Cerus Corporation (Nasdaq:CERS) announced today study results demonstrating that the INTERCEPT Blood System inactivates SARS-CoV-2, the causative agent for COVID-19, in plasma components intended for transfusion. These data are consistent with prior INTERCEPT studies showing complete inactivation, to below the limit of detection, of other coronaviruses associated with severe pulmonary disease: MERS-CoV1,2 (2018, 2019) and SARS-CoV-13 (2005).
The in vitro study evaluated inactivation of SARS-CoV-2 in plasma components using both infection and molecular assays, as well as cell culture passaging experiments, allowing the confirmation of complete inactivation over time. Under the Principal Investigators Prof. Esam Ibraheem Azhar (Special Infectious Agents Unit - BSL3, King Fahd Medical Research Center, King Abdulaziz University, Jeddah, Saudi Arabia) and Prof. Salwa Hindawi (Department of Hematology, Faculty of Medicine), the study was conducted at the Special Infectious Agents Unit - BSL3, King Fahd Medical Research Center, King Abdulaziz University, Jeddah, Saudi Arabia, with a local clinical SARS-CoV-2 isolate. This center is known for its expertise in coronavirus research. A manuscript for publication is currently in preparation. The investigators are currently conducting a subsequent study to assess the ability of the INTERCEPT Blood System to inactivate SARS-CoV-2 in platelet components. These studies are funded by the Saudi Arabia Ministry of Health and supported by Cerus.
"Given the ongoing global COVID-19 pandemic, these study results are significant in showing efficacy against a highly pathogenic coronavirus," said Dr. Richard Benjamin, Cerus’ chief medical officer. "While no transfusion transmitted SARS-CoV-2 infections have been reported to date, viral RNA has been observed in the plasma of some patients; and the inactivation data from this study indicate that the INTERCEPT Blood System could reduce the potential risk of SARS-CoV-2 transmission by transfusion of convalescent plasma from recovered COVID-19 patients."
Separately, Cerus is conducting a set of in vitro studies in the United States to assess the INTERCEPT Blood System’s ability to inactivate SARS-CoV-2 in red blood cells, as well as platelets and plasma. These studies are funded by the Biomedical Advanced Research and Development Authority (BARDA) as part of Cerus’ recent contract amendment and associated funding increase.
BARDA is part of the Office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services. The development of the INTERCEPT red blood cell program has been funded in whole or in part with federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. HHSO100201600009C.
The INTERCEPT Blood Systems for platelets, plasma, and red cells plasma are proactive interventions designed to inactivate a broad spectrum of viruses, bacteria, protozoa, and contaminating donor leukocytes in plasma components to reduce the risk of transfusion transmitted infections especially in pandemics of emerging pathogens before donor testing is available.
- Hindawi, S. I., A. M. Hashem, et al. (2018). "Inactivation of Middle East respiratory syndrome-coronavirus in human plasma using amotosalen and ultraviolet A light." Transfusion 58(1): 52-59.
- Hashem, A. M., A. M. Hassan, et al. (2019). "Amotosalen and ultraviolet A light efficiently inactivate MERS-coronavirus in human platelet concentrates." Transfusion Medicine 29 (6): 434-441.
- Pinna, D., A. Sampson-Johannes, et al. (2005). "Amotosalen photochemical inactivation of severe acute respiratory syndrome corona virus (SARS-CoV) in human platelet concentrates." Transfusion Medicine 15: 269-276.
ABOUT SPECIAL INFECTIOUS AGENTS UNIT –BSL3
The unit was established in late 2003 at King Fahd Medical Research Center, King Abdulaziz University with the aim of performing research projects and diagnostic assays for a wide range of infectious agents (Bacterial, Viral, Fungal, and Parasites). The unit is equipped with state-of-the-art technologies that allow to provide epidemic aid and conducts epidemiologic studies on the detection, prevention, and control of highly hazardous viral diseases. The unit provides primary isolation, identification, and characterization of highly hazardous disease agents that require biosafety level 3 laboratory conditions for their safe handling; develops, evaluates, and improves methods for treatment, prevention, and laboratory diagnosis of hazardous disease agents. The unit also conducts laboratory, clinical, and epidemiological investigations on the pathogenesis, pathophysiology, and prevention of viral infections caused by risk group 3 viruses; develops and evaluates education programs for educating health professionals about infection, prevention and laboratory diagnosis of infectious diseases.
Cerus Corporation is dedicated solely to safeguarding the world’s blood supply and aims to become the preeminent global blood products company. Based in Concord, California, our employees are dedicated to deploying and supplying vital technologies and pathogen-protected blood components for blood centers, hospitals and ultimately patients who rely on safe blood. With the INTERCEPT Blood System, we are focused on protecting patients by delivering the full complement of reliable products and expertise for transfusion medicine. Cerus develops and markets the INTERCEPT Blood System and remains the only company in the blood transfusion space to earn both CE Mark and FDA approval for pathogen reduction of both platelet and plasma components. Cerus currently markets and sells the INTERCEPT Blood System in the United States, Europe, the Commonwealth of Independent States, the Middle East and selected countries in other regions around the world. The INTERCEPT Red Blood Cell system is in clinical development. For more information about Cerus, visit www.cerus.com and follow us on LinkedIn.
INTERCEPT and the INTERCEPT Blood System are trademarks of Cerus Corporation.
Forward Looking Statements
Except for the historical statements contained herein, this press release contains forward-looking statements concerning the potential reduction in the risk of transmission of SARS-CoV-2 as a result of the transfusion of convalescent plasma for COVID-19 patients, and other statements that are not historical facts. Actual results could differ materially from these forward-looking statements as a result of certain factors, including, without limitation, risk that further studies may indicate that the INTERCEPT Blood System does not successfully inactivate SARS-CoV-2; that applicable regulatory authorities may disagree with Cerus‘ interpretations of the data from the in vitro studies; as well as other risks detailed in Cerus’ filings with the Securities and Exchange Commission, including Cerus’ Quarterly Report on Form 10-Q for the quarter ended March 31, 2020, filed with the SEC on May 5, 2020. In addition, to the extent that the COVID-19 pandemic adversely affects Cerus’ business and financial results, it may also have the effect of heightening many of the other risks and uncertainties described above. Cerus disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release.
Tim Lee – Investor Relations Director