Flagship-launched Empress aims to be a small molecule speedster, with up to 4 INDs over next 2 years

Flagship Pioneering has launched its latest venture, taking the sheet off Empress Therapeutics to rapidly accelerate the development of small-molecule medicines, with the biotech planning to ask regulators to greenlight clinical trials multiple times in the next two years.

The unveiling, announced Wednesday, includes $50 million in capital to further the company’s ongoing development work, which includes 15 drug leads in a single year. Those drug leads are expected to result in up to four applications to the FDA to enter human trials over the next two years. 

Empress Therapeutics CEO Jason Park told Fierce Biotech that the concept for the company spawned some six years ago, with a simple question at the forefront: How could genetics speed up small-molecule drug creation? 

The answer for much of Empress’ early work has existed in the microbe, a tiny organism that exists in the body by the dozens of trillions. Microbial cells served as genetic artifacts through which Empress has been able to build a database of genes that code for potential compounds worth drugging. The targets the company has landed on include ion channels, cytokines, enzymes and G protein-coupled receptors.

“We have this tool to reach into this evolutionary databank, essentially, of R&D that's been taking place inside of humans since the dawn of time,” Park said. 

What that database enables is a reverse identification of potentially druggable compounds; instead of sifting through the compounds themselves, Empress taps into the genetic code that produces the compounds to map where they could be. It’s to that process Park credits the speed at which the company has been able to land on its early list of front-runners, which could be aimed at a plethora of indications including immunology, oncology, neurology, metabolic and pain disorders. 

The potential of the platform has drawn in Murray McKinnon, Ph.D., who previously was the global leader of Janssen's World Without Disease Accelerator and head of immunosciences for the accelerator. Park recounted that when McKinnon was introduced to Empress he said, "I haven't seen anything like this." 

None of the 15 drug leads today have been tested in nonhuman primates, but some have undergone toxicology studies in rats, Park said. He added that the $50 million should give the company time to choose multiple development candidates and push some into the clinic before the biotech prioritizes more financing. 

"Obviously, like every other biotech company, at some point, once you get into the clinic, you got to raise more money because clinical trials are very expensive,” he said. “We’re very excited because it's so efficient, that we got a lot of flexibility.” 

The efficiency is sourced to the company’s relatively low head count, with 30-35 employees behind the current number of drug leads. But Park expects that number to grow in light of the new financing and growing partnering aspirations. 

“We'll have to grow the team as we advance to the clinic, as we consider doing partnering,” he said. Park added that conversations with potential pharma suitors are already underway.