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Oncimmune Scottish Study Results Could Fuel Move Into Screening as Firm Eyes CDx Opportunities

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NEW YORK – Nottingham, UK-based Oncimmune is highlighting strong new data presented at a conference last week on the ability of its proteomic assay, EarlyCDT-Lung, to identify at-risk individuals who have developed or are beginning to develop lung cancer.

The data, shared at the 2019 World Conference on Lung Cancer in Barcelona, comes from a randomized controlled trial conducted in Scotland, which has recruited and tested more than 12,000 individuals with an elevated risk of lung cancer, following them to see if use of the Oncimmune assay can help increase the number of early cancers detected (and thus reduce the number of advanced cancers) in this population.

According to investigators from the Early Detection of Cancer of the Lung Scotland, or ECLS study, there have been substantially more people diagnosed at an early diseases stage after taking the EarlyCDT-Lung test — which measures levels of seven autoantibodies — than in the control arm in the two years so-far analyzed.

Researchers reported that there was a total of 127 lung cancers diagnosed in the study period, including 56 in the intervention group that got the Oncimmune test and 71 in the control arm that did not. Among all the individuals tested in the intervention arm, 9.8 percent tested positive, and 3.4 percent of these were diagnosed with lung cancer during the study period.

Among those people who received EarlyCDT-Lung test and went on to develop lung cancer within the next two years, investigators reported that 41 percent were diagnosed at an early stage (stage I or II) compared to about 27 percent of those diagnosed in the control group.

This translates to a 36 percent reduction in later stage cancer presentations for those randomized to receive the EarlyCDT test. The reseachers also calculated that The EarlyCDT-Lung test showed a sensitivity 52 percent for early cancers, yielding a positive for 12 of the 23 early tumors detected, though a much lower sensitivity, of 18 percent, for late-stage cancers.

Adam Hill, Oncimmune's CEO, said in an interview that the company views the Scottish trial data as the "most significant" in its history. "It is also the largest randomized study of a blood-based biomarker for lung cancer detection, so I think it's important data for the industry, for clinicians, and for patients," he added.

At the same time, Hill said, the trial's success so far also bring into sharper focus some of the practical questions Oncimmune will face as it works to try to gain adoption of the test for screening. Accordingly, the company is now grappling with "how much data is enough data to implement a screening program and what pragmatic ways forward there may be to develop evidence in the real world," he said.

Although the Scottish screening study has involved numerous EarlyCDT-Lung tests performed in the UK, Oncimmune's primary commercialization of the assay thus far has been in the US and for a slightly different use case: guiding care for patients who have a suspicious lung nodule identified via radiologic imaging.

Hill said that the company has sold nearly 160,000 tests in the US to date. Notably, the firm made the move this June to sell its US operations and US rights to EarlyCDT-Lung to Biodesix, which had previously been a potential competitor to Oncimmune after acquiring Seattle-based Integrated Diagnostics and that firm's XL2 test — an assay also designed to aid in decision-making for patients with lung nodules.

Hill, who joined Oncimmune as chief medical officer and chief scientific officer in early 2018 before transitioning to CEO a few months later, spearheaded a strategic review aimed at looking for ways to better capitalize on the company's proprietary auto-antibody platform over the next few years.

As a result of that analysis, Hill said that Oncimmune is easing off of test provision and commercialization and increasing its attention on finding new ways to apply its proprietary technology including in new areas outside of early detection like companion and complementary diagnostics.

Handing US nodule testing off to Biodesix is one aspect of that new strategy, as was the firm's acquisition of Protagen Diagnostics six months ago, which Hill said plays directly into the firm's new ambition to using its technology to discover and develop predictive signatures for immune-related cancer drugs.

Although the company launched a new test last year for early detection of liver cancer, Hill said that Oncimmune is going to step back from directly advancing the other tests that were coming up in its pipeline — for breast, ovarian, and prostate cancers — instead hoping to partner with other companies for their commercialization.

"We're not accelerating these assays [at this point] because I see them as partnership opportunities," Hill said. "Given the care pathways as they stand today, we believe that our products can enhance existing products, so we are having those conversations with those that might be referred to as our competitors."

"There are a number of other approaches, worthy approaches, that have pros and cons, as does ours," he added. "But … inevitably, my panel plus your panel, whatever that panel might be, leads to a better panel."

Easing off from early detection test commercialization puts Oncimmune in a better position to push its auto-antibody methodology into new applications, like companion and complementary diagnostics, which Hill said is something to "look out for" from the firm moving forward.

"We are working with pharma companies at the moment, taking their samples, identifying patients which may or may not respond to some forms immunotherapy, identifying those that are going to go on to get adverse events, and I would hope that some of those partnerships grow and become a little bit more strategic," he said.

However, the company is also still faced with the question of whether it can chart a path for EarlyCDT-Lung not in the lung nodule indication, but in screening of high-risk, asymptomatic individuals — whether in the UK, on the shoulders of the Scottish screening trial data, or potentially in the US under Biodesix's new stewardship of the test in that region.

Data from the recent presentation at the World Conference on Lung Cancer not only showed that use of the test is associated with higher rates of early-stage diagnosis, but also suggested, albeit inconclusively, that this could produce a real mortality benefit.

"The study wasn't intended to give a readout on mortality, and indeed the result is not at this point statistically significant," Hill said. "It is an interesting finding, and as we follow up in three, four, five years we may find that that has become statistically significant and solves that question that [national screening committees] ... are interested in, which is does it save lives, reduce the number of deaths, and can it be deployed."

"The challenge that I think we all have as stakeholders, industry, patients, [and] health systems now, is that we have a product … that demonstrates you can pick up early-stage disease. In many ways you might argue we have an ethical obligation to start to implement that. But there is a barrier, quite likely, to implementing these types of programs that needs to be overcome," Hill added.

A pragmatic way forward, he said, may be to try to conduct a larger case-control trial, which is something "there is significant interest in."