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Classified in: Health, Science and technology
Subjects: HEALTH, Clinical Study

Qu Biologics to Launch Phase 2B Clinical Trial to Assess Reduction of Postoperative Immune Suppression and Disease Progression in Patients with Late-Stage Colorectal Cancer


BURNABY, British Columbia, Sept. 26, 2022 (GLOBE NEWSWIRE) -- Qu Biologics Inc., a clinical stage biopharmaceutical company developing Site Specific Immunomodulators (SSIs), a novel immunotherapy platform designed to restore innate immune function, is pleased to announce it has received Health Canada clearance (No Objection Letter) and institutional-level ethics approval to proceed with a randomized placebo-controlled Phase II multicenter trial to assess the effectiveness of QBECO SSI in reducing postoperative immune suppression and improving cancer outcomes in patients with late-stage colorectal cancer undergoing surgical resection of liver metastases. QBECO SSI is a first-in-class innate immune modulator specifically designed to restore innate immune function in the gastrointestinal (GI) tract, including the liver. The study, which is led by gastroenterology (GI) oncology surgeons Dr. Rebecca Auer (Ottawa Hospital Research Institute) and Dr. Paul Karanicolas (Sunnybrook Health Sciences Centre) and managed by the Centre of Clinical Trial Support at the Sunnybrook Research Institute, will enroll patients through a minimum of six academic oncology centers in Ontario.

Major surgery results in immune paralysis in the days following surgery that can contribute to cancer growth and metastases, leading to poor outcomes for cancer patients undergoing surgical treatment. By programming immune cells to remain functionally active to deal with any postoperative remnants of cancer and targeting that response to the liver and GI tract, QBECO SSI is singularly positioned to overcome surgery-induced immune suppression and its negative consequences on patient outcomes.

Dr. Hal Gunn, CEO of Qu Biologics, stated, "A majority of patients diagnosed with cancer undergo surgery in the hope of cure. However, surgery profoundly suppresses immune function in the postoperative period, enabling residual cancers cells to grow and spread. This exciting study is designed to test whether we can prevent that postoperative immune suppression resulting in improved outcomes and survival." Immunologist Dr. Shirin Kalyan, Qu's VP of Scientific Innovation, noted, "Proof-of-concept studies have shown that QBECO SSI treatment overcomes both cancer-induced and the more profound surgery-induced immune suppression through innate immune training and natural killer cell (NK cell) activation resulting in clearance of cancer cells in the targeted organ. This trial will assess whether perioperative QBECO SSI treatment can serve as a unique multi-pronged approach to transform outcomes for cancer patients undergoing surgery." Dr. Paul Karanicolas, study co-lead investigator noted, "Patients with late-stage colorectal cancer with liver metastases can potentially be cured by surgical excision of those metastases. Unfortunately, the majority of patients go on to have cancer recurrence and disease progression following surgery. There aren't any current treatments that have been shown to improve overall survival in these patients; new effective treatments that improve survival are urgently needed." Dr. Rebecca Auer, co-lead investigator of the study and leading researcher in the field of postoperative immune suppression added, "As surgeons we recognize the significant impact of surgery on the immune system and, given the central role that the immune system plays in the clearance of cancer cells, it is paramount to find a therapeutic strategy to enhance postoperative immune function. Preclinical studies suggest that QBECO SSI could be that therapy for colorectal cancer surgery."

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 restore innate immune function in targeted organs to reverse the immune dysregulation underlying many important diseases including cancer, chronic inflammatory diseases, and infection. Qu Biologics has completed four Phase 2 studies in lung cancer, Crohn's disease, and ulcerative colitis. Qu Biologics' fifth Phase 2 study is underway in early-stage colon cancer. Two additional Phase 2 randomized placebo-controlled studies, in late-stage colon cancer and immunosenescence, will begin enrolling in Q4 2022.

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.

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.



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