NEW YORK – To Lincoln Nadauld, the $10 million raised by his fledgling company Culmination Bio in its first financing round is market validation of the industry-wide need for detailed, longitudinal data on patients' entire healthcare experiences, from the diseases they've had, to the treatments and tests they've received, to how they fared.
On Thursday, the Intermountain Health spinout announced that Merck Global Health Innovation Fund and Amgen Ventures had invested $10 million, which Culmination will use to continue building out its Culmination Intelligence Platform, a disease-agnostic, deidentified databank consisting of multimodal data on more than 5 million patients spanning more than 40 years. "What we mean by multimodal data is the entire comprehensive set of electronic health record-derived data: CPT codes, ICD codes, medications, labs, images, diagnostic tests, and its matched tissue or liquid biopsy or some specimen attached to that clinical journey," Nadauld said. "And from that specimen, we derive additional DNA data or RNA data or some form of omics data."
Culmination has only named a few of its initial partners, including Cofactor Genomics and Amgen subsidiary Decode Genomics, but Nadauld said Culmination is gearing up to announce in the coming months other collaborators that will use its data in drug discovery and development. "We have several pharma partnerships that are signed and many agreements with diagnostic and biotech companies," Nadauld said. "Our target market and customer segment is pharma and biotech."
These partners come to Culmination shopping for data that can help them answer a specific question or achieve a goal.
"Our partners come to us and say, 'Hey, we are trying to better understand this disease state,' and then they can define a cohort of interest based on drug treatment and say, 'Hey, we need to better understand better what happens to patients treated with this particular drug, or why certain patients have a negative outcome and some have a positive outcome, and maybe that will help us better understand who to target with these therapies,’” Nadauld explained. “Culmination can then help aggregate that cohort defined by their needs and deliver that in a bundled dataset to better explain certain outcomes or responses.”
Nadauld said drugmakers might use Culmination’s data to help identify the best biomarker-defined patient population for drugs they’re developing or further understand cohorts of rare disease patients for whom comprehensive longitudinal data can be hard to gather. Drugmakers can use Culmination’s data to create synthetic control arms, which is often necessary in precision oncology trials when recruiting actual patients to a control arm is challenging. But by culling Culmination’s data, its research partners could also directly identify, consent, and enroll patients onto clinical trials, and the claims data in the Culmination Intelligence Platform can also help them understand the economic impact of their therapies, he added.
Pros and cons of data from single health system
All of the data in the Culmination Intelligence Platform come from patients treated within the Intermountain Health network, and that will continue to be the case as Culmination adds some 300,000 new biospecimens to the collection each year.
The advantage of this data coming from a single source, according to Nadauld, is that they are uniformly formatted, which streamlines collection and analyses, and eliminates the need to standardize data from different health systems stored in inconsistent formats.
Another advantage, he said, is that these patients aren’t typically coming to Intermountain Health just to see a cancer specialist, but often their entire healthcare journeys happen within the expansive network that serves several hundred clinics and hospitals in the Mountain West region of the US. “Other companies in this space … might have a year or two of oncology data on patients with a specific type of cancer, but if that patient had any cardiology care or an autoimmune disorder, or some other comorbid condition, they really wouldn’t understand very well what happened to that patient,” he said.
Culmination’s data tends not to have those gaps, according to Nadauld. “Our data is totally comprehensive, and the care journey from start to finish is filled in, inclusive of comorbid conditions,” he said, adding that the field to date has largely lacked the ability to look at how someone’s cancer treatment may be impacting their heart health, for instance.
But the fact that Culmination’s data is a reflection of the population Intermountain treats may also have some disadvantages. The healthcare system has clinics and hospitals in Utah, Idaho, Nevada, Colorado, Montana, Wyoming, and Kansas, and several of these states are among the least ethnically and racially diverse in the country, according to US Census data. The trials that pharmaceutical and biotech firms conduct to develop their drugs and tests have persistently lacked racial and ethnic diversity, which by many accounts, is exacerbating healthcare disparities, particularly as more pricey precision oncology and rare disease drugs come to market.
Asked about the potential issue of diversity in the new company’s database, Nadauld countered that the data are, in fact, representative of the US population on the whole.
“While it might not look like an East Coast or West Coast population, we have found that because we understand the demographics and ethnic background of these patients’ journeys, we can enrich the data to find cohorts to have the kind of makeup that we want,” he said. “If you have a population size and biobank and data size that is millions and you need a cohort of a thousand, for example, you can pull in the kinds of patient populations that you need to have it represent your wishes. … We haven't found that we're unable to meet the requests of a customer yet." The company is still in its early days, however.
Growing Culmination
In addition to building its entire database with Intermountain Health patients, Culmination Bio has built much of its functional workforce with Intermountain Health employees. Although the new company only has 20 full-time employees, many of the people who built Culmination are employees of Intermountain Health, which supports its spinout in identifying and collecting samples.
The $10 million investment will help Culmination grow, meet the needs of current customers, and take on additional partners. Nadauld declined to share how many deals the firm has inked to date but said there has been no shortage of interest in the new company's data assets. "We're working quickly to expand our capabilities to meet that demand," he said. "So far, we haven't had to turn anybody away."
Growing the Culmination team is a priority in the short term, as is performing RNA and DNA analysis on more samples and enriching its omics repository for data queries.
"This is the first investment we've taken since we founded the company a year and a half ago," Nadauld said, explaining that the firm had initial funding agreements in place that allowed it to focus on setting up the business instead of needing to raise funds right away. "We accepted this funding now largely because we believe it represents our industry partners saying that [there's a] gap that exists in terms of data access that we have recognized."