Coronavirus' signature gets a closer look from Eastern Shore scientists
By HANNAH COMBS www.myeasternshoremd.com
CAMBRIDGE — Life as we know it changed early in 2020 across the United States, but here on the Eastern Shore two scientists had already developed a test that will be instrumental in predicting a patient’s risk of advanced coronavirus disease and death.
In Cambridge, IES Life Sciences, Inc. a biotechnology company “with patented technology that interrogates the human immune system to improve diagnosis and treatment of traditionally hard-to-diagnose diseases at their earliest stages,” has developed the process for a test for COVID-19 that could provide confirmation of diagnosis and identify high mortality risk patients.
For high risk patients, COVID-19 evades and tricks the immune system into attacking the body’s own lung tissues, leading to pneumonia and death without successful hospitalization. The virus tricks the immune system through a “cytokine storm,” disruptions to cytokine signaling, part of a patient’s normal immune messaging system.
While a test to positively identify whether a patient has COVID-19 already exists, the technology created by IES has the ability not only to test pre-symptomatic individuals, but also to measure the severity of the infection and the risk of experiencing a fatal cytokine storm — whether mild or requiring hospitalization — and see where that patient is on the bell curve, said David Spiegel, chief executive officer and co-founder.
“It is a very predictive test,” Spiegel said. “No other tests measure (like this one) and is the most effective test we have seen.”
For this specific test — although IES has the patent and is a for-profit company— “in a national emergency we just want to be able to cover our costs,” Spiegel said.
In March, IES published a white paper about the test, outlining a proposal for collaboration in which IES requires clinical collaborators to supply blood specimens from confirmed COVID-19 infected patients in order to quickly develop a CVID test for COVID-19.
The paper further states, “Both traditional statistical analysis and machine learning methods will be employed to define Coronavirus Interferon Disruption Test (CVID) data providing insight into infectivity, progression, clinical symptoms and survivor CVID patterns over the course of the viral infection and resolution. Our CVID development strategy is comprised of 3 phases spanning a 12-month project period.”
Those three phases include putative or exploratory CVID screening, CVID confirmation, longitudinal analysis and immunomodulatory interventional guidance. In layman’s terms, it means running tests several times throughout the infection to see how the immune system and clinical treatments succeed and fail against the infection.
The point of contact and lead scientist for this project is Robert W. Figliozzi, Ph.D., IES Life Sciences director of research and development. Dr. Figliozzi has over eight years of experience in immunology and Biosafety-Level-2 virology research and development. He has been managing collaborative research between IES and UMES/USM for over two years.
Scientific founder Ron Jubin, Ph.D., has 30 years of experience as a virologist developing several drugs and conducting novel research towards the patient's immune response to infection. Dr. Jubin will provide key strategic oversight and detailed data review to ensure accurate and timely data-driven decisions are being made to rapidly advance the test to clinical readiness.
The initial target for test development by IES was lupus. Jubin became involved with this first test because of his sister’s experience with lupus – and a frustration when doctors explained there was no definitive diagnostic test for the condition.
Jubin and Figliozzi are both classically trained in virology. "The company had a heartstring for lupus," Figliozzi said, "We started looking at RSV, allergies, and influenza, with the goal in mind to develop a tool to identify lupus earlier than it is currently able to be diagnosed by the process of ruling out other disease processes."
Jubin worked with the FDA to develop a test that measures interferons, immune system regulatory genes, through qPCR, an FDA-approved assay that measures gene expression. The test was patented and IES has rights to use technology for commercial development and the FDA gets to use patent for academic research.
Early on in the research and development phase, before even COVID-19 was a recognizable concern for the U.S., the IES team realized this test could identify contagious diseases immediately following exposure with a simple blood test, and in conjunction with key advisory board member retired U.S. Army Maj. Gen. Kenneth Dowd, began looking at the implications this technology could have for significant national security and military applications.
“In the event of an outbreak of a disease of unknown origin, the IES test can be deployed to quickly and reliably identify the source of the outbreak, accelerating response times and significantly aiding in containing and combatting the outbreak,” Spiegel said.
IES has been established in the Eastern Shore Innovation Center, which houses their corporate offices in Cambridge, for nearly four years now and they have no intention of leaving, Spiegel said. “It is a very friendly, social place, and the staff there makes our lives easier in the business world. We absolutely love it.”
The decision to locate in Dorchester County was in large part due to the availability of a Maryland tax credit program that allows investors a 75% tax credit on their investment, Spiegel said. Right now, more than ever, funding is critical to their moving forward with this testing for COVID-19.
With the assay or test developed by IES, they can show a body’s immune system response to exposure within an hour. But two of the holdbacks keeping the development of the test for COVID-19 from moving forward more quickly is availability of blood samples and funding, Spiegel said. The lab currently has enough supplies to conduct 50 to 100 tests, he said, but they need funding to get more supplies to continue the process. Human samples are in the range of $2,000 per sample, another significant expense.
“I think we can do this, apply this test to COVID, the way this virus is presenting like this — a multi-system autoimmune attack — and potentially help guide application immunomodulating pharmaceuticals,” Figliozzi said.
Figliozzi recognized similarities between the way COVID-19 was tricking the immune system into attacking itself and the way that autoimmune diseases like lupus result from scrambled immune signaling. From his research, Figliozzi said he believes that autoimmune disease medicines might help protect against advanced COVID-19 disease and mortality.
Figliozzi agreed the biggest hurdle is getting patient samples, which must be obtained through strict approved protocols, and — with liability issues to consider with human research — comes at a big expense.
“Our test would be pretty easy to implement and the sample we need is the same one they are collecting anyway; the actual sample is very small,” Figliozzi said.
“We can help the pharmaceutical companies,” Spiegel said, “In the pharmaceutical world it is not the big guys who are leading in innovation, it’s smaller companies and researchers.”
For now, speeding up the process and making the test available to providers sooner rather than later could be key in how COVID-19 is handled. “We really want to get this white paper in front of the right people,” Figliozzi said.
There is more sharing of information in research now (more) than ever, he said. “I am feeling very confident that we will see something with our assay.
“The test when used on this virus makes sense because COVID-19 (SARS-2) has evolved to evade and suppress our immune system and this is what our test measures," Figliozzi said.
"With the test we should be able to measure if your body is able to handle the virus and if you have it, what the response will likely be, and maybe alleviate some of the fear of the virus by measuring the way it scrambles the communication of our immune system and identify medicines that can restore healthy immune communication reacts,” Figliozzi said.