CVAC CureVac N.V.
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| Drug | Stage | Catalyst Date |
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CVnCoV
COVID-19
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Phase 2
Phase 2
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Drug Pipeline
| Drug | Stage | Notes |
|---|---|---|
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CV7202
Rabies
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Phase 1
Phase 1
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Phase 1 trial ongoing.
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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.
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CV8102
Solid tumors
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Phase 1
Phase 1
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Phase 1 ongoing.
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Latest News
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CureVac N.V. (NASDAQ:CVAC), a biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid (mRNA), and Wacker Chemie AG announced today that they had signed a contract for the manufacturing of CureVac's COVID-19 vaccine candidate CVnCoV.
Under the terms of the initial agreement, WACKER will ramp up GMP (Good Manufacturing Practice) production of the mRNA drug substance for CVnCoV at its biotech site in Amsterdam in the first half of 2021. Preparations for the start of production, technology transfers and test runs are already underway. It is planned to produce more than 100 million doses of the CureVac vaccine per year at WACKER's Amsterdam site. There is also further potential for expansion at the site in order to meet rising demand in the future.
WACKER's CEO Rudolf Staudigl said: “We are proud and highly motivated to make a contribution to the fight against the spread of the coronavirus pandemic together with CureVac.” As a CDMO (Contract Development and Manufacturing Organization), Wacker Biotech bundles WACKER Group's biopharmaceutical activities. Its Amsterdam site has been producing vaccines for clinical development and commercial supply for 20 years. The portfolio ranges from conventional live and killed vaccines to protein-based, polysaccharide and glycoconjugate vaccines. In recent months, WACKER has invested in the site to extend production to include mRNA-based vaccines. This new class of vaccines expands the broad vaccine portfolio Wacker Biotech offers to its customers.
Dr. Florian von der Mülbe, Chief Production Officer of CureVac, added: “With WACKER, we have found a committed and highly experienced partner for the production of our vaccine candidate in the Netherlands.” CureVac is building an integrated European vaccine manufacturing network with several CDMO partners. With this strategy, the company will significantly increase the manufacturing capacity already existing within CureVac for CVnCoV up to several hundred million doses per year and will manage potential supply chain risks by working with several partners for each of the key manufacturing process steps.
About CVnCoVCureVac began development of its mRNA-based COVID-19 vaccine candidate in January 2020. The compound is an optimized, non-chemically modified mRNA, encoding the prefusion stabilized full-length spike protein of the SARS-CoV-2 virus. 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 immune response was comparable to recovered COVID-19 patients, closely mimicking the immune response after natural COVID-19 infection. The data support CureVac's decision to advance a 12µg dose in its upcoming pivotal Phase 2b/3 study, which CureVac plans to initiate before the end of 2020. Clinical trial material is provided by the company's substantial production capacities for mRNA vaccines at its headquarters in Tübingen, supported by the current expansion of manufacturing capacities to allow for broad-scale manufacturing of CVnCoV for potential commercial supply preparedness.
About CureVacCureVac 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 500 people at its sites in Tübingen, Frankfurt, and Boston, USA. Further information can be found at www.curevac.com.
About Wacker BiotechWacker Biotech GmbH and Wacker Biotech B.V. are full-service contract manufacturers of therapeutic proteins, LMPs and vaccines based on microbial systems. The company's portfolio extends from strain/process development, through analytical testing, to production for clinical and commercial applications. Wacker Biotech maintains three GMP-compliant (Good Manufacturing Practice), FDA- and EMA-certified production plants at its German sites in Jena and Halle as well as in Amsterdam in the Netherlands. Wacker Biotech GmbH and Wacker Biotech B.V. are wholly owned subsidiaries of the Munich-based company Wacker Chemie AG (WCH888). Further information can be found at www.wacker.com/biologics
Forward-Looking Statements
Wacker Chemie AG
This press release contains forward-looking statements based on assumptions and estimates of WACKER's Executive Board. Although we assume the expectations in these forward-looking statements are realistic, we cannot guarantee they will prove to be correct. The assumptions may harbor risks and uncertainties that may cause the actual figures to differ considerably from the forward-looking statements. Factors that may cause such discrepancies include, among other things, changes in the economic and business environment, variations in exchange and interest rates, the introduction of competing products, lack of acceptance for new products or services, and changes in corporate strategy. WACKER does not plan to update its forward-looking statements, nor does it assume the obligation to do so.
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 (the “company”) regarding future events or future results, in contrast with statements that reflect historical facts. Examples include discussion of 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 CureVac'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.
— WebWireID266936 —
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- Building an integrated European vaccine manufacturing network with experienced partners
- Managing supply chain risk by collaborating with several partners for each manufacturing step
- Increasing capacity to reach up to 300 million doses in 2021 and up to 600 million doses in 2022
TÜBINGEN, GERMANY and BOSTON, MA / ACCESSWIRE / November 17, 2020 / CureVac N.V. (NASDAQ:CVAC), a biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid (mRNA), announced today that it is accelerating the expansion of its manufacturing network to deliver pandemic-scale volumes of its COVID-19 vaccine candidate, CVnCoV. Preparations for the start of production and required technology transfers are underway.
CureVac aims to build a broad and integrated European vaccine manufacturing network with highly experienced CDMO (Contract Development and Manufacturing Organization) partners for each of the key manufacturing steps for CVnCoV. With this strategy, the company is expecting to significantly increase its existing manufacturing capacities for CVnCoV to up to 300 million doses in 2021 and up to 600 million doses in 2022, while managing potential supply chain risks. An additional large-scale production facility supported by the European Investment Bank (EIB) at CureVac's headquarters in Tübingen is currently in development.
"It is our goal to ramp up the production capacity of our vaccine candidate within a short period of time to ensure a stable supply," said Dr. Florian von der Mülbe, Chief Production Officer of CureVac. "We are currently working with experienced CDMOs across Europe to establish a solid production network. Geographic proximity is an important factor for facilitating alignment and technology transfers."
Over the coming weeks, CureVac expects to announce key CDMO and supplier partnerships. CureVac's CVnCoV manufacturing network will leverage expertise and capacity across Germany, France, the Netherlands, Belgium, Spain and Austria, as well as potentially Sweden, Poland, Italy and Ireland.
About CVnCoV
CureVac began development of its mRNA-based COVID-19 vaccine candidate in January 2020. The compound is an optimized, non-chemically modified mRNA, encoding the prefusion stabilized full-length spike protein of the SARS-CoV-2 virus. 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 immune response was comparable to recovered COVID-19 patients, closely mimicking the immune response after natural COVID-19 infection. The data support CureVac's decision to advance a 12µg dose in its upcoming pivotal Phase 2b/3 study, which CureVac plans to initiate before the end of 2020. Clinical trial material is provided by the company's substantial production capacities for mRNA vaccines at its headquarters in Tübingen, supported by the current expansion of manufacturing capacities to allow for broad-scale manufacturing of CVnCoV for potential commercial supply preparedness.
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 500 people at its sites in Tübingen, Frankfurt, and Boston, USA. Further information can be found at www.curevac.com.CureVac Media Contact
Thorsten Schüller, Vice President Communications
CureVac, Tübingen, Germany
T: +49 7071 9883-1577
[email protected]CureVac Investor Relations Contact
Dr. Sarah Fakih, Vice President Investor Relations
CureVac, Tübingen, Germany
T: +49 7071 9883-1298
M: +49 160 90 496949
[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 (the "company") regarding future events or future results, in contrast with statements that reflect historical facts. Examples include discussion of 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 AG via EQS Newswire
View source version on accesswire.com:
https://www.accesswire.com/617105/CureVac-Establishes-European-Based-Network-to-Ramp-Up-Manufacturing-of-its-COVID-19-Vaccine-Candidate-CVnCoV
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- Contract spans 225 million initial doses and the option for an additional 180 million doses
- Upfront payment to support financing of advanced clinical development of CVnCoV, ramp-up of European manufacturing network and market supply preparations
TÜBINGEN, GERMANY and BOSTON, MA / ACCESSWIRE / November 16, 2020 / CureVac N.V. (NASDAQ:CVAC), a biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid ("mRNA"), reports the European Commission's announcement that tomorrow it will authorize an Advanced Purchase Agreement for CureVac's mRNA-based COVID-19 vaccine candidate, CVnCoV.
Once finalized, the contract with the European Commission will provide member states of the European Union with up to 225 million doses of the vaccine and includes the option for an additional purchase of 180 million doses. The mRNA vaccine will be supplied once it has proven to be safe and effective against COVID-19. CureVac will receive an upfront payment to support the advanced clinical development of CVnCoV and the current ramp-up of its manufacturing network, as well as market launch and supply preparations.
"CureVac is leveraging 20 years of expertise in mRNA technology to develop a COVID-19 vaccine that can contribute to the end of the COVID-19 pandemic and to potentially allow all of us to return to an unrestricted life, where we are free again to engage in all activities we enjoy doing," said Dr. Franz-Werner Haas, Chief Executive Officer of CureVac. "As an important step toward that goal, we are proud to potentially supply our COVID-19 vaccine to citizens of the European Union. Beyond the European Union, we are actively engaging with governments and multilateral organizations across the globe to ensure broad and equitable access to our COVID-19 vaccine candidate."
CureVac is currently expanding manufacturing capacities for the large-scale manufacturing of CVnCoV. Vaccine doses are expected to be produced both at CureVac's in-house, GMP-certified manufacturing site in Germany and across a broad European manufacturing network.
About CVnCoV
CureVac began development of its mRNA-based COVID-19 vaccine candidate in January 2020. The compound is an optimized, non-chemically modified mRNA, encoding the prefusion stabilized full-length spike protein of the SARS-CoV-2 virus. The Phase 1 clinical study of CVnCoV began in June 2020 at clinical study centers in Germany and Belgium in collaboration with the Coalition for Epidemic Preparedness Innovation (CEPI). At the end of September 2020, CVnCoV entered into a Phase 2a clinical trial in Peru and Panama, extending clinical studies into older adults and regions with high-incidence of COVID-19 infections. 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 immune response was found to be comparable to recovered COVID-19 patients, closely mimicking the immune response after natural COVID-19 infection. The data support the decision to advance a 12µg dose in the upcoming pivotal Phase 2b/3 study.
CureVac plans to initiate the pivotal Phase 2b/3 clinical study before end of 2020. Clinical trial material is provided by the company's production capacities for mRNA vaccines at its headquarters in Tübingen supported by the current expansion of those manufacturing capacities to allow for broad-scale manufacturing of CVnCoV for potential commercial supply preparedness.About CureVac
CureVac is a global biopharmaceutical company active 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 500 people at its sites in Tübingen, Frankfurt, and Boston, USA. Further information can be found at www.curevac.com.CureVac Media Contact
Thorsten Schüller, Vice President Communications
CureVac, Tübingen, Germany
T: +49 7071 9883-1577
[email protected]CureVac Investor Relations Contact
Dr. Sarah Fakih, Vice President Investor Relations
CureVac, Tübingen, Germany
T: +49 7071 9883-1298
M: +49 160 90 496949
[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 (the "company") regarding future events or future results, in contrast with statements that reflect historical facts. Examples include discussion of 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 AG
View source version on accesswire.com:
https://www.accesswire.com/616970/European-Commission-Announces-That-Tomorrow-It-Will-Authorize-the-Agreement-with-CureVac-for-the-Supply-of-up-to-405-Million-Doses-of-mRNA-Based-COVID-19-Vaccine-Candidate-CVnCoV
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- Data publication follows positive topline data reported November 2, 2020
- Full pre-print manuscript available on medRxiv
- Company to host conference call and webcast today at 5 p.m. CET (11 a.m. EST)
TÜBINGEN, GERMANY and BOSTON, MA / ACCESSWIRE / November 10, 2020 / 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 publication of detailed interim Phase 1 data, following the reporting of positive topline data on November 2, 2020. The manuscript is available on medRxiv and will also be submitted for publication in a peer-reviewed journal.
The previously announced interim data showed that CVnCoV was generally well tolerated across all tested doses (2-12µg) and induced strong binding and neutralizing antibody responses in addition to first indication of T cell activation. The quality of immune response was found to be comparable to recovered COVID-19 patients, closely mimicking the immune response after natural COVID-19 infection.
CureVac will host a conference call and webcast today at 5 p.m. CET (11 a.m. EST) to provide more insight on the detailed Phase 1 interim trial data. The live webcast link and corresponding presentation slides can be accessed via the Investor Relations section of the CureVac homepage at https://www.curevac.com/en/newsroom/events/
About CVnCoV
CureVac began development of its mRNA-based COVID-19 vaccine candidate in January 2020. The compound is an optimized, non-chemically modified mRNA, encoding the prefusion stabilized full-length spike protein of the SARS-CoV-2 virus. The Phase 1 clinical study of CVnCoV began in June 2020 at clinical study centers in Germany and Belgium in collaboration with the Coalition for Epidemic Preparedness Innovation (CEPI). At the end of September 2020, CVnCoV entered a Phase 2a clinical trial in Peru and Panama, extending clinical studies into older adults and regions with high-incidence of COVID-19 infections. CureVac plans to initiate a pivotal Phase 2b/3 clinical study by the end of 2020. Clinical trial material is provided by the company's substantial production capacities for mRNA vaccines at its headquarters in Tübingen. The company is currently expanding those manufacturing capacities to allow for broad-scale manufacturing of CVnCoV for potential commercial supply preparedness.About CureVac
CureVac is a global clinical-stage 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 500 people at its sites in Tübingen, Frankfurt, and Boston, USA. Further information can be found at www.curevac.com.CureVac Media Contact
Thorsten Schüller, Vice President Communications
CureVac, Tübingen, Germany
T: +49 7071 9883-1577
[email protected]CureVac Investor Relations Contact
Dr. Sarah Fakih, Vice President Investor Relations
CureVac, Tübingen, Germany
T: +49 7071 9883-1298
M: +49 160 90 496949
[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 (the "company") regarding future events or future results, in contrast with statements that reflect historical facts. Examples include discussion of 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 via EQS Newswire
View source version on accesswire.com:
https://www.accesswire.com/615730/CureVac-Publishes-Detailed-Interim-Phase-1-Data-of-its-COVID-19-Vaccine-Candidate-CVnCoV
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- Balanced immune response with strong induction of binding, and neutralizing antibodies and first indications of T cell activation
- Quality of immune response comparable to recovered COVID-19 patients, closely mimicking immune response after natural COVID-19 infection
- CVnCoV generally well tolerated across tested dose range of 2-12µg
- Data support 12µg dose for pivotal Phase 2b/3 clinical trial
- On track to initiate pivotal Phase 2b/3 before end of 2020
TÜBINGEN, GERMANY and BOSTON, MA / ACCESSWIRE / November 2, 2020 / 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 positive interim data from its ongoing Phase 1 dose-escalation study evaluating the safety, reactogenicity and immunogenicity of CVnCoV, its investigational SARS-CoV-2 vaccine candidate. The vaccine candidate was generally well tolerated across all tested doses (2-12µg) and induced strong binding and neutralizing antibody responses in addition to first indication of T cell activation. CureVac intends to provide a detailed Phase 1 data overview and publication in a scientific journal in the coming weeks. CVnCoV is currently also being investigated in a Phase 2a clinical trial in older adults in Peru and Panama.
"We are very encouraged by the interim Phase 1 data. It represents a critical milestone in our COVID-19 vaccine program and strongly supports the advancement of our vaccine candidate," said Dr. Franz-Werner Haas, Chief Executive Officer of CureVac. "Following further data readouts and discussion with regulatory authorities, we remain fully committed and on track to initiate a pivotal Phase 2b/3 trial before the end of 2020."
The Phase 1 study has enrolled to date more than 250 healthy individuals aged 18 to 60 years. Individuals were vaccinated intramuscularly with CVnCoV at escalating dose levels of 2, 4, 6, 8 and 12µg on days 1 and 29. Per dose level, the trial included up to 10 participants who had previously tested positive for a COVID-19 infection (seropositives) to further evaluate the safety and immunogenicity of CVnCoV in this sub-population.
The data support the decision to advance the 12µg dose in the upcoming pivotal Phase 2b/3 study.
Immunogenicity data showed induction of binding antibody titers, translating into relevant titers of virus neutralizing antibodies at all tested dose levels. Geometric Mean Titers (GMTs) of binding and neutralizing antibodies of study participants were compared to peak serum titers of 67 symptomatic convalescent COVID-19 patients (human convalescent sera, or HCS). The applied HCS panel was composed to provide a medically relevant comparator to validate CVnCoV potency. The panel was highly representative of the immune activation of seriously ill patients with multiple symptoms of whom approximately 24% were hospitalized.
At 12µg, GMTs of binding antibodies increased to the level measured in the HCS panel. Virus neutralizing antibodies increased to HCS levels at 12µg and were measured in a live-virus micro-neutralization assay. Analysis of T cell mediated immunity is ongoing. Early data show indications of functional T cells confirming activation of cellular immune response.
"These initial data show a robust and highly efficient immune response to our natural mRNA-based CVnCoV vaccine candidate, including antibody and initial T cell responses at the level of a relevant panel of symptomatic convalescent patients," said Dr. Mariola Fotin-Mleczek, Chief Technology Officer of CureVac. "We are grateful to all study volunteers who are helping to enable the development of a vaccine that will provide the best possible protection for people."
CVnCoV's unique mode of action mimics the natural immune response to the infection observed in recovered COVID-19 patients. This is reflected in the relative proportion of neutralizing to binding antibody levels, which are similar in vaccinated individuals and convalescent patients.
"The data are highly encouraging," said Prof. Dr. Peter Kremsner, Director of the Institute of Tropical Medicine of the University of Tübingen and lead investigator of the Phase 1 trial. "In this accelerated development program, it is paramount to ensure safety while generating a favorable level of immunogenicity. With this study, we had a strong focus on identifying the optimal dose for CVnCoV and we have succeeded in that."
Reactogenicity of CVnCoV was continuously monitored by a Data and Safety Monitoring Board, and the vaccine was generally well tolerated across all tested doses. No related serious adverse events were observed. At 12µg, grade 3 adverse events occurred mostly after administration of the second dose and included fatigue, headache, chills, muscle pain, and to a lesser extent, fever. All reported events were transient and resolved rapidly, usually within 24 to 48 hours.
Formulation of CVnCoV is based on state-of-the-art lipid nanoparticle (LNP) technology licensed from CureVac's long-standing partner Acuitas Therapeutics.
About CVnCoV
CureVac began development of its mRNA-based COVID-19 vaccine candidate in January 2020. The compound is an optimized, non-chemically modified mRNA, encoding the prefusion stabilized full-length spike protein of the SARS-CoV-2 virus. The Phase 1 clinical study of CVnCoV began in June 2020 at clinical study centers in Germany and Belgium in collaboration with the Coalition for Epidemic Preparedness Innovation (CEPI). At the end of September 2020 CVnCoV entered a Phase 2a clinical trial in Peru and Panama, extending clinical studies into older adults and regions with high-incidence of COVID-19 infections. CureVac plans to initiate a pivotal Phase 2b/3 clinical study by the end of 2020. Clinical trial material is provided by the company's substantial production capacities for mRNA vaccines at its headquarters in Tübingen. The company is currently expanding those manufacturing capacities to allow for broad-scale manufacturing of CVnCoV for potential commercial supply preparedness.About CureVac
CureVac is a global clinical-stage 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 approximately 500 people at its sites in Tübingen, Frankfurt, and Boston, USA. Further information can be found at www.curevac.com.CureVac Media Contact
Thorsten Schüller, Vice President Communications
CureVac, Tübingen, Germany
T: +49 7071 9883-1577
[email protected]CureVac Investor Relations Contact
Dr. Sarah Fakih, Vice President Investor Relations
CureVac, Tübingen, Germany
T: +49 7071 9883-1298
M: +49 160 90 496949
[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 (the "company") regarding future events or future results, in contrast with statements that reflect historical facts. Examples include discussion of 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 via EQS Newswire
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https://www.accesswire.com/613812/CureVac-Reports-Positive-Interim-Phase-1-Data-for-its-COVID-19-Vaccine-Candidate-CVnCoV
