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CureVac to Shift Focus of COVID-19 Vaccine Development to Second-Generation mRNA Technology COVID-19 vaccine efforts to be re-allocated to accelerate the development of second-generation program in collaboration with GSK

Key Takeaway: to Shift Focus of COVID-19 Vaccine Development to Second-Generation mRNA Technology COVID-19 vaccine efforts to be re-allocated to accelerate the development of second-generation program in collaboration with GSK First-generation vaccine candidate, CVnCoV, to be withdrawn fr

Full Press Release Details

to Shift Focus of COVID-19 Vaccine Development to Second-Generation mRNA Technology
COVID-19 vaccine efforts to be re-allocated to accelerate the development of second-generation program in collaboration with GSK
First-generation vaccine candidate, CVnCoV, to be withdrawn from regulatory review due to potential overlap with approval timelines for a second-generation candidate
Germany/ BOSTON, USA - October 12, 2021 - CureVac N.V. (Nasdaq: CVAC), a global biopharmaceutical company developing
a new class of transformative medicines based on messenger ribonucleic acid ("mRNA"), today announced the strategic decision
to focus its COVID-19 vaccine development towards the development of second-generation mRNA vaccine candidates in collaboration with
GSK and to withdraw its first-generation COVID-19 vaccine candidate, CVnCoV, from the current approval process with the European Medicines
Agency (EMA). In view of a recent EMA communication, CureVac estimates that the earliest potential approval of CVnCoV would come in the
second quarter of 2022. By this time, the companies expect the candidates from the second-generation vaccine program to have progressed
to late-stage clinical development. The decision is also aligned with the evolving dynamics of the pandemic response towards a greater
need for differentiated vaccines to address the developing endemic SARS-CoV2 situation. As a direct consequence, the existing Advanced
Purchase Agreement with the European Commission, which was predicated on employing CVnCoV to address the acute pandemic need, will cease.
CureVac is assessing the possibility of leveraging CVnCoV commitments for the second-generation vaccine candidates. CureVac remains in
contact with the European Commission and is supportive of its public health efforts.
have tightened their collaboration by adding further resources and experts to accelerate development and manufacturing of the broad second-generation
program. The companies anticipate entering clinical development in the next months, aiming to achieve regulatory approval for market
readiness of an improved COVID-19 vaccine in 2022. Published pre-clinical results have shown the strong potential of the initial second-generation
mRNA COVID-19 vaccine candidate, CV2CoV, compared to CureVac's first generation mRNA, CVnCoV. The data demonstrates up to 10x higher
immunogenicity in animal models. In parallel to the work on the second-generation mRNA vaccine technology, GSK and CureVac will accelerate
efforts to progress the development of modified mRNA vaccine constructs.
global fight against COVID-19 continues, and we remain committed to making a difference with a safe and efficacious vaccine. This
goal has not changed, but the requirements to effectively address the virus and emerging variants have changed. In the ongoing
transition from acute pandemic to endemic, our decision to withdraw CVnCoV from the regulatory approval process and focus our
efforts on second-generation mRNA vaccine candidates reflects expected changes in public health needs that our second generation can
potentially address," said Franz-Werner Haas, Chief Executive Officer of CureVac. "We will now take advantage of CVnCoV
learnings and infrastructures to focus our resources on advanced second-generation vaccines in close collaboration with GSK, a
global leader in the vaccine field." Rino Rappuoli, Head of Vaccines R&D, GSK said: "We welcome CureVac's
focus on the promising second-generation mRNA vaccine technology we are developing together as it has shown strong improvement
compared to CureVac's first-generation candidate, CVnCoV, in pre-clinical testing. To complement the development of this
second generation non-modified mRNA technology, we have also initiated the development of modified mRNA technologies as part of our
CureVac-GSK COVID-19 collaboration builds on the existing strategic mRNA technology partnership both companies started in July 2020 for
several selected targets in the field of infectious diseases. The collaboration was recently extended, allocating additional resources
across both companies. The joint development focuses on optimized second-generation mRNA vaccines that offer the potential to target
different COVID-19 variants, the ability to address different diseases in a combination shot and improved vaccine administration formats.
will host a webcast and conference call on Tuesday, October 12, 2021 at 3:00 p.m. CET / 9:00 a.m. EST. The live conference call dial-in
details and webcast link can be accessed via the Investor Relations section of the CureVac homepage at https://www.curevac.com/en/newsroom/events/
Corresponding presentation
slides will be posted shortly before the start of the webcast. A replay will be made available at this website after the event.
CureVac will also host a virtual press
conference in German on Tuesday, October 12, 2021 at 2:00 p.m. CET. The live conference call dial-in details and webcast link can be
accessed via the Investor Relations section of the CureVac website at https://www.curevac.com/en/newsroom/events/ Corresponding
presentation slides will be posted shortly before the start of the webcast.
is a global biopharmaceutical company in the field of messenger RNA (mRNA) technology, with more than 20 years of expertise in developing
and optimizing 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
had its initial public offering on the New York Nasdaq in August 2020. It is headquartered in T bingen, Germany, and employs more
than 700 people at its sites in T bingen, Frankfurt, and Boston, USA. Further information can be found at www.curevac.com.
CureVac Investor Relations Contact
Dr. Sarah Fakih, Vice President Corporate
Communications and Investor Relations
CureVac, T bingen, Germany
T: +49 7071 9883-1298
M: +49 160 90 496949
CureVac Media Contact
Anna Kamilli, Manager Communications
CureVac, T bingen, Germany
T: +49 7071 9883-1684
Bettina J dicke-Braas, Manager
CureVac, T bingen, Germany
T: 49 7071 9883-1087
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 AG, CureVac Real Estate GmbH,
CureVac Inc., CureVac Swiss AG and CureVac Corporate Services GmbH (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, 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, 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 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
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.
Last updated: Oct 12, 2021