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Cerus Forms Group to Research Optimal Production of COVID-19 Convalescent Plasma

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Cerus Corporation (NASDAQ:CERS) announced today that it has formed a collaborative research group with the aim of optimizing convalescent plasma therapy for COVID-19 patients. The research group seeks to define the key characteristics that influence the efficacy of convalescent plasma, including the level and nature of anti-COVID-19 antibodies, optimal collection timing, dosing and how these influence responses to the therapy regimen. Cerus' research group collaborators include the California Department of Public Health, the University of California, Irvine's Vaccine Development Research Laboratory, the Vitalant Research Institute, the California National Primate Research Center, and Enable Biosciences.

"Convalescent plasma is one of few interventions that can be made available rapidly following the emergence of a new epidemic, and globally a number of investigators are already initiating this promising therapy," said Dr. Laurence Corash, Cerus' chief scientific officer. "Given the emergent conditions under which convalescent plasma is used, there is often very little opportunity to fully characterize each unit of plasma; yet doing so is likely to give us very important insights into the responses seen in patients. This research group brings together the tools and experience to generate data that may help improve production of convalescent plasma to treat COVID-19, as well as applying the information to future uses of convalescent plasma as new pathogens continue to emerge."

As the number of convalescent or asymptomatic COVID-19 individuals in the community increases, the sources of convalescent plasma become more abundant. Data from China indicate that antibodies collected from recovered COVID-19 patients can prevent infection of cells, and protect against infection in a COVID-19 primate model(1,2). During an earlier SARS epidemic, patients who received convalescent plasma with antibodies to SARS recovered more rapidly(3).

Some convalescent plasma therapies have been produced using pathogen reduction technology, such as Cerus' INTERCEPT Blood System, to reduce the risk of other viruses, bacteria, and parasites that could be present in the convalescent plasma donation. The INTERCEPT plasma system has approved label claims for SARS-CoV inactivation in both the US and Europe. SARS-CoV-2 is the causative agent of COVID-19 and the genetic sequence is at least 70% similar to that of SARS-CoV4.

"The use of the INTERCEPT technology improves the overall safety of convalescent COVID-19 plasma by reducing the risk of other sources of infection in the plasma; and may enable earlier collection of plasma from recovered donors than would otherwise be possible," continued Dr. Corash. "We are already supporting a number of our customers who are initiating convalescent plasma collection programs."

"Prior studies have shown the potential benefit of convalescent plasma," said Edward L. Snyder, MD attending physician at the Yale New Haven Hospital Transfusion Service. "There is a critical need to characterize the antibody in the convalescent plasma as this Research Consortium has proposed. This approach may allow researchers to optimize a therapeutic approach to combating the COVID-19 viral pandemic."

  1. Aylward B, Liang W. Report of the WHO-China Joint Mission on Coronavirus Disease 2019 (COVID-19). World Health Organization, 2020.
  2. Bao L, Deng W, Gao H, Xiao C, Xue J, lv Q, et al. Reinfection could not occur in SARS-CoV-2 infected rhesus macaques. bioRxiv. 2020;doi.org/10.110/2020.03.13990226.
  3. Cheng Y, Wong R, Soo YO, Wong WS, Lee CK, Ng MH, et al. Use of convalescent plasma therapy in SARS patients in Hong Kong. Eur J Clin Microbiol Infect Dis. 2005;24(1):44-6. Epub 2004/12/24.
  4. Hui DS, Azhar EI, Madani TA, Ntoumi F, Kock R, Dar O, Ippolito G, Mchugh TD, Memish ZA, Drosten C, Zumla A, Petersen E. The continuing 2019-nCoV epidemic threat of novel coronaviruses to global health - The latest 2019 novel coronavirus outbreak in Wuhan, China. International Journal of Infectious Diseases, Volume 91, 264 – 266 (https://doi.org/10.1016/j.ijid.2020.01.009)

BACKGROUND INFORMATION

ABOUT CONVALESCENT PLASMA:

Passive immunity has proven effective for cytomegalovirus (CMV), hepatitis B virus, rabies, tetanus, varicella, certain SARS variants, Argentine Hemorrhagic Fever, and various other illnesses. Convalescent plasma has been cited as a potential therapy for viral infection dating back to the 1918 Spanish influenza A (H1N1) pandemic. Since that time, convalescent plasma as passive immune therapy has been evaluated in the treatment of: Ebola, SARS coronavirus (SARS-CoV), 2009 pandemic influenza A (H1N1), Argentine Hemorrhagic Fever, CMV, Parvovirus B19, and others. Furthermore, a February 2020 WHO report states "The cellular infectivity of the isolated viruses could be completely neutralized by the sera collected from convalescent patients." [Source: https://www.who.int/docs/default-source/coronaviruse/who-china-joint-mission-on-covid-19-final-report.pdf ]

ABOUT CERUS

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.

ABOUT ENABLE BIOSCIENCES

Enable Biosciences is a multi-award-winning serologic diagnostics company operating a CLIA certified high-complexity clinical reference laboratory and research facility in South San Francisco. Enable's fully automated high-throughput ultrasensitive and highly specific multiplex antibody detection analyzer uses its novel Antibody Detection by Agglutination PCR (ADAP) chemistry to service global clients in the infectious disease, autoimmunity and allergy spaces. ADAP is 100 to 10,000 times more sensitive than ELISA and ultraspecific, enabling the earliest possible detection of multiple disease-related antibodies simultaneously for optimal treatment timing to yield the best outcomes. Enable has produced the independently-assessed world's best performing serologic tests for Type 1 diabetes and HIV in oral fluid and other infectious diseases including Zika and Dengue. For more information about Enable Biosciences visit www.enablebiosciences.com and follow us on Twitter.

ABOUT VITALANT RESEARCH INSTITUTE AND VITALANT BLOOD CENTERS

The Vitalant Research Institute (VRI), San Francisco is an integral component of the Vitalant national blood collection establishment. VRI is directed by Dr. Michael Busch. Established in 1959, VRI has been a major component of the Retroviral Epidemiology Donor Study (REDS) funded by NHLBI to conduct surveillance studies of epidemic transfusion-transmitted infections and infectious pathogens that may impact the blood supply.

ABOUT THE VACCINE RESEARCH AND DEVELOPMENT CENTER, UC IRVINE

The UC Irvine Vaccine Research and Development Center (VRDC) is directed by Dr. Philip Felgner. His laboratory is experienced in high throughput cloning and protein microarray chip technology to screen for antibody epitope specificity. Protein microarray technology developed in the VRDC has been used to detect antibodies against tens of thousands of antigens from multiple infectious pathogens in thousands of serum specimens collected worldwide and is poised to apply the technology to better understand protective immunity against COVID-19.

ABOUT THE CALIFORNIA DEPARTMEN OF PUBLIC HEALTH

Dr. Carl V Hanson is Clinical Laboratory Director of the Viral and Rickettsial Disease Laboratory (VRDL), California State Department of Public Health (CDPH). The laboratory of Dr. Carl Hanson is highly experienced in the isolation and culturing of human viruses and has developed neutralizing antibody assays for many viral diseases.

ABOUT THE CALIFORNIA NATIONAL PRIMATE RESEARCH CENTER (CNPRC)

The CNPRC is associated with the University of California, Davis. It currently has an animal census of ~4,200 rhesus monkeys (Macaca mulatta). The vivarium, which is part of the UC Davis AAALAC-accredited program, includes indoor animal space with animal housing areas, hospitals, surgery suites, nurseries, radioactive monitoring housing areas, and infectious animal housing, included dedicated space for animals infected with specific infectious agents.

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