This week’s episode of “WisBusiness: the Podcast” is with Roland Green, CEO of Madison-based Invenra.
The pharmaceutical biotechnology company earlier this year announced the FDA has approved special designations for its rare pediatric cancer treatment. These designations are meant to incentivize the drug’s development due to the impact it could have on affected patients.
“We focus on developing antibody therapeutic drugs for a variety of diseases,” Green said. “Oncology, immunology, we’re starting to move into radiotherapy. So it’s basically using nature’s approach to fighting the bad guys.”
The FDA’s Rare Pediatric Disease and Orphan Drug Designations were announced in late August for Invenra’s INV724 antibody product, which is meant for patients with a form of cancer called neuroblastoma. It was created through a longstanding collaboration with Dr. Paul Sondel, a pediatric oncologist and researcher at UW-Madison.
“When he saw what we could do with bispecific antibodies, he realized we would be able to make a … drug that could replace a current antibody drug that’s on the market for neuroblastoma,” he said.
While that existing drug is effective at treating the cancer, it also causes extreme pain in the children receiving it, making for a “very, very harsh treatment regimen.” The goal with Invenra’s product is to achieve the same level of efficacy without causing that severe pain. After submitting initial findings to the FDA showing the drug’s promise, the company received the designations from the federal agency.
“Those are programs that the FDA put in place to try to encourage companies to develop drugs for these rare diseases that are small markets, and the economics don’t really encourage companies to develop drugs for them, because there’s not enough profit there,” Green said.
He praised the RPDD and ODD programs, noting they give drugs like the one Invenra is developing a “fast pass” to market.
“It doesn’t cost taxpayers any money, the pharma companies that want a fast pass and cut in line ahead of their competitors will pay for those vouchers, but it encourages people to develop drugs for these diseases,” Green said.
He also discusses the path ahead for the drug’s development and how it could help young patients, highlighting ongoing negotiations with potential partners that could help bring it to market.