CureVac COVID-19 Vaccine (CV2CoV) Description For 2022
CureVac's CV2CoV vaccine candidate is based on an advanced second-generation messenger ribonucleic acid (mRNA) backbone. CV2CoV was engineered with specifically optimized non-coding regions to improve mRNA translation for increased and extended protein expression than the first-generation mRNA backbone.
In a preclinical development stage, the vaccine candidate is a non-chemically modified mRNA encoding the prefusion stabilized full-length spike protein of the SARS-CoV-2 betacoronavirus and formulated within Lipid Nanoparticles (LNPs). In addition, preclinical studies in different animal models demonstrate CV2CoV's ability to induce earlier and more robust immune responses. CVnCoV was the company's first-generation mRNA COVID-19 vaccine candidate.
CureVac's proprietary technology principle is mRNA as a data carrier to instruct the human body to produce proteins capable of fighting a wide range of diseases. This innovative mRNA technology instructs the human body to activate its defense mechanism. It uses the natural messenger substance mRNA that contains the construction manual needed to produce proteins. This messenger substance is programmed with information about one coronavirus protein and injected into the human body.
The human body recognizes the protein produced by our cells as something unknown and activates its immune cells to produce antibodies and T-cells against it. This way, the body copies the natural viral infection and starts the endogenous defense system, says the company. The mRNA is also encapsulated in a protective shell to prevent the mRNA's degradation and improve vaccine effectiveness, says the U.S. CDC.
CureVac's RNAoptimizer platform aims to optimize mRNA medicines' properties based on its three core pillars: protein design, mRNA optimization, and mRNA delivery. CureVac's technology can also be adapted to avoid immune activation for protein therapy and antibodies, thereby providing potential new therapeutic modalities for patients suffering from various diseases. The different parts of a CureVac-customized mRNA molecule create a packaged product specially optimized for various indications.
The first-generation vaccine candidate, CVnCoV, was withdrawn from regulatory review in October 2021 due to potential overlap with approval timelines for a second-generation candidate.
On March 30, 2022, CureVac N.V. announced that the first participant was dosed in a Phase 1 study of COVID-19 second-generation mRNA vaccine candidate, CV2CoV, developed with GSK.
On April 11, 2022, the companies confirmed a contract with the German federal government to supply mRNA vaccines within a broader tender for pandemic preparedness in Germany with access to CureVac’s manufacturing capacity until 2029.
A non-peer-reviewed study published on April 20, 2022, found the bivalent mRNA vaccine candidate significantly reduced viral replication in both Beta- and Delta-challenged mice. In addition, sera from bivalent mRNA vaccine immunized Wistar rats also contained neutralizing antibodies against the B.1.1.529 (Omicron BA.1) variant. These data suggest that low-dose and fit-for-purpose multivalent mRNA vaccines encoding distinct S-proteins are a feasible approach for increasing the potency of vaccines against emerging and co-circulating SARS-CoV-2 variants.
As of May 25, 2022, the Phase 1 dose-escalation study for COVID-19 with CV2CoV, recruitment is ongoing.
The CureVac-GSK COVID-19 collaboration was announced in February 2021. CureVac N.V. (Nasdaq: CVAC) is a global biopharmaceutical company in the field of mRNA technology, with more than 20 years of expertise in developing, optimizing, and manufacturing this versatile biological molecule for medical purposes. It is headquartered in Tübingen, Germany, and employs more than 900 people in Tübingen, Frankfurt, and Boston, USA. Officially founded in 2000, CureVac is the world's first company to harness mRNA for medical purposes successfully. Further information can be found at www.curevac.com.
CureVac COVID-19 Vaccine (CVnCoV) History
The Company withdrew CVnCoV from review on October 12, 2022. The EMA confirmed it had ended the rolling review of CVnCoV.
CureVac COVID-19 Vaccine (CV2CoV) Indication
CureVac's CVnCoV vaccine is indicated to prevent infection from the SARS-CoV-2 coronavirus, which causes COVID-19 disease.
CureVac COVID-19 Vaccine (CV2CoV) Dosage
Within a pre-clinical study, transgenic mice expressing the human ACE2 receptor were immunized on day 0 and day 28 with a 0.5 µg dose of the monovalent second-generation vaccine candidate against either the ancestral virus (CV2CoV), the Beta (CV2CoV.351) or the Delta (CV2CoV.617.2) variant, or with a 0.5 µg dose of the bivalent vaccine candidate combining the Beta and Delta variant (CV2CoV.351+ CV2CoV.617.2). Vaccinated animals were challenged on day 56 with either the Beta or the Delta virus variant. Vaccine-induced T cells, including lung-resident memory CD8+ T cells, were characterized by flow cytometry. Additionally, the neutralizing capacity of the mono- and bivalent candidates was tested against multiple virus variants, including Omicron in serum samples of immunized Wistar rats.
CureVac COVID-19 Vaccine (CV2CoV) Storage Requirements
The stability of the liquid drug product of CVnCoV was tested at the anticipated storage concentration and stored at +5°C (+41°F) as well as below -60°C (-76°F).
CureVac COVID-19 Vaccine (CV2CoV) FAQs
Updated Frequently asked questions about the CureVac COVID-19 vaccine candidates.
CureVac N.V. (Nasdaq: CVAC) Financial News For 2021 - 2022
May 25, 2022 - The Company confirmed revenues amounted to €24.4 million for the three months ended March 31, 2022, representing an increase of €14.4 million, or 144%, from €10.0 million for the same period in 2021.
April 11, 2022 - Under a new contract, the German federal government will pay CureVac and GSK an annual standby fee after completing the setup period, which requires the companies to maintain manufacturing capacity at constant readiness. The five-year contract enables the production of up to 80 million vaccine doses at short notice of a public health emergency.
November 18, 2021 - CureVac N.V. announced financial results for the third quarter and first nine months of 2021 and provided a business update. Cash position of €1.06 billion as of September 30, 2021. CureVac continues to assess supplier commitments related to the withdrawal of the first-generation COVID-19 vaccine candidate. Revenues amounted to €29.3 million and €61.8 million for the three and nine months ended September 30, 2021, respectively, representing an increase of €24.1 million and €19.0 million, or 463% and 44%, from €5.2 million and €42.8 million for the same periods in 2020.
May 26, 2021 - The company reported cash and cash equivalents increased from €1,323 million as of December 31, 2020, to €1,497 million as of March 31, 2021, mainly due to the raising of €405 million in net proceeds in a follow-on public offering, which closed in February 2021.
CureVac COVID-19 Vaccine (CVnCoV, CV2CoV) News For 2020 - 2022
April 21, 2022 - CureVac N.V. announced non-peer-reviewed preclinical data demonstrating immune responses and protective efficacy of a bivalent second-generation COVID-19 vaccine candidate jointly developed with GSK, combining two mRNAs encoding for the Beta and the Delta variant.
April 11, 2022 - CureVac N.V. and GSK announced a contract with the German federal government to supply mRNA vaccines enabling the availability of 80 million mRNA-based vaccine doses during the remainder of the current COVID-19 pandemic or in future infectious disease outbreaks.
March 30, 2022 - The Company announced that the first participant was dosed in a Phase 1 study of COVID-19 second-generation mRNA vaccine candidate, CV2CoV,
November 18, 2021 - CureVac N.V. announced the online publication of the extended preclinical study of the second-generation vaccine candidate, CV2CoV, in the journal Nature.
October 28, 2021 - CureVac and GSK published preclinical data on the second-generation mRNA technology, which improved immune response compared to CureVac's first-generation mRNA COVID-19 therapy. Data demonstrated high protective efficacy of the second-generation mRNA lead candidate, CV2CoV, in animal models in a SARS-CoV-2 challenge study.
October 12, 2021 - CureVac N.V. announced the strategic decision to focus its COVID-19 vaccine development on developing second-generation mRNA vaccine candidates in collaboration with GSK and to withdraw its first-generation COVID-19 vaccine candidate, CVnCoV, from the current approval process with the European Medicines Agency.
September 14, 2021 - CureVac N.V. announced its strategic decision to adjust the long-term footprint of the external European manufacturing network for its mRNA product pipeline. The decision was made in response to the reduced short-term peak demand for vaccines following the first wave of the COVID-19 pandemic vaccination efforts and corresponding changes in the demand for its first-generation COVID-19 vaccine candidate, CVnCoV currently under regulatory review by the European Medicines Agency (EMA). As a result, the existing contracts with WACKER to manufacture the mRNA drug substance of CVnCoV and Celonic for the manufacturing and formulation of the mRNA drug substance of CVnCoV will be terminated. CureVac's existing agreements with Rentschler Biopharma and Novartis for mRNA production and formulation are unaffected by this adjustment and remain in place. As a result, streamlining of capacity does not limit the availability of clinical trial material for CV2CoV, the second-generation COVID-19 vaccine candidate jointly developed with GSK, expected to enter the clinic in the fourth quarter of 2021.
September 1, 2021 - KoreaBioMed reported GSK and the German biopharmaceutical company CureVac said their second-generation mRNA Covid-19 vaccine demonstrated an improved immune response than the first generation, marking higher neutralizing antibody capacity against the variant strains.
August 16, 2021 - CureVac N.V. and GSK today announced the publication of preclinical data investigating immune responses as well as the protective efficacy of CureVac's first-generation vaccine candidate, CVnCoV, and second-generation vaccine candidate, CV2CoV, against SARS-CoV-2 challenge in non-human primates.
July 21, 2021 - Novartis confirmed it is prepared to deliver CureVac COVID-19 vaccines. Finance officer Harry Kirsch told reporters, "We have started the production as planned. We are planning to deliver 50 million doses this year," reported Reuters.
June 30, 2021 - CureVac N.V. 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.
June 18, 2021 - The journal Nature published an article: CureVac COVID vaccine let-down spotlights mRNA design challenges.
June 16, 2021 - CurVac N.V. confirmed 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 coronavirus.
May 26, 2021 - CureVac N.V. (Nasdaq: CVAC) announced business updates and financial results for the first quarter of 2021.
April 15, 2021 - CureVac N.V. announced business updates and financial results for the fourth quarter and full-year 2020. The company's COVID-19 vaccine candidate, CVnCoV, is in the final stage of clinical development and is believed to be well on track to provide data for conditional approval based on EMA rolling submission.
March 30, 2021 - CureVac N.V. and Celonic Group announced their partnership for the production of CureVac's mRNA-based COVID-19 vaccine candidate, CVnCoV. In total, Celonic will be prepared to manufacture more than 100 million doses of CVnCoV.
March 23, 2021- CureVac N.V. announced the publication of preclinical data demonstrating that their COVID-19 vaccine candidate, CVnCoV, protects against challenge infections with the SARS-CoV-2 Variant of Concern B.1.351 (also referred to as the "South African" variant) and a strain of the original SARS-CoV-2 B1 lineage (BavPat1) in a transgenic mouse model.
March 22, 2021 - CureVac N.V. announced plans to expand and further specify the protocols of its ongoing late-stage clinical trials with CVnCoV, its COVID-19 vaccine candidate.
March 4, 2021 - CureVac N.V. and Novartis AG announced that they had signed an initial agreement to manufacture CureVac's COVID-19 vaccine candidate, CVnCoV.
February 12, 2021 - The European Medicines Agency human medicines committee announced it had started a rolling review of CVnCoV, a COVID‑19 vaccine developed by CureVac AG.
February 5, 2021 - CureVac N.V. announced that it collaborated with the U.K. Government to develop and manufacture potential vaccine candidates against SARS-CoV-2 variants.
February 3, 2021 - Germany-based CureVac N.V. announced a new €150m collaboration with GSK, building on their existing relationship to develop next-generation mRNA vaccines for COVID-19 with the potential for a multi-valent approach to address multiple emerging variants in one vaccine.
February 2, 2021 - CureVac N.V. announced closing its follow-on public offering for approximately $450 million total gross proceeds.
February 1, 2021 - In a joint press briefing with German Health Minister Jens Spahn, Minister-President of North Rhine-Westphalia, Armin Laschet, and Chief Executive Officer of CureVac N.V., Franz-Werner Haas, Member of the Board of Management, Bayer AG, and President of the Bayer's Pharmaceuticals Division, Stefan Oelrich, made the following statement: "Following discussions with the German government it has become clear that current manufacturing capacities for vaccines need to be increased, particularly for potential variants of the SARS-CoV-2 virus. Therefore, we are planning to add 160 million doses of CureVac's vaccine in 2022 to expand further their supply network and overall capacity using the manufacturing network of Bayer. The first commercial product from this expansion may already be available towards the end of 2021. To accomplish this, we will rely on our own product supply network, including our site in Wuppertal, Germany. This includes the need to expand production capacity as well as related manufacturing expertise in Germany."
February 1, 2021 - CureVac N.V. and Rentschler Biopharma S.E. announced that the companies had initiated the set-up of manufacturing capabilities for CureVac's COVID-19 vaccine, CVnCoV. From its headquarters in Laupheim, Germany, and its site in Milford, MA, USA, Rentschler Biopharma offers process development and manufacturing of biopharmaceuticals and related consulting activities, including project management and regulatory support.
January 11, 2021 - CureVac NV announced that preclinical data from its COVID-19 vaccine candidate CVnCoV had confirmed the induction of a pronounced immune response in non-human primates.
January 7, 2021 - Bayer announced signing a collaboration and services agreement with CureVac N.V. Under the terms of the agreement, Bayer will support the further development, supply, and key territory operations of CureVa's COVID-19 vaccine candidate CVnCoV.
December 9, 2020 - CureVac N.V. and Fareva today announced an agreement regarding the fill & finish manufacturing of CureVac's COVID-19 vaccine candidate, CVnCoV, at Fareva's Pau and Val-de-Reuil-sites in France.
November 23, 2020 - Germany-based CureVac N.V. and Wacker Chemie AG announced that they had signed a contract to manufacture CureVac's COVID-19 vaccine candidate CVnCoV.
November 16, 2020 - CureVac N.V. reports the European Commission announced that tomorrow it would 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.
November 12, 2020 - CureVac N.V. announced that its mRNA-based COVID-19 vaccine candidate, CVnCoV, remained stable and within defined specifications for at least three months when stored at a standard refrigerator temperature of +5°C (+41°F) and up to 24 hours as a ready-to-use vaccine when stored at room temperature.
November 2, 2020 - Germany-based CureVac N.V. announced positive interim data from its ongoing Phase 1 dose-escalation study evaluating the safety, reactogenicity, and immunogenicity of CVnCoV 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 the first indication of T cell activation.
September 29, 2020 - CureVac announced today that the first participant had been dosed in a Phase 2a clinical trial of its COVID-19 vaccine candidate, CVnCoV.
August 4, 2020 - CureVac announced that Dr. Franz-Werner Haas had been appointed Chief Executive Officer.
July 21, 2020 - CureVac AG announced closing its latest private financing round, raising a total of USD 640 million.
July 20, 2020 - GSK and CureVac announced a strategic collaboration agreement for the research, development, manufacturing, and commercialization of up to 5 mRNA-based vaccines and monoclonal antibodies (mAbs) targeting infectious disease pathogens. The collaboration complements GSK's existing mRNA capabilities with CureVac's integrated mRNA platform. However, this agreement reportedly does not include CureVac's existing COVID-19 mRNA vaccine research program, CVnCoV SARS-CoV-2.
June 17, 2020 - CureVac to Initiate Phase 1 Clinical Trial of its SARS-CoV-2 Vaccine Candidate.
June 15, 2020 - The German Federal Minister for Economic Affairs and Energy, Peter Altmaier, and Dietmar Hopp, announced that the Federal Republic of Germany would invest 300 million Euros in the biopharmaceutical company CureVac AG, a pioneer in the preclinical and clinical development of mRNA-based drugs.
May 14, 2020 - CureVac AG, a clinical-stage biopharmaceutical company developing a new class of transformative medicines based on optimized mRNA, announced positive preclinical results at a low dose for its lead vaccine candidate against the novel Coronavirus (SARS-CoV-2).
CVnCoV, CV2CoV Vaccine Clinical Trials
CureVac AG COVID-19 mRNA vaccine candidate tests the immunogenicity, safety, and efficacy in clinical trials.
CV2CoV is a second-generation mRNA vaccine with optimized non-coding regions and enhanced antigen expression. Here we report a head-to-head study of the immunogenicity and protective efficacy of CVnCoV and CV2CoV in nonhuman primates. CV2CoV induced substantially higher binding and neutralizing antibodies, memory B cell responses, and T cell responses as compared with CVnCoV. CV2CoV also induced more potent neutralizing antibody responses against SARS-CoV-2 variants, including B.1.351 (beta), B.1.617.2 (delta), and C.37 (lambda). While CVnCoV provided partial protection against the SARS-CoV-2 challenge, CV2CoV afforded robust protection with markedly lower viral loads in the upper and lower respiratory tract. Antibody responses correlated with protective efficacy. These data demonstrate that optimization of non-coding regions can greatly improve the immunogenicity and protective efficacy of an mRNA SARS-CoV-2 vaccine in nonhuman primates.
The Phase 1 dose-escalation study is being conducted at clinical sites in the U.S. and is expected to enroll up to 210 healthy adults to evaluate the safety, reactogenicity, and immunogenicity of CV2CoV in the dose range of 2 to 20µg. Data results from the Phase 1 study are expected in the second half of 2022. The program follows the recent start of the Phase 1 clinical study for the jointly developed seasonal influenza vaccine candidate, CVSQIV, also applying the optimized second-generation mRNA backbone.
Within the new study, CV2CoV and CVnCoV were tested in cynomolgus macaques immunized with a 12µg dose of the respective candidate on day 0 and day 28. For comparison with Comirnaty®, animals were vaccinated twice, on day 0 and day 21, with 30µg of the licensed vaccine, and antibody titers were measured at peak immunity at week 5. Within the comparison of CV2CoV with CVnCoV, CV2CoV consistently showed better activation of innate and adaptive immune responses, resulting in earlier response onset, higher antibody titers, and stronger memory B and T cell activation. Higher antibody neutralizing capacity was observed with CV2CoV across a range of relevant variants, including the Delta variant. During challenge with the original SARS-CoV-2 virus, animals vaccinated with CV2CoV were found to be better protected than animals vaccinated with CVnCoV based on effective clearance of the virus in the lungs and nasal passages.