CVnCoV Vaccine Description
CureVac's CVnCoV is an mRNA vaccine candidate that utilizes nucleotides without chemical modifications in the mRNA. The mRNA encodes the full-length spike protein of SARS-CoV-2 coronavirus and is formulated with lipid nanoparticles.
The principle of CureVac's proprietary technology is the use of mRNA as a data carrier to instruct the human body to produce its own proteins capable of fighting a wide range of diseases.
This innovative mRNA technology instructs the human body to activate its own defense mechanism. To that, 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 protein of the coronavirus and inject it into the human body.
The body recognizes the protein produced by our cells as something unknown and activates its immune cells to produce antibodies and T-cells against it. In this way, the natural viral infection and activate the endogenous defense system, says the company.
Traditional vaccine approaches administer live or inactivated pathogens or use recombinant protein to generate an immune response. However, the mRNA vaccine candidate delivers mRNA into a cell of the vaccine, instructing it to produce a specific protein or antigen (i.e., a foreign substance that induces an immune response). The induced immune response is directed against the encoded protective antigen. To prevent degradation of the mRNA and improve vaccine effectiveness, the mRNA is also encapsulated in a protective shell.
CureVac’s RNAoptimizer platform aims to optimize the properties of mRNA medicines based on its 3 core pillars: protein design, mRNA optimization, and mRNA delivery.
The technology can also be adapted to avoid immune activation for purposes of protein therapy and antibodies, thereby providing potential new therapeutic modalities for patients suffering from a vast range of diseases. All the different parts of a CureVac-customized mRNA molecule create a packaged product specially optimized for different indications.
The company's website says 'based on the low dosing of our rabies vaccine in humans, we have the capacity to produce up to several hundred million doses of bulk RNA material per annum with our current GMP III facility. Beyond that, we are planning to put a new GMP IV suite into operation within two years where we can produce 1 billion or more vaccine doses per year.'
CureVac AG is a clinical-stage biotechnology company located in Tübingen, Germany, and Boston, USA.
CVnCoV Vaccine Indication
CVnCoV is indicated to prevent infection from the SARS-CoV-2 coronavirus which causes COVID-19 disease.
CVnCoV Vaccine Dosage
The Phase 1 study evaluated the safety and reactogenicity profile after 1 and 2 dose administrations of CVnCoV at different dose levels. A dose range of 2 µg to 8 µg will be tested to determine the optimal dose as well as to evaluate the safety and immune profile of the vaccine in humans.
The Phase 2a study is evaluating different dose levels starting at 6 µg.
CVnCoV Vaccine News
October 23, 2020 - CureVac announced data from preclinical studies of CVnCoV, in mice and hamsters. The vaccine candidate elicited balanced humoral and cellular immune responses, featuring high antibody titers and very good T cell activation. In addition, the vaccine candidate induced favorable Th1 cytokine levels. Furthermore, CVnCoV efficiently protected hamsters against a live SARS-CoV-2 viral challenge without evidence of vaccine-induced disease enhancement.
September 29, 2020 - CureVac announced today that the first participant has been dosed in a Phase 2a clinical trial of its COVID-19 vaccine candidate, CVnCoV. The dose-confirmation study, entitled CV-NCOV-002, is being conducted in Peru and Panama and will enroll a total of 690 healthy participants in two distinct groups: older adults ages 61 and above, and younger participants 18 to 60 years old. The participants will receive two vaccinations at intervals of 28 days. Different dose levels will be investigated, starting at 6 µg, with the aim to confirm safety and evaluate the reactogenicity of the vaccine in older adults.
September 4, 2020 - CureVac N.V. announced it has received notification from the German Federal Ministry of Education and Research (BMBF) that CureVac is expected to receive up to 252 million euros to support the development of its COVID-19 vaccine candidate. The grant is expected to be used for the rapid expansion of vaccine production.
August 20, 2020 - CureVac concluded exploratory talks outlining an Advanced Purchase Agreement for our potential mRNA-based COVID-19 vaccine. The envisaged contract with the European Commission is intended to provide all EU Member States with up to 225 million doses and an option for an additional purchase of 180 million doses, to be supplied once our mRNA-based vaccine has proven to be safe and effective against COVID-19.
August 14, 2020 - CureVac B.V. announced the pricing of its initial public offering which produced total gross proceeds of approximately $213.3 million.
August 4, 2020 - CureVac announced that Dr. Franz-Werner Haas has been appointed Chief Executive Officer.
July 24, 2020 - CureVac B.V. filed for an initial public offering in the USA, with plans to list on Nasdaq under the ticker "NVAC."
July 21, 2020 - CureVac AG announced the closing of 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, CureVac’s existing COVID-19 mRNA vaccine research program, CVnCoV SARS-CoV-2, is reportedly not included in this agreement.
July 6, 2020 - European Investment Bank and CureVac sign a €75 million loan agreement for the development and large-scale production of vaccines, including CureVac’s vaccine candidate against SARS-CoV-2, CVnCoV. The InnovFin Infectious Diseases Finance Facility (IDFF) is a financial product dedicated to supporting the fight against infectious diseases. The joint European Commission and EIB Group initiative fall under Horizon2020, the 2014-2020 EU research and innovation program.
July 2, 2020 - Elon Musk Tweeted Tesla Inc. is building mobile molecule printers to help make the potential COVID-19 vaccine named CVnCoV being developed by CureVac in Germany.
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 will 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, today announced positive pre-clinical results at a low dose for its lead vaccine candidate against the novel Coronavirus (SARS-CoV-2). The data showed a fast induction of a balanced immune response with high levels of virus-neutralizing titers (VNTs) and T-cell responses. VNTs are a major criterion supporting that the vaccine candidate has the potential to induce a strong immunologic response to neutralize SARS-CoV-2.
CVnCoV Vaccine Clinical Trials
Phase 2 - Clinical Trial NCT04515147: A Dose-Confirmation Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Vaccine CVnCoV in Healthy Adults - Last updated on September 11, 2020.
- A Phase 2a, Partially Observer-blind, Multicenter, Controlled, Dose-confirmation Clinical Trial to Evaluate the Safety, Reactogenicity, and Immunogenicity of the Investigational SARS-CoV-2 mRNA Vaccine CVnCoV in Adults >60 Years of Age and 18 to 60 Years of Age.
- The study design was coordinated with and approved by the health authorities and ethics committees of Peru and Panama and is based on preliminary safety and immunogenicity data from CureVac’s ongoing Phase 1 CV-NCOV-001 study in healthy adult volunteers in Germany and Belgium.
Phase 1 - Clinical Trial NCT04449276: A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Vaccine CVnCoV in Healthy Adults - Last updated on July 1, 2020.
- A Partially Blind, Placebo-controlled, Dose-escalation, First-in-human, Clinical Trial to Evaluate the Safety, Reactogenicity, and Immunogenicity After 1 and 2 Doses of the Investigational SARS-CoV-2 mRNA Vaccine CVnCoV Administered Intramuscularly in Healthy Adults.
- In the initial part of the dose-escalation, participants will be enrolled in sentinel groups in an open manner. In the second part, participants will be enrolled in placebo-controlled groups in an observer-blind manner.
- Estimated completion date: August 2021
- Depending on the data of Phase 1 study, CureVac expects to start the next clinical trial phase with a significant number of participants.