There are a lot of radical ideas for treating cancer, and most are pure bunk. But now one of Seattle’s most promising biotech startups, Alder Biopharmaceuticals, says it has the first hard evidence to support a concept that would have gotten them laughed out of the room by most cancer physicians a year ago.
Alder’s big idea is to treat cancer without fighting the tumor. And even without shrinking tumors or keeping them from spreading, the company now says it has evidence that suggests its drug will help cancer patients live longer, and enjoy a higher quality of life. The first glimpse of solid data to back this up, from a 124-patient study of cancer patients who got Alder’s experimental drug or a placebo, is coming out next month on the biggest stage in the world of cancer drug development, the American Society of Clinical Oncology’s annual meeting.
“When we got our first data and proposed this study, we ran into oncologists who said, ‘If you’re not killing the tumor, we’re not interested,'” says Randy Schatzman, Alder’s co-founder and CEO. “But then we talked to others who said it’s really nice to have something that treats the patient, not the tumor.”
Alder comes from humble beginnings as a true bootstrapped company, and it first rose to national prominence last November. That’s when pharmaceutical giant Bristol-Myers Squibb agreed to pay Alder as much as $1 billion over time for the right to co-develop the small company’s experimental antibody drug for rheumatoid arthritis. The drug is so highly prized because it is made in a yeast-based manufacturing system that is much faster and cheaper than the traditional approach, which makes biotech drugs in mammalian cells. Roche has already proven that it can win FDA approval for a new drug that hits an inflammatory protein known as IL-6, which is the same molecule that Alder is seeking to tamp down with what it considers a better, faster, cheaper alternative.
What few people realized about that deal at the time is that Alder retained 100 percent global ownership rights to the same drug that targets IL-6, ALD518, for use as a cancer therapy. Research has been pouring out of academia for years that shows how excess inflammation from proteins like IL-6 is what Schatzman calls “the true villain” that really kills people who have cancer. About one-third of cancer patients suffer from cachexia (pronounced Kuh-KECK-see-uh), which is extreme fatigue and muscle atrophy that comes from inflammatory overdrive. Doctors can give patients generic immune-suppressors, but they are blunt instruments that have unwanted side effects. Most of the time doctors are so concerned about the tumors, they don’t bother to treat the inflammation that makes people feel miserable.
Regardless of what the X-rays or CT scans might say about how well chemotherapy is doing to shrink tumors, the extreme fatigue of cachexia causes patients to lose weight, lie in bed, get depressed, and basically waste away until they die. “Eventually, a lot of people sort of lose the will to live,” says Mark Litton, Alder’s chief business officer.
The concept is that ALD518, given in an intravenous infusion, will specifically latch onto the excess IL-6 inflammatory molecules and neutralize them. Since overactive inflammation consumes extraordinary amounts of energy—if you’ve had the flu, you know what I mean—then it stands to reason that if you tamp down excess inflammation, people will feel more vigorous. For a cancer patient, that could mean