent about 16% of the population in Canada, 90% of COVID-19 linked deaths in the country have been in this age group. Decline in innate immunity with aging contributes substantially to this vulnerability. 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. Given QBKPN’s broad innate immune protective effect, 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.
Dr. Hal Gunn, CEO of Qu Biologics, stated, “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.” Immunologist Dr. Shirin Kalyan, Qu’s VP of Scientific Innovation, noted, “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.”
For more information about Qu Biologics and the science behind SSIs, please visit www.qubiologics.com.
About Qu Biologics
Qu Biologics is a clinical stage biotechnology company developing Site Specific Immunomodulators (SSI), a novel class of immunotherapies designed to stimulate an innate immune response in targeted organs to reverse the immune dysregulation underlying many 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 underway in early-stage colon cancer, with two additional upcoming Phase 2 randomized placebo-controlled studies in late-stage colon cancer and immunosenescence.
Backed by a prestigious group of scientific advisors and board members, Qu Biologics is led by a management team that includes co-founder and CEO Dr. Hal Gunn, a physician and expert on the body’s immune response to chronic disease; and Chief Medical Officer Dr. Simon Sutcliffe, former CEO of the BC Cancer Agency and a distinguished clinician, scientist and leader in cancer control in Canada and internationally. For more information, please visit www.qubiologics.com.
For more information regarding this press release, contact:
Hal Gunn, MD
CEO
Qu Biologics Inc.
Phone: 604.734.1450
Email: media@qubiologics.com
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Qu Biologics Inc. cautions you that statements included in this press release that are not a description of historical facts may be forward-looking statements. Forward-looking statements are only predictions based upon current expectations and involve known and unknown risks and uncertainties. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of release of the relevant information, unless explicitly stated otherwise. Actual results, performance or achievement could differ materially from those expressed in, or implied by, Qu Biologics’ forward-looking statements due to the risks and uncertainties inherent in Qu Biologics’ business including, without limitation, statements about: the progress and timing of its clinical trials; difficulties or delays in development, testing, obtaining regulatory approval, producing and marketing its products; unexpected adverse side effects or inadequate therapeutic efficacy of its products that could delay or prevent product development or commercialization; the scope and validity of patent protection for its products; competition from other pharmaceutical or biotechnology companies; and its ability to obtain additional financing to support its operations. Qu Biologics does not assume any obligation to update any forward-looking statements except as required by law.