CVAC CureVac N.V.
Drug Pipeline
| Drug | Stage | Notes |
|---|---|---|
|
BI 1361849 (CV9202)
Non-small cell lung cancer (NSCLC)
|
Phase 1/2
Phase 1/2
|
Phase 1/2 trial ongoing.
|
|
CV8102
Solid tumors
|
Phase 1
Phase 1
|
Phase 1 expansion cohort initiation announced February 4, 2021.
|
|
CVnCoV
COVID-19
|
Phase 2/3
Phase 2/3
|
Phase 2b/3 trial initiation announced December 14, 2020.
|
|
CV7202
Rabies
|
Phase 1
Phase 1
|
Phase 1 trial ongoing.
|
Latest News
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TÜBINGEN, GERMANY and BOSTON, MA / ACCESSWIRE / February 18, 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 that it will be participating in the following upcoming investor conferences:
- Leerink 10th Annual Global Healthcare Conference (virtual)
Wednesday, February 24, 2021
Presentation: 8:00 am EST- Credit Suisse 2021 London Global Healthcare Conference (virtual)
Tuesday, March 2, 2021
Fireside Chat: 12:00 pm GMT / 7:00 am ESTUp to date event participation and associated presentation slides or webcast links can be accessed via the Investor Relations section of the CureVac homepage at https://www.curevac.com/en/newsroom/events/.
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 Investor Relation Contact
Dr. Sarah Fakih, Vice President Investor Relations
CureVac, Tübingen, Germany
T: +49 7071 9883-1298
M: +49 160 90 496949
[email protected]CureVac Media Contact
Thorsten Schüller, Vice President Corporate Communications
CureVac, Tübingen, Germany
T: +49 7071 9883-1577
[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 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.
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- Rolling submission with EMA initiated to accelerate time to potential marketing authorization of CVnCoV
- Submission of CVnCoV pre-clinical data package marks start of the rolling process
TÜBINGEN, GERMANY and BOSTON, MA / ACCESSWIRE / February 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 initiation of a rolling submission with the European Medicines Agency (EMA) for CVnCoV, the company's mRNA-based COVID-19 vaccine candidate, currently in late-stage clinical testing. The process was initiated when the first data package consisting of CVnCoV pre-clinical data was submitted to EMA and passed the technical validation.
"We are confident in the potential of our mRNA technology to contribute to the fight against the global public health emergency that is COVID-19," said Dr. Lidia Oostvogels, Vice President Area Head Infectious Diseases at CureVac. "Working together with the EMA to initiate a rolling regulatory process is a critical step in enabling potential access to our vaccine by the many people who still need protection from this deadly disease."
The rolling submission represents a time-optimized route to provide and review all necessary data needed for a potential market authorization during a public health emergency. Over the course of the rolling submission process, EMA will assess CVnCoV's compliance with standards for vaccine efficacy, safety, and pharmaceutical quality on the basis of individually submitted data packages as a prerequisite for a formal market authorization application.
CVnCoV is currently being investigated in a randomized, observer blind, placebo-controlled Phase 2b/3 clinical trial called HERALD in healthy adults at a dose of 12 µg at sites in Europe and Latin America.
About CVnCoV
CureVac began development of its mRNA-based COVID-19 vaccine candidate in January 2020. The vaccine 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 Nano Particles (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 immune response was comparable to recovered COVID-19 patients, closely mimicking the immune response after natural COVID-19 infection. The data supported CureVac's decision to advance a 12µg dose into its current pivotal Phase 2b/3 study, the HERALD study, which started in December 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 in Europe, allowing 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 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 AG
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TÜBINGEN, GERMANY and BOSTON, MA / ACCESSWIRE / February 5, 2021 / CureVac N.V. (NASDAQ:CVAC), a global biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid ("mRNA"), will host a conference call and webcast on today, Friday February 5, 2021 at 4:00 p.m. CET / 10:00 a.m. EST.
Conference call and webcast details
Dial-in numbers to participate in the conference call:
U.S. Toll-Free: +1 877-407-0989
International: +1 201-389-0921
Germany: 0800-182-0040The live 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.
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 Company's opinions, expectations, beliefs, plans, objectives, assumptions or projections 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 candidate 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.
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- Collaboration combines expertise, resources and technology from both parties to develop and manufacture variant vaccines for commercial supply and distribution in the UK and its territories
- Objective is to mitigate the effects of the current pandemic and to help manage future outbreaks by forming a rapid response unit leveraging the unique strengths of CureVac's mRNA platform
- Under this agreement, CureVac is expected to supply 50 million doses of variant vaccines to the UK, subject to regulatory approval
TÜBINGEN, GERMANY and BOSTON, MA / ACCESSWIRE / February 5, 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 that it has entered a collaboration with the UK Government to develop and manufacture potential vaccine candidates against SARS-CoV-2 variants. Any resulting vaccine candidates will be manufactured and distributed in the UK and its overseas and dependent territories, subject to regulatory approval. The objective of the collaboration is to mitigate the effects of the current pandemic and help prepare against future SARS-CoV-2 outbreaks by working on multiple variant vaccines.
"One of the biggest challenges we continue to face in combating COVID-19 is the emergence of multiple variants, each of which poses a potentially significant threat to public health," said Dr. Antony Blanc, Chief Business Officer and Chief Commercial Officer of CureVac. "The UK Government and its Vaccines Taskforce (VTF) has been at the forefront of surveillance, vaccine development and delivery of vaccines for deployment during this pandemic. At CureVac, we believe we have the ability to quickly adapt our mRNA technology to address current variants and prepare for the emergence of new strains. This collaboration is expected to bring to bear our significant combined forces to ensure vaccines keep winning against COVID-19."
Dr Clive Dix, Interim Chair of the UK Vaccines Task Force added : "Today's agreement will help ensure the UK is best prepared against the emergence of any significant new virus variant as mRNA vaccines can be rapidly adapted to be effective against new virus variants more easily than traditional vaccine technologies. We are constantly tracking the virus so we can identify any significant new variant as quickly as possible; therefore, as part of this agreement, CureVac and the UK Government will assess multiple virus variants and are expected to generate multiple vaccine candidates against those selected."
The research and development collaboration combines CureVac's resources and technological expertise in mRNA vaccine development with the scientific experience of the Vaccines Taskforce and the UK's network of experts and capabilities in SARS-CoV-2 vaccine research and development. As part of the collaboration, the VTF, informed by the newly-formed Variant Vaccine Expert Advisory Group, and CureVac, with its unique mRNA vaccine platform, will assess multiple SARS-CoV-2 variants and are expected to generate vaccine candidates against those selected. Clinical studies will be expedited in the UK in order to secure emergency or conditional marketing authorizations for selected vaccine candidates against the most threatening variant viruses.
CureVac will also transfer its technology to enable the manufacturing of clinical and commercial quantities of any vaccines that result from the collaboration, as well as manufacturing of CureVac's existing vaccine against SARS-CoV-2 (CVnCoV), which is currently in Phase 3 clinical trials.
The collaboration with the VTF and the UK government complements and accelerates CureVac's COVID-19 program and its ability to contribute to stopping the pandemic. CureVac's CVnCoV vaccine candidate currently in development is supported by Bayer, and CureVac is co-developing its next-generation COVID-19 vaccine candidates with GlaxoSmithKline (GSK). Both collaborations will benefit from the variants developed with the VTF.
Subject to regulatory approval, the agreement includes an initial supply of 50 million doses of variant vaccines to the UK with some production expected to take place in the UK. Additionally, the agreement foresees that manufacturing capabilities will be in place for rapid production of large quantities of variant vaccines for the UK if and when needed over the next three years. CureVac is expecting to use its broader manufacturing network to produce variant vaccine candidates for global supply.
CureVac tackling COVID-19
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 immune response was comparable to recovered COVID-19 patients, closely mimicking the immune response after natural COVID-19 infection. In December 2020 CureVac initiated a pivotal Phase 2b/3, the HERALD study, with a 2µg dose of CVnCoV.
CureVac has entered into several strategic partnerships for the further development, production and commercialization of CVnCoV. The company entered into a collaboration agreement with Bayer in January 2021 with regards to CureVac's current CVnCoV currently in clinical Phase 2b/3. Earlier this week, CureVac and the British pharmaceutical company GlaxoSmithKline (GSK) agreed to jointly develop next-generation multi-valent mRNA vaccines against COVID-19. The development of new vaccine candidates is strengthened by a partnership with the UK Government and its Vaccines Taskforce, which CureVac entered in February 2021. GSK will also potentially contribute to this collaboration. Clinical trial and commercial 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 in Europe, allowing 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]UK Government Media Inquiries
[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 potential efficacy of the company's vaccine candidate 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:
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- CV8102 recommended dose identified; expansion trial to confirm safety, tolerability, and efficacy
- Trial expansion focuses on advanced melanoma, an indication of high medical need
TÜBINGEN, GERMANY and BOSTON, MA / ACCESSWIRE / February 4, 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 start of an expansion of the ongoing Phase 1 study with its lead RNA-based cancer drug candidate, CV8102. Initial results from the dose-escalation part in four solid cancer types were presented at the SITC conference in 2020. CV8102 had shown promising evidence of efficacy after intratumoral application as a single agent, and in combination with systemic anti-PD-1 antibody treatment. Translation of a locally induced immune response into a systemic immune response was observed in several patients, showing the ability of CV8102 to impact injected as well as distant lesions. The objective of the expansion is to confirm safety, tolerability, and efficacy of CV8102 in patients with advanced melanoma at 600µg, the selected dose to be advanced in a Phase 2 clinical trial. Furthermore, the trial expansion will evaluate the effects of CV8102 on systemic and intratumoral immune markers, which will provide additional clinical insights on CV8102's mode of action.
"Initial clinical data in cancer has demonstrated the ability of our RNA immunomodulator to trigger a systemic immune response attacking cancer not only at the site of injection but also in other areas of the body," said Ulrike Gnad-Vogt, Senior Vice President Area Head Oncology at CureVac. "The CV8102 trial expansion is expected to provide further insights into clinical efficacy and mechanism of action in patients with advanced PD-1 refractory melanoma, an indication with a high unmet medical need. We are very pleased to see CV8102 progress to the next stage, an important step to further leverage the potential of immunostimulating RNA therapeutics in oncology."
The expansion part of the trial will enrol 30 patients with PD-1 refractory melanoma, who will receive intratumoral injections of CV8102 in combination with PD-1 antibodies, as well as 10 patients who will be treated with CV8102 only. Initially, CV8102, with or without co-administration of anti-PD-1 treatment, will be injected weekly for five weeks, followed by three injections at two- or three-week intervals depending on the anti-PD-1 antibody schedule. Patients showing evidence of clinical benefit are eligible for further injections for up to 12 months.
About CV8102
CV8102 is a noncoding single stranded RNA complexed with a cationic peptide and functions as a strong immunomodulator based on TLR (toll-like receptor) 7/8 and RIG-1 (retinoic-acid-inducible protein 1) activation. It is designed to modulate the tumor microenvironment following intratumoral injection and to translate a local immune response towards released tumor antigens into a systemic immune response to control both injected as well as distant lesions. The currently ongoing Phase 1 dose escalation study is assessing tolerability as well as activity of CV8102 in the dose range of 25 to 900 µg. It is administered as both a single agent and in combination with systemic anti-PD-1 antibodies for the intratumoral treatment of four types of solid tumors: cutaneous melanoma, adenoid cystic carcinoma, squamous cell carcinoma of the skin, and squamous cell carcinoma of the head and neck. Initial results from the dose-escalation study presented at the SITC conference in November 2020 showed that the 600µg dose was tolerated without dose limiting toxicities as a single agent and in combination with anti-PD-1 antibodies. Preliminary evidence of efficacy was observed in the single agent and combination group, with several patients showing responses of distant noninjected lesions.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 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/627882/CureVac-Expands-Lead-RNA-Cancer-Program-Phase-1-Trial-in-Advanced-Melanoma