Logistical and manufacturing complexities have tempered hype around personalized cancer vaccines for years, with skeptics questioning the viability of removing, reprogramming and reintroducing immune cells on commercial scales. An implantable vaccine aims to overcome these problems.
Once implanted in the body, the Harvard University-developed device is designed to recruit and reprogram immune cells to attack tumors. Performing the reprogramming in the body ends the need to remove immune cells and ship them to a production plant, potentially cutting costs by eliminating a logistical challenge. These complexities are one of the issues affecting the profitability of Dendreon's ($DNDN) prostate cancer vaccine Provenge.
Evidence the device could overcome these problems first emerged in 2009, when its developers published data showing it eliminated tumors in mice. Since then the team has worked to ready the device for human trials, culminating in the start of a Phase I melanoma study this week. "It is rare to get a new technology tested in the laboratory and moved into human clinical trials so quickly. We're beyond thrilled with the momentum, and excited about its potential," Harvard Medical School professor Glenn Dranoff said.
Phase I safety data is due in 2015. As Cancer Research U.K. told The Independent, the implant is still early in development and will need to show efficacy in multiple large trials before winning approval. Late-phase trials have undone many promising cancer vaccines in recent years, with GlaxoSmithKline's ($GSK) disappointing MAGE-A3 data the latest in a string of flops.