CSL Limited (ASX:CSL; USOTC:CSLLY) today announces that its subsidiary, CSL Seqirus, has entered into a collaboration and license agreement with Arcturus Therapeutics Holdings Inc (“Arcturus Therapeutics”) to access their late stage self-amplifying mRNA (sa-mRNA) vaccine platform technology.
Arcturus Therapeutics (NASDAQ: ARCT) is currently developing next generation mRNA vaccines. It has developed a COVID-19 vaccine candidate and has recently reported results from a large Phase III vaccine efficacy study, meeting its primary and secondary endpoints of prevention of infection and severe disease with a favorable safety and tolerability profile.
“This collaboration is an exciting opportunity to complement CSL’s own next generation mRNA program with a partner who developed a platform to deliver late stage clinical supplies at scale. These combined capabilities will accelerate our journey in mRNA,” said CSL Chief Operating Officer Paul McKenzie.
Steve Marlow, CSL Seqirus General Manager, added “Importantly, it is another step towards our long-term aim to advance public health by developing and commercializing enhanced vaccines for influenza and multi-pathogen pandemic preparedness. The collaboration also provides a pathway to offer a COVID-19 booster, providing another differentiated option to healthcare providers and governments around the world.”
CSL Seqirus is a global leader in influenza prevention and has a longstanding heritage in influenza vaccines. This along with CSL R&D’s established capabilities in vaccine research and clinical development, positions CSL well to make strategic investments in both the development of the company’s existing platforms and in longer-term, high opportunity development activities.
CSL Seqirus produces influenza vaccines across its global manufacturing network, which includes facilities in the U.S., U.K. and Australia. CSL also continues to grow its R&D footprint and is investing in a new facility located in Waltham, Mass. that will support the company’s R&D portfolio, with a focus on the sa-mRNA technology platform. This facility will serve as an R&D center for current and future vaccine design, and collaborations with stakeholders from across industry and academia.
CSL’s Head of R&D and Chief Medical Officer, Dr Bill Mezzanotte said, “This collaboration on next generation mRNA is another example of CSL’s relentless pursuit of disruptive innovation when public health and patients can benefit. We look forward to working closely with Arcturus to shape the future therapeutic landscape of influenza vaccines and also using this exciting scientific and strategic platform to develop and commercialize vaccines for other seasonal and pandemic respiratory viruses with high unmet need.”
COVID-19 is a disease caused by a virus named SARS-CoV-2 and is highly contagious.1 COVID-19 may cause respiratory symptoms – ranging from mild symptoms to life threatening severe illness.1 Symptoms may appear 2-14 days after exposure to the virus.2 During the COVID-19 pandemic, there have been over 95 million confirmed cases of the disease and over 1 million deaths in the United States.3 The Centers for Disease Control and Prevention (CDC) recommend COVID-19 vaccination for everyone ages 6 months and older in the United States for the prevention of COVID-19.4 It is recommended to stay up-to-date on COVID-19 vaccination by completing a primary series vaccination and receiving the most recent booster dose recommended for them by the CDC.4
About Seasonal Influenza
Influenza is a common, contagious seasonal respiratory disease that may cause severe illness and life-threatening complications in some people.5 Influenza can lead to clinical symptoms varying from mild to moderate respiratory illness to severe complications, hospitalization and in some cases, death.5 Because transmission of influenza viruses to others may occur one day before symptoms develop and up to 5 to 7 days after becoming sick, the disease can be easily transmitted to others.5 Estimates from the CDC report that during the 2019/20 influenza season, there were an estimated 405,000 influenza-related hospitalizations in the U.S.6 The CDC recommends annual vaccination for individuals aged 6 months and older, who do not have any contraindications.7 Since it takes about two weeks after vaccination for antibodies to develop in the body that help protect against influenza virus infection, it is recommended that people get vaccinated before influenza begins spreading in their community.7 The CDC recommends that people get vaccinated by the end of October.7
About Pandemic Influenza
Pandemic influenza, is a contagious airborne respiratory disease which is unpredictable in timing and severity.8 The risk of influenza-associated morbidity and mortality is greater with pandemic influenza than with seasonal influenza because there is likely to be little or no pre-existing immunity to the virus in the human population.9 Four influenza pandemics have occurred over the past century, with the 1918 pandemic being the most severe in recent history, estimated to have killed up to 50 million people worldwide.10 According to the CDC, a novel influenza A virus such as the highly pathogenic avian A(H5N1) strain can cause severe disease and have a high mortality rate.11 If the influenza A(H5N1) virus were to change and become easily transmissible from person to person while retaining its capacity to cause severe disease, the consequences for public health could be severe.8
CSL (ASX:CSL; USOTC:CSLLY) is a leading global biotechnology company with a dynamic portfolio of lifesaving medicines, including those that treat haemophilia and immune deficiencies, vaccines to prevent influenza, and therapies in iron deficiency, dialysis and nephrology. Since our start in 1916, we have been driven by our promise to save lives using the latest technologies. Today, CSL – including our three businesses, CSL Behring, CSL Seqirus and CSL Vifor – provides lifesaving products to patients in more than 100 countries and employs 30,000 people. Our unique combination of commercial strength, R&D focus and operational excellence enables us to identify, develop and deliver innovations so our patients can live life to the fullest. For inspiring stories about the promise of biotechnology, visit CSLBehring.com/Vita and follow us on Twitter.com/CSL.
For more information about CSL, visit www.CSL.com.
About CSL Seqirus
CSL Seqirus is part of CSL Limited (ASX: CSL). As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. With state-of-the-art production facilities in the U.S., the U.K. and Australia, and leading R&D capabilities, CSL Seqirus utilizes egg, cell and adjuvant technologies to offer a broad portfolio of differentiated influenza vaccines in more than 20 countries around the world. For more information about CSL Seqirus, visit www.seqirus.com.
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1 Centers for Disease Control and Prevention (CDC). (2021). Basics of COVID-19. Retrieved from: https://www.cdc.gov/coronavirus/2019-ncov/your-health/about-covid-19/basics-covid-19.html#:~:text=COVID%2D19%20is%20caused%20by,East%20respiratory%20syndrome%20(MERS). Accessed October 2022.
2 CDC. (2022). Symptoms of COVID-19. Retrieved from: https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms.html. Accessed October 2022.
3 CDC. (2022). COVID Data Tracker. Retrieved from: https://covid.cdc.gov/covid-data-tracker/#datatracker-home. Accessed October 2022.
4 CDC. (2022). Getting Your COVID-19 Vaccine. Retrieved from: https://www.cdc.gov/coronavirus/2019-ncov/vaccines/expect.html?s_cid=11782:how%20soon%20after%20covid%20can%20you%20get%20vaccine:sem.ga:p:RG:GM:gen:PTN.Grants:FY22. Accessed October 2022.
5 CDC. (2022). Key Facts about Influenza. Retrieved from https://www.cdc.gov/flu/about/keyfacts.htm. Accessed October 2022.
6 CDC. (2022). Estimated Influenza Illnesses, Medical visits, Hospitalizations, and Deaths in the United States – 2019-2020 Influenza Season. Retrieved from: https://www.cdc.gov/flu/about/burden/2019-2020.html. Accessed October 2022.
7 CDC. (2022). Who Needs a Flu Vaccine and When. Retrieved from: https://www.cdc.gov/flu/prevent/vaccinations.htm. Accessed October 2022.
8 CDC. (2016). Pandemic Basics. Retrieved from: https://www.cdc.gov/flu/pandemic-resources/basics/index.html. Accessed October 2022.
9 WHO. (2014). How pandemic influenza emerges. Retrieved from: https://www.who.int/europe/news-room/fact-sheets/item/how-pandemic-influenza-emerges. Accessed October 2022.
10 WHO. (2017). Pandemic Influenza Risk Management: A WHO guide to inform and harmonize national and international pandemic preparedness and response. Retrieved from: https://apps.who.int/iris/bitstream/handle/10665/259893/WHO-WHE-IHM-GIP-2017.1-eng.pdf;jsessionid=4421F16879D2F8B96481F8D0C745C7F3?sequence=1. Accessed October 2022.
11 CDC. (2015). Highly Pathogenic Asian Avian Influenza A(H5N1) in People. Retrieved from: https://www.cdc.gov/flu/avianflu/h5n1-people.htm. Accessed October 2022.