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Seqirus Announces Investment in Next-Generation Influenza Vaccine Technology, Self-Amplifying Messenger RNA (sa-mRNA)

• Appoints Roberta Duncan as new program lead to drive technology advancement
• Accelerates development of sa-mRNA vaccine candidates for seasonal and pandemic influenza

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Seqirus, a global leader in influenza prevention and a business of CSL Limited (ASX:CSL), today announced plans to accelerate the development of its next generation of messenger RNA (mRNA) vaccine technology, self-amplifying messenger RNA (sa-mRNA), with the creation of a dedicated sa-mRNA program and senior leadership appointment. 

Seqirus is currently developing a number of sa-mRNA-based influenza vaccine candidates, with pre-clinical results demonstrating promise as compared to more traditional influenza vaccine technologies. The company is targeting the commencement of clinical trials for both seasonal and pandemic influenza vaccine candidates in the second half of 2022.

“While the COVID-19 pandemic has brought mRNA vaccines to prominence, Seqirus has been researching sa-mRNA as a viable influenza vaccine technology for a number of years and is now forging ahead into clinical trials to ensure we build the best possible technology platform for both seasonal influenza and pandemic response, more broadly,” said Stephen Marlow, General Manager at Seqirus. “As part of Seqirus’ investment in this next-generation sa-mRNA technology, I’m proud to announce the appointment of Roberta Duncan in the newly-created role of Vice President, mRNA Program Lead, who will execute a cross-functional effort across the Seqirus enterprise to drive this exciting advancement on our differentiated influenza portfolio from development through to commercialization.” 

mRNA vaccines help protect against infectious diseases by giving instructions to cells in the body to make a protein, stimulating the immune response and leaving a blueprint to recognize and fight future infection.1 Self-amplifying mRNA, the next generation version of today’s mRNA technology, also instructs the body to replicate mRNA, amplifying the amount of protein made.2 This could enable vaccine manufacturers to potentially develop more effective vaccines with a smaller dosage and with lower rates of reactogenicity, underscoring the application in both pandemic and seasonal settings.2 In preclinical research, sa-mRNA technology demonstrated the potential to raise stronger cellular responses and generate significantly higher antibody titers at the same dose level as mRNA.2 

Based on its longstanding heritage in influenza, Seqirus is well positioned to make strategic investments in both the development of its existing platforms and in longer-term, high opportunity development activities. While its current focus remains on influenza, Seqirus is also exploring the potential for sa-mRNA vaccines in other disease areas. Seqirus sees this technology as an important element in its R&D pipeline, in addition to its adjuvanted, cell-based influenza vaccine (aQIVc) candidate, a highly flexible platform for rapid pandemic response, regardless of influenza virus strain, which is currently in Phase 2 clinical trials.3,4,5  

“As the industry leader in influenza vaccines, we recognize the important role that we must play to develop this platform, today and for years to come,” said Roberta Duncan, Vice President, mRNA Program Lead. “It’s an exciting time for the industry and for Seqirus, as we continue actively pursuing technological advances to improve influenza protection and help safeguard our communities around the world against this potentially serious virus.”

Seqirus produces influenza vaccines across its global manufacturing network, which includes facilities in the U.S., U.K. and Australia. Seqirus is currently considering a number of global locations to establish scaled manufacturing capabilities for its sa-mRNA platform technology. 

Seqirus continually works on improving the effectiveness of its seasonal and pandemic influenza vaccines through investment in optimization of current technologies and developing new, transformative approaches to future vaccine development. Seqirus remains committed to collaborating with other partners to advance its understanding of how the human immune system responds to influenza, and the implications for development of next generation vaccines that better protect against influenza.

Roberta Duncan
Vice President, mRNA Program Lead

Roberta Duncan joined Seqirus in 2017 as Head of Business Operations, Shared Services and Clinical Compliance (BOSS-CC). In 2019, Roberta was promoted to Executive Director of R&D Portfolio and Program Management & Business Operations, Shared Services (PPM-BOSS), where she was responsible for ensuring the Seqirus R&D portfolio aligned to and met the company’s strategic objectives. In June 2021, Roberta was appointed Vice President, mRNA Program Lead, responsible for the execution of the Seqirus mRNA program.

Roberta has nearly 25 years of global experience in the pharmaceutical sector in program management, clinical development, asset strategy, business operations and team leadership. She earned her BA in Biochemistry from New York University and a dual MBA in International Management from Krannert School of Management (Purdue University) and TiasNimbas Business School (Tilburg University, The Netherlands).

About Seasonal Influenza
Influenza is a common, contagious seasonal respiratory disease that may cause severe illness and life- threatening complications in some people.6 Influenza can lead to clinical symptoms varying from mild to moderate respiratory illness to severe complications, hospitalization and in some cases, death.6 The CDC recommends annual vaccination for individuals aged six months and older, who do not have any contraindications.7 Because transmission of influenza viruses to others may occur one day before symptoms develop and up to five to seven days after becoming sick, the disease can be easily transmitted to others.6 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.8 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.9 The CDC recommends that people get vaccinated by the end of October.9 For non-pregnant adults, getting vaccinated too early (for example, in July or August), should be avoided, unless there is concern that later vaccination may not be possible, as it can be associated with reduced protection against influenza infection later in the flu season.9 However, getting vaccinated later can still be beneficial and vaccination should continue to be offered throughout the influenza season, even into January or later.9

About Pandemic Influenza
Pandemic influenza, is a contagious airborne respiratory disease which is unpredictable in timing and severity.10 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.11 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.12 According to the WHO, a novel influenza A virus such as the highly pathogenic avian A (H5N1) strain can cause severe disease and have a high mortality rate.13 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 catastrophic, with an estimated 60% mortality rate.13

About Seqirus

Seqirus is part of CSL Limited (ASX: CSL). As one of the largest influenza vaccine providers in the world, 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, Seqirus utilizes egg, cell and adjuvant technologies to offer a broad portfolio of differentiated influenza vaccines in more than 20 countries around the world.

About CSL
CSL (ASX:CSL) is a leading global biotechnology company with a dynamic portfolio of life-saving medicines, including those that treat hemophilia and immune deficiencies, as well as vaccines to prevent influenza. Since our start in 1916, we have been driven by our promise to save lives using the latest technologies. Today, CSL — including our two businesses, CSL Behring and Seqirus - provides life- saving products to more than 100 countries and employs more than 27,000 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 more information about CSL Limited, visit www.csl.com.

For more information visit www.seqirus.com and www.csl.com.

Intended Audience
This press release is issued from Seqirus USA Inc. in Summit, New Jersey, USA and is intended to provide information about our global business. Please be aware that information relating to the approval status and labels of approved Seqirus products may vary from country to country. Please consult your local regulatory authority on the approval status of Seqirus products.

Forward-Looking Statements
This press release may contain forward-looking statements, including statements regarding future results, performance or achievements. These statements involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performances or achievements expressed or implied by the forward-looking statements. These statements reflect our current views with respect to future events and are based on assumptions and subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements.


USA-CRP-21-0046

MEDIA CONTACT
Maria Tortoreto 
+1 (201) 248-5208
Maria.Tortoreto@Seqirus.com

REFERENCES

CDC. (2021). Understanding mRNA COVID-19 Vaccines. Retrieved from: https://www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines/mrna.html. Accessed August 2021.

Vigel, B., Lambert, L., Kinnear, E., et al. (2018). Self-Amplifying RNA Vaccines Give Equivalent Protection against Influenza to mRNA Vaccines but at Much Lower Doses. American Society of Gene & Cell Therapy. 

CDC. (2020). Cell-Based Flu Vaccines. Retrieved from: https://www.cdc.gov/flu/prevent/cell-based.htm. Accessed August 2021.

Camilloni B, Neri M, Lepri E, Iorio AM. Cross-reactive antibodies in middle-aged and elderly volunteers after MF59-adjuvanted subunit trivalent influenza vaccine against B viruses of the B/Victoria or B/Yamagata lineages. Vaccine. Jun 2009;27(31):4099-103. doi:10.1016/j.vaccine.2009.04.078.

Kavian N, Hachim A, Li AP, et al. Assessment of enhanced influenza vaccination finds that FluAd conveys an advantage in mice and older adults. Clin Transl Immunology. 2020;9(2):e1107. doi:10.1002/cti2.1107.

CDC. (2019). Key Facts about Influenza (Flu). Retrieved from: https://www.cdc.gov/flu/about/keyfacts.htm. Accessed August 2021.

CDC. (2021). WG Considerations and Proposed Influenza Vaccine Recommendations, 2021-22 . Retrieved from: https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2021-06/03-influenza-grohskopf-508.pdf. Accessed August 2021.

CDC. (2021). 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 August 2021.

CDC. (2021). Who Needs a Flu Vaccine and When. Retrieved from: https://www.cdc.gov/flu/prevent/vaccinations.htm. Accessed August 2021.

10 CDC. (2016). Pandemic Basics. Retrieved from: https://www.cdc.gov/flu/pandemic-resources/basics/index.html. Accessed August 2021.

11 WHO. (2021). How pandemic influenza emerges. Retrieved from: https://www.euro.who.int/en/health-topics/communicable-diseases/influenza/pandemic-influenza/how-pandemic-influenza-emerges. Accessed August 2021.

12 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 August 2021.

13 (WHO). (2012). Influenza: H5N1. Retrieved from: https://www.who.int/news-room/q-a-detail/influenza-h5n1. Accessed August 2021.