Bethesda, MD's Northwest Biotherapeutics ($NWBO) has watched as rivals Dendreon ($DNDN) and ImmunoCellular ($IMUC) have run into serious roadblocks with personalized cancer vaccines over the past year, but with a major Phase III study underway, the biotech believes it can change the narrative.
As Reuters reports, Northwest's brain cancer-treating DCVax-L is like its dendritic forebears in that it uses a patients' own immune cells to attack tumors. However, as the company takes pains to point out, its vaccine differs by using a full set of tumor antigens to target its attack, instead of tapping a pre-selected bunch of biomarkers. That, Northwest believes, makes for a more effective treatment and differentiates DCVax-L from ImmunoCellular's ICT-107, which failed a Phase II trial in glioblastoma in December.
Now it's up to Northwest to prove it. After a touch-and-go cash situation forced it to pause enrollment in 2010, the company is in the midst of a 312-patient Phase III study with a primary endpoint of progression-free survival, expecting data by mid 2015. In a Phase II trial, patients in the treatment arm more than tripled the average time without tumor recurrence and survived more than twice as long as those receiving standard of care.
And despite ImmunoCellular's high-profile failure and Dendreon's prolonged inability to capitalize on an FDA approval, investors seem to be willing to give dendritic vaccines another shot. Northwest had little trouble raising about $27 million in a November public offering, and North Carolina's Argos Therapeutics ($ARGS), which is developing a similar treatment for kidney cancer, pulled off a $45 million IPO earlier this month. Agenus ($AGEN), which is working on a personalized glioblastoma vaccine of its own, has nearly doubled its share value since the fall thanks to some promising Phase II results.
But analysts believe Northwest could be the star of dendritic vaccines' next wave, according to Reuters, and a Phase III win could position DCVax-L for a swift approval and a major role in the brain cancer market.
"If it has a positive result, it could be the new standard of care for brain cancer and have potential for hundreds of millions of dollars in sales for newly diagnosed patients," Summer Street Research analyst Carol Werther told Reuters. "And if it works against other solid tumors, it could be a multibillion-dollar product."
Northwest, counterintuitively headquartered in the Mid-Atlantic, is also developing the solid tumor-treating DCVax-Direct, which is now working through a 60-patient Phase I/II trial, and the company has secured the FDA's blessing to kick off a 612-patient Phase III study for DCVax-Prostate.
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