Qu Biologics Launches Phase 2a Clinical Trial for Non-small Cell Lung Cancer (NSCLC)

VANCOUVER, BRITISH COLUMBIA--(Marketwired - Jan. 20, 2015) - Qu Biologics Inc., a biotechnology company developing Site Specific Immunomodulators (SSIs) that aim to restore the body's normal immune function in the targeted diseased organ, announced that it has initiated a Phase 2a clinical trial in non-small cell lung cancer to study QBKPN SSI investigational treatment.

The trial is a Phase 2a Open Label, Single-Arm, Exploratory Study to evaluate the immunological effects and safety, tolerability and compliance of QBKPN SSI in subjects with lung cancer recurrence following surgical resection of Stage 1 non-small cell lung cancer. The trial is taking place at the BC Cancer Agency Research Centre under Principal Investigator Dr. Stephen Lam. QBKPN SSI is derived from components of inactivated bacteria, and is designed to activate an anti-cancer immune response in the lungs.

Qu Biologics' CEO Dr. Hal Gunn stated, "We are very pleased to have initiated this important study in lung cancer. SSIs represent a promising new approach to treating cancer by engaging the body's own immune response." He added, "Lung cancer is the leading cause of cancer death worldwide. We anticipate that this trial will provide the basis for a larger randomized controlled trial to assess the effectiveness of QBKPN SSI in the treatment of late stage lung cancer."

Prior to this clinical trial, Qu Biologics' QBKPN SSI was used to treat 105 patients with late stage lung cancer or lung metastases in a compassionate use program. An independent research group initiated a case-matched study of late-stage cancer patients treated with SSIs in the compassionate use program as a preliminary assessment of SSI efficacy. The study assessed the survival of 43 matched cases, including 7 matched cases of late stage lung cancer. Each patient treated with SSI was matched with a patient treated at the same clinic with the same type/stage of cancer who did not receive SSI. The case matched study found that patients with late stage lung cancer treated with SSI had a median survival of 15 months longer than those patients not treated with SSI.

The compassionate use program was not randomized or prospective and therefore, no definitive conclusions can be drawn with respect to SSI efficacy. Patients were receiving other concurrent therapies and many were diagnosed months before enrolling in the compassionate use program. However, the results provide the precedent for this Phase 2a study, which is now underway and enrolling trial participants, and for future studies to assess the effect of SSI treatment on survival in late stage cancers.

About Qu Biologics

Qu Biologics develops Site Specific Immunomodulators (SSI), a novel class of immunotherapies that aim to restore the body's normal immune response. SSIs are designed to stimulate an immune response in targeted organs or tissues to potentially reverse the chronic inflammation underlying many conditions including cancer and immune-related diseases. The company is currently recruiting participants for a Phase 1/2 placebo-controlled, randomized clinical trial in Crohn's disease and a Phase 2a open-label clinical trial in non-small cell lung cancer to research SSI treatment.

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, Chief Medical Officer Dr. Simon Sutcliffe, former CEO of the BC Cancer Agency and a distinguished clinician, scientist and leader in cancer control internationally, and Chief Scientific Officer Dr. David Mullins, Assistant Professor of Microbiology and Immunology in the Norris Cotton Cancer Center at the Geisel School of Medicine at Dartmouth, and recognized expert in immune cell trafficking to tumours. For more information, visit www.qubiologics.com.

About the BC Cancer Agency

The BC Cancer Agency, an agency of the Provincial Health Services Authority, is committed to reducing the incidence of cancer, reducing the mortality from cancer, and improving the quality of life of those living with cancer. It provides a comprehensive cancer control program for the people of British Columbia by working with community partners to deliver a range of oncology services, including prevention, early detection, diagnosis and treatment, research, education, supportive care, rehabilitation and palliative care. Visit www.bccancer.bc.ca. The BC Cancer Foundation is the bridge that connects philanthropic support and research breakthroughs in cancer.

Qu Biologics Inc. cautions you that statements included in this release that are not a description of historical facts may contain forward-looking statements. These forward-looking statements are only predictions and may involve known and unknown risks, uncertainties and other factors that may cause the actual results, events or developments to be materially different from those expressed or implied by such forward-looking statements. Readers are cautioned not to place undue reliance on such forward-looking statements. Qu Biologics does not assume any obligation to update any forward-looking statements except as required by law.