28.05.2024 13:00:31 - dpa-AFX: EQS-News: CureVac Announces Dosing of First Participant in a Phase 2 Study in Seasonal Influenza; Development in Collaboration with GSK (english)

CureVac Announces Dosing of First Participant in a Phase 2 Study in Seasonal
Influenza; Development in Collaboration with GSK

Issuer: CureVac / Key word(s): Study
CureVac Announces Dosing of First Participant in a Phase 2 Study in Seasonal
Influenza; Development in Collaboration with GSK

28.05.2024 / 13:00 CET/CEST
The issuer is solely responsible for the content of this announcement.

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CureVac Announces Dosing of First Participant in a Phase 2 Study in Seasonal
Influenza; Development in Collaboration with GSK

  * Phase 2 study to assess updated formulations for improved immune
    responses of multivalent vaccine candidate against influenza B strain


  * Study initiated following previously reported interim data from Phase 2
    Part of combined Phase 1/2 study in seasonal influenza


  * Composition of vaccine candidate changed to match all three
    WHO-recommended flu strains, following recommendation to exclude
    B/Yamagata lineage


TÜBINGEN, Germany/BOSTON, USA - May 28, 2024 - CureVac N.V. (Nasdaq: CVAC)
('CureVac'), a global biopharmaceutical company developing a new class of
transformative medicines based on messenger ribonucleic acid ('mRNA'), today
announced dosing of the first participant in a Phase 2 study of the
multivalent seasonal influenza vaccine candidate developed in collaboration
with GSK. The study will assess targeted optimizations for improved immune
responses of the vaccine candidate against the relevant influenza B strain.

This new Phase 2 study in the joint CureVac/GSK seasonal influenza program
has been initiated following interim data from the Phase 2 part of the
ongoing combined Phase 1/2 study in seasonal influenza reported on April 4,
2024. The reported data showed that among younger and older adults, serum
hemagglutinin inhibition (HAI) geometric mean titers elicited by the vaccine
candidate against influenza A strains numerically exceeded those of the
applied licensed comparator vaccines consistently across all tested dose
levels. For influenza B strains, serum HAI geometric mean titers were lower
than those elicited by the licensed comparator vaccines across tested age
groups and dose levels.

For the now initiated Phase 2 study, the design of the multivalent vaccine
candidate has been changed to address all three World Health Organization
(WHO)-recommended influenza strains, following its recommendation from
February 2024 to exclude the influenza B/Yamagata lineage and apply a
trivalent vaccine format going forward. The three remaining influenza
strains include two influenza A strains and one influenza B strain.

'The previously reported positive interim data of the Phase 2 part of the
combined Phase 1/2 study in seasonal influenza confirmed that our technology
platform elicits strong overall antibody titers at well-tolerated dose
levels, underscoring the potential of our second-generation mRNA backbone in
our collaborative seasonal influenza vaccine program,' said Dr. Myriam
Mendila, Chief Scientific Officer of CureVac. 'Historically, it's been
challenging to target influenza B strains with a potent vaccine strategy. We
are making progress in adapting and optimizing our clinical approach to
address this challenge and improve performance against the remaining B
strain.'

The Phase 2 study assesses the reactogenicity, safety, and immunogenicity of
different dose levels of a modified, multivalent vaccine candidate, encoding
antigens matched to all three WHO-recommended flu strains. The study will
include 250 healthy younger adults aged 18 to 64 and 250 healthy older
adults aged 65 to 85. In each age group, different dose levels will be
tested in comparison to an age-appropriate, licensed comparator vaccine.


About CureVac
CureVac (Nasdaq: CVAC) is a global biopharmaceutical company in the field of
messenger RNA (mRNA) technology, with more than 20 years of expertise in
developing, optimizing, and manufacturing this versatile biological molecule
for medical purposes. The principle of CureVac's proprietary technology is
the use of optimized mRNA as a data carrier to instruct the human body to
produce its own proteins capable of fighting a broad range of diseases. In
July 2020, CureVac entered in a collaboration with GSK to jointly develop
new products in prophylactic vaccines for infectious diseases based on
CureVac's second-generation mRNA technology. This collaboration was later
extended to the development of second-generation COVID-19 vaccine
candidates, and modified mRNA vaccine technologies. Based on its proprietary
technology, CureVac has built a deep clinical pipeline across the areas of
prophylactic vaccines, cancer therapies, antibody therapies, and the
treatment of rare diseases. CureVac N.V. has its headquarters in Tübingen,
Germany, and has more than 1,100 employees across its sites in Germany, the
Netherlands, Belgium, Switzerland, and the U.S. Further information can be
found at www.curevac.com.


CureVac Media Contact
Patrick Perez, Junior Manager Public Relations
CureVac, Tübingen, Germany
T: +49 7071 9883-1831
patrick.perez@curevac.com

CureVac Investor Relations Contact
Dr. Sarah Fakih, Vice President Corporate Communications and Investor
Relations
CureVac, Tübingen, Germany
T: +49 7071 9883-1298
M: +49 160 90 496949
sarah.fakih@curevac.com


Forward-Looking Statements CureVac
This press release contains statements that constitute 'forward looking
statements' as that term is defined in the United States Private Securities
Litigation Reform Act of 1995, including statements that express the
opinions, expectations, beliefs, plans, objectives, assumptions or
projections of CureVac N.V. and/or its wholly owned subsidiaries CureVac SE,
CureVac Manufacturing GmbH, CureVac Inc., CureVac Swiss AG, CureVac
Corporate Services GmbH, CureVac RNA Printer GmbH, CureVac Belgium SA and
CureVac Netherlands B.V. (the 'company') regarding future events or future
results, in contrast with statements that reflect historical facts. Examples
include discussion of the potential efficacy of the company's vaccine and
treatment candidates and the company's strategies, financing plans, cash
runway, growth opportunities and market growth. In some cases, you can
identify such forward-looking statements by terminology such as
'anticipate,' 'intend,' 'believe,' 'estimate,' 'plan,' 'seek,' 'project,' or
'expect,' 'may,' 'will,' 'would,' 'could,' 'potential,' 'intend,' or
'should,' the negative of these terms or similar expressions.
Forward-looking statements are based on management's current beliefs and
assumptions and on information currently available to the company. However,
these forward-looking statements are not a guarantee of the company's
performance, and you should not place undue reliance on such statements.
Forward-looking statements are subject to many risks, uncertainties and
other variable circumstances, including negative worldwide economic
conditions and ongoing instability and volatility in the worldwide financial
markets, ability to obtain funding, ability to conduct current and future
preclinical studies and clinical trials, the timing, expense and uncertainty
of regulatory approval, reliance on third parties and collaboration
partners, ability to commercialize products, ability to manufacture any
products, possible changes in current and proposed legislation, regulations
and governmental policies, pressures from increasing competition and
consolidation in the company's industry, the effects of the COVID-19
pandemic on the company's business and results of operations, ability to
manage growth, reliance on key personnel, reliance on intellectual property
protection, ability to provide for patient safety, fluctuations of operating
results due to the effect of exchange rates, delays in litigation
proceedings, different judicial outcomes or other factors. Such risks and
uncertainties may cause the statements to be inaccurate and readers are
cautioned not to place undue reliance on such statements. Many of these
risks are outside of the company's control and could cause its actual
results to differ materially from those it thought would occur. The
forward-looking statements included in this press release are made only as
of the date hereof. The company does not undertake, and specifically
declines, any obligation to update any such statements or to publicly
announce the results of any revisions to any such statements to reflect
future events or developments, except as required by law.

For further information, please reference the company's reports and
documents filed with the U.S. Securities and Exchange Commission (SEC). You
may get these documents by visiting EDGAR on the SEC website at www.sec.gov.


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   Language:       English
   Company:        CureVac
                   Friedrich-Miescher-Str. 15
                   72076 Tübingen
                   Germany
   EQS News ID:    1912779




End of News EQS News Service
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Name WKN Börse Kurs Datum/Zeit Diff. Diff. % Geld Brief Erster Schluss
CUREVAC N.V. O.N. A2P71U Xetra 3,246 26.06.24 16:47:31 -0,092 -2,76% 3,244 3,266 3,370 3,338

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