Cerus Corporation (Nasdaq: CERS) announced today that the University Hospital Basel transfused the first two COVID-19 patients with INTERCEPT treated coronavirus convalescent plasma (CCP). Cerus' field team supported the INTERCEPT system implementation which was completed in one week.
The University Hospital Basel and the regional blood transfusion service of the Swiss Red Cross, Basel initiated one of the first CCP programs outside of China and are leveraging the INTERCEPT pathogen-reduction technology to enhance plasma transfusion safety and enable collections from convalesced donors earlier after their infection than might otherwise be possible The INTERCEPT plasma system has demonstrated effective inactivation of the SARS-CoV and MERS coronaviruses1,2,3
"Plasma collected from individuals who have recovered from coronavirus disease contains antibodies against the virus that may help fight the infection. Prior experience has shown a benefit from immune plasma in other viral diseases, such as Argentine Hemorrhagic Fever, a viral epidemic disease with high mortality; as well as the earlier epidemic of severe acute respiratory syndrome (SARS) 4,5. The preliminary data from China on the use of CCP in COVID-19 patients is promising," says Dr. Laurence Corash, Cerus' chief scientific officer. "The use of INTERCEPT has been shown to improve the overall safety of plasma by inactivating residual virus and other infectious pathogens that may be present in donor blood. A recent publication indicated that neutralizing antibodies to the Ebola virus were retained after INTERCEPT treatment. As the number of convalesced or asymptomatic COVID individuals increases, sources of CCP will become more abundant, which could make this treatment or prophylactic modality widely available before other interventional drug therapies and vaccines have been validated."
Based on WHO data, plasma collected from recovered COVID-19 patients contains antibodies that neutralize SARS-CoV-2 infectivity and may improve a patient's ability to fight COVID-19. A clinical study evaluating the efficacy of CCP is currently underway in China and the potential for the therapy is promising. As witnessed in geographies around the globe, the COVID-19 pandemic has burdened hospitals with a high number of patients with severe respiratory illnesses. The absence of approved treatments for COVID-19 has led to urgent worldwide interest in developing CCP programs for treatment of acutely ill individuals and potential prophylaxis for high risk individuals exposed to COVID-19.
Cerus has facilitated the generation of pathogen reduced convalescent plasma for transfusion in other viral diseases, such as Ebola, for which Cerus provided technology for a multi-site clinical study in 2015. Cerus, a leader in the field of pathogen inactivation to improve blood transfusion safety, is supporting blood centers and national transfusion services across the globe with the production of CCP, as well as pathogen reduced platelets and plasma, and has formed a multi-organizational consortium focused on antibody characterization, plasma processing, and pre-clinical testing of pathogen inactivated CCP which will allow blood centers to evaluate the clinical efficacy of well characterized, pathogen inactivated CCP in acutely ill COVID-19 patients.
ABOUT CONVALESCENT PLASMA:
Passive immunity has been demonstrated effective for treatment of infections caused by cytomegalovirus (CMV), hepatitis B virus, rabies, tetanus, varicella, prior SARS viruses, 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. Two preliminary clinical series from China reported that transfusion of COVID-19 convalescent plasma resulted in improved clinical status for patients requiring mechanical ventilation6 and significant improvement in clinical symptoms, blood oxygen saturation, and clearance of SARS-CoV-2 virus7. The transfusions were well tolerated in both studies. Use of convalescent plasma is supported by a February 2020 WHO report which 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
- Hashem AM, Hassan AM, Tolah AM, Alsaadi MA, Abunada Q, Damanhouri GA, El-Kafrawy SA, Picard-Maureau M, Azhar EI, Hindawi SI. Amotosalen and ultraviolet A light efficiently inactivate MERS-coronavirus in human platelet concentrates. Transfus Med 2019 (https://onlinelibrary.wiley.com/doi/abs/10.1111/tme.12638)
- Hindawi SI, Hashem AM, Damanhouri GA, El-Kafrawy SA, Tolah AM, Hassan AM, Azhar EI. Inactivation of Middle East respiratory syndrome-coronavirus in human plasma using amotosalen and ultraviolet A light. Transfusion 2018;58: 52-9 (https://onlinelibrary.wiley.com/doi/abs/10.1111/trf.14422)
- Pinna D, Sampson-Johannes A, Clementi M, Poli G, Rossini S, Lin L, Vicenzi E. Amotosalen photochemical inactivation of severe acute respiratory syndrome coronavirus in human platelet concentrates. Transfus Med 2005;15: 269-76.
- Enria, D. A., A. M. Briggiler, et al. (2008). "Treatment of Argentine hemorrhagic fever." Antiviral Res 78(1): 132-139.
- Enria, D. A., A. M. Briggiler, et al. (1984). "Importance of dose of neutralising antibodies in treatment of Argentine haemorrhagic fever with immune plasma." Lancet 2(8397): 255-256.
- Shen, C., Z. Wang, et al. (2020). "Treatment of 5 Critically Ill Patients With COVID-19 With Convalescent Plasma." JAMA.
- Duan, K., B. Liu, et al. (2020). "The feasibility of convalescent plasma therapy in severe COVID-19 patients: a pilot study." medRxiv.
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 relating to therapeutic benefits to COVID-19 patients who receive convalescent plasma, as well as 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 risks related to the efficacy of CCP as a therapeutic or prophylactic treatment option for COVID-19 patient, as well as other risks detailed in Cerus' filings with the Securities and Exchange Commission, including Cerus' Annual Report on Form 10-K for the year ended December 31, 2019, filed with the SEC on February 21, 2020. Cerus disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release.
Tim Lee Investor Relations Director