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he remembered it from his days working at the DNAX Research Institute years ago. Then he started reading more of the updated scientific literature, including a paper Mumm and Oft got published in 2011 in Cancer Cell. It was about how pegylated IL-10 appeared to be effective against tumors in mice. Interestingly, it also appeared to “teach” the immune system to recognize cancer and attack it again months later.
Armo set out to get a license to the technology from Merck, and rolled up some other intellectual property from Renovo to make sure it had freedom to operate. Given the drug had already been in so many clinical trials, it took less than a year for Armo to get the modified pegylated version in position to start its first clinical trial.
The first clinical study is enrolling patients with a variety of solid tumors at a variety of doses, and will assess safety, Van Vlasselaer says. The historic record of IL-10 in clinical trials suggests it has mild side effects, with fever, chills, headaches that last no more than a few days. Besides purely looking at safety, the company hopes to see some kind of anti-tumor effect as it ramps up dosing. It also plans to look for biomarkers which might be able to help predict which patients are likely to respond—something that other immunotherapies have been unable to do.
Besides cancer immunotherapy, Armo has plans to test its molecule against fibrosis, homozygous familial hypercholesterolemia, and potentially other uses in 2014. There are tough competitors in those areas—incluing Sanofi/Isis Pharmaceuticals and Aegerion Pharmaceuticals in homozygous familial hypercholesterolemia—but Van Vlasselaer said he’s undeterred. “We believe if you look at the science, the mechanism of action of peg IL-10 is really unique,” Van Vlasselaer says.