By Jonathan D. Grinstein, PhD
Rehan Verjee is no stranger to making medicines, having taken several candidates through FDA approvals as the former president of EMD Serono and global head of the Innovative Medicine Franchises at Merck KGaA. But his experience racing through decisions during drug development left him wishing he had access to more informative data.
“All too often in drug development, you are making decisions without access to the correlative science that could be really informative,” Verjee told GEN Edge. “It can be really hard to get your hands on that information. You’re often making drug development decisions without access to a lot of good biological information.”
Verjee also wishes that the drugs he helped develop had companion diagnostics to fine-tune treatment based on the modulation of a patient’s biology.
That’s the reason that Verjee founded Precede Biosciences, which today emerges from stealth mode with its technology that provides insight into the molecular processes that correlate with gene expression changes. Precede’s platform uses advanced and unique molecular biology and machine learning to create profiles of circulating chromatin and the DNA methylome. This gives users access to a dynamic and feature-rich space of about 20,000 gene promoters, one million gene enhancers, and 50,000 CpG islands.
This platform aims to enable drug developers to accelerate drug development with a research-use-only (RUO) platform, while also developing blood-based clinical tests to advance precision medicine in clinical practice. The icing on the cake is that the technology can deliver resolution into the dynamic activation of individual genes and pathways in diseased tissues from just 1 mL of plasma.
Since its inception, the Boston-based company’s genome-wide profiling technology for circulating chromatin and the DNA methylome has secured $57 million in backing from leading venture capital and private equity investors. The funding will support Precede’s ability to engage in business with biopharma while also progressing some of these lead clinical tests as candidates, which he hopes will be available for use in a “two-plus year period.”
Precede was co-founded through the 4:59 Initiative at 5AM Ventures and supported in the seed round by both 5AM Ventures and Binney Street Capital of the Dana-Farber Cancer Institute. Illumina Ventures, Bristol Myers Squibb, Osage University Partners, and Qatar Investment Authority (QIA) joined 5AM Ventures and Lilly Asia Ventures in co-leading the company’s Series A financing.
Dynamic biology readouts
Verjee likes to say that Precede’s technology measures “dynamic biology” instead of something static. Instead of looking for a genetic variant, which provides a binary readout, Verjee said that Precede’s technology provides a much finer resolution.
“If you have Phase I assets and want to understand what’s happening over time, looking at a mutation wouldn’t help, but with our tech, you’d be able to see how this pathway has been impacted and how that correlates with response,” said Verjee. “You want to be able to see that a gene and enhancer switched on in the context of resistance, and, therefore, either we should drug it with a new sort of drug that we should develop or we should throw in an old drug that works against that mechanism and combine it. That’s what we’re interested in doing.”
As Verjee was establishing Precede’s direction, he had the choice of taking the technology in two directions regarding drug development. He could either collect a ton of proprietary information as the foundation for a drug discovery and development company—or become a platform technology to support drug development through collaborations and partnerships.
Verjee chose the latter path, concluding that rather than developing one or two drugs over a 5–10-year period, he could influence a far greater number of drugs—50 or 100—across the ecosystem simultaneously.
This wasn’t a particularly difficult decision for Verjee, saying that the business model for this approach has already been proven. He cites the success of Guardent Health and Foundation Medicine in generating value and revenue by enabling biopharmaceutical companies to make better drug development decisions with a blood test.
To establish proof of function for its technology, Precede needs to make an impact on early drug development programs, which the company is trying to do by already engaging in several partnerships with biopharma companies.
In addition to drug development decisions, Precede’s genomic liquid biopsy technology has clinical applications, which have primarily stuck to cancer in the ten years since the FDA approved the first liquid biopsy test, the CellSearch® CTC enumeration platform. Since then, a few others have emerged, including Guardant360® CDx and FoundationOne® Liquid CDx.
While Verjee believes that Precede’s technology enables them to look beyond cancer because they’re looking at dynamic biology changes to a given target or pathway, they still plan to stick with clinical cancer testing to begin with.
Precede has decided to use a central lab to help make the correct clinical decisions. Verjee said the centralization makes the technology accessible because Precede takes on most of the work after sample collection through data analysis of this complex molecular biology. To do so, they have been designing the platform with turnaround times in mind and the right level of cost to make it a viable enterprise over time.
“We’ve done a lot of that engineering from the very beginning, and we’ve gotten to the point where we actually think we’re there,” said Verjee. “Hence, we can emerge and offer the platform more broadly.”
The turnaround timeframe looks like it will be somewhere up to a week, which Verjee thinks is on par with any other process associated with the diagnostic workup.
Bringing precision to medicine
With their technology, Precede aims to do something that Verjee doesn’t think is being done optimally—precision medicine. What this typically looks like, according to Verjee, is the use of invasive tissue-based tests to enrich the population for patients that could potentially respond based on the presence or absence of the marker.
“Because they require invasive tissue-based tests, all too often those tests aren’t done or they’re done badly,” said Verjee. “Even though it’s precision medicine, it’s not used in a precise way.”
That’s where Verjee thinks Precede can excel—by creating minimally invasive alternatives to those tissue-based standards and, as a consequence, making it easier to use the medicine in the precise way that it was intended.
Ultimately, Verjee’s mission with Precede is to take medicines that can be used in a precise way but require tissue-based standards and assessments and then be able to say, “Hey, this is the drug you should be using.”
Now, that’s precision medicine!