By Lindsey Hellenbrand
Almost everyone has been affected by cancer in some way. Despite increased spending and research, some types of cancers still have low survival rates. Pancreatic cancer is a well-known example.
“Pancreatic cancer currently afflicts 48,000 Americans per year, with a five-year survival rate of less than 6 percent. In Wisconsin, pancreatic cancer is now the second leading cancer killer,” said Dr. Michael James, founder of Essential Biotechnology LLC.
A spinout from the Medical College of Wisconsin, Essential Biotechnology was created to develop a first-in-class targeted, antibody-based cancer therapy. The idea started with academic science intended to understand basic mechanisms of cancer. A team of seasoned industry veterans, committed scientists, clinical experts and clinical trial directors have assembled to work on bringing this therapy to cancer patients.
“There is such a dire need for better therapy for cancer patients, especially in our initial markets of pancreatic cancer and therapy-resistant disease,” James said.
Clinical outcomes for pancreatic cancer have made little improvement over the years, despite tripling the spending on research. Current therapy is dominated by cytotoxic chemotherapies that have been used for more than 20 years. They typically extend life by weeks and have significant toxicities.
Using the anti-CRR9 therapy, the research team is able to target a new mechanism in cancer. There is potential to extend survival of patients’ significantly more than existing therapies being used. Additionally, this therapy answers the market need by using significantly less toxic drugs. This approach seems to be effective in other types of cancers, as well. The team has shown it to be effective against lung cancer in animal models.
“There absolutely are other cancers that this could work for. It is important to have focus at first, to obtain unambiguous results in a short period of time,” James said.
Advancement to Phase I trials in pancreatic cancer patients, followed by other resistant cancers, will increase value for Essential Biotechnology and decrease risk for potential pharmaceutical licensees. Rigorous testing will assure that the therapy is safe and effective, before advancing to the market place. The Food and Drug Administration must approve an investigational new drug to be tested and eventually approved for broad use.
After the initial studies, venture funding will be necessary to do toxicity testing, produce the therapeutic agents for trials, and conduct the Phase I clinical trials. It can take capital in the range of eight figures to complete all of these steps. But as James noted, “The upside for investors is this market is very large and the regulatory path is straightforward.”
Essential Biotechnology LLC is finalist in the 2016 Governor’s Business Plan Contest, which culminates June 7-8 in Madison at the Wisconsin Entrepreneurs’ Conference. In October 2015, the company was accepted into the competitive Innovation Corps, which is sponsored by the National Science Foundation. It previously won the top prize in the Southeast Wisconsin Healthcare Innovation Pitch Event.
Hellenbrand is a student in the UW-Madison departments of Life Sciences Communication and Dairy Science.