Screening for early stage cancer has gained a promising entrant with Thrive Earlier Detection Corp., which has raised a $110 million series A round to back its ongoing pan-cancer detection research. The Cambridge, Mass.-based startup was spun out of Johns Hopkins University, where the science backing it was already relatively far along.

In 2018, the Johns Hopkins team saw the publication in Science of a retrospective study in eight cancers on the gene and protein panel known as Cancerseek. As a follow-up to that work, they started a prospective clinical trial in partnership with Geisinger, a not-for-profit health care provider in Pennsylvania and New Jersey.

Specifically in women between the ages of 65 and 75 with no prior history of cancer, that study is known as DETECT. It's a five-year trial that is fully enrolled. The study applies the Cancerseek panel test, which includes at least 16 tumor DNA genetic mutations, as well as 11 protein markers.

Gender control

"Hopkins selected women as the entry criteria, largely to take control of the gender variable, given that there were only going to be 10,000 subjects in the trial. Also, there was some interest in researching cancers prevalent in women from a funding perspective," Steven Kafka, Thrive CEO and partner at Third Rock Ventures, explained to BioWorld.

"These are women [who] are currently on their mammograms and colonoscopies with no immediate family history of cancer," he added. "One of the things we're trying to do here is learn about test performance; we kind of stacked the deck against ourselves a bit in the sense that this is a highly screened and healthy population."

Patients give a blood sample for the test and complete three health surveys over the five years. If they have positive test results, they are given a second blood test. With two consecutive positive panel results, patients are given a whole-body positron emission tomography–computed tomography scan to locate the cancer site.

Data is being analyzed from the study, enabling Thrive to continue to improve and adapt Cancerseek. Thrive expects to start reporting DETECT study results within the next year or so.

Cancerseek has received breakthrough device designation from the U.S. FDA to detect genetic mutations and proteins associated with pancreatic and ovarian cancers. These are two of the most deadly kinds of cancers, which are often not caught until the later stages.

Thrive is aiming for a multicancer detection label in a healthy population for Cancerseek. This financing is intended to support the company through sufficient clinical testing to enable regulatory approvals and establish broad reimbursement. Thrive plans to integrate real-world data and machine learning to continue to improve Cancerseek as a screening tool for use by primary physicians with healthy patients.

Early efforts

"We are really starting to see an important shift for earlier stage cancer. So much of our time, energy and dollars have gone towards late-stage, and we're making strides," noted Kafka. "But the benefit that we bring the patient is measured in weeks or maybe months. It's really difficult to do better than that.

"[W]hen we switch to the earlier stage diagnosis, we know that treatment options are better, and the outcomes are measured in years or even cured cancers," he continued. "So, there is this shift in terms of research and investment dollars – that is the trend. That's [important] because we need the whole community of health care systems and payers to be helping us."

Thrive also is very focused on limiting the cost of Cancerseek, which is likely to appeal to payers. The sweet spot is roughly between the price of mammography, which is about $100 to $200, and the Cologuard test for colorectal cancer, which is about $600 to $700, Kafka said.

Cologuard is an early example of a genomic screening cancer test that has gained wide adoption and reimbursement. Aggregating sufficient health economic data is going to be crucial to making the case for adoption and reimbursement for Cancerseek, as was the case with Exact Sciences Corp.'s Cologuard.

In the Science results, the sensitivity varied widely. Cancerseek was able to detect 98% of ovarian and liver tumors, but only 33% of breast cancers. In five cancers – ovarian, liver, stomach, pancreas and esophageal – the sensitivity ranged from 98% to 69%, with a specificity of greater than 99%.

Kafka noted that, as a screening tool, it's crucial for the test to maintain a very high specificity to eliminate as many false positives as possible – as well as the costly, unnecessary care that would follow them. However, refining this sort of test can involve trading some specificity to improve sensitivity.

Solid foundation

Thrive pulls its executives largely from Foundation Medicine Inc., which was acquired by its investor and partner Roche at a valuation of $5.4 billion in 2018, as well as Third Rock Ventures, which was a Foundation investor. These include Kafka, who was president and chief operating officer (COO) at Foundation and is a partner at Third Rock, as well as Geoff Otto, Thrive's senior vice president and head of product development. He was the VP of product development at Foundation.

Alexis Borisy, co-founder and former chairman of Foundation, as well as the company's ex-CEO, Michael Pellini, are both members of the Thrive board. Third Rock entrepreneur-in-residence Samantha Singer is the Thrive COO. Third Rock partner Christoph Lengauer is a co-founder, chief innovation officer and director at Thrive.

Former VP and lead med-tech analyst at Goldman Sachs Isaac Ro is the Thrive CFO, while Isaac Kinde, a co-inventor of the tech behind Cancerseek, is a co-founder and head of research and innovation at the new company.

Third Rock led the series A round with participation from Section 32, Casdin Capital, Biomatics Capital, Bluecross Blueshield Venture Partners, Invus, Exact Sciences, Cowin Venture, Camden Partners, Gamma 3 LLC and other undisclosed investors.

"Over the past 30 years, we have made great strides in understanding cancer. Combining this knowledge with the latest in molecular testing technologies, our founders have developed a simple and affordable blood test for the detection of many cancers at relatively early stages," said Lengauer. "We envision a future where routine preventative care includes a blood test for cancer, just as patients are now routinely tested for early stages of heart disease. We know that if cancer is caught early enough, it can often be cured."