NEW YORK – Immunovia is making progress in moving tests for two different indications closer to clinical use.
The Swedish molecular diagnostics company recently announced a partnership with investigators at Leiden University Medical Center in the Netherlands to study the use of its Immray platform to diagnose patients with rheumatoid arthritis (RA). Separately, the company announced progress in a partnership with a pharmaceutical partner related to lung cancer.
While tests derived from both partnerships are likely years away from clinical use, the deals reflect progress by the Lund-based company toward expanding its test menu.
Currently, Immunovia is preparing to launch PanCan-d, a liquid biopsy test for early-stage pancreatic cancer detection that runs on its antibody microarray platform. According to CCO Laura Chirica, PanCan-d will be rolled out in the third quarter of 2020 via its lab outside Boston as a laboratory-developed test, as well as through its lab in Lund. The test launch has been delayed several times. The company will also seek a CE-IVD mark for the assay, she said.
While that work continues, the company is also moving ahead with RA. Immunovia has been applying its core technology in autoimmune diseases for several years now, and also has projects ongoing related to systemic lupus erythematosis (SLE), among other indications. In terms of RA, the company has completed three studies to date. The first two showed that its assay could distinguish between SLE, RA, and other conditions. The latest study showed that the platform could distinguish RA patients negative for anti-cyclic citrullinated peptide (CCP) from healthy controls.
CCP is an antibody present in some RA patients that allows clinicians to diagnose patients via a blood test. However, the antibody is often present only when the disease progresses, making early-stage diagnosis of the disease difficult, especially compared to patients suffering from RA-like symptoms. Those who are negative for the marker but who are clinically diagnosed with the disease are called seronegative patients.
To further develop its test, Immunovia recently partnered with LUMC, which has access to a cohort of several hundred patients, some of whom were diagnosed with RA and others of whom suffered from RA-like conditions.
"Of course, we would like to be able to see that we can get good accuracy in diagnosing the CCP-negative cohort versus overlapping RA-like diseases," Chirica said of the firm's ambitions. "From there, we would be able to proceed into deriving a signature and moving on with the next steps of test development," she said.
The study has yet to commence as Immunovia and its partners seek various institutional approvals to run it. Chirica said it will likely start at the beginning of 2020. Immunovia's assay for RA is called called Immray RA-d.
"It's an important pipeline project, but we are at the initial steps," she said. "We are looking forward to being able to conduct this study with controls that are different from the first few studies," she added. She noted that the LUMC cohort is "quite challenging," as it includes patients who have RA symptoms but not RA. A positive assay performance could therefore augment test development.
Immunovia in general considers autoimmune disease to be an opportunity for the company in parallel with cancer. As the firm's platform is an antibody array designed to measure immune responses, it therefore lends itself toward looking for new signatures related to various autoimmune conditions. "This is something that could for sure work for autoimmune diseases where there is a big need for such kinds of early diagnosis platforms," Chirica said.
She said that Immunovia reached out to LUMC given the center's expertise in RA. Thomas Huizinga, professor of rheumatology at LUMC, said the cohort to be studied includes around 400 people. He said that he agreed to take part in the study both to make the cohort useful for scientific research, but also because of a need for early stage diagnostics in RA.
"As a doctor, I think we urgently need a diagnostic test for seronegative arthritis," said Huizinga. "Society will be helped if we can identify such a test, and that is why I am keen to do this research project," he said. "If I can help patients, that is important for me."
According to Huizinga, about 40 percent of RA patients are actually seronegative. He said that it's difficult to make a positive clinical diagnosis of RA patients, as the condition affects people differently. "You normally do x-rays and examinations if antibodies are not recognized," he said. "Then you look at the symptoms to make a working diagnosis."
Huizinga noted that molecular methods for diagnosing RA have been tried before, adding that gene expression-based approaches, while being "easy to do nowadays," have not yet yielded the answers needed. Immunovia's approach of looking at proteins is different, but he cautioned that protein markers are generated all over the body, meaning that tests might measure a diverse set of potential markers, creating a risk for false positives.
"After we have found something positive, we need to replicate it to see that it's really true," he said. "From a technical view [the test] is fine to do, but we have to be careful we do not find false positives or signatures that cannot be replicated."
Chirica underscored that they need to complete the study and look at the results before they make any predictions about its performance.
One aspect about the LUMC study that Chirica drew attention to is the use of fresh blood samples. She said that Immunovia is committed to building its tests using fresh samples, as these are in the same state as the blood draws that will eventually be used in the clinical application of its tests. "The use of fresh samples is a prerequisite for building our test models, the same way that we did with PanCan-d," she said.
There may be other studies on the horizon around RA. Part of the company's strategy is to engage experts like Huizinga as it develops its RA test, Chirica said.
Lung cancer pipeline
Separately, Immunovia last week announced that an ongoing lung cancer collaboration with a global pharmaceutical partner has entered a new stage. Immunovia disclosed the study last year, noting it was focused on non-small cell lung cancer.
That part of the study included interrogating 100 blood samples to assess the performance of the company's platform to diagnose the disease. In the new phase of the study, the objective is to see if the Immray platform can be used to predict response to drug treatments, enabling clinicians to select the right therapies for patients. The company said the study will also benefit its early detection program and will generate more data related to the capabilities of the Immray platform.
Immunovia said it will receive blood samples from its pharma partner by the end of the year and intends to finish up analyses by the second quarter of 2020.
Chirica declined to name the pharma partner. She characterized Immunovia's lung cancer pipeline as being in the "early stages of development," but said initial data around the assay has been promising. She also noted that the firm, which consists of 15 people, is also quite focused at the moment on delivering PanCan-d to the market next year.
"We are focusing most of our effort, time, and energy on that," she said. "With lung cancer, we are moving into the next stage and will communicate more about that as soon as we get results."