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Response to Novel Immune Therapy for Ulcerative Colitis Associated with Genetic and Immune Biomarkers

By October 9, 2017No Comments

Qu Biologics Inc., a biopharmaceutical company developing Site Specific Immunomodulators (SSIs), a unique platform of immunotherapies designed to “reboot” the body’s innate immune system, has identified specific ulcerative colitis (UC) genetic markers that may predict response to QBECO SSI therapy and important immunological biomarkers that may be used to track response. These discoveries came from genetic and cytokine analyses of Qu Biologics’ recently completed Phase 2 Study in ulcerative colitis.

As previously reported, 73% of UC study participants responded to QBECO SSI treatment (as defined by a reduction in Mayo score of ≥ 3 points), with histological improvement in colonic biopsies in the majority of patients. Study participants’ response to treatment was associated with specific ulcerative colitis related single nucleotide polymorphisms (SNPs) associated with genes of high relevance to SSI’s mechanism of action (i.e., activation of innate immune function and clearance of bacterial infection/dysbiosis). In addition, response to QBECO SSI treatment was accompanied by an increase in the levels of cytokines reflective of innate immune response to bacterial infection, the underlying mechanism of SSI therapy in ulcerative colitis. These cytokines were also found to be strongly associated with QBECO SSI response/non-response in Qu Biologics’ Phase 2 randomized placebo-controlled trial in Crohn’s disease, providing further evidence for this immunological mechanism of action and the important potential of improving innate immune function in inflammatory bowel diseases (IBD), such as ulcerative colitis and Crohn’s disease.

“For patients with IBD, including ulcerative colitis and Crohn’s disease, we are hopeful that these results mean that they may now be closer to having a treatment that restores rather than suppresses immune function”, stated Dr. Hal Gunn, CEO of Qu Biologics. “Unlike current IBD treatments, which suppress the adaptive immune system and inflammation, QBECO SSI targets the upstream underlying genetic and immunological pathways of the disease, allowing personalized medicine to be applied in IBD for the first time.” Dr. Shirin Kalyan, Qu Biologics’ Director of Scientific Innovation, added, “The observation that QBECO SSI treatment shows a genetic link in IBD patients that is relevant to QBECO SSI’s immunological mechanism of action, activates innate immune pathways consistent with this mechanism, and improves disease at the tissue level in the colon, is exciting in terms of what it informs us about the disease and QBECO SSI treatment. These results highlight the potential of this new approach to treating ulcerative colitis by restoring rather than suppressing immune function.”

Qu Biologics will initiate a follow-up trial in Crohn’s disease in Q1 2018 to determine the optimal timepoint to assess mucosal healing with QBECO SSI therapy, the predictive value of genetic biomarkers, and the correlation of cytokine biomarkers with response. As Dr. Gunn summarized, “The ability to predict an IBD patient’s response to treatment would be an important turning point for patients with inflammatory bowel diseases and their health care providers who currently have to resort to trial and error in selecting treatments, which is often a burdensome exercise in terms of time, resources, disease symptoms and treatment side-effects for all parties involved.”

For more information about Qu Biologics and the science behind SSIs, please visit

About Qu Biologics
Qu Biologics is a Vancouver-based private clinical stage biopharmaceutical company developing Site Specific Immunomodulators (SSI), a novel class of immunotherapies. SSIs are designed to stimulate an innate immune response in targeted organs or tissues to reverse the chronic inflammation underlying many conditions including cancer, inflammatory bowel disease, inflammatory lung disease and arthritis. SSIs are a broad platform technology being tested in multiple disease indications, including Health Canada approved clinical trials in lung cancer, Crohn’s disease and Ulcerative Colitis.

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 regarding this press release, contact:

Hal Gunn, MD
Qu Biologics Inc.
Phone: 604.734.1450