It’s not too often that a biotech company marches into the FDA and asks permission to run human tests of a remedy derived from parasitic worms. But the agency will likely be entertaining just such a request sometime in the next couple of months, when Coronado Biosciences files an Investigational New Drug (IND) application for CNDO-201, a brew that contains 2,500 eggs from a parasite found in pigs. The company—which is moving from New York to Boston in August—plans to test the therapy in patients suffering from Crohn’s disease, an autoimmune condition that strikes the intestinal tract.
Coronado has been around since 2006, but it wasn’t until recently that it came out of stealth mode—in a rather dramatic fashion. On July 6, the company revealed that it raised $25.8 million in a funding round led by National Securities Corporation. The financing came close on the heels of a $21.6 million private round last November. And earlier this week, Coronado filed a Form 10 with the SEC so it could become a public company by registering all its private shares as common stock. That will make financing Coronado easier going forward, says CEO Bobby Sandage. “We don’t intend to partner our products, so we will need to raise more money,” he says.
Management’s deliberate decision not to seek out Big Pharma partners to bankroll its clinical trials may seem bold at a time when cash-strapped biotechs need all the help they can get. But Sandage and his team of seven are confident that their two experimental treatments—CNDO-201 and an anti-cancer molecule called CNDO-109—are so promising that they can afford to handle the research themselves, so they can ultimately hold onto all the profits. “They have such broad applications for huge unmet medical needs,” Sandage says, adding that Coronado keeps costs down by outsourcing R&D.
Coronado started its life as an oncology company with three experimental molecules. Late last year, after investors started overhauling the management team, the company ditched two of the drugs so it could focus on the most promising molecule, CNDO-109, which Coronado is developing to treat acute myeloid leukemia (AML). CNDO-109 is a compound that activates so-called Natural Killer (NK) cells, which then go on to destroy cancer cells.
Then the management team went looking for a complimentary drug to add to the pipeline. In 2011, Coronado acquired San Diego-based Asphelia Pharmaceuticals, which was developing the parasite treatment.
While the two drugs may seem quite different, they’re similar in that they take an immunotherapeutic approach to combating disease. By harnessing NK cells, CNDO-109 follows a well-known technique for fighting cancer. But drugs generally used to activate NK cells are toxic. So Coronado is developing a way to
