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This morning, Northwest Biotherapeutics (NASDAQ:NWBO) announced the initiation of a 60-patient Phase I/II trial at the MD Anderson Cancer Center for the newest version of their personalized cancer immunotherapy DCVax-Direct - here is the press release (link). The trial will consist of a standard dose escalation phase, which should determine the optimal regimen for the Phase II portion of the trial, which will examine the efficacy of the therapy with a RECIST-measured tumor shrinkage endpoint. Particularly interesting about the Phase II portion is that patients will be arranged in cohorts, depending on their type of cancer. This should provide some clues as to which types of cancer DCVax works best in.

As mentioned by company management, there are few concerns about the safety profile of the therapy, since the DCVax platform uses a patient's own cells. This bodes well for the future approval process of the therapy, given that it can meet particular thresholds in efficacy.

Worth noting is that Northwest is also enrolling glioblastoma patients into a Phase III trial for the glioblastoma multiforme indication, which is expected to produce top-line data near the end of 2014. Of the two trials mentioned thus far, I believe that the market will pay more attention to this late-stage, since it could bring DCVax-L to the market as early as late 2015 or early 2016. Existing treatments for glioblastoma, a very aggressive brain cancer, are currently limited to mainstream drugs like Avastin for patients who have advanced stages of the disease.

Since DCVax offers a radically new mechanism of action to target the tumor cells without introducing toxicity, market penetration could be very significant if the Phase III results show significant overall survival [OS] benefit. Data from Phase I/II development for DCVax-L implies that we may see median 19-20 month extension of late-stage glioblastoma patients' lifespans - significantly better than glioblastoma therapies on the market today.

It's because of this potential to do very well in the glioblastoma patient population in a late stage trial that I think the market will be especially excited about Northwest's data in late 2014. This would be the data release that could feasibly move shares of NWBO well above their all-time highs.

Mechanism of Action

DCVax is a cell therapy that involves the extraction of a patients' dendritic cells and the introduction of antigens (biomarkers) expressed by tumor cells, which results in "education" of the dendritic cells. Essentially, the process that Northwest Bio uses will prepare a patient's dendritic cells to signal a T-cell response against the tumor cells of each individual patient.

Since the particular mechanism of action of this therapy is very broad and even fundamental (due to its reliance of the immune system), DCVax has the capacity to move into a large number of cancer indications.

DCVax-Direct, the version that has just begun human testing at MD Anderson, is particularly interesting since it is a specialized therapy for inoperable solid tumors. This is one of the particularly challenging oncologic indications, although animal data has suggested that personalized immunotherapy can bypass many of the problems that disrupt the function of protein-targeting molecules and chemotherapies.

Source: Northwest Biotherapeutics: Targeting Glioblastoma With Immunotherapy