Essential Biotechnology moves toward clinical trials for cancer-treating drug

Innovations

Essential Biotechnology LLC
Innovation: Cancer-treating drug Big Bend
http://essentialbiotech.com/


If all goes as planned, Big Bend-based Essential Biotechnology will have its cancer-treating drug in phase one clinical trials within three years.

“It’s aggressive, but it’s achievable given our clear regulatory path,” said Mike James, chief scientific officer at the 2016 Governor’s Business Plan Contest finalist.

James

James

James still works as an assistant professor of surgical oncology at the Medical College of Wisconsin, which is where the startup began. The Medical College handles the intellectual property, licensing it to Essential Biotechnology. The company also counts William Clarke, director of research commercialization in the college’s Office of Technology Development, among its team. Clarke serves as the company’s chief executive officer.

James said it was important to put the right team together to drive toward clinical trials.

The intellectual property behind Essential Biotechnology is the discovery of a protein on the surface of tumor cells that James said is critical to the tumor’s survival. The company is developing a drug that will inhibit the protein, which James said the early data shows not only kills tumor cells, but also makes them more susceptible to other treatments.

Because the company’s treatment would kill tumor cells through multiple mechanisms, rather than simply slowing their growth, James said the cancer is much less likely to evolve around the therapies.

The result should be better survival rates and reduced exposure to chemotherapy or radiation. While James says the evidence suggests the treatment should be applicable to most types of cancer, Essential Biotechnology has chosen to focus first on ovarian cancer because of the prevalence of resistance and recurrence. The National Ovarian Cancer Coalition says recurrence happens in 70 percent of cases.

James said ovarian cancer offers the chance to get results quickly and also to track how well the drug is working. He sees pancreatic cancer as a subsequent target for the company.

Essential Biotechnology’s drug is one of a handful of technologies coming out of the Medical College and being developed toward commercialization, James said. He noted there has long been a good environment for commercialization at institutions on either the east or west coasts and in Madison.

“It’s kind of a growing environment here to support that,” he said, adding that he has received strong institutional support.

Clarke said as far as he knows, the Medical College is the only institution of its kind with an experienced biotechnology expert that has time dedicated to helping faculty commercialize their work.

“We actively try to facilitate interested and able faculty,” he said. “It’s a unique setup we’ve got here.”

The startups launching out of the Medical College over the last few years include TAI Diagnostics Inc., which is developing genetic testing for transplant rejection and raised $8 million last year; Germantown-based Somna Therapeutics LLC, a medical device company that began selling a device for extra-esophageal acid reflux disease last year; Protein Foundry, which manufactures recombinant proteins; and several others, some of which have been acquired.

Clarke cautioned that not all research ideas address large enough problems while also being protectable by patents to be commercialized.

“If I get one a year, I feel like I’m doing pretty well,” he said.

The challenge now, as Essential Biotechnology has moved from a research project to a lean development program, is finding the right investors and partners.

“It’s always a challenge when you’re in a relatively early development program to reduce the perceived risk to potential investors and partners,” James said.

As a biotech company, Essential has a long road ahead of it. Clarke hopes to be able to have extended conversations with those who have expressed interest in funding the idea in the near future. He also cautioned that early stage funding for biotech companies is hard to come by in the state, and even the country.

The company was able to take a step toward reducing those risks in December, winning the inaugural Wisconsin Healthcare Innovation Pitch event organized and sponsored by Bridge to Cures, Clinical and Translational Science Institute, the Medical College and Concordia University.

Essential Biotechnology won $50,000 and was named Southeast Wisconsin Healthcare Innovator of the Year.

Essential Biotechnology LLC
Innovation: Cancer-treating drug Big Bend
http://essentialbiotech.com/


If all goes as planned, Big Bend-based Essential Biotechnology will have its cancer-treating drug in phase one clinical trials within three years.

“It’s aggressive, but it’s achievable given our clear regulatory path,” said Mike James, chief scientific officer at the 2016 Governor’s Business Plan Contest finalist.

James

James

James still works as an assistant professor of surgical oncology at the Medical College of Wisconsin, which is where the startup began. The Medical College handles the intellectual property, licensing it to Essential Biotechnology. The company also counts William Clarke, director of research commercialization in the college’s Office of Technology Development, among its team. Clarke serves as the company’s chief executive officer.

James said it was important to put the right team together to drive toward clinical trials.

The intellectual property behind Essential Biotechnology is the discovery of a protein on the surface of tumor cells that James said is critical to the tumor’s survival. The company is developing a drug that will inhibit the protein, which James said the early data shows not only kills tumor cells, but also makes them more susceptible to other treatments.

Because the company’s treatment would kill tumor cells through multiple mechanisms, rather than simply slowing their growth, James said the cancer is much less likely to evolve around the therapies.

The result should be better survival rates and reduced exposure to chemotherapy or radiation. While James says the evidence suggests the treatment should be applicable to most types of cancer, Essential Biotechnology has chosen to focus first on ovarian cancer because of the prevalence of resistance and recurrence. The National Ovarian Cancer Coalition says recurrence happens in 70 percent of cases.

James said ovarian cancer offers the chance to get results quickly and also to track how well the drug is working. He sees pancreatic cancer as a subsequent target for the company.

Essential Biotechnology’s drug is one of a handful of technologies coming out of the Medical College and being developed toward commercialization, James said. He noted there has long been a good environment for commercialization at institutions on either the east or west coasts and in Madison.

“It’s kind of a growing environment here to support that,” he said, adding that he has received strong institutional support.

Clarke said as far as he knows, the Medical College is the only institution of its kind with an experienced biotechnology expert that has time dedicated to helping faculty commercialize their work.

“We actively try to facilitate interested and able faculty,” he said. “It’s a unique setup we’ve got here.”

The startups launching out of the Medical College over the last few years include TAI Diagnostics Inc., which is developing genetic testing for transplant rejection and raised $8 million last year; Germantown-based Somna Therapeutics LLC, a medical device company that began selling a device for extra-esophageal acid reflux disease last year; Protein Foundry, which manufactures recombinant proteins; and several others, some of which have been acquired.

Clarke cautioned that not all research ideas address large enough problems while also being protectable by patents to be commercialized.

“If I get one a year, I feel like I’m doing pretty well,” he said.

The challenge now, as Essential Biotechnology has moved from a research project to a lean development program, is finding the right investors and partners.

“It’s always a challenge when you’re in a relatively early development program to reduce the perceived risk to potential investors and partners,” James said.

As a biotech company, Essential has a long road ahead of it. Clarke hopes to be able to have extended conversations with those who have expressed interest in funding the idea in the near future. He also cautioned that early stage funding for biotech companies is hard to come by in the state, and even the country.

The company was able to take a step toward reducing those risks in December, winning the inaugural Wisconsin Healthcare Innovation Pitch event organized and sponsored by Bridge to Cures, Clinical and Translational Science Institute, the Medical College and Concordia University.

Essential Biotechnology won $50,000 and was named Southeast Wisconsin Healthcare Innovator of the Year.

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