CureVac: Finale Analyse der zulassungsrelevanten Phase 2b/3-Studie HERALD - Donnerstag, 1. Juli 2021
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CureVac: Finale Analyse der zulassungsrelevanten Phase 2b/3-Studie HERALD Donnerstag, 1. Juli 2021 Pressekonferenz
Forward-Looking Statements
The information set forth herein does not purport to be complete or to contain all of collaboration partners, ability to commercialize products, ability to manufacture any
the information you may desire. Statements contained herein are made as of the date products, possible changes in current and proposed legislation, regulations and
of this document unless stated otherwise, and neither the delivery of this document at governmental policies, pressures from increasing competition and consolidation in the
any time, nor any sale of securities, shall under any circumstances create an company’s industry, the effects of the COVID-19 pandemic on the company’s
implication that the information contained herein is correct as of any time after such business and results of operations, ability to manage growth, reliance on key
date or that information will be updated or revised to reflect information that personnel, reliance on intellectual property protection, ability to provide for patient
subsequently becomes available or changes occurring after the date hereof. safety, and fluctuations of operating results due to the effect of exchange rates or
other factors. Such risks and uncertainties may cause the statements to be inaccurate
This presentation of CureVac N.V. and/or its wholly owned subsidiaries CureVac AG,
and readers are cautioned not to place undue reliance on such statements. Many of
CureVac Real Estate GmbH, CureVac Inc., CureVac Swiss AG and CureVac
these risks are outside of the company’s control and could cause its actual results to
Corporate Services GmbH (the “company”) contains statements that constitute
differ materially from those it thought would occur. The forward-looking statements
“forward-looking statements” as that term is defined in the United States Private
included in this presentation are made only as of the date hereof. The company does
Securities Litigation Reform Act of 1995, including statements that express the
not undertake, and specifically declines, any obligation to update any such
company’s opinions, expectations, beliefs, plans, objectives, assumptions or
statements or to publicly announce the results of any revisions to any such
projections of the company regarding future events or future results, in contrast with
statements to reflect future events or developments, except as required by law.
statements that reflect historical facts. Examples include discussion of the potential
efficacy of the company’s vaccine and treatment candidates and the company’s For further information, please reference the company’s reports and documents filed
strategies, financing plans, growth opportunities and market growth. In some cases, with the U.S. Securities and Exchange Commission (SEC). You may get these
you can identify such forward-looking statements by terminology such as “anticipate,” documents by visiting EDGAR on the SEC website at www.sec.gov.
“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
CureVac Pressekonferenz │ Finale Analyse der Phase 2b/3-Studie HERALD 01.07.2021 | 2Die HERALD-Studie: Geografisch vielfältig und variantenreich
Europa
~25%
der Studienpopulation
The
Die
Latein- HERALD
HERALD
amerika Studie
Study
~75%
der Studienpopulation
~40.000
Studienteilnehmer
~35.000 im Alter 18 – 60
~5.000 im Alter von > 60
10
Länder
CureVac Pressekonferenz │ Finale Analyse der Phase 2b/3-Studie HERALD 01.07.2021 | 3COVID-19-Realität: Besorgniserregende Varianten breiten sich in Europa
und Lateinamerika aus
Andere inkl.
EUROPA
Andere inkl. Originalstamm
Originalstamm Lambda
(C.37)
Lambda
(C.37) Delta
Delta (B.1.617.2)
(B.1.617.2) Gamma
Gamma (P.1, 501Y.V3)
(P.1, 501Y.V3) Beta
(B.1.351, 501Y.V2)
Beta Alpha
(B.1.351, 501Y.V2) (B.1.1.7, 501Y.V1)
Alpha
(B.1.1.7 / 501Y.V1)
SÜDAMERIKA
Länder, in denen die Phase 2b/3-Studie
durchgeführt wird
*Stand 25. Juni 2021; Quelle: www.nextstrain.org / Südamerika- oder Europa-fokussierte Teilstichproben
CureVac Pressekonferenz │ Finale Analyse der Phase 2b/3-Studie HERALD 01.07.2021 | 4Wirksamkeitsprofil in der Altersgruppe 18 bis 60 zur Bekämpfung der Pandemie
und der Variantenausbreitung
IN DER ALTERSGRUPPE VON 18 BIS 60 JAHREN
B.1 (wild type) A.2.5 B.1.429 (Epsilon) B.1.1.348
100 %
B.1.1 (wild type)
SCHUTZ VOR KRANKENHAUS-
AUFENTHALT ODER TOD
B.1.111 C.37 (Lambda) B.1.1.318
PRIMÄRER
(0 Impfstoffgruppe vs.
6 Placebo-Gruppe) WIRKSAMKEITSENDPUNKT
B.1.1.1 (wild type)
77 % (Alpha)
B.1.526 P.2 (Zeta) N.5
48%
B.1.177.73
B.1.1.7
(9 Impfstoffgruppe vs.
B.1.623
SCHUTZ VOR MODERATER BIS
SCHWERER ERKRANKUNG P.1.2 B.1.621IN (Colombia)
ALLEN
ALTERSGRUPPEN
36 Placebo-Gruppe)
B.1.351 (Beta) B.1.160 B.1.1.519 (Mexico) C.36.3
53 %
C.36 P.1 (Gamma) B.1.177 B.1.177.43 B.1.177.53
GESAMTWIRKSAMKEIT DES
(71 Impfstoffgruppe vs. IMPFSTOFFS CVNCOV 228
B.1.617.2 (Delta) B.1.177.43 B.1.617.2 (Delta)
136 Placebo-Gruppe)
B.1.236
bestätigte COVID-19-Fälle
CureVac Pressekonferenz │ Finale Analyse der Phase 2b/3-Studie HERALD 01.07.2021 | 5Die HERALD-Studie: Schlüsseldaten der finalen Analyse
Ursprünglicher Stamm
Andere
204
Alpha (B.1.1.7)
B.1.621 (Kolumbien)
sequenzierte,
bestätigte
Lambda (C.37) Fälle
Gamma (P.1) 15 COVID-19-STÄMME
Delta (B.1.617.2)
~ 51% Besorgniserregende
Varianten
21% Lambda
(C.37) ~ 35% Varianten von
besonderem Interesse
~ 11% Weniger erforschte
Varianten
~ 3% Wildtyp-Stamm
CureVac Pressekonferenz │ Finale Analyse der Phase 2b/3-Studie HERALD 01.07.2021 | 6Die HERALD-Studie: Kernaussagen
Einzigartige zulassungsrelevante Studie mit 40.000 Probanden
1 in zehn Ländern auf zwei Kontinenten in beispielloser
Studienumgebung mit 15 aufgetretenen Virusstämmen
Gutes CVnCoV-Wirksamkeitsprofil in der Altersgruppe von
18 bis 60 Jahren mit signifikantem Schutz vor moderater bis
2 schwerer Erkrankung und Hospitalisierung oder Tod über alle
Varianten
1
Volles Engagement für die Fortsetzung der regulatorischen
3 Zulassungsprozesse und laufender Dialog mit der Europäischen
Arzneimittelagentur (EMA)
Weiterhin Aufbau der Produktionskapazitäten und erfolgreich
4 laufendes COVID-19-Programm mit Partner GSK für COVID-19-
Impfstoffe der zweiten Generation
CureVac Pressekonferenz │ Finale Analyse der Phase 2b/3-Studie HERALD 01.07.2021 | 7HERZLICHEN DANK FÜR
IHRE AUFMERKSAMKEIT
CureVac
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