GoodCell has kicked off a multi-stage program with the New York Blood Center in a study designed to determine how specific acquired and inherited generic blood characteristics might contribute to a COVID-19 patient’s severity and recovery. Researchers hope to advance a broader understanding of patients’ susceptibility to severe disease and COVID-19 risk factors, ultimately informing the generation of a COVID-19 susceptibility test.
Outsourcing-Pharma (OSP) recently discussed the novel project with GoodCell chief medical officer Salvatore Viscomi (SV), who told us about the collaboration and the effect the pandemic has had on research.
OSP: How has COVID-19 impacted your company and your work?
SV: We have found that now more than ever, people are interested in knowing about their wellness, their immunity and steps they can take to mitigate risk.
Prior to COVID-19, GoodCell had an assay for accumulated genetic variation in our blood cells, which are changes caused by common errors our cells make when duplicating themselves. These errors become more likely as we age and as a result of environmental exposure.
Also known as acquired or somatic variants, these changes are associated with risk of blood cancers, heart diseases, overall mortality, and cardiovascular disease mediated by an aberrant inflammatory response of the immune system. This is something experienced by a percentage of individuals with extreme COVID-19 cases.
When we learned about the cascade of events that led to severe disease in some COVID-19 patients, we found some interesting similarities. Both the individuals identified by our assay with the accumulated genetic changes in blood and the sick COVID-19 patients have a dysfunctional immune system manifested by elevated cytokines (cytokine storms) and decreased interferons.
Additionally, sick COVID-19 patients not only have severe pulmonary symptoms but also acute and chronic cardiac sequalae and arterial and vascular thrombosis. Therefore, we filed for IP of an assay targeting the specific accumulated genetic variation associated with such conditions; while we are awaiting results from our study, recent peer-reviewed studies have shown a very high frequency of hospitalized patients with these acquired genetics changes.
In tandem, following a recent funding round, we are also exploring broader implications for our assays and technology platform as it relates to supporting emerging scientific developments for cell quality, autoimmune and inflammatory disease assessments, among other therapeutic categories.
OSP: How did you come to work with New York Blood Center—have you partnered on research before?
SV: In my previous work developing a novel plasma thawing device, we worked with the NYBC in developing our protype and collecting data that ultimately led to FDA approval. Given the NYBC's groundbreaking work in collecting and studying convalescent plasma for antibodies, we thought this would be an ideal partnership in studying the somatic (accumulated) genetic changes in COVID-19 individuals with mild and severe disease.
OSP: How has understanding of the pandemic, vulnerabilities of certain patient populations, and risk factors evolved since COVID-19 landed on us?
SV: Early on we knew that certain risk factors (and co-morbidities) such as asthma, diabetes, hypertension, and cardiovascular disease played a role in predicting which patients were at risk from severe disease and required ICU admittance. However, very little was known about individual risk beyond that. Now we are increasingly learning that genetics plays a role; most of the studies have focused on inherited genetic variants that are associated with risk.
On the other hand, GoodCell has been evaluating acquired genetic changes that occur as random mutations or from environmental stressors over time. We believe that understanding somatic changes and their impact on health risk will have broad population and personal health benefits, for COVID-19 and beyond.
For example, testing for these accumulated variations could help to identify the most at-risk individuals in the population, which is critical to vaccine distribution and informing one’s own decision to self-isolate amid reports of rising cases. These insights could also form the basis for other risk assessment strategies and enable individuals to better see and get ahead of potential health concerns.
OSP: Does GoodCell plan on expanding the research to other regions?
SV: We have assays evaluating cell quality which is particularly important given the current landscape of CAR-T and stem cell therapies. Selecting the best starting cellular material and assessing the damage that happens to cells in the manufacturing process are useful in making sure the recipient of such therapies has the highest quality cells.
Another assay is related to autoimmune diseases – understanding the genetic differences between individuals may inform who may be more responsive or refractory to a certain anti-inflammatory therapy.
OSP: What else would you like to tell us that we haven’t touched upon in the above questions?
SV: GoodCell’s platform leverages the power of blood to assess risk. As such, we of course look at acquired and inherited genetic changes, but there are many more opportunities afforded by blood to understand and assess risk, including routine blood chemistry tests, tests for biomarkers of disease, including emerging capabilities in liquid biopsy for earlier detection of solid tumor cancers.
As another example, testing for lipids in the blood is proving effective in assessing cardiovascular disease risk. Ultimately, we are always looking to incorporate novel health and data insights into our product platform to better inform both an individual’s health, as well as population-based health.