Developing in vivo diagnostic sensors for a new generation of engineered, targeted biomarkers.
CEO: Caroline Loew
Based: Cambridge, Massachusetts
The scoop: Detecting disease has always been far from perfect science. Many measures are aimed at gathering downstream indicators: the biomarkers and leftovers that only hint at the unseen biological processes at play, providing snapshots that—even with the truly massive amounts of data the industry is capable of generating today—still don’t satisfy the desire to peek under the hood.
Glympse Bio hopes to go straight to the source for information by using a new class of traveling artificial nanosensors that directly query the body’s disease before reporting back to us on the outside.
The company’s platform is based on a cocktail of bespoke biomarkers that, after being injected into a patient, interacts with the disease as it passes through the body, creating a signal that is simply collected from the urine. More interactions result in a stronger signal, allowing physicians to gather measurements on disease onset, stage, progression and responses to treatment without an invasive physical biopsy.
What makes Glympse fierce: “What it's really allowing us to do is see things inside the body that would otherwise have to be taken outside the body to be diagnosed and detected,” says President and CEO Caroline Loew, who believes the engineered sensors can be customized to report on a range of biological targets, including the presence of diseases, tissues and cells—starting with nonalcoholic steatohepatitis, or NASH.
Also known as fatty liver disease, NASH is a chronic and difficult-to-diagnose disease and is on track to become the leading cause of liver transplantations in the U.S.
“It's sort of a silent killer,” Loew tells FierceMedTech. “By the time many patients are diagnosed, their disease is in a very advanced condition.”
In addition, NASH does not develop evenly across the liver—its heterogeneous presentation means that a painful punch biopsy sample may not grab the tissue that represents how advanced the disease could be. In short, you can miss.
“The use of that diagnostic is also essentially prolonging the development pathway for patients, because it's taking a long time to understand whether there are actually pharmacologic responses to the treatments that are being developed,” said Loew, who took the reins at Glympse last December after leaving Bristol Myers-Squibb, where she was a VP and head of R&D strategy and planning.
NASH has become a potentially lucrative target, with a high unmet need and a range of drugs racing each other through development. Gilead, Allergan, Genfit and Intercept Pharmaceuticals all hope to deliver phase 3 data this year, while BMS itself has two ongoing phase 2b studies. In fact, Glympse recently reported preclinical data with Gilead in NASH showing how it can track drug responses.
And while having a noninvasive NASH diagnostic that can accurately gauge treatment progress would be extremely valuable on its own, Glympse has an eye on the bigger picture—developing a platform that can be tuned to multiple diseases, including infections and autoimmune disorders.
Based on protease enzyme biology, the company’s artificial sensors are cleaved at the disease site through natural reactions, releasing barcoded particles that are filtered out of the body and detected through a simple analysis. To know what it has to work with, Glympse has mapped out all the proteases in the genome and, in the case of NASH, codes for all the proteases related to the fibrotic disease state.
Backed by Johnson & Johnson Innovation’s JLABS and housed at LabCentral’s shared startup facility in Cambridge, Massachusetts, the MIT spinout debuted last October with a $22 million series A round to help push it into first-in-human trials of healthy volunteers later this year.
“The great thing about the potential of the technology is that it can be applied to patients to identify pharmacological responses to the disease, and then help identify whether there is an ongoing change in the disease state,” Loew said. “Wherever you see that, in drug development or in a patient-care setting, I think you're going to see utilization of our platform.”