KallyopeNew York City-based Kallyope is one of the few biotechs focused solely on the gut-brain axis. 

The privately-held company has built a cross-disciplinary team that weaves together advanced technologies in sequencing, bioinformatics, neural imaging, human genetics, and cellular and molecular biology. 

The company has raised $479 million to date, including a $236 million Series D financing in February.

Jay Galeota

Jay Galeota

The president and CEO of the company is Jay Galeota, who worked at Merck & Co. (NYSE:MRK) for almost three decades.  

“I was fortunate enough to lead the team that brought Merck into diabetes with Januvia (sitagliptin) and Janumet (sitagliptin/metformin),” Galeota said. Last year, the drugs generated $5.3 billion in revenue.

The discoverers of sitagliptin, Nancy Thornberry and Ann Weber, are both Merck alumni who are now senior executives at Kallyope. Thornberry cofounded the biotech and currently serves as chair of R&D, while Weber is a senior vice president of preclinical development. 

Thornberry convinced Galeota to take over the CEO role in August 2021 so that she could focus on research.  

A wet-lab-equipped office in Manhattan

The focus on science was part of what drew Galeota in. “When you come off the elevator on our floor in this tower in New York City, you think you’re in an academic wet lab,” Galeota said. “You see all around hoods and the equipment and everything. I’d say 90% of our employees are scientists, which is super exciting.” 

Galeota said the company is a “for-profit lab as much as we are a biopharma company, although we now have three compounds in the clinic.” 

Kallyope has explored using novel biology and basic science to unlock previously unknown neural signaling pathways between the gastrointestinal (GI) tract and the brain. 

The goal is to map the neural and hormonal signaling pathways between the GI tract and the brain to learn how to elicit systemic responses that have a therapeutic effect. “Those atlases were created, the targets were identified and validated,” Galeota said. 

Kallyope’s pipeline

The company now has three distinct programs. 

The first is focused on metabolism and metabolic circuits. “That is specifically in diabetes and obesity, but also other conditions that are related,” Galeota explained. “We have compounds in the clinic in that area, and we have follow-on compounds that are in development.”

Kallyope pipeline

[Image courtesy of Kallyope]

The second area focuses broadly on gut disorders. This area involves the cellular junctions in the GI tract that form the epithelium. “This area relates to a lot of GI-related diseases, but other disease states as well,” Galeota said. 

The company’s CNS (central nervous system) franchise is centered around neuro disease. “We’ve got a lead program in migraine that we’re super excited about,” Galeota said. “Our chief medical officer ran the migraine programs at Merck. Then we’ve got several follow-on compounds in other areas like Parkinson’s disease and other types of neurodegenerative disease.” 

In the long run, the company sees many potential diseases its pipeline could address, including conditions ranging from anaphylaxis to food allergy to Parkinson’s.  

“There are also other potential applications such as chronic cough and syndromes like binge eating disorders that are mediated by these gut-brain signaling pathways,” Galeota explained.