idea of making it into an ex vivo model of someone’s own cancer. That term refers to taking a person’s cells outside of the body, but not growing them.
“The reason that we chose to do it that way is so that we can try and maintain these cells to be as close to what they are like inside the person’s body,” Pak explains. “The worry is that if you culture these and if you grow them out or expand them, they can potentially change.”
Lynx’s assay, called MicroC3, falls into a class of tests known as companion diagnostics. Pak says that most of these diagnostics measure a biomarker, such as a gene or a protein, which could show response to a particular drug. However, because the measurement of MicroC3 is whether cells live or die after coming into a contact with a drug, the startup could potentially develop the test as a companion diagnostic to any blood cancer therapy, Pak says.
Other companies, including Seattle-based Presage Biosciences, are developing methods of testing combinations of cancer drugs in live tumors. However, Pak says that as far she knows, most of them are working to create assays that measure the sensitivity or resistance of cells to chemotherapies with treatments for solid tumor cancers in mind.
“Their technology can’t be applied to blood cancers,” Pak says of Presage Biosciences. “We believe that this is an untapped space for us to move into.”
Once Pak and her fellow researchers had created a model of its co-culture system, they began using it to test drugs against samples of patient cells in collaboration with Natalie Callander, a hematologist who directs of the Myeloma Clinical Program at the UW Carbone Cancer Center. The first drug they tested was bortezomib, a common component of multiple myeloma therapies. The group then decided to conduct a small (17 patients), retrospective clinical study involving the drug and its system.
Pak says that the drug responses the researchers found with their test were the same as what was produced in the clinic.
They described some of their findings in a paper, which was published by Integrative Biology in 2015.
Since it was a retrospective study, the researchers proved only that a correlative—but not necessarily causal—relationship between the device and clinical conclusions.
Lynx now wants to prove that more than just a correlation exists, and last March kicked off a prospective study to prove that MicroC3 can actually predict clinical responses. The trial will draw from three sites in Wisconsin, Pak says.
The company hopes to close out the study later this year, and start the next one—Lynx’s pivotal clinical trial—in early 2018, Pak says. It would be the first time MicroC3 would be used to “stratify” patients, or determine which ones receive bortezomib-containing therapy, and which ones don’t, she adds.
Pak says that it would likely take between 12 and 18 months to enroll patients in the pivotal
