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IMV to Initiate New Phase II of DPX-Survivac for Glioblastoma

By Grant Zeng, CFA

Earlier today (May 30, 2013), Immunovaccine Inc. (IMV.V) announced that it has agreed to use its lead cancer product, DPX-Survivac, in a study based in Rome designed to extend life for glioblastoma patients.

The multicenter Phase II trial will be led by Professor Marianna Nuti, Ph.D., Department of Experimental Medicine at the University of Rome, and conducted in collaboration with neurosurgeons and oncologists coordinated by Professor Maurizio Salvati, M.D. Four major trial centers across Italy will be involved, with the cost of the trial being assumed by the university.

The randomized, placebo-controlled Phase II study will evaluate DPX-Survivac therapy in combination with temozolomide, the standard of care therapy for newly diagnosed gliobastoma patients following surgery and radiation. The trial will enroll more than 50 patients.

Patients will be randomized into three groups to receive either DPX-Survivac; a dendritic cell (DC) based survivin vaccine; or, the standard of care with a placebo vaccine. The primary goal of the study is to evaluate the effectiveness of DPX-Survivac. Secondary endpoints will include progression-free survival and overall survival following the proposed combination therapy.

The study is expected to start in Q4 of 2013.

The rationale for this trial is that survivin is over expressed on most glioblastoma (brain cancer) cells and IMV’s DPX-Survivin targets survivin. DPX-Survivac has demonstrated promising immunogenicity in a clinical trial in ovarian cancer patients.

The New Clinical Trial Expand IMV’s Pipeline

The new Phase II study of DPX-Survivin is a surprise for us, which will expand the Company’s pipeline. As a result of the new Phase II trial, IMV will have two Phase II clinical studies by the end of this year.

Earlier this year, IMV reported positive results from the Company's Phase I clinical trial of DPX-Survivac for ovarian cancer. Data showed all patients that had received DPX-Survivac in combination with cyclophosphamide produced targeted immune responses and that there were multiple strong responders among this group who presented circulating target and sustained specific T cells (CD8 T cells) in their blood.

The presence of circulating CD8 T cells is critical in treating cancer because these particular T cells are implicated in identifying cancer cells, infiltrating tumors and killing cancer targets. Data also demonstrated that the vaccine had no systemic side effects or dose limiting toxicities.

The Phase II trial of DPX-Survivin for ovarian cancer will be a randomized, double-blinded, placebo-controlled study with a single vaccine dose selected based on the Phase I results.  The Phase II trial will assess the clinical benefit of DPX-Survivac in patients with advanced ovarian cancer.



A Big Market for DPX-Survivin Glioblastoma

The new indication of DPX-Survivin for glioblastoma also targets the big market of brain cancer.

Great Market Opportunities for ICT-107

Glioblastoma multiforme
(GBM), also called glioblastoma, is the most common and most aggressive type of primary brain tumor and accounts for approximately 50% to 60% of all primary brain tumors.

According to National Cancer Institute (NCI) data, the peak incidence occurs between the ages of 45 and 70 years. In the United States, the age-adjusted brain tumor incidence rate was 6.5 per 100,000 men and women per year. The age-adjusted death rate was 4.3 per 100,000 men and women per year. It is estimated that 22,020 men and women (11,980 men and 10,040 women) will be diagnosed with and 13,140 men and women will die of cancer of the brain and other nervous system in 2010 in the US.

Worldwide, approximately 176,000 new cases of brain and other CNS tumors were diagnosed in the year2000, with an estimated mortality of 128,000.

Glioblastomas are among the most aggressively malignant human neoplasms. The median survival time from the time of diagnosis without any treatment is usually less than 1 year. Despite multimodality treatment consisting of open craniotomy with surgical resection of as much of the tumor as possible, followed by concurrent or sequential gamma knife radiotherapy, chemoradiotherapy, targeted therapy, and symptomatic care with corticosteroids, median survival is about 14 months. The overall 5-year survival is less than 10% with the standard of care today. Increasing age (> 60 years of age) carries a worse prognostic risk. Death is usually due to cerebral edema or increased intracranial pressure.

Surgery and radiation
is the mainstay of treatment for glioblastoma

A pivotal clinical trial carried out in the early 1970s showed that GBM patients who received radiation had a median survival more than double those who did not receive radiation therapy. Subsequent clinical research has attempted to build on the backbone of surgery followed by radiation.

(including targeted therapy) is a third method to treat glioblastoma. Although the addition of chemotherapy to radiation improves survival in many cancer types, this is not the case for glioblastoma. Most studies showed no benefit from the addition of chemotherapy to radiation for glioblastoma patients. However, currently, two chemotherapeutic agents (including one targeted therapy) approved by the FDA are frequently used for the treatment of glioblastoma in combination with radiation therapy. They are Temodar (temozolomide) from Merck/Schering Plough for newly diagnosed GBM and Avastin from Roche for recurred GBM.

A large clinical trial of 573 newly diagnosed GBM patients randomized to standard radiation versus radiation plus temozolomide chemotherapy showed that the group receiving temozolomide survived a median of 14.6 months as opposed to 12.1 months for the group receiving radiation alone. This treatment regime is currently considered standard of care for glioblastoma and has a 26% survival at two years.

The US FDA recently approved Avastin (bevacizumab) to treat patients with recurred glioblastoma (but not newly diagnosed GBM which is DPX-Survivin’s initial target) after standard therapy based on the results of 2 studies that showed Avastin reduced tumor size in some glioblastoma patients. In the first study, the efficacy of Avastin was demonstrated by an objective response rate of 25.9%. Median duration of response was 4.2 months. In the second study, the efficacy of Avastin was supported by an objective response rate of 19.6%. Median duration of response was 3.9 months.

Clearly, there is an unmet medical need for the treatment of glioblastoma.

The glioblastoma market is a multibillion dollar business. Worldwide sales of Temodar reached $1 billion in 2009. If DPX-Survivin ultimately reaches the market, it will command a huge market share of the GBM market due to its outstanding safety profile in our view. This means a lot to a small biotech company like IMV even with a few hundred million dollars in sales.

With the Phase II trial to enroll patients soon, IMV is one step closer to achieve its long term goal. The market potential is even greater if we consider that DPX-Survivin can also target other cancer indications, such as ovarian cancer.

A copy of the latest research report can be downloaded here >>  Immunovaccine Report

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