CSL to access late-stage next-generation mRNA
platform technology, enabling development of vaccines for COVID-19,
influenza, multi-pathogen pandemic preparedness and other
respiratory pathogens
KING OF
PRUSSIA, Pa., Dec. 12,
2022 /PRNewswire/ -- CSL Limited (ASX:CSL;
USOTC:CSLLY) today announced that its subsidiary, CSL Seqirus,
finalized its global collaboration and license agreement with
Arcturus Therapeutics Holdings Inc ("Arcturus Therapeutics";
NASDAQ: ARCT). The agreement grants access to Arcturus
Therapeutics' late-stage self-amplifying mRNA (sa-mRNA) vaccine
platform technology, which recently reported results from a large
COVID-19 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.
The agreement was announced last month and under the terms of
the agreement, Arcturus Therapeutics will receive an upfront
payment of US$200 million and will be
eligible to receive further payments dependent upon the achievement
of certain development and commercial milestones along with
royalties/profit sharing on future product sales.
"This agreement provides CSL with an opportunity to strengthen
and accelerate our goals for the next generation of mRNA vaccines
and underscores our commitment to pursuing new and innovative ways
of protecting public health," said CSL Chief Operating Officer
Paul McKenzie. "This is a
significant leap forward with a demonstrated platform that will
allow us to further explore influenza-adjacent
therapies."
Under the agreement, CSL will have the exclusive license to
Arcturus' next generation mRNA technology in the fields of
influenza, COVID-19 and other respiratory viral diseases, and a
non-exclusive license in the multi-pathogen pandemic preparedness
field with the right to turn exclusive.
"Like gene therapy for rare diseases, sa-mRNA is a disruptive
technology that is on the leading-edge of innovation, when it comes
to vaccine development," said Dr. Bill
Mezzanotte, Head of R&D and Chief Medical Officer, CSL.
"Next-generation mRNA technology serves as one of our strategic
scientific platforms at CSL and in our evaluation of Arcturus, we
saw the right external innovation to strategically complement our
in-house next-generation mRNA capabilities and reinforce our
longstanding leadership in influenza."
About COVID-19
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. 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 U.S.3 The Centers for Disease Control and
Prevention (CDC) recommends COVID-19 vaccination for everyone ages
six months and older in the U.S. 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 five to seven 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 six 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
that 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
About CSL
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.
Media Contact
CSL R&D Communications
Greg Healy
Mobile: +1 610 906 4564
Email: Greg.Healy@cslbehring.com
CSL Seqirus Communications
Polina Miklush
Mobile: +1 908 608 7170
Email: Polina.Miklush@seqirus.com
References
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 December 2022.
2 CDC. (2022). Symptoms of COVID-19. Retrieved
from: https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms.html.
Accessed December 2022.
3 CDC. (2022). COVID Data Tracker. Retrieved
from: https://covid.cdc.gov/covid-data-tracker/#datatracker-home.
Accessed December 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 December 2022.
5 CDC. (2022). Key Facts about Influenza. Retrieved
from https://www.cdc.gov/flu/about/keyfacts.htm. Accessed
December 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 December 2022.
7 CDC. (2022). Who Needs a Flu Vaccine and When.
Retrieved
from: https://www.cdc.gov/flu/prevent/vaccinations.htm.
Accessed December 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 December 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 December 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
December 2022.
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SOURCE CSL