SSIs for Cancer

“Qu is developing new therapies that take advantage of our body’s natural immune response to bacteria in a manner that stimulates our immunity to recognize and destroy cancer cells.”

 

Site Specific Immunomodulators (SSIs), Qu Biologics’ proprietary technology platform, are a new class of immunotherapies, derived from components of inactivated bacteria, designed to stimulate an innate immune response to treat cancer. Rather than targeting the cancer cells, Qu Biologics SSIs are designed to activate the body’s own immune cells to target the cancer, restoring our body’s own innate capacity to clear cancer.

Lab photos_tubesWIDE

Our immune system is built to destroy cancer cells

In most cases, our immune system is capable of recognizing and destroying newly forming cancer cells, a process called immune surveillance. However, cancer cells can evade or suppress this immune response, thereby gaining a foothold and growing into tumours. Most cancer therapies target the cancer cells, but these treatments often have serious side effects including immune suppression, and cancer cells often develop resistance to these drugs.

At Qu, we believe there’s a better way to fight cancer. Rather than trying to kill the cancer cells directly, Qu Biologics’ SSIs are designed to restore normal immune function and activate the patient’s own immune cells to target the cancer. SSIs are derived from components of inactivated bacteria and mimic acute (short-term) infection, without actually causing infection. Administered by simple subcutaneous injection, SSIs are designed to recruit activated immune cells to the targeted organ or tissue in which the cancer is growing, stimulating an anti-cancer immune response in the tumour. Acute infection is one of the most effective ways to activate the immune system and, by mimicking acute infection and targeting the reponse, SSIs are designed to restore normal immune function in the tumour and jump-start immune responses against cancer cells, restoring the body’s own ability to target and eliminate cancer cells.

Dr. Hal Gunn talks about SSIs for Cancer

Qu Biologics’ CEO Dr. Hal Gunn how Site Specific Immunomodulators work in the context of cancer treatment.

Correlation between acute infection and cancer

Historical clinical observation and published evidence suggests that acute bacterial infection has the potential to reverse cancer progression, even in advanced stages.1,2 Anecdotally, dating back centuries, many clinicians have observed that people who develop cancer are less likely to have experienced acute infections and that acute infection can sometimes result in cancer remission, even in advanced cancer.3,4,5 Simply put, by stimulating the immune system’s natural surveillance and defense actions, acute bacterial infection may restore immune function and enable the immune system to halt tumour growth and reverse cancer development.

Transforming an old concept into a leading edge cancer treatment

Dr. William B. Coley, an American surgical oncologist in the late 1800s and early 1900s, recognized the link between acute infection and cancer regression and originated the field of cancer immunotherapy with a treatment, eponymously named Coley’s toxins, derived from killed bacteria. Dr. Coley is now recognized as a pioneer of modern cancer immunotherapy.

While Coley noted well documented “occasional miracles” and observed that a significant portion of patients benefited from his therapy,6,7,8 a consistent, effective, and safe means of driving infection-associated anti-cancer immune responses eluded Coley. In addition to inconsistent results, Coley designed his treatment to generate a full body (i.e., systemic) immune response, by injecting his treatment intravenously or directly into the tumour. The resultant fever and chills, lasting 12 – 24 hours, was challenging for patients, particularly since the treatment was given every two or three days for at least several months.

At Qu Biologics, we believe we have discovered why Coley’s treatment worked in some cases but not in others, and that a systemic response is not required. By discovering the underlying mechanism of how acute infection helps our body fight cancer, we believe that we have discovered a simple, safe, consistent and effective means of restoring immune function in the targeted organ or tissue, administered by simple subcutaneous injection, and, in doing so, a modern leading edge cancer immunotherapy platform.

Targeted SSIs stimulate immune function at the site of the cancer

Effective anti-cancer immunity requires targeted activation of innate and adaptive anti-cancer immune responses in the organ or tissue in which the cancer is growing. Each SSI is derived from inactivated bacterial components from a single bacterial species known to be a common cause of infection in the targeted organ or tissue, for example, the lungs. Self-administered by simple subcutaneous injection (i.e., similar to an insulin injection), SSIs are designed to recruit activated immune cells to the targeted organ or tissue in which the cancer is growing, where they restore normal immune function and induce an anti-cancer immune response through a broad range of immunological mechanisms and immune cells, including both the innate and adaptive immune systems. Unlike other cancer immunotherapies that are designed to block or stimulate a specific receptor, SSIs are designed to restore normal immune function, which includes a wide range of normal anti-cancer immune responses.

Designed to initiate the innate immune response associated with acute infection, each SSI is designed to target a specific organ or tissue. For example, an SSI derived from inactivated K. pneumoniae, a bacterial species that is a common cause of lung infection, is designed to recruit activated immune cells to the lungs to treat lung cancer and cancer metastases growing in the lung. An SSI derived from an enteropathic (i.e., gastrointestinal infection) strain of E. coli is designed to treat colorectal and other abdominal cancers. Administered by simple subcutaneous injection, SSIs are designed to restore immune function in the targeted organ or tissue in which the cancer is growing, supporting the body’s own innate capacity to heal.

SSIs for cancer

The SSI approach is designed to have significant treatment advantages:

  • Chemotherapy and radiation suppress immune function, often leading to chronic impaired immune function. SSIs on the other hand, are designed to restore normal immune function and stimulate an anti-cancer immune response. Read more about how SSIs work.
  • Most immunotherapeutics are designed to block or stimulate a specific receptor or pathway, leading to (1) side-effects in other organs/tissues and (2) resistance to the drug since multiple pathways typically provide a means to circumvent the blocked or stimulated receptor or pathway. SSIs, on the other hand,have had an excellent safety profile in our oncology clinical experience to date and are designed to restore normal immune function, including engaging a broad range of immunological mechanisms and immune cells and normal anti-cancer immune responses.
  • Unlike other cancer treatments, SSIs are organ specific, not cancer-type specific. For example, a lung-targeted SSI is designed to treat any cancer growing in the lung, regardless of the primary origin of the cancer. By restoring normal immune function in the lung, a lung-targeted SSI is designed to treat primary lung cancer or cancer that has metastasized to the lungs (from, for example, melanoma, colon cancer, breast cancer, prostate cancer, etc.)
  • SSIs are designed to drive normal immune activation.The immune system, by its nature and purpose, is highly adaptive when functioning normally. As cancer mutates, resulting in resistance to conventional chemotherapeutic agents, a normally functioning immune system can evolve and respond to these mutations, keeping cancer in check.
  • SSIs are designed to induce protective immune memory, which may prevent the cancers from metastasizing.
Lung cancer clinical trial enrollment complete

Qu Biologics has completed enrollment of a Health Canada-approved 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 assesses the immunological effects of SSI treatment and will provide the precedent for a larger, randomized, controlled trial to assess the effectiveness of QBKPN SSI for the treatment of late stage lung cancer.

Promising compassionate use clinical data (cancer)

Qu Biologics SSIs were first used clinically in a compassionate use program in patients with advanced cancer. From 2008 to 2012, 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. Read more about the excellent safety profile and promising clinical data in Qu Biologics’ compassionate use program in advanced cancer.

Synergistic effects of SSI treatment

Synergy occurs when two treatments help each other work better, producing results that are greater than the sum of their individual effects (i.e., 1 + 1 = >2). In preclinical mouse models, Qu Biologics’ scientific team have demonstrated that SSI treatment works synergistically with standard chemotherapy to enhance its effectiveness, suggesting that, in addition to their potential as individual cancer treatments, SSIs may be important adjuncts to standard cancer treatments. Read more about this preclinical synergy data and the mechanism of action of this synergy. Qu is currently assessing the capacity of SSIs to augment the activity of other standard therapies and novel immunotherapeutics.

SSIs restore macrophage function, leading to effective anti-cancer immunity

Macrophages, important cells of our body’s innate immune system, play an essential role in defense against bacterial infection and cancer. SSIs are designed to mimic acute bacterial infection and stimulate site specific recruitment of activated macrophages to the tumour, initiating an anti-cancer immune response. Activated macrophages within tumours help to stimulate our body’s immune system. Their presence within tumours is associated with better survival across a range of cancer types. In preclinical studies, Qu Biologics scientific team and academic collaborators have demonstrated that SSI treatment results in targeted recruitment of activated macrophages with reduction in tumour burden and increased survival. Read more about the role of macrophages in cancer and SSI treatment.

  1. Everson TC, Cole WH. Spontaneous regression of cancer. A study and abstract of reports in the world medical literature and personal communications concerning spontaneous regression of malignant disease.W.B Saunders Co. Philadelphia. 1966.
  2. HoptionCann et al. Spontaneous regression: a hidden treasure buried in time. Medical Hypotheses. 2002; 58(2): 115-119
  3. Abel U, Becker N, Angerer R, et al. Common infections in the history of cancer patients and controls. J Cancer Res ClinOncol. 1991; 117(4):339-344.
  4. Kolmel K, Gefeller O, Haverkamp B. Febrile infections and malignant melanoma: results of a case-control study. Melanoma Res. 1992; 2:207-211.
  5. Stephenson HE, Delmez JA, Renden DI, et al. Host immunity and spontaneous regression of cancer evaluated by computerized data reduction study. SurgGynecol Obstet. 1971 Oct;133(4):649-55.
  6. Coley WB. The treatment of malignant tumors by repeated inoculations of erysipelas: with a report of ten original cases. .Am J Med Sci 1893; 105:487-511.
  7. Nauts HC, Fowler GA, Bogatko FH. A review of the influence of bacterial infection and of bacterial products (Coley’s toxins) on malignant tumors in man.Acta Med Scan Suppl 1953; 276:1-103.
  8. Nauts HC. The beneficial effects of bacterial infections on host resistance to cancer: end results in 449 cases. 2nd Ed. Monograph No.8. New York: Cancer Research Institute, 1980.

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