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SSI Platform

Qu’s discovery has far-reaching potential, not only for cancer, but also for the increasingly prevalent conditions rooted in immune dysregulation, which include chronic inflammatory disorders, diseases of aging, and emerging infectious threats.

Dr. Simon Sutcliffe, Chief Medical Officer – Oncology

Based on Qu’s important discovery that the cells of the innate immune system can be effectively trained and targeted to a specific organ to treat or prevent disease, Qu has developed a platform of Site Specific Immunomodulators (SSIs) designed to restore all the cells, pathways, and functions of innate immunity in a targeted diseased organ. Each SSI contains components from an inactivated bacterial species that is a common endogenous cause of infection in the targeted organ, ensuring universal priming of the SSI therapeutic response.

Three SSIs are in clinical development, each targeting immune restoration in a specific organ:

QBECO SSI: derived from inactivated E. coli, targeting the gastrointestinal tract and related organs where E. coli is endogenous and a common cause of infection

QBKPN SSI: derived from inactivated K. pneumoniae, targeting the lungs and respiratory tract where K. pneumoniae is endogenous and a common cause of infection

QBSAU SSI: derived from inactivated S. aureus, targeting the skin, soft tissue, and bone where S. aureus is a common cause of infection

Qu Biologics' SSIs

SSIs restore innate immune function in a targeted organ/tissue

Helping the Body Heal Itself

Moa DiagramMost current immunotherapies for cancer and chronic inflammatory diseases force a single immune pathway in one direction, with significant potential side effects. Qu is approaching the treatment of these important diseases in a very different way – SSIs are designed to restore normal function and balance of all the cells, pathways, and roles of innate immunity to help the body heal itself.

SSIs are made from inactivated bacteria, so they can’t cause infection. SSIs are anticipated to have a strong safety profile, like that of traditional vaccination, as evidenced to date in more than 360 patients treated. The SSI response is targeted to the area of pathology rather than healthy tissue, and if there is no pathology in the targeted organ, the SSI response is muted, further contributing to safety.

SSIs can be easily self-administered by subcutaneous injection in any accessible area (e.g., upper arm, thigh, or abdomen), similar in technique to an insulin injection. Once administered, SSIs direct activated innate immune cells to the targeted organ (via myelopoiesis and organ-specific chemokine release) to restore the cells, pathways, and roles of innate immunity in the targeted diseased organ.

Restoring Innate Immunity

The innate immune system is capable of clearing not only bacterial infection, but also cancer and inflammation. SSI treatment is designed to safely and effectively restore all the roles and functions of innate immunity in the targeted diseased organ, including regulating adaptive immunity, controlling inflammation, regulating metabolism, supporting tissue regeneration, regulating the health of the microbiome, maintaining barrier function, and clearing dead and dying cells. Once these important roles of innate immune function are restored, the immune system can initiate the effector functions necessary to clear cancer or chronic inflammatory disease in the targeted organ. Through this unique mechanism, each of Qu’s SSIs are positioned to treat or prevent cancer, immunosenescence (diseases of aging), and chronic inflammatory diseases in the targeted diseased organ.

Clinical Proof of Principle

Qu has completed four Phase 2 clinical studies in lung cancer, Crohn’s disease, and ulcerative colitis, demonstrating immunological restoration consistent with the novel mechanism of SSIs and clinical proof of principle, including downregulation of PD-1 and PD-L1 and upregulation of M1 macrophages in lung cancer, innate immune training and endoscopic and histological response in Crohn’s disease, and endoscopic and histological response in ulcerative colitis. Supporting the broad application of SSIs across multiple important diseases, Qu has published SSI efficacy data in animal models in multiple cancers and infections, inflammatory bowel disease, COPD, and asthma, including SSIs’ novel mechanism. If you would like to learn more, click the indications, below.

“Qu’s SSIs restore innate immune function in a targeted organ to recognize and destroy cancer cells.”
- Dr. Shirin Kalyan, VP Scientific Innovation

Our Immune System is Built to Clear Cancer Cells

Our immune system is designed to not only eradicate infectious organisms, but also to screen for, and destroy cancer cells through a process called immune surveillance. If the innate immune system becomes dysregulated, cancer can begin to grow. Cancer itself further suppresses and dysregulates innate immune function, resulting in a vicious cycle that leaves innate immune cells within a cancer tumour unable to mount an effective response.

Qu’s SSIs are uniquely different from chemotherapy, radiation, or monoclonal antibody immunotherapies. While monoclonal antibody immunotherapies (e.g., checkpoint inhibitors) are designed to force a single immune pathway to one extreme, Qu’s SSIs are designed to restore normal function of all the cells, roles, and pathways of innate immunity in a targeted diseased organ to support the safe eradication of cancer cells. Qu has published demonstration of this strategy in the context of lung cancer in OncoImmunology, a peer-reviewed, open-access scientific journal.

Clinical Use of SSIs in Cancer

Lung Cancer

Qu completed a Phase 2a exploratory clinical trial to evaluate the mechanism of action and the safety, tolerability, and compliance of QBKPN SSI for the treatment of recurrent lung cancer. The study assessed the immunological effects of SSI treatment, demonstrating downregulation of PD-1 and PD-L1, downregulation of M2 (i.e., immune-suppressing) macrophages, and upregulation of M1 (i.e., immune-activating) macrophages. Results from this study were published in the peer-reviewed journal, OncoImmunology.

Compassionate Use

Qu Biologics’ SSIs were first used clinically in a compassionate use program in patients with advanced cancer. More than 250 patients with advanced cancer (including breast, prostate, lung, colon, liver, skin, bone, and ovarian cancer) were treated with one or more SSIs, with compelling safety and early clinical data.

Colon Cancer

A Phase 2 randomized, placebo-controlled, double-blind study (PERIOP-06 study) assessing the effectiveness of QBECO SSI to prevent postoperative immune suppression and improve survival in patients with late-stage colon cancer undergoing resection of liver metastases is currently underway. More information can be found here.

The detailed science behind Qu’s discovery and our novel immunotherapeutic approach has been published in Scientific Reports, an open-access, peer-reviewed journal, that is a part of the Nature group of publications.

At Qu Biologics, we recognize that sustainable recovery from cancer and chronic inflammatory diseases is contingent upon restoring healthy immune function and harnessing the body’s intrinsic ability to heal. It is with this central aim that Qu Biologics has developed SSIs to activate the body’s innate immune system to re-establish balance and more optimal function.