In the face of immense uncertainty, Renalytix AI remains committed to utilizing our scientific resources and technology to improve patient outcomes, both in chronic kidney disease and beyond. Read about our developmental efforts related to COVID-19 below.
Kantaro Biosciences: Joint venture for scaled production of COVID-19 antibody test kits
Renalytix has entered into a joint venture with the Icahn School of Medicine at Mount Sinai (“Mount Sinai”), Kantaro Biosciences, LLC (“Kantaro”), to develop and scale production of COVID-19 antibody test kits.
The test kits are based on the Mount Sinai-developed high-performance serologic assay for SARS-CoV-2 antibodies. Kantaro has partnered with Minneapolis-based Bio-Techne Corporation to develop and launch the new kit, with the goal of producing more than ten million patient tests per month by July. The two companies have formed a joint commercialization and distribution team to support the rapid distribution of kits to clinical laboratories in the US and around the world.
Kantaro’s SARS-CoV-2 test kits are designed for use in any authorized clinical testing laboratory without the need for proprietary equipment. The technology underlying the kits was created by a team of internationally recognized scientists and clinicians, including members from the Departments of Microbiology and Pathology, Molecular and Cell-Based Medicine within the Icahn School of Medicine at Mount Sinai. The original Mount Sinai test was validated in The Mount Sinai Hospital’s Clinical Laboratories, and has been performed on over 30,000 patient samples. The Kantaro test kit, an enzyme-linked immunosorbent assay (ELISA), builds on this test technology and is designed to measure the presence or absence of anti-COVID-19 antibodies in addition to measuring the titer (level) of antibodies a person has produced.
Mount Sinai developed the underlying assay in response to the critical needs of thousands of patients within the hospital system, including those who were severely ill and could potentially benefit from convalescent plasma for emergency therapy. Mount Sinai was issued an Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA) for clinical testing in its CLIA certified laboratory on April 15th. Kantaro plans to seek EUA for the test kit following final validation.
“Antibody testing will be critical to providing patients and governments the essential information they need to help the world economies reopen and begin to recover from COVID-19,” said Florian Krammer, PhD, Professor of Microbiology at the Icahn School of Medicine. “With the launch of Kantaro, we look forward to bringing a kit based on our highly specific and sensitive test to every corner of the globe.”
KidneyIntelX™ to predict major adverse kidney events in COVID-19 patients
The KidneyIntelX™ platform will be used by investigators from the Icahn School of Medicine at Mount Sinai to assess the risk of adverse kidney events in patients diagnosed with COVID-19. Acute and chronic kidney disease is strongly associated with severity of disease and fatal outcomes in COVID-19 patients. Evaluation of a patient’s kidney risk status at the time of COVID-19 diagnosis, through recovery and during follow-on monitoring, can be of potentially high clinical value.
The KidneyIntelX platform will be used in a large study of COVID-19 admitted patients at Mount Sinai called “Pred-MAKER” (Prediction of Major Adverse Kidney Events and Recovery). Pred-MAKER will study clinical features and biomarkers, including multiple plasma biomarkers and urine proteomics and RNA sequences, as predictors of major adverse kidney events in patients hospitalized with COVID-19. The study has been submitted for Institutional Review Board (IRB) review and approval.
Dr. Steven Coca, co-founder of RenalytixAI and co-Investigator in Pred-MAKER, stated:
“Given the evidence that there is extensive systemic inflammation as well as kidney tubular injury in patients with COVID-19, the KidneyIntelX platform is well positioned to play a prominent role in understanding which patients are at highest risk of severe kidney complications and which patients are more likely to experience longer-term detrimental effects of COVID-19 infection.”
The overall goal of the study is to improve the understanding of mechanisms of COVID-19-associated kidney disease, and to leverage the KidneyIntelX platform to deploy comprehensive machine-learned prediction models that utilize clinical data along with plasma and urine biomarkers to risk stratify Covid-19 patients into low, medium and high-risk strata for major adverse events. Dr. Coca anticipates an accelerated timeline for the conduct of the study, given the current clinical work-load impact of COVID-19 at Mount Sinai and other New York City area hospitals.
KidneyIntelX in Multi-Center Study to Monitor and Predict Kidney Risk in COVID-19 Patients
Surge in Chronic Kidney Disease and Kidney Failure Expected Post-COVID-19
Mount Sinai-Led Study to Assess 4,000 Surviving COVID-19 Patients
NEW YORK, August 3, 2020 – Mount Sinai Health System and Renalytix AI plc (LSE: RENX) (NASDAQ: RNLX), announce the initiation of a multi-center study to conduct in-depth investigations into kidney-related complications and long-term outcomes linked to COVID-19. KidneyIntelX, the artificial intelligence-enabled in vitro diagnostic platform, will be used to assess the risk of kidney disease progression and kidney failure, among other kidney complications, in patients surviving COVID-19 from multiple centers in the United States. As of July 30, 2020, over 300,000 Americans had been hospitalized for COVID-19.1
The study, titled “Multi-center Assessment of Survivors for Kidney Disease after COVID-19 (MASKeD-COVID),” expands on the Pred-MAKER study previously announced April 20, 2020 which focuses on the impact of COVID-19 in the acute hospitalized setting (https://renalytixai.com/kidneyintelx-covid-19/). Investigative teams expected to participate in the study include the Mount Sinai Health System Icahn School of Medicine at Mount Sinai in New York, Yale New Haven Health/Yale School of Medicine, Michigan Medicine/University of Michigan Medical School, Johns Hopkins Medicine/The Johns Hopkins University Medical School, and Rutgers, The State University of New Jersey/Rutgers New Jersey Medical School.
KidneyIntelX will be used to assess risk for new chronic kidney disease (CKD) in the short-term or kidney disease progression over the longer-term in patients who have recovered from COVID-19. Diverse data inputs, including validated blood and urine-based biomarkers, inherited genetics and extensive patient data from electronic health record systems, will be incorporated into the KidneyIntelX machine learning-enabled algorithm to generate a unique patient risk score. In addition, Mount Sinai Health System’s high-performance serologic SARS-CoV-2 testing will be used to assess a patient’s antibody levels to COVID-19 over time, providing valuable insights into the interaction between immune response and kidney-related complications in this patient population.
“With the pandemic spread of COVID-19 and the increased morbidity and mortality from COVID-19 in patients with diabetes, CKD and acute kidney injury, it is imperative to define the underlying mechanisms of COVID-associated kidney disease and develop solutions to guide patient care,” said F. Perry Wilson, M.D., MSCE, MASKeD-COVID Principal Investigator, Yale School of Medicine. “This can be best achieved through collaboration in all aspects including data sharing, biomarker analysis, data analytics and clinical translation. RenalytixAI and Mount Sinai have assembled an outstanding team to address critical issues regarding COVID-19 and kidney disease.”
“This collaborative approach is vital for us to further develop some important findings by the respective groups to date,” said Matthias Kretzler, M.D., MASKeD-COVID Principal Investigator at University of Michigan. “We have demonstrated that ACE2 (the SARS-CoV-2 receptor) is co-expressed with a set of genes in the proximal tubules also having functions in viral entry, establishment of viral replication, and innate immunity.2 We look forward to working with this outstanding team to further expand on this research and further define the underlying mechanisms of COVID-associated kidney disease.”
SARS-CoV-2 is believed to result in acute kidney injury through multiple mechanisms, including severe inflammation, endothelial damage, microthrombi, and possibly direct invasion of the virus into kidney epithelial cells.3 The burden and incidence of post-COVID-19 CKD and end-stage kidney disease (ESKD) is currently unknown, given the recency of the pandemic. However, emerging evidence suggests patients surviving COVID-19 will experience a significant increased risk of kidney disease, including the following:
- Approximately 20% to 45% of patients hospitalized with COVID-19 in the United States and over 60% of patients admitted to the ICU for COVID-19 in the United States experience acute kidney injury (AKI), approximately 25% to 45% of whom require acute dialysis;4
- Data from an analysis of over 3,000 patients admitted to Mount Sinai indicates that 50% of surviving patients who experienced AKI during hospitalization for COVID-19 had persistently abnormal kidney function at the time of discharge;5
- It has been established in the literature that AKI is strongly associated with development of CKD, CKD progression, and ESKD;6
- Given the observed severity of kidney injury in many COVID-19 patients, both clinically and histopathologically, the risk for subsequent transition to CKD and ESKD is likely to be high in survivors.7
“There are so many questions yet to be answered regarding COVID-19 and kidney disease. For example, we don’t yet know the risk factor and mediators of AKI to CKD transition after COVID-19. We also don’t know the predictors of long-term outcomes after COVID-19,” said Evren Azeloglu, Ph.D., Assistant Professor of Nephrology and Pharmacological Sciences at the Icahn School of Medicine at Mount Sinai. “Moreover, we need to understand how this “second hit” from COVID-19 interacts with other risk factors such as underlying APOL1 genotypes to heighten the potential for proteinuric nephropathy. Additional work with biomarker research, kidney tissue histopathology, and gene expression signatures is needed to understand the disease and the long-term implications.”
The MASKeD-COVID study will be coordinated by Mount Sinai, which has already implemented a COVID-19 Center of Excellence Registry and begun longitudinal follow-up with detailed assessments along with biospecimens collection.8 Initial research findings are expected to be reported in late 2020, with the goal of launching KidneyIntelX commercialization activities in this COVID-19 population targeted for H1 2021.
About the Mount Sinai Health System
The Mount Sinai Health System is New York City’s largest academic medical system, encompassing eight hospitals, a leading medical school, and a vast network of ambulatory practices throughout the greater New York region. Mount Sinai is a national and international source of unrivaled education, translational research and discovery, and collaborative clinical leadership ensuring that we deliver the highest quality care—from prevention to treatment of the most serious and complex human diseases. The Health System includes more than 7,200 physicians and features a robust and continually expanding network of multispecialty services, including more than 400 ambulatory practice locations throughout the five boroughs of New York City, Westchester, and Long Island. The Mount Sinai Hospital is ranked No. 14 on U.S. News & World Report’s “Honor Roll” of the Top 20 Best Hospitals in the country and the Icahn School of Medicine as one of the Top 20 Best Medical Schools in country. Mount Sinai Health System hospitals are consistently ranked regionally by specialty and our physicians are in the top 1% of all physicians nationally by U.S. News & World Report.
RenalytixAI is a commercial-stage artificial intelligence-enabled in vitro diagnostics company, focused on optimizing clinical management in CKD to help drive improved patient outcomes and significantly lower healthcare costs. KidneyIntelX, our first-in-class diagnostic platform, employs a proprietary artificial intelligence-enabled algorithm that combines diverse data inputs, including validated blood-based biomarkers, inherited genetics and extensive personalized patient data from electronic health record, or EHR, systems to generate a unique patient risk score. KidneyIntelX is based on technology developed by Mount Sinai faculty and licensed to RenalytixAI. Mount Sinai and Mount Sinai faculty have a financial interest in RenalytixAI.
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This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts, and in some cases can be identified by terms such as “may,” “will,” “could,” “expects,” “plans,” “anticipates,” and “believes.” These statements include, but are not limited to, statements regarding the conduct, design and timing of the MASKeD-COVID clinical trial, including the timing of initial research findings and the timing and viability of commercialization of KidneyIntelX in the COVID-19 population, as well as the participation of other institutions in the MASKeD-COVID clinical trial and the potential benefits of KidneyIntelX in assessing kidney disease in the context of COVID-19. Any forward-looking statements are based on management’s current views and assumptions and involve risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. We may not actually achieve the plans and objectives disclosed in the forward-looking statements, and you should not place undue reliance on our forward-looking statements. Various important factors could cause actual results or events to differ materially from those that may be expressed or implied by our forward-looking statements, including those described in the “Risk Factors” section of our final prospectus filed with the Securities and Exchange Commission (SEC) on July 17, 2020 and other filings we make with the SEC from time to time. All information in this press release is as of the date of the release, and we undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise, except as required by law.
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