About Us | ScientistCVAC CureVac N.V.
Drug Pipeline
| Drug | Stage | Notes |
|---|---|---|
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CVnCoV
COVID-19 vaccine
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Phase 2/3
Phase 2/3
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Phase 2b/3 final data released June 30, 2021. 48% efficacy against COVID-19 of any severity. Efficacy of 77% against moderate and severe disease.
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BI 1361849 (CV9202)
Non-small cell lung cancer (NSCLC)
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Phase 1/2
Phase 1/2
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Phase 1/2 trial ongoing.
|
|
CV8102
Solid tumors
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Phase 1
Phase 1
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Phase 1 expansion cohort initiation announced February 4, 2021.
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|
CV7202
Rabies
|
Phase 1
Phase 1
|
Phase 1 trial ongoing.
|
Latest News
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- Unique pivotal study conducted in 10 countries in fast changing variant environment; 15 COVID-19 variant strains present for efficacy analysis; original strain almost completely absent
- Statistical success criteria for primary endpoint met on basis of 228 adjudicated cases
- Vaccine efficacy of 48% against COVID-19 of any severity across all age groups and 15 variants
- Significant vaccine efficacy demonstrated in participants aged 18 to 60 and across all 15 variants:
- Efficacy of 53% against disease of any severity
- Efficacy of 77% against moderate and severe disease
- Full protection against hospitalization or death
- CureVac in ongoing dialogue with EMA; continuing regulatory submissionTÜBINGEN, GERMANY & BOSTON, MA / ACCESSWIRE / June 30, 2021 / CureVac N.V. (NASDAQ:CVAC), a clinical-stage biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid ("mRNA"), today announced results from the final analysis of its 40,000 subject international pivotal Phase 2b/3 study (the HERALD study) of the first-generation COVID-19 vaccine candidate, CVnCoV. In the unprecedented context of 15 strains circulating within the study population at the time of final analysis, CVnCoV demonstrated an overall vaccine efficacy of 48% (vaccine 83 vs. 145 placebo) against COVID-19 disease of any severity, including single non-respiratory mild symptoms. Significant protection was demonstrated among participants in the age group of 18 to 60, with an efficacy of 53% (vaccine 71 vs. 136 placebo) against disease of any severity and across all 15 identified strains; protection against moderate to severe disease was calculated to be 77% (9 vaccine vs. 36 placebo). In the same age group, CVnCoV provided 100% protection (vaccine 0 vs. 6 placebo) against hospitalization or death. In participants above 60 years, who represented 9% of the analysed cases, the available data did not enable a statistically significant determination of efficacy. The data confirm the favorable safety profile of CVnCoV in all age groups. The study will continue to complete follow-up analyses for trial participants. Available data have been communicated to the European Medicines Agency (EMA).
"In this final analysis, CVnCoV demonstrates a strong public health value in fully protecting study participants in the age group of 18 to 60 against hospitalization or death and 77% against moderate and severe disease - an efficacy profile, which we believe will be an important contribution to help manage the COVID-19 pandemic and the dynamic variant spread," said Dr. Franz-Werner Haas, Chief Executive Officer of CureVac. "In the current context of an increasingly diverse environment of COVID-19 variants, and with very little residual prevalence of the original strain, we are confident that the HERALD study offers clinically relevant data regarding the effect of emerging variants on vaccine efficacy."
In total, 228 adjudicated COVID-19 cases (83 vaccine vs. 145 placebo) were assessed in the final analysis. In the age group of 18 to 60, across strains of higher prevalence, strain-dependent vaccine efficacy ranged from approximately 42% to up to 67%. Out of the 228 cases, 204 were sequenced to identify the variant causing the infection. Approximately 86% of these cases were caused by Variants of Concern (~51%) and Variants of Interest (~35%), the latter including the Lambda strain, first identified in Peru (~21%) and B.1.621, first identified in Colombia (~14%). Approximately 3% of cases were attributable to the original SARS-CoV-2 virus. The remaining 11% were caused by less-explored strains.
The HERALD study, enrolled approximately 40,000 participants in ten countries in Latin America and Europe. Statistical success criteria for the final analysis were met on the basis of 228 cases, occurring at least two weeks after administration of the second dose, including 68 additional adjudicated cases compared to the pre-defined 160 cases as per trial protocol. To identify COVID-19 strains within the trial, sequencing of virus variants has been performed on 588 COVID-19 cases, of which 204 fulfilled adjudication criteria and were included in the efficacy analysis.
Beyond CVnCoV, the company is developing second-generation COVID-19 vaccine candidates in partnership with GSK. These candidates are based on new mRNA backbones and include potential variants in multivalent vaccine formats as well as combination vaccines for potential protection against multiple infectious diseases in single injection. Preclinical data from the first vaccine candidate, CV2CoV, has recently been published in Nature Communications. CureVac and GSK expect to progress the second-generation vaccine candidate into clinical testing in the third quarter of 2021, with the goal of introducing the vaccine in 2022, subject to regulatory approval.
CureVac will host an investors and analyst webcast and conference call on Thursday, July 1, 2021 at 2:00 p.m. CET / 8:00 a.m. EDT. 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.
A replay will be made available on this website after the event.CureVac will also host a virtual German-speaking press conference on Thursday, July 1, 2021 at 10:00 a.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.About CVnCoV
CureVac began development of mRNA-based COVID-19 vaccine candidates in January 2020. The vaccine candidate chosen for first clinical development, CVnCoV, is an optimized, non-chemically modified mRNA, encoding the prefusion stabilized full-length spike protein of the SARS-CoV-2 virus, and formulated within Lipid Nanoparticles (LNPs). Phase 1 and 2a clinical trials of CVnCoV began in June and September 2020, respectively. Phase 1 interim data reported in November 2020 showed that CVnCoV was generally well tolerated across all tested doses and induced strong antibody responses in addition to first indication of T cell activation. The quality of the immune response was comparable to recovered COVID-19 patients, closely mimicking the immune response after natural COVID-19 infection. A pivotal Phase 2b/3, the HERALD study, with a 12µg dose of CVnCoV was initiated in December 2020. In February 2021, CureVac initiated a rolling submission with the European Medicines Agency (EMA) for CVnCoV.
About CureVac
CureVac is a global biopharmaceutical company in the field of messenger RNA (mRNA) technology, with more than 20 years of expertise in developing and optimizing the versatile biological molecule for medical purposes. The principle of CureVac's proprietary technology is the use of non-chemically modified mRNA as a data carrier to instruct the human body to produce its own proteins capable of fighting a broad range of diseases. Based on its proprietary technology, the Company 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 Tübingen, Germany, and employs more than 700 people at its sites in Tübingen, 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, Tübingen, Germany
T: +49 7071 9883-1298
M: +49 160 90 496949
[email protected]
CureVac Media Contact
Anna Kamilli, Manager Communications
CureVac, Tübingen, Germany
T: +49 7071 9883-1684
[email protected]Bettina Jödicke-Braas, Manager Communications
CureVac, Tübingen, Germany
T: 49 7071 9883-1087
[email protected]Forward-Looking Statements
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 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 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.
SOURCE: CureVac
View source version on accesswire.com:
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TÜBINGEN, GERMANY and BOSTON, MA / ACCESSWIRE / June 30, 2021 / CureVac N.V. (NASDAQ:CVAC), a global clinical-stage biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid ("mRNA"), today announced the appointment of Dr. Malte Greune as Chief Operating Officer (COO) effective July 1, 2021. In this position, he will strengthen the company's Management Board and will head, among others, CureVac's clinical and commercial manufacturing activities. Dr. Greune joins CureVac with extensive experience in the global pharmaceutical industry, including manufacturing of vaccines and fill & finish of biologics.
CureVac also announced that Dr. Florian von der Mülbe, co-founder and Chief Production Officer, will now focus his extensive production expertise exclusively on the expansion and accelerated development of The RNA Printer(R), CureVac's solution for mobile, autonomous and fully automated manufacturing of GMP-grade RNA vaccines and therapeutics. To drive this key strategic project forward, which requires building its own operational infrastructure, Dr. von der Mülbe will resign from the Management Board of CureVac N.V.. Dr. Greune will assume Dr. von der Mülbe's position on the Management Board.
"On behalf of the Supervisory Board I would like to welcome Dr. Greune to the Management Board. Dr. Greune is a recognized expert in the global pharmaceutical industry with many years of experience in various management positions. His appointment is a great asset for CureVac as the company continues to grow, further expanding its one-stop shop strategy for RNA-based vaccines and therapeutics with strong manufacturing capabilities," said Jean Stéphenne, Chairman of the Supervisory Board of CureVac. "I would like to thank Dr. von der Mülbe for his service on the CureVac Management Board. As a co-founder of CureVac, he has played a key role in building the company and establishing its strong manufacturing expertise that he will now transition to ensure The RNA Printer(R) becomes another key growth driver for the company."
Dr. Greune joins CureVac from Sanofi-Aventis Deutschland GmbH where he held various management positions for almost ten years. As General Manager and Vice President Cartridges, Devices & Insulin Technology Group he was responsible for several manufacturing sites in Frankfurt. Under his leadership, six isolator filling lines for insulins, oncology drugs and biologics were set up including one for a COVID-19 vaccine. Prior to his position as Head of Diabetes, Oncology and Devices at Sanofi, he worked as Senior Vice President of Animal Health Manufacturing for the Merck Manufacturing Division, USA, where he led an international network of 28 sites - including 18 integrated vaccine sites. Furthermore, he held various leadership roles at the pharmaceutical companies Schering-Plough and Intervet International B.V.. Dr. Greune started his career at Hoechst AG in Corporate Planning.
Dr. Greune received his Ph.D. in Economics from the University of Cologne, Germany, graduated from the University of Trier, Germany, and completed a Master of Business Administration at Clark University in Worcester, USA.
"Dr. Greune has a broad range of expertise in the international pharmaceutical sector which will benefit CureVac's growth even further," said Dr. Franz-Werner Haas, Chief Executive Officer of CureVac. "We are confident that his outstanding experience will support us in accelerating our development from a science-driven to a commercial pharmaceutical company. I would like to thank Dr. Florian von der Mülbe for combining founder's mindset with a growing commercialized company which he will continue to provide by the accelerated development of The RNA Printer(R)."
"Strong manufacturing capabilities represent an important part of our corporate strategy and I am proud of what we have built-up together in this area over the last 21 years," said Dr. Florian von der Mülbe. "I am happy that Dr. Greune is taking over to further develop our manufacturing capabilities and I am looking forward to using all my strength and expertise to rapidly drive forward The RNA Printer(R) as an accelerator of the RNA-field."
"It is a great pleasure to join CureVac at such an exciting phase of corporate transformation that centers on a diversified RNA-based product pipeline across different indications," added Dr. Malte Greune. "This technology is just starting to change today's medicine. I am looking forward to taking on this important task with the goal of bringing multiple mRNA drugs to market which may improve human health worldwide."
About CureVac
CureVac is a global biopharmaceutical company in the field of messenger RNA (mRNA) technology, with more than 20 years of expertise in developing and optimizing the versatile biological molecule for medical purposes. The principle of CureVac's proprietary technology is the use of non-chemically modified mRNA as a data carrier to instruct the human body to produce its own proteins capable of fighting a broad range of diseases. Based on its proprietary technology, the Company 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 Tübingen, Germany, and employs more than 700 people at its sites in Tübingen, 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, Tübingen, Germany
T: +49 7071 9883-1298
M: +49 160 90 496949
[email protected]CureVac Media Contact
Anna Kamilli, Manager Communications
CureVac, Tübingen, Germany
T: +49 7071 9883-1684
[email protected]Bettina Jödicke-Braas, Manager Communications
CureVac, Tübingen, Germany
T: 49 7071 9883-1087
[email protected]Forward-Looking Statements
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 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 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.
SOURCE: CureVac
View source version on accesswire.com:
https://www.accesswire.com/653699/CureVac-Announces-Appointment-of-Dr-Malte-Greune-as-Chief-Operating-Officer-and-Transition-of-Dr-Florian-von-der-Mlbe-to-Lead-Accelerated-Development-of-The-RNA-PrinterR
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TÜBINGEN, GERMANY and BOSTON, MA / ACCESSWIRE / June 25, 2021 / CureVac N.V. (NASDAQ:CVAC), a global clinical-stage biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid ("mRNA"), today announced the voting results of the Company's annual general meeting.
The shareholders of the Company voted in favour of all proposals, except for agenda item 13 relating to the authorization of the management board to acquire shares (or depositary receipts for shares) in the Company's capital. The proposals voted in favour for included the appointments of Antony Blanc and Klaus Edvardsen as managing directors, the re-appointment of Pierre Kemula as managing director and adjustments to the compensation of the supervisory board. A table containing tabulations of the votes casted is expected to be released in the coming days.
About CureVac
CureVac is a global biopharmaceutical company in the field of messenger RNA (mRNA) technology, with more than 20 years of expertise in developing and optimizing the versatile biological molecule for medical purposes. The principle of CureVac's proprietary technology is the use of non-chemically modified mRNA as a data carrier to instruct the human body to produce its own proteins capable of fighting a broad range of diseases. Based on its proprietary technology, the Company 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 Tübingen, Germany, and employs more than 700 people at its sites in Tübingen, 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, Tübingen, Germany
T: +49 7071 9883-1298
M: +49 160 90 496949
[email protected]
CureVac Media Contact
Anna Kamilli, Manager Communications
CureVac, Tübingen, Germany
T: +49 7071 9883-1684
[email protected]Bettina Jödicke-Braas, Manager Communications
CureVac, Tübingen, Germany
T: 49 7071 9883-1087
[email protected]Forward-Looking Statements
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 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 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.
SOURCE: CureVac
View source version on accesswire.com:
https://www.accesswire.com/653083/CureVac-Announces-Voting-Results-of-General-Meeting
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TÜBINGEN, GERMANY and BOSTON, MA / ACCESSWIRE / June 23, 2021 / CureVac N.V. (NASDAQ:CVAC), a global clinical-stage biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid ("mRNA"), today announced that Dr. Ingmar Hoerr, former Founding-CEO and former member of the Supervisory Board of CureVac, has withdrawn his candidacy for nomination to the Supervisory Board. Dr. Hoerr, who had retired from his duties with the company for acute health reasons in March 2020, has stated continuing health problems, which do not allow him to resume his duties.
"I would like to express my deepest gratitude and respect to Ingmar for his vision to advance new vaccine and therapeutic opportunities utilizing mRNA technology, and his tireless dedication in building CureVac around this vision," said Jean Stéphenne, Chairman of the Supervisory Board of CureVac. "Ingmar's pioneering work in making mRNA accessible has helped to form the basis of a key technology that is now addressing today's COVID-19 pandemic as well as future medical challenges in vaccines and therapeutics."
The Company further announced that Dr. Timothy M. Wright is resigning from his role as Independent Director from CureVac's Supervisory Board to focus on his own professional endeavors. His resignation will become effective on June 24, 2021. Dr. Wright joined the CureVac Supervisory Board in June 2018 and served as member of the Audit Committee.
"On behalf of our Board of Directors, I wish to thank Timothy for investing his valuable time, talent, passion and wisdom to grow the Company. Timothy's experience in drug development has helped shape the Company and prepare it for a successful future," added Jean Stéphenne, Chairman of the Supervisory Board of CureVac.
About CureVac
CureVac is a global biopharmaceutical company in the field of messenger RNA (mRNA) technology, with more than 20 years of expertise in developing and optimizing the versatile biological molecule for medical purposes. The principle of CureVac's proprietary technology is the use of non-chemically modified mRNA as a data carrier to instruct the human body to produce its own proteins capable of fighting a broad range of diseases. Based on its proprietary technology, the Company 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 Tübingen, Germany, and employs more than 700 people at its sites in Tübingen, 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, Tübingen, Germany
T: +49 7071 9883-1298
M: +49 160 90 496949
[email protected]CureVac Media Contact
Anna Kamilli, Manager Communications
CureVac, Tübingen, Germany
T: +49 7071 9883-1684
[email protected]Bettina Jödicke-Braas, Manager Communications
CureVac, Tübingen, Germany
T: 49 7071 9883-1087
[email protected]Forward-Looking Statements
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 AG, CureVac Real Estate GmbH, CureVac Inc. and CureVac Swiss AG (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 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.
SOURCE: CureVac N.V.
View source version on accesswire.com:
https://www.accesswire.com/652815/CureVac-Provides-Supervisory-Board-Update
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- Pivotal study conducted in 10 countries in fast changing environment of at least 29 COVID-19 variant strains; original strain almost completely absent
- At second interim analysis, statistical success criteria not met. Favorable safety profile confirmed
- Initial analyses show trend for age and variant dependent efficacy
- Results communicated to EMA, study progressing to final analysis within the next few weeks.
TÜBINGEN, GERMANY & BOSTON, MA / ACCESSWIRE / June 16, 2021 / CureVac N.V. (NASDAQ:CVAC), a clinical-stage biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid ("mRNA"), today announced results of the second interim analysis of its international pivotal Phase 2b/3 study in approximatively 40,000 subjects (the HERALD study) of CureVac's first-generation COVID-19 vaccine candidate, CVnCoV. In the unprecedented context of at least 13 variants circulating within the study population subset assessed at this interim analysis, CVnCoV demonstrated an interim vaccine efficacy of 47% against COVID-19 disease of any severity and did not meet prespecified statistical success criteria. Initial analyses suggest age and strain dependent efficacy. Available data were communicated with the European Medicines Agency (EMA). The Data Safety Monitoring Board (DSMB) confirmed a favorable safety profile for CVnCoV. The study is continuing to the final analysis and the totality of the data will be assessed for the most appropriate regulatory pathway.
In total, 134 Covid-19 cases were assessed in this interim analysis. Out of these cases, 124 were sequenced to identify the variant causing the infection. The outcome confirms that only one single case was attributable to the original SARS-CoV-2 virus. More than half of the cases (57%) were caused by Variants of Concern. Most of the remaining cases were caused by other less characterised variants such as Lambda or C.37, first identified in Peru (21%) and B.1.621, first identified in Colombia (7%). In this context, the interim results suggest efficacy in younger participants but did not allow to conclude on efficacy in the age group above 60.
"While we were hoping for a stronger interim outcome, we recognize that demonstrating high efficacy in this unprecedented broad diversity of variants is challenging. As we are continuing toward the final analysis with a minimum of 80 additional cases, the overall vaccine efficacy may change," said Dr. Franz-Werner Haas, Chief Executive Officer of CureVac. "In addition, the variant-rich environment underlines the importance of developing next-generation vaccines as new virus variants continue to emerge."
The HERALD study, conducted by Curevac in conjunction with Bayer, enrolled approximately 40,000 participants in ten countries in Latin America and Europe. The second interim analysis included 134 cases, occurring at least two weeks after administration of the second dose. To identify strains causing COVID-19 infections within the trial, sequencing of virus variants has so far been performed on 424 COVID-19 cases, of which 124 fulfilled adjudication criteria and were included in the present efficacy analysis.
CureVac remains committed to COVID-19 vaccine development. Beyond CVnCoV, the company develops in partnership with GSK second-generation COVID-19 vaccine candidates. These candidates are based on new mRNA backbones and include potential variants in multivalent vaccine formats as well as combination vaccines for potential protection against multiple infectious diseases in one vaccine. Preclinical data from the first vaccine candidate, CV2CoV, has recently been accepted for publication in Nature Communications. CureVac and GSK expect to progress the second-generation vaccine candidate into clinical testing in the third quarter of 2021, with the goal of introducing the vaccine in 2022, subject to regulatory approval.
CureVac will also host a webcast and conference call on Thursday, June 17, 2021 at 2:00 p.m. CET / 8:00 a.m. EST. The live conference call dial-in details and webcast link can be accessed via the Investor Relations section of the CureVac website 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 on this website after the event.
About CVnCoV
CureVac began development of mRNA-based COVID-19 vaccine candidates in January 2020. The vaccine candidate chosen for first clinical development, CVnCoV, is an optimized, non-chemically modified mRNA, encoding the prefusion stabilized full-length spike protein of the SARS-CoV-2 virus, and formulated within Lipid Nanoparticles (LNPs). Phase 1 and 2a clinical trials of CVnCoV began in June and September 2020, respectively. Phase 1 interim data reported in November 2020 showed that CVnCoV was generally well tolerated across all tested doses and induced strong antibody responses in addition to first indication of T cell activation. The quality of the immune response was comparable to recovered COVID-19 patients, closely mimicking the immune response after natural COVID-19 infection. A pivotal Phase 2b/3, the HERALD study, with a 12µg dose of CVnCoV was initiated in December 2020. In February 2021, CureVac initiated a rolling submission with the European Medicines Agency (EMA) for CVnCoV.About CureVac
CureVac is a global biopharmaceutical company in the field of messenger RNA (mRNA) technology, with more than 20 years of expertise in developing and optimizing the versatile biological molecule for medical purposes. The principle of CureVac's proprietary technology is the use of non-chemically modified mRNA as a data carrier to instruct the human body to produce its own proteins capable of fighting a broad range of diseases. Based on its proprietary technology, the Company 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 Tübingen, Germany, and employs more than 700 people at its sites in Tübingen, 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, Tübingen, Germany
T: +49 7071 9883-1298
M: +49 160 90 496949
[email protected]CureVac Media Contact
Anna Kamilli, Manager Communications
CureVac, Tübingen, Germany
T: +49 7071 9883-1684
[email protected]Bettina Jödicke-Braas, Manager Communications
CureVac, Tübingen, Germany
T: 49 7071 9883-1087
[email protected]Forward-Looking Statements
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 AG, CureVac Real Estate GmbH, CureVac Inc and CureVac Swiss AG. (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 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.
SOURCE: CureVac
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