Qu Biologics Inc. has completed enrollment of all 72 participants in the RESILIENCE Study, a randomized placebo-controlled Phase 2 clinical trial evaluating the company's first-in-class immunomodulator QBKPN SSI for restoring innate immunity in people 65 years of age and older. The Vancouver-based clinical stage biopharmaceutical company announced the milestone on July 23, 2025.
Novel Approach to Age-Related Immune Decline
QBKPN SSI belongs to Qu Biologics' Site Specific Immunomodulators (SSIs) platform, designed to restore and enhance innate immune function—the body's first line of defense against infections and diseases including cancer. The RESILIENCE Study is assessing whether QBKPN treatment can restore innate immune function in elderly patients, with implications for improving response to immunological threats and reducing all-cause mortality.
"Completing enrolment of a clinical study is an exciting milestone, particularly in this case, since there are no current treatments that prevent the decline in immune function that occurs with aging," stated Dr. Hal Gunn, CEO of Qu Biologics. "This age-related immune decline is the largest unmet need in healthcare since it increases the risk of pre-mature aging, infections, inflammatory diseases, and cancer."
Scientific Rationale and Previous Evidence
As people age, innate immune function naturally declines, leaving individuals vulnerable to infectious threats—as demonstrated during the COVID-19 pandemic—as well as chronic inflammatory diseases, metabolic disease, and cancer. Dr. Shirin Kalyan, Qu's VP of Scientific Innovation and an immunologist, explained that the company has previously demonstrated in proof-of-concept studies that QBKPN treatment can reverse immune dysregulation occurring with aging, inflammatory diseases, and cancer to improve health outcomes.
"Qu's SSIs are designed, not just to treat disease, but to restore health and clear important underlying causes of disease – a fundamentally different way of thinking about the treatment of disease and what medicines could be," Kalyan stated.
Clinical Development Pipeline
Beyond the RESILIENCE Study, Qu Biologics has completed four Phase 2 studies in lung cancer, Crohn's disease, and ulcerative colitis. The company currently has two additional Phase 2 randomized placebo-controlled studies underway, including one in late-stage colon cancer and another in immunosenescence.
The SSI platform is designed to restore innate immune function in targeted organs to reverse immune dysregulation underlying various diseases including cancer, chronic inflammatory diseases, metabolic disease, and infection.
Business Development and Funding
In advance of results from the RESILIENCE Study, Qu Biologics is completing a $2 million bridge funding round and actively seeking pharmaceutical partners for co-development opportunities. The company's leadership team includes co-founder and CEO Dr. Hal Gunn, Chief Medical Officer - Oncology Dr. Simon Sutcliffe (former CEO of the BC Cancer Agency), and Chief Medical Officer – Infectious Disease Dr. Ted Steiner, who heads the University of British Columbia Division of Infectious Diseases.
Positive results from the RESILIENCE Study could have significant implications for extending healthy longevity, according to company leadership, addressing what they characterize as a fundamental gap in current healthcare approaches to aging-related immune dysfunction.
