ViewPoints: Glympse takes a second look at NASH diagnostics

A new startup is taking a hard look at novel ways to improve the diagnostic landscape of diseases like non-alcoholic steatohepatitis  (NASH), bringing in some new engineering tools to create its own non-invasive biomarkers- and is already attracting the attention of NASH powerhouses like Gilead Sciences.

What happened

Glympse Bio premiered on October 9 with $22 million from LS Polaris Innovation Fund and Arch Ventures, which co-led a series A financing. The round followed up the $6.6-million seed financing it received during its spinout from the Massachusetts Institute of Technology (MIT) in 2015.

The company is developing nanotechnology for use as diagnostics, based on work from Sangeeta Bhatia's lab at MIT.

Why it matters

Glympse has earmarked NASH diagnostics as its lead indication, where is has the potential to help accelerate clinical development for the lucrative indication, while also improving patient outcomes. Diagnosis currently relies on invasive liver biopsies, which are the gold standard for clinical development but also have a high patient burden. Some key opinion leaders have also identified the lack of non-invasive diagnostics as a significant commercial hurdle that will limit uptake once a NASH therapeutic is finally approved. (See KOL Views Results: Clinical progress in the NASH space continuing apace but commercial stumbling blocks loom)

Just a day out of stealth mode, Glympse said it has "signed multiple collaborations in NASH with pharmaceutical companies," without naming names. But of course it's worth noting that its series A investors include Gilead, ever on the prowl for a leg up in NASH, as well as Heritage Provider Network, a California-based managed care organisation likely interested in keeping its patient costs down.

The bigger picture

Glympse hasn't disclosed many specifics behind its diagnostic strategy, but has nonetheless left behind a long trail of publications. Bhatia first described iron oxide 'nanoworms' back in 2008- the segmented strings of nanoparticle beads can cruise through vasculature without activating immune responses. The nanoparticles also tend to naturally congregate in tumours, given their more permeable blood vessels, as well as in the liver, spleen, and lymph nodes. The particles also have plenty of room to pack on diverse payloads, with the increased surface area along the string of beads available to load up on a drug, antibody, or diagnostic tool.

In Glympse's case, it's starting with a NASH biomarker for its lead programme. It made an early case for the technology back in 2013, with a publication describing nanoworms' ability to home to fibrotic livers. The particles were loaded with substrates for proteases that are enriched in fibrotic tissues, such as matrix metalloproteinases, which cleaved them into fluorescent biomarkers detectable in urine and abrogating the need for an invasive biopsy. The authors argue that their method has advantages over existing serum or imaging biomarkers because it doesn't rely on precise detection of diluted plasma proteins, and allows for simultaneous measurement of multiple markers for more nuanced readouts.

Next steps

While the company has specifically earmarked NASH, there's some undeniably broad potential for an inert particle that homes to specific tissues with a modular payload. In a statement, Glympse noted potential applications for the technology in fibrosis, immune responses, infectious diseases, and cancer.

In fact, the same publication also describes the company's forays into cancer detection, where the authors argued that their synthetic urinary biomarkers outperformed serum carcinoembryonic antigen (CEA) in detecting early stage colorectal cancer in a mouse model; the nanoworm's fluorescent biomarkers showed greater elevations in response to smaller tumour burdens than CEA. In some settings, their multiplexed composite of 10 biomarkers delivered via nanoworms had at least a nine-fold improvement over CEA detection- adding to the list of developments to watch for coming out of Glympse's home base.

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