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bells and whistles to their experimental products. One example is safety switches—methods to disable the cells if they go awry once in the body. Another is extra stimulation to help T cells overcome some of the tricks solid tumors use to suppress immune response. (There are a host of other start-ups, many of which Xconomy has written about, working on improvements to T cells, checkpoint inhibitors, and other kinds of immunotherapy. You can read about some of them here, here, here, and here.)
There’s one other hurdle the T-cell based immunotherapy companies will have to surmount: manufacturing. The companies tell us they’ve learned lessons from Dendreon, whose pioneering cell-based immunotherapy for prostate cancer came to market but failed to catch on—at least not enough to dig the company out from its massive debt load. (Juno CEO Bishop ran Dendreon’s operations.)
But so many things can go wrong making biologically active products. Just ask Genzyme, which was weakened and ultimately acquired less than two years after manufacturing glitches shut down a key Boston-area plant.
One investor, whose exchange-traded fund of 70 biotech companies includes nine clinical-stage immuno-oncology companies, says manufacturing worries him more than side effects. “It’s not a sexy topic, but it’s extremely important,” says Andrew McDonald, who helps manage the BioShares Biotechnology Clinical Trials Fund. “These will be challenging therapies to manufacture in a reproducible fashion.”
Manufacturing isn’t a problem the checkpoint inhibitors face, but those drugs have had no traction in treating blood cancers. It’s a good example how each type of cancer immunotherapy has its own set of challenges and trade-offs. “The impact of the entire swath of immunotherapy strategies leaves a lot on the table,” says Flaherty of Mass General. “I’m an optimist, but there’s a long way to go.”
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