1. Eastman, Peggy

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The National Cancer Institute (NCI) has launched the Serological Sciences Network (SeroNet) for COVID-19 and awarded funding to researchers with the goal of understanding the human immune response to SARS-CoV-2, the virus that causes COVID-19. Several awards relate specifically to patients with cancer.

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SeroNet, one of the largest coordinated efforts to increase the scientific understanding of SARS-CoV-2, is funded through $306 million allocated to NCI from the emergency appropriation Congress enacted last April as the coronavirus pandemic spread. The appropriation came from the Paycheck Protection Program and Health Care Enhancement Act.


In related news, NCI-along with the National Institute of Biomedical Imaging and Bioengineering-has received Congressionally appropriated funding to develop innovative digital health technologies for COVID-19. NCI says this funding could lead to user-friendly tools such as smartphone apps, wearable devices, and software that can identify and trace contacts of infected people, keep track of verified COVID-19 test results, and monitor the health status of infected and potentially infected individuals.


According to NCI, SeroNet will engage more than 25 U.S. institutions to study the immune response to COVID-19 in order to support and foster testing, treatments, and vaccine development. SeroNet is the largest of NCI's serological science initiatives funded by the COVID-19 emergency appropriation, accounting for half the allocation, said the institute. NCI is collaborating with the National Institute of Allergy and Infectious Diseases on this initiative, along with other parts of the National Institutes of Health (NIH) and the Department of Health & Human Services, including the FDA. The NIH "All of Us" research program is already working with SeroNet; the goal is to gather data from 1 million or more people living in the United States to accelerate research and improve health.


"The nation's top researchers in academia, government, and private industry have come together in an unprecedented effort to fight the pandemic," said Dinah Singer, PhD, NCI's Deputy Director for Scientific Strategy and Development. "Through SeroNet, we are examining the immune response to the coronavirus to speed delivery of testing, treatments, and vaccine development for COVID-19. What we learn could be applied immediately and will prove invaluable to public health beyond the current pandemic. We are at a defining moment for public health...Collectively, we face one of the greatest public health challenges of our careers."


Singer and NCI Principal Deputy Director Douglas R. Lowy, MD, pointed out in an NCI commentary that "the widespread availability of reliable serology tests is critical to understanding who has been infected with SARS-CoV-2 and supporting accurate population-wide seroprevalence studies." One hope is that research may yield insights into resistance to reinfection.


The SeroNet strategy includes five components:


1. Serological Sciences Centers of Excellence to conduct two or three serological research projects per center;


2. Serological Sciences Research Projects for emergency awards for research on SARS-CoV-2;


3. Serological Sciences Capacity Building Centers designed to develop and expand the U.S. serological testing capacity with the eventual goal of scaling up to a screening capacity of 5,000 patients per week, per center;


4. A SeroNet Serology Laboratory that draws on the expertise of the HPV Serology Lab at NCI's Frederick National Laboratory for Cancer Research (FNLCR), which is already engaged in evaluating the sensitivity and specificity of SARS-CoV-2 test kits (this lab is working with the FDA to support decisions on which test kit manufacturers can market); and


5. A Serological Sciences Network Coordinating Center to foster coordination and collaboration across all SeroNet components.



According to the NCI, the FNLCR is an example of NCI's longstanding commitment to studying viruses that cause cancer. Before shifting to COVID-19 serology, the HPV serology lab at FNLCR, with co-funding from the Bill and Melinda Gates Foundation, was developing global standards for assays used to measure antibody responses to the HPV vaccine and to natural HPV infection. When COVID-19 emerged as a global pandemic, NCI's HPV serology lab began expanding its capacity to support the growing need for serology testing.


Examples of specific SeroNet research areas of interest include the following, according to NCI:


* characterize the immune responses from SARS-CoV-2 viral infection;


* understand mechanisms driving serological, humoral, and cellular immune responses;


* determine the host, genetic, and environmental modifiers of the immune response;


* determine the serological correlates of disease pathogenesis, including whether, and to what extent, there is protection against future infection; and


* define barriers to access, communication, and implementation related to SARS-CoV-2 serological testing.



As previously reported in Oncology Times, insights gained from treating cancer patients with immunotherapies are helping to unravel the mysteries of the COVID-19 pandemic.


"Oncology is now about the host immune system reacting to the tumor, and there are technologies being developed at breakneck speed to study the host immune system in cancer patients...and those technologies can be applied to the benefit of understanding the host immune response in a pandemic," said CAR T-cell therapy pioneer Carl June, MD, Director of the Center for Cellular Immunotherapies at the Perelman School of Medicine and Director of the Parker Institute for Cancer Immunotherapy at the University of Pennsylvania.


"Over the past 10 years, the cancer immunotherapy field has gone into explicit detail to match therapies to the right kind of patient. So applying that in COVID-19 gives us an opportunity to understand which patients are suffering from the hyperinflammatory state, and which patients may have failed to mount an appropriate immune response and may need antivirals and maybe immune activation," added E. John Wherry, PhD, Chair of the Department of Systems Pharmacology and Translational Therapeutics in the Perelman School of Medicine at Penn.


One of the goals of the NCI SeroNet initiative is to study the unequal impact of COVID-19 on racial and ethnic minorities. One of the recent grant awards went to the Cedars-Sinai Health System in Los Angeles, which serves a racially diverse population. It has been designated one of the eight SeroNet Centers of Excellence.


"There is a critical need for more knowledge regarding the determinants of COVID-19-related risks in minority subgroups," said Susan Cheng, MD, MPH, MMSc, Director of Public Health Research at the Smidt Heart Institute at Cedars-Sinai. "We are finding widening ethnic and racial disparities in both the risk of infection and the severity of this disease." Cheng is also Associate Professor of Cardiology and one of three co-principal investigators for the NCI grant.


To accelerate its research on SARS-CoV-2 and COVID-19, Cedars-Sinai has formed a network of clinicians and scientists from a number of institutions, primarily located in Southern California, to conduct the Coronavirus Risk Associations and Longitudinal Evaluation (CORALE) study. According to medical center, CORALE will consist of two parts: Project 1 will examine the natural history and longitudinal trajectories that represent the diversity of SARS-CoV-2 exposure, infection, recovery, and clinical immunity patterns across populations at risk, and Project 2 will investigate the determinants of SARS-Co-V-2 response among people who have altered immune function related to either chronic disease or their therapies.


In addition to the Cedars-Sinai grant, NCI has awarded other grants as part of its SeroNet initiative. These include the following:


* The University of Massachusetts Medical School in Worcester: Enhancing Racial and Ethnic Diversity in COVID-19 Research Participation Through Storytelling (COVIDStory)


* Yale University: Immuno-Serological Assays for Monitoring COVID-19 in Patients with Hematologic Malignancies


* Icahn School of Medicine at Mount Sinai: Vulnerability of SARS-CoV-2 Infection in Lung Cancer Based on Serological Antibody Analyses


* Wadsworth Center of the New York State Department of Health: High-Throughput Dried Blood Spot (HT-DBS) Technologies in SARS-CoV-2 Serology and Vaccinology


* University of Puerto Rico Medical Sciences Campus: SARS-CoV-2 Correlates of Protection in a Latino-Origin Population.



Peggy Eastman is a contributing writer.