By Tom Ballard, Chief Alliance Officer, PYA
One of the pieces of advice that start-up entrepreneurs receive is to have one or more back-up plans in their back pocket in case their first path forward does not produce the results they wanted.
That’s certainly the case with EDP Biotech Corporation, according to Eric Mayer, the Knoxville-based company’s Chief Executive Officer (CEO), echoing the philosophy of company Founder and serial entrepreneur Tom Boyd who says: “keep trying new things until you find what works.”
With March being National Colorectal Cancer Awareness Month, we wanted to get an update on the progress the start-up is making in developing products, initially for colorectal cancer detection, to identify and purify proteins present in the early stages of biological changes in an individual.
“We’ve made a pretty big pivot,” Mayer told us in our recent conversation. “We’re building a new product and going after a faster path to market in a slightly different (part of the colon cancer screening) market segment, using state-of-the-art data science to solve a complex biologic problem.” EDP’s goal remains detection of early-stage cancers and precancerous polyps, but doing so in a more cost-effective manner for healthcare systems.
When we posted this teknovation.biz article a little more than a year ago, EDP Biotech’s CEO said that its original product – its ColoMarker® – was “our top target,” but added that the company had other innovative technologies in its portfolio that could help with early detection. That reservoir has proved to be significant.
The company’s initial target market for the product remains the European Union where 24 countries either have implemented or are in the process of implementing compulsory screening for colon cancer. After all, if colon cancer is detected and treated early, the survival rate is about 90 percent after five years.
“What we learned as a small company, is it is hard to move the needle with so many players already in, or soon looking to enter, that (EU) market,” Mayer said. “But as a small company, we are able to move quicker and adapt to market changes perhaps faster than big biotechs.”
The company began assessing a slightly different path forward in mid-2017, based on some of its parallel research, after recognizing that the European market needs had begun to change.
“We did a lot of prototyping in 2017 and have multiple independent assessments that this approach is working, and should be scaleable to meet the screening needs of European national health services,” Mayer said. Those discussions included input from clinical research organizations (CROs) and contract manufacturers early in the product life cycle.
The board of directors approved, and the new plans were announced to company stockholders in December.
“This had been our parallel Path C, but quickly replaced other paths as a more modern solution to the colorectal cancer screening problem” Mayer said. It is a new technology, new product, and new brand – ColoPlex®. The initial focus is still as an early detector for the possibility of colon cancer, especially in high-risk populations, but the revised business plan opens-up many additional possibilities.
Without getting too technical, EDP Biotech still analyzes blood drawn from a patient during a routine physical examination for the presence of protein-based biomarkers that would indicate that the individual should have a confirmatory colonoscopy. The results are provided to the individual’s physician. What has changed are the biomarkers being measured, how they are being measured, and how the final result is being delivered.
“ColoPlex® is a new type of testing called multiplexing,” Mayer explains, emphasizing the “multi” part of the word.
“This is a totally new platform technology that could allow us to look at up to 50 proteins from a single blood draw,” he says, using new instrumentation. Coupled with artificial intelligence and machine learning, more data per patient will give a more accurate picture of that individual’s disease. That opens-up significant possibilities of strategic partnerships with companies focused on modern approaches to fighting cancer and other diseases.
If everything goes as planned with existing trials in the EU, Mayer says EDP Biotech could be in the market in Europe by the end of this year. That timing is based on several factors. They include clinical studies that were set-up in 2015 and what Mayer calls “off-the-shelf” components that EDP Biotech can incorporate into ColoPlex®.