Immunovaccine and NCIC Clinical Trials Group To Collaborate on Phase II Study of DPX-Survivac

Immunovaccine Inc., a clinical stage vaccine company, today announced that Canada’s NCIC Clinical Trials Group (NCIC CTG) will sponsor and conduct a randomized Phase II study of Immunovaccine’s cancer vaccine, DPX-Survivac, in patients with advanced ovarian cancer. The study is designed to assess whether IMV’s vaccine therapy can delay or prevent cancer recurrence.

The Phase II trial is a randomized, blinded, placebo-controlled study with DPX-Survivac in combination with low dose oral cyclophosphamide as an immune modulator. The study will enroll approximately 250 patients with ovarian cancer at an estimated 20 clinical centers. The NCIC CTG is a Canadian-based academic clinical trials cooperative group conducting large multi-center clinical trials across Canada and internationally.

Patients in the trial will have undergone surgery and standard post-operative chemotherapy. Patients will be randomized to two groups, one receiving the combination vaccine therapy and another receiving a placebo vaccine and cyclophosphamide. Immune responses and disease-related biomarkers including CA125 will be measured for correlative analyses. The results may guide further development of DPX-Survivac.

“NCIC CTG’s decision to become actively involved in the development of our cancer vaccine validates the approach we have been pursuing for the therapy of ovarian cancer,” said John Trizzino, CEO of Immunovaccine. “Directing the bulk of the resources required to complete this study to NCIC CTG will help us realize our ultimate goal, to bring advanced science to patients in need.”

Earlier this year, Immunovaccine published positive results from the Company’s Phase I clinical trial of DPX-Survivac. The data showed that all 18 patients who had received DPX-Survivac in combination with cyclophosphamide produced targeted immune responses and that the majority of patients in one cohort of the study were strong responders who presented sustained circulating specific T cells (CD8 T cells) in their blood.

The presence of circulating CD8 T cells is thought to be critical in treating cancer because they are implicated in identifying and eradicating residual cancer cells. Controlling or eliminating these escaped cells may be one way of delaying or preventing recurrence of the cancer.

The Phase I trial demonstrated that the vaccine had no systemic side effects or dose-limiting toxicities.

DPX-Survivac is among a class of immunotherapeutic treatments that have attracted widespread interest in recent months. Bristol-Myers Squibb Company and Merck & Co Inc. both announced in May that immunotherapeutic drugs they are developing can dramatically influence the course of disease in cancer patients. (View announcements: BMS and Merck.)

As the incidence of cancer rises world-wide, researchers have been seeking ways to reprogram a patient’s own immune system to fight the disease and prolong life. The results of the Bristol-Myers and Merck trials provide a leap forward in immunotherapy. DPX-Survivac is an immunotherapeutic that is intended to teach the immune system to recognize and kill cells displaying the survivin signature. Survivin is present in many different types of cancer, including breast, colon and melanoma among others.

Ovarian cancer accounts for more deaths than any other gynecologic cancer. Symptoms do not occur until it is in the later stages of the disease, reducing the chance for successful treatment and remission. It kills more than 100,000 women annually around the world. Improved surgical techniques have helped to reduce the rate of recurrence according to some studies, but the average life expectancy of newly diagnosed ovarian cancer patients is less than 4 years.

The agreement between NCIC CTG and Immunovaccine will provide a framework for the NCIC CTG to sponsor the randomized Phase II trial and assume responsibility for conducting the trial in accordance with good clinical practice. The Company is in discussion with potential co-development partners to support the NCIC CTG-sponsored trial.

“The NCIC CTG is recognized for its effectiveness in conducting large international clinical trials,” Trizzino said. “By working with the NCIC CTG, we are able to advance our breakthrough science in an efficient and cost effective manner.”

The trial is expected to get underway in 2014 with results in 2017.

About the NCIC Clinical Trials Group
The NCIC Clinical Trials Group (NCIC CTG) is a cancer clinical trials cooperative group that conducts Phase I-III trials testing anti-cancer and supportive therapies across Canada and internationally. It is a national research program of the Canadian Cancer Society. The NCIC CTG's Central Office is located at Queen's University in Kingston, Ontario, Canada. The Group is committed to assessing all modalities of therapy for a spectrum of cancer types. More than 60 member institutions, from major cancer centres to community hospitals, enroll patients in NCIC Clinical Trials Group studies. Connect at http://www.ctg.queensu.ca/

About DPX-Survivac
DPX-Survivac consists of survivin-based peptide antigens formulated in the DepoVax™ adjuvanting platform. Survivin has been recognized by the National Cancer Institute (NCI) as a promising tumor-associated antigen (TAA) because of its therapeutic potential and its cancer specificity. Survivin is broadly over-expressed in multiple cancer types in addition to ovarian cancer, including breast, colon and lung cancers. Survivin plays an essential role in antagonizing apoptosis, supporting tumor-associated angiogenesis, and promoting resistance to various anti-cancer therapies. Survivin is also a prognostic factor for many cancers and it is found in a higher percentage of tumors than other TAA’s.

The DPX-Survivac vaccine is thought to work by eliciting a cytotoxic T-cell immune response against cells presenting survivin peptides on HLA class I molecules. This targeted therapy attempts to use the immune system to actively and specifically search for and destroy tumor cells. Survivin-specific T cells have been shown to target and kill survivin-expressing cancer cells while sparing normal cells.

About DepoVax™
DepoVax™ is a patented formulation that provides controlled and prolonged exposure of antigens plus adjuvant to the immune system, resulting in a strong, specific and sustained immune response with the capability for single-dose effectiveness. The DepoVax™ platform possesses impressive flexibility, allowing it to work with a broad range of target antigens in various therapeutic applications. The technology is also commercially scalable, with potential for years of stability and ease of use in the clinic.