In certain patients who are being treated for cancer, it’s possible for cells to detach from the tumors inside their bodies and begin moving through the bloodstream.
These circulating tumor cells, or CTCs, can help oncologists and other clinicians determine how a disease is progressing, and how effective treatments given to that patient have been.
But getting this information requires capturing CTCs, which is not an easy task, in part because CTCs are so rare. That’s according to Seungpyo Hong, a professor at the University of Wisconsin-Madison School of Pharmacy. He is also the co-founder of Capio Biosciences, a startup that’s seeking to commercialize a device that he says could help researchers and healthcare workers capture greater numbers of CTCs than they are able to with the one system that has been cleared for clinical use to date.
Hong joined the faculty at UW-Madison from the University of Illinois at Chicago last month. Capio, which gets its name from the Latin word for “capture,” also changed addresses as part of the move.
The startup, which was launched in 2013 by Hong and Andy Wang, an associate professor of radiation oncology at the University of North Carolina at Chapel Hill, recently raised $2.9 million in equity financing from investors. Hong says that China-based Betta Pharmaceuticals was the “major investor” in the Series A funding round. It could top out at $4.5 million, he says, provided Capio is able to hit certain milestones. Hong declined to provide specifics on what those are.
Hong and Wang met when they were both working as researchers in the lab of Robert Langer, a professor at MIT (and an Xconomist). According to the university, Langer has nearly 1,050 patents worldwide, which have in turn been licensed or sublicensed to hundreds of science and healthcare-focused companies.
Capio’s two co-founders were both at MIT from 2006 to 2008. That was not long after the FDA cleared Raritan, NJ-based Veridex to market CellSearch, a testing kit for capturing and counting CTCs. (Veridex, which is part of Johnson & Johnson (NYSE: JNJ), is now known as Janssen Diagnostics.) There was a lot of buzz around CTCs at the time—“the field was about to explode,” Hong says—so he and Wang decided to take a closer look.
Today, CellSearch remains the only system for CTC diagnostics to receive FDA clearance. But Hong says that over the past few years, he and Wang have grown more confident that Capio’s device, which they are calling OncoSense CTC, will allow users to capture more tumor cells than they can using CellSearch or systems from likely competitors.
The process of designing and engineering OncoSense CTC involved trying to imitate what nature does, Hong says. Cells flowing quickly through the bloodstream can experience “binding events” while rolling along the wall of a blood vessel, and then transmigrate out of the blood vessel into another region and start a tumor or inflammation, he adds.
“We mimicked that rolling and adhesion process,” Hong says. “In addition, we introduced some of the nanomaterials based on polymers that can maximize the binding events to be as effective as possible. By doing that, we have been able to show that our device can capture CTCs really well.” And when more cells are captured, it becomes easier for clinicians to spot trends, he says.
But Hong is careful to not get ahead of himself.
“It’s a little too early to tell,” he says. “We don’t have that [much data] yet, but based on the patients we’ve seen so far, their CTC trend has been really well coordinated with the clinical outcome.”
So far, Capio has conducted three clinical studies that together have involved 60-plus patients, Hong says. Many of them receive care at UNC Health Care in Chapel Hill, NC, near where Wang works.
Hong says that a typical patient is recruited upon receiving a cancer diagnosis, then undergoes a liquid biopsy, a minimally invasive blood test to look for cancer cells. Additional blood samples are collected after each round of treatment, he adds.
“If the CTC numbers go down, their response is typically good,” Hong says. “If the CTC numbers go back up, their response is not really good. That’s how we read their cancer progress.”
Capio, which only has two full-time employees but gets help from postdoctoral researchers who work in the co-founders’ labs, has looked at several different types of cancer; the list includes head and neck, renal, prostate, and lung. Currently, CellSearch is intended for use in patients with breast, prostate, or colorectal cancer, according to Janssen Diagnostics’ website.
Capio established a joint venture with Betta Pharmaceuticals that specifically targets lung cancer, in part because that disease is so prevalent in China, Hong says.
“The joint venture is to develop this technology in China for the Chinese market,” he says. “Betta has strong interest in non-small cell lung cancer targeted therapies. We see some synergy there.”
Meanwhile, in the U.S., Hong says Capio will continue to collect data from clinical studies, and he hopes the startup will be ready to apply for FDA clearance in two or three years.
Hong referred to OncoSense CTC as a “diagnostic device,” but says the company has not yet decided whether it will go down the regulatory pathway for a diagnostic, or the one for a medical device.
“It is a bit premature…to clearly state our strategies [regarding] the regulatory clearance process,” he says.
Capio also still has yet to determine which cancer OncoSense CTC will target first, but he says that after receiving its first FDA clearance in a cancer, regulatory nods for other forms of the disease would likely follow.
“But our technology is a platform technology, so we can expand to other types of diseases as well,” Hong says.