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Zorecimeran - CureVac

Drug Profile

Zorecimeran - CureVac

Alternative Names: Coronavirus vaccine - CureVac; CV07050101; CVnCoV vaccine - CureVac; nCoV-2019 vaccine - CureVac

Latest Information Update: 04 Jul 2022

At a glance

  • Originator CureVac
  • Class COVID-19 vaccines; RNA vaccines; Viral vaccines
  • Mechanism of Action Immunostimulants
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity No
  • Available For Licensing Yes

Highest Development Phases

  • Preregistration COVID 2019 infections

Most Recent Events

  • 08 Jun 2022 CureVac completes a phase III trial in COVID-2019 infections (Prevention, In adults, In elderly) in Germany (Intramuscular, Injection) (NCT04674189)
  • 03 Jun 2022 CureVac AG completes a phase-II/III trial in COVID-2019 infections (Prevention) in Belgium, Germany, Mexico, Netherlands, Peru, Argentina, Colombia, Dominican Republic, Panama and Spain (IM) (NCT04652102)(EudraCT 2020-003998-22)
  • 13 May 2022 CureVac terminates a phase III trial in COVID-2019 infections (Prevention) in Belgium (IM) (EudraCT2020-004070-22) (NCT04860258)

Development Overview

Introduction

Zorecimeran, an mRNA based vaccine is being developed by CureVac, in collaboration with Coalition for Epidemic Preparedness Innovations, by using Curevac's mRNA technology, for the prevention of COVID-2019 infections. The vaccine uses The RNA Printer™ technology, that delivers mRNA directly into the cell, to be translated against specific viral protein/antigen to induce immune response. The active ingredient is based on optimized, chemically unmodified mRNA, which codes for the prefusion-stabilized full spike protein of the SARS-CoV-2 virus. To prevent mRNA degradation and improve it effectiveness the mRNA is encapsulated into the lipid nanoparticles. The RNA Printer™ technology is capable of producing several grams of LNP-formulated mRNA within few weeks, making it cost effective and time saving compared to traditional vaccine platforms. Zorecimeran is under regulatory review in the European Union and Switzerland. Clinical developement is underway in several countries.

Company Agreements

In 2022, GlaxoSmithKline (now GSK) and CureVac expanded their development strategy to also test chemically modified mRNA technologies in addition to unmodified mRNA. In February 2021, Glaxo Smith Kline announced a new agreement built on the existing collaboration to jointly develop mRNA vaccines for COVID-19 infection and pontially against its variants as well. GSK also announced its support to manufacture 100 million doses of CureVac's first generation COVID-19 vaccine candidate CVnCoV in 2021. Earlier in July 2020, CureVac and GlaxoSmithKline had entered into a research and development agreement to co-develop mRNA based vaccines and monoclonal antibodies for the treatment of infectious diseases. According to the terms of the agreement, GSK will make an equity investment in CureVac of $US178.25m, representing close to a 10% stake, an upfront cash payment of $US142.6m and a one-time reimbursable payment of $US35.65m for manufacturing capacity reservation, upon certification of CureVac’s commercial scale manufacturing facility currently under construction in Germany. CureVac will be eligible to receive development and regulatory milestone payments of up to $US380.27m, commercial milestone payments of up to $US451.57m and tiered royalties on product sales. GSK will fund research and development activities related to the development projects covered by the collaboration. CureVac will be responsible for the preclinical and clinical development through phase I trials of these projects, after which GSK will be responsible for further development and commercialisation. CureVac will be responsible for the GMP manufacturing of the product candidates, including for commercialisation, and will retain commercialisation rights for selected countries for all product candidates. [1] [2] [3]

In March 2021, Novartis signed an initial agreement with CureVac to manufacture the mRNA and bulk drug product for CVnCoV against the COVID-2019 infection in a new high-tech production facility at the Novartis site in Kundl, Austria. [4]

In November 2020, CureVac entered into a manufacturing agreement with Rentschler Biopharma for CVnCoV vaccine in Germany. Under the terms of the agreement, Rentschler will be responsible for manufacturingof active pharmaceutical ingredient, downstream processing and formulation of drug substance for the vaccine. It is expected to produce more than 100 million doses of the CureVac vaccine per year in Germany. Financial terms of the agreement were not disclosed. [5]

In January 2021, Bayer signed a collaboration and service agreement with CureVac. As part of this agreement, Bayer will support CureVac's further development and delivery of the COVID-19 vaccine candidate CVnCoV as well as local activities in selected countries. To this end, Bayer will contribute its specialist knowledge and established infrastructure in areas such as operational study implementation, regulatory tasks, pharmacovigilance activities, medical information and supply chain services, as well as providing support in selected countries. Based on the agreement, CureVac will be the marketing authorisation holder for the product, while Bayer will support CureVac with country activities within the European Union (EU) and selected other markets. Bayer has option to become a holder of marketing authorisation in other markets outside of Europe. Financial details of the deal were not disclosed. [6] [7]

In Novemeber 2020, CureVac and Wacker Biotech signed manufacturing contract for 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. [8]

In January 2020, CureVac and Coalition for Epidemic Preparedness Innovations (CEPI) extended their collaboration to develop vaccine against COVID-2019 infections. Initial funds up to $US8.3 miilion will be provided by CEPI to CureVac for the vaccine development, manufacturing and clinical tests. In February 2019, Coalition for Epidemic Preparedness Innovations (CEPI) and CureVac entered into a partnership agreement worth upto $US34 million for The RNA Printer™ prototype to develop lipid-nanoparticle (LNP)-formulated mRNA vaccine candidates. Under the terms of the three-year partnership agreement, CureVac will use its mRNA plaform to undertake preclinical development of vaccine candidates against coronavirus infections, Lassa Fever (which is listed on the WHO’s R&D blueprint for priority diseases), Rabies, and Yellow Fever. Following successful preclinical tests for the three named indications, two of the vaccine candidates will undergo phase I clinical trials in humans. [9] [10]

Key Development Milestones

In April 2021, CureVac announced the start of the rolling approval process to Swissmedic for the approval of zorecimeran for the prevention of COVID-2019 infection, in Switzerland. The approval by Swissmedic is a prerequisite for the agreed delivery of five million vaccine doses to the Swiss government [11] .

In February 2021 CureVacit had initiated a rolling submission of the new drug application of zorecimeran to the European Medicines Agency (EMA) for the prevention of COVID-2019 infection [12]

In May 2022, CureVac terminated a phase III trial early based on the principal investigators and company's decision, following a change to the risk/benefit profile, which evaluated the safety, reactogenicity and immunogenicity of zorecimeran for the prevention of COVID-2019 infections in adults with co-morbidities (NCT04860258; EudraCT2020-004070-22; CV-NCOV-003). The open-label trial was initiated in April 2021 and enrolled 129 patients in Belgium [13] .

In June 2022, CureVac completed a phase III trial that evaluated the safety and immunogenicity of zorecimeran administered as a two-dose schedule in healthy adults (CV-NCOV-005; EudraCT2020-004066-19; NCT04674189). The randomised, observer-blinded, placebo-controlled trial was initiated in December 2020 and enrolled 23521 volunteers in Germany [14] .

In June 2022, CureVac completed a phase IIb/III HERALD trial which evaluated the safety and efficacy of zorecimeran in the prevention of Covid-2019 infection in healthy adults (NCT04652102; CV-NCOV-004; Eudra CT 2020-003998-22). The randomised, observer-blinded, placebo-controlled trial was initiated in December 2020, enrolled approximately 40 000 volunteers in Belgium, Germany, Mexico, Netherlands, Peru, Argentina, Colombia, Dominican Republic, Panama and Spain. The trial initiated as phase IIb part that will transition into a phase III effectiveness trial [15] [16] . In May 2021, CureVac announced that the independent Data Safety Monitoring Board (DSMB) confirmed the conduct of an interim analysis of 59 verified COVID-19 cases. Following DSMB recommendation, zorecimeran continues to demonstrate efficacy in a variant-based environment in phase IIb/III. The DSMB confirmed that there are no safety concerns for zorecimeran. The COVID-19 cases in the study are being sequenced to provide critical complementary data to the efficacy readout. The primary objective of the study is to demonstrate the efficacy of a two-dose administration of 12µg of zorecimeran in preventing COVID-19 infection of any severity in participants without prior exposure to SARS CoV-2 [17] . In June 2021, the company released the interim safety and efficacy results. The initial analyses suggest age and strain dependent efficacy and the available data were communicated with the European Medicines Agency (EMA). The Data Safety Monitoring Board (DSMB) confirmed a favourable safety profile for zorecimeran. The study will continue to the final analysis and the totality of the data will be assessed for the most appropriate regulatory pathway. The second interim analysis included 134 COVID-19 cases, occurring at least two weeks after administration of the second dose. To identify strains causing COVID-19 infections within the trial, sequencing of virus variants has so far been performed on 474 COVID-19 cases, of which 124 fulfilled adjudication criteria and were included in the present efficacy analysis [18] .

In November 2020, CureVac announced the expansion of European manufacturing network to deliver pandemic-scale volumes of its zorecimeran [19] .

In February 2022, CureVac and German Federal Ministry of Education and Research completed a phase IIa trial to assess the safety and reactogenicity profile of a third dose of zorecimeran (booster dose) in healthy volunteers (NCT04515147; CV-NCOV-002). The randomised, double-blind trial, initiated enrolment and doesed first patient in September 2020 and enrolled 674 participants in Panama and Peru. In March 2021, CureVac submitted a protocol amendment for inclusion of a secondary objective evaluating the vaccine efficacy [12] [20] [21] . In May 2021, CureVac announced that no increased side effects were reported after booster vaccination compared to the two doses of the primary vaccination [11] .

In August 2020, CureVac and the European Commission completed exploratory discussions on an Advanced Purchase Agreement (APA) for Coronavirus vaccine [22] .

In December 2021, CureVac completed a phase I trial that evaluated the safety and reactogenicity profile after 1 and 2 dose administrations of zorecimeran in healthy volunteers (NCT04449276; EudraCT2020-001286-36; CV-NCOV-001). The randomised, partially-blind, dose-escalation study was initiated in June 2020 and enrolled 280 volunteers in Belgium and Germany. In November 2020, CureVac released immunogenicity and safety data from the trial. Data showed that balanced immune response with strong induction of binding, and neutralizing antibodies and first indications of T cell activation. Data supportted 12µg dose for upcoming pivotal phase IIb/III clinical trial [23] [24] .

In June 2020, German Health Authority Paul-Ehrlich-Institute (PEI) and the Belgian Federal Agency for Medicines and Health Products (FAMHP) approved a phase I clinical trial for coronavirus vaccine to prevent COVID-2019 infection [25] .

CureVac was planning a phase III trial that was designed to evaluate the humoral immune response to zorecimeran in elderly adults aged ≥65 years and younger adults aged 18-45 years, 14 days after the second dose administration (NCT04838847; EudraCT2020-005064-54; CV-NCOV012). However, in August 2021, the trial was withdrawn prior to initiation [26] .

CureVac in collaboration with Bayer was planning the phase III CV-NCOV-011 trial to evaluating the immunogenicity, safety, and reactogenicity for COVID-2019 infections, when co-administered with a licensed quadrivalent influenza vaccine versus separate administration of the two vaccines in adults 60 years of age and older (21819; NCT04848467). However, in August 2021, the trial was withdrawn prior to initiation [27] .

In November 2020, CureVac announced results from stability studies of zorecimeran, which show that the vaccine was 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 ready-to-use vaccine when stored at room temperature. The stability studies were conducted as per International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). Stability of the liquid drug product of zorecimeran was tested at the anticipated storage concentration and stored at +5°C (+41°F) as well as below -60°C (-76°F) [28] .

In October 2020, CureVac released positive preclinical data of zorecimeran in mice and hamsters which demonstrated that the coronavirus vaccine has the potential to induce an effective and balanced immune response that mimics natural immune defences and has full lung protection in a relevant challenge animal model [29] .

In February 2022, CureVac presented results from preclinical trial at the 29th Conference on Retroviruses and Opportunistic Infections (CROI) [30] . In March 2021, CureVac released preclinical results with the SARS-CoV-2 variant of Concern B.1.351 ('South African' variant) and a strain of the original SARS-CoV-2 B1 lineage (BavPat1) from a transgenic mouse models [31] .

In January 2021, CureVac announced the publication of preclinical data demonstrating the induction of robust antibody and T cell responses of zorecimeran, in non-human primates [32]

In January 2020, CureVac launched pre-clinical tests with a variety of potential antigenic constructs based on the spike protein to elicit high immunogenicity. As of May 2020, in preclinical studies, vaccine showed a fast induction of a balanced immune response with high levels of virus neutralizing titers (VNTs) and T-cell responses [33] .

Financing information

CureVac, in September 2020, announced that company will receive funding of up to €EUR252 million from the German Federal Ministry of Education and Research. The funds, which are contingent on predefined milestones, will support the development of the coronavirus vaccine, as well as be used to expand the vaccine production capacities [34] .

In August 2020, CureVac reported that it intends to offer and sell in an underwritten public offering of 13,333,333 common shares. The net proceeds from the public offering and a concurrent private placement will be used to fund the coronavirus vaccine program against SARS-CoV-2 through the completion of phase III, to advance CV 8102 [see Adis Insight Drug profile 800045436] and CV 7202 [see Adis Insight Drug profile 800050651], through the completion of the phase II clinical trial and to invest in further development of the Company’s mRNA technology platform and to advance the development of other preclinical and clinical programs [35] .

In July 2020, CureVac entered into $US85 million loan agreement with European Investment Bank. The amount will be used to support the ongoing development of vaccines against infectious diseases, including its vaccine candidate CVnCoV aimed at preventing SARS-CoV-2 infections, expansion of manufacturing and to further invest in the mRNA technology platform to fight life-threatening diseases [36] .

A coronavirus vaccine received financial support from the Coalition for Epidemic Preparedness Innovations (CEPI), the Bill & Melinda Gates Foundation as well as from the Defense Advanced Research Projects Agency (DARPA), an agency of the US Department of Defense [33] .

Drug Properties & Chemical Synopsis

  • Route of administration IM
  • Formulation Injection
  • Class COVID-19 vaccines, RNA vaccines, Viral vaccines
  • Mechanism of Action Immunostimulants
  • WHO ATC code

    J07B-X (Other viral vaccines)

  • EPhMRA code

    J7A9 (Other specified single component)

Biomarkers Sourced From Trials

Indication Biomarker Function Biomarker Name Number of Trials

cOVID 2019 infections

Eligibility Criteria

FSH

2

cOVID 2019 infections

Outcome Measure

vitronectin

1

Biomarker

Drug Name Biomarker Name Biomarker Function
Zorecimeran - CureVac FSH Eligibility Criteria
vitronectin Outcome Measure
For more detail, check out BiomarkerBase: the leading source of information about biomarkers used in drug development and diagnostic tests, tracking a comprehensive list of biomarker uses worldwide by over 800 companies

Development Status

Summary Table

Indication Qualifier Patient Segment Phase Countries Route / Formulation Developers Event Date
COVID 2019 infections rolling submision rolling submission Prevention Preregistration European Union, Switzerland IM / Injection CureVac 19 Apr 2021
COVID 2019 infections - Prevention Phase II/III Argentina, Belgium, Colombia, Dominican Republic, Germany, Mexico, Netherlands, Panama, Peru, Spain IM / Injection CureVac 28 May 2021

Commercial Information

Involved Organisations

Organisation Involvement Countries
CureVac Originator Germany
CureVac Owner Germany
Bill & Melinda Gates Foundation Funder USA
German Federal Ministry for Education and Research Funder Germany
Defense Advanced Research Projects Agency Funder USA
Coalition for Epidemic Preparedness Innovations Collaborator Norway
Bayer Collaborator Germany

Licensing Availability

Licensing Organisation Available Indication Available Phase Region Date
CureVac - Unspecified - 31 Jan 2020

Scientific Summary

Adverse Events

Phase IIb/III

Interim results from the phase IIb/III HERALD trial demonstrated favourable safety profile for zorecimeran [18] .

Phase I

Safety data from the phase I trial showed that the coronavirus vaccine was generally well tolerated across tested dose range of 2-12µg. No related serious adverse events were observed. At 12µg, fatigue, headache, chills, muscle pain, and to a lesser extent, fever were the most commonly reported grade 3 adverse events mostly after administration of the second dose. All reported events were transient and resolved rapidly, usually within 24 to 48 hours. The randomized evaluated the safety and reactogenicity profile after 1 and 2 dose administrations of zorecimeran in healthy volunteers [23] [24] .

Pharmacodynamics

Summary

In preclinical studies, CV2CoV [see AdisInsight drug profile 800063837] showed significantly high immunogenicity and efficacy as compared to the CVnCoV against SARS-CoV-2 in nonhuman primates (cynomolgus macaques). Overall, CV2CoV showed higher binding and neutralizing antibodies, memory B cell responses, and T cell responses as compared to CVnCoV in cynomolgus macaques. CV2CoV also produced antibodies against SARS-CoV-2 variants, including B.1.351 (beta), B.1.617.2 (delta), and C.37 (lambda). CV2CoV demonstrated significant decrease in viral loads in the upper and lower respiratory tract and provided robust protection compared to the partial protection of CVnCoV [30] .

Preclinical data in non-human primates demonstrated upon challenge infection,coronavirus vaccine (CVnCoV) vaccinated animals showed a reduced viral load in the upper respiratory tract (nose and throat) and full protection of the lower respiratory tract (lungs), where the virus was not detectable. Furthermore, rhesus macaques were shown to be protected from challenge infection with SARS-CoV-2 following vaccination with 8µg of CVnCoV [32]

In transgenic mouse model, administration of the CVnCoV vaccine neutralized the capacity of robust antibody titers, which was impacted by the B.1.351 variant compared to the original strain. However, vaccinated animals were fully protected from lethal challenge infections with both strains. Vaccination resulted in robust antibody responses and complete protection (100% survival) against the original SARS-CoV-2 strain and also B.1.351 challenge infections. CVnCoV vaccination efficiently blocked viral replication of B.1.351 in the lower respiratory tract and brain, and reduced viral replication in the upper respiratory tract in vaccinated and challenged animals [31] .

In preclinical studies, the mice vaccinated with CVnCoV showed a positive induction of multifunctional IFNg + / TFN + CD4 + and CD8 + T cells. Both were detected in convalescent COVID-2019 patients, with CD4 + T cells still being essential for the formation of B memory cells. The mean values ​​of CD4 + and CD8 + T cells were 0.34 percent and 10.5 percent after vaccination on days 0 and 28 and also benefited from longer injection intervals. The administration of a CVnCoV dose of 10 µg to hamsters showed a very good reduction in the viral load in the upper respiratory tract and complete protection of the lungs. The lungs of the vaccinated animals continued to show no signs of increased disease as a result of the challenge virus infection [29] .

Immunogenicity

Summary

Phase I

Immunogenicity data from the phase I trial showed that the coronavirus vaccine demonstrated 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 compared to peak serum titers of 67 symptomatic convalescent COVID-19 patients (human convalescent sera (HCS) showed that at 12µg, GMTs of binding antibodies increased to the level measured in the HCS panel. Virus neutralizing antibodies increased to HCS levels at 12µg as measured in a live-virus micro-neutralization assay. Early analysis data of T cell mediated immunity showed indications of functional T cells confirming activation of cellular immune response. The randomized evaluated the safety and reactogenicity profile after 1 and 2 dose administrations of CVnCoV in healthy volunteers [23] [24] .

Preclinical data in non-human primates demonstrated that coronavirus vaccine (CVnCoV) induced robust humoral and cellular immune responses at lower dose of vaccine than tested in phase III trial. These responses included high levels of spike protein and RBD specific binding, virus neutralizing antibodies and T cells [32]

In preclinical studies in mice and hamsters, CVnCoV triggers a balanced humoral and cellular immune response, which is characterized by high antibody titers and very good T-cell activation and was able to elicit favorable Th1 cytokine levels. CVnCoV showed a dose-dependent activation of the humoral immune system in mice at doses of 0.25, 1 and 4 µg. The induction of strong IgG1- and IgG2a-binding antibody titers were observed in all doses which were converted into neutralizing antibodies with high efficiency. Neutralizing antibodies could still be detected even at the lowest dose and began to develop 3 weeks after the first vaccination. The titers rose sharply after the second vaccination. The influence of different dosage regimens based on two vaccinations, a prime and a boost vaccination, was investigated for 2 µg with 1, 2, 3 or 4 weeks between the first and second vaccination. The data showed the formation of binding IgG1 and IgG2a antibodies 7 days after the first vaccination. The titers increased after the second vaccination and showed better immune responses after longer injection intervals. Binding antibodies were efficiently converted into neutralizing antibodies, which began to develop 4 weeks after the first vaccination and increased significantly after the second vaccination. The efficient formation of neutralizing antibodies corresponded to a favorable IgG2a / IgG1 ratio, which indicates a balanced Th1 / Th2 profile. There was no evidence of a Th2-heavy immune response, suggesting a low likelihood of vaccine-induced disease exacerbation [29] .

Therapeutic Trials

Interim results from the phase IIb/III HERALD trial showed that zorecimeran demonstrated an interim vaccine efficacy of 47% against COVID-19 disease of any severity and did not meet prespecified statistical success criteria. In total, 134 Covid-19 cases were assessed in this interim analysis. Out of these cases, 124 were sequenced to identify the variant causing the infection. The outcome confirms that only one single case was attributable to the original SARS-CoV-2 virus. More than half of the cases (57%) were caused by variants of concern. Most of the remaining cases were caused by other less characterised variants such as Lambda or C.37, first identified in Peru (21%) and B.1.621, first identified in Colombia (7%). In this context, the interim results suggest efficacy in younger participants but did not allow to conclude on efficacy in the age group above 60 [18] .

Future Events

Expected Date Event Type Description Updated
30 Jun 2021 Regulatory Status CureVac announces intention to apply for market authorization in second quarter of 2021 [12] 26 Mar 2021
30 Jun 2021 Trial Update CureVac plans a phase II trial for COVID-2019 infections (Prevention, In elderly) in France in Q2 2021 [15] 28 Apr 2021
14 May 2021 Trial Update CureVac plans a phase III trial for COVID-2019 infections (Prevention) (IM, Injection) in May 2021 (NCT04838847) 03 Sep 2021
30 Apr 2021 Trial Update CureVac in collaboration with Bayer plans the phase III CV-NCOV-011 trial for COVID-2019 infections (Prevention, In adults, In the elderly) in April 2021 in Argentina, Columbia and Peru (IM) (NCT04848467) 17 Aug 2021
30 Jun 2020 Trial Update CureVac plans a phase I/IIa trial for COVID 2019 infections (In volunteers) in June 2020 [33] 10 Jul 2020

Development History

Event Date Update Type Comment
08 Jun 2022 Trial Update CureVac completes a phase III trial in COVID-2019 infections (Prevention, In adults, In elderly) in Germany (Intramuscular, Injection) (NCT04674189) Updated 04 Jul 2022
03 Jun 2022 Trial Update CureVac AG completes a phase-II/III trial in COVID-2019 infections (Prevention) in Belgium, Germany, Mexico, Netherlands, Peru, Argentina, Colombia, Dominican Republic, Panama and Spain (IM) (NCT04652102)(EudraCT 2020-003998-22) Updated 08 Jul 2022
13 May 2022 Trial Update CureVac terminates a phase III trial in COVID-2019 infections (Prevention) in Belgium (IM) (EudraCT2020-004070-22) (NCT04860258) Updated 26 May 2022
21 Feb 2022 Trial Update CureVac and German Federal Ministry of Education and Research completes a Phase II trial in COVID-2019 infections (Prevention) in Panama, Peru (IM) (NCT04515147) Updated 29 Mar 2022
12 Feb 2022 Scientific Update Pharmacodynamics data from a preclinical trial in COVID-2019 infections presented at the 29th Conference on Retroviruses and Opportunistic Infections (CROI-2022) [30] Updated 29 Mar 2022
21 Dec 2021 Trial Update CureVac completes a phase I trial in COVID-2019 infections (Prevention) in Belgium and Germany (IM) (NCT04449276) Updated 20 Jan 2022
16 Aug 2021 Trial Update CureVac withdraws a phase III trial for COVID-2019 infections (Prevention) (IM, Injection) (NCT04838847) Updated 03 Sep 2021
11 Aug 2021 Trial Update CureVac in collaboration with Bayer withdraws the phase III CV-NCOV-011 trial for COVID-2019 infections (Prevention, In adults, In the elderly) (IM) (NCT04848467) Updated 17 Aug 2021
22 Jul 2021 Biomarker Update Biomarkers information updated Updated 02 Oct 2021
16 Jun 2021 Scientific Update Interim efficacy and safety data from a phase IIb/III trial in COVID-19 infections released by CureVac [18] Updated 21 Jun 2021
28 May 2021 Phase Change - II/III Phase-II/III clinical trials in COVID-2019 infections (Prevention) in Argentina (IM) [17] (NCT04652102)(EudraCT 2020-003998-22) Updated 01 Jun 2021
28 May 2021 Phase Change - II/III Phase-II/III clinical trials in COVID-2019 infections (Prevention) in Belgium (IM) [17] (NCT04652102)(EudraCT 2020-003998-22) Updated 01 Jun 2021
28 May 2021 Phase Change - II/III Phase-II/III clinical trials in COVID-2019 infections (Prevention) in Colombia (IM) [17] (NCT04652102)(EudraCT 2020-003998-22) Updated 01 Jun 2021
28 May 2021 Phase Change - II/III Phase-II/III clinical trials in COVID-2019 infections (Prevention) in Dominican Republic (IM) [17] (NCT04652102) (EudraCT 2020-003998-22) Updated 01 Jun 2021
28 May 2021 Phase Change - II/III Phase-II/III clinical trials in COVID-2019 infections (Prevention) in Germany (IM) [17] (NCT04652102)(EudraCT 2020-003998-22) Updated 01 Jun 2021
28 May 2021 Phase Change - II/III Phase-II/III clinical trials in COVID-2019 infections (Prevention) in Netherlands (IM) [17] (NCT04652102) (EudraCT 2020-003998-22) Updated 01 Jun 2021
28 May 2021 Phase Change - II/III Phase-II/III clinical trials in COVID-2019 infections (Prevention) in Panama (IM) [17] (NCT04652102)(EudraCT 2020-003998-22) Updated 01 Jun 2021
28 May 2021 Phase Change - II/III Phase-II/III clinical trials in COVID-2019 infections (Prevention) in Spain (IM) [17] (NCT04652102)(EudraCT 2020-003998-22) Updated 01 Jun 2021
19 Apr 2021 Trial Update CureVac in collaboration with Bayer plans the phase III CV-NCOV-011 trial for COVID-2019 infections (Prevention, In adults, In the elderly) in April 2021 in Argentina, Columbia and Peru (IM) (NCT04848467) Updated 17 Aug 2021
19 Apr 2021 Phase Change - Preregistration Preregistration for COVID-2019 infections (Prevention) in Switzerland (IM) [11] Updated 01 Jun 2021
15 Apr 2021 Trial Update CureVac completes enrolment in thephase IIb/III HERALD trial for COVID-2019 infections (Prevention) in Belgium, Germany, Mexico, Netherlands, Peru and Spain (IM) (NCT04652102) [15] Updated 28 Apr 2021
15 Apr 2021 Trial Update CureVac plans a phase II trial for COVID-2019 infections (Prevention, In elderly) in France in Q2 2021 [15] Updated 28 Apr 2021
12 Apr 2021 Trial Update CureVac initiates a phase III trial in COVID-2019 infections (Prevention) in adults with co-morbidities in Belgium (IM) (EudraCT2020-004070-22) Updated 27 Apr 2021
09 Apr 2021 Trial Update CureVac plans a phase III trial for COVID-2019 infections (Prevention) (IM, Injection) in May 2021 (NCT04838847) Updated 03 Sep 2021
23 Mar 2021 Scientific Update Pharmacodynamics data from preclinical studies in COVID-2019 infections released by CureVac [31] Updated 30 Mar 2021
22 Mar 2021 Regulatory Status CureVac announces intention to apply for market authorization in second quarter of 2021 [12] Updated 26 Mar 2021
28 Feb 2021 Phase Change - Preregistration Preregistration for COVID-2019 infections (Prevention) in European Union (IM) [12] Updated 26 Mar 2021
28 Feb 2021 Regulatory Status CureVacit initiates rolling submission of new drug application to the European Medicines Agency (EMA) for Covid-2019 infections [12] Updated 26 Mar 2021
11 Jan 2021 Scientific Update Immunogenicity and pharmacodynamics data from a preclinical trials in COVID-2019 infections released by CureVac [32] Updated 15 Jan 2021
07 Jan 2021 Licensing Status Bayer and CureVac signed a collaboration agreement for CVnCoV [6] Updated 11 Jan 2021
18 Dec 2020 Phase Change - III Phase-III clinical trials in COVID-2019 infections (Prevention, In adults) in Germany (IM) (NCT04674189) (EudraCT2020-004066-19) Updated 24 Dec 2020
16 Dec 2020 Trial Update CureVac plans a phase III trial in COVID-2019 infections (Prevention, In adults, In elderly) in Germany (Intramuscular, Injection) (NCT04674189) Updated 23 Dec 2020
16 Dec 2020 Phase Change - II/III Phase-II/III clinical trials in COVID-2019 infections (Prevention, In adults) in Germany (IM) (Eudra CT2020-003998-22) Updated 18 Dec 2020
11 Dec 2020 Phase Change - II/III Phase-II/III clinical trials in COVID-2019 infections (Prevention) in Mexico, Peru (IM) (NCT04652102) Updated 28 Apr 2021
11 Dec 2020 Phase Change - II/III Phase-II/III clinical trials in COVID-2019 infections (Prevention, In adults) in Netherlands (IM) (EudraCT2020-003998-22) Updated 01 Jan 2021
03 Dec 2020 Trial Update CureVac plans a phase IIb/III trial for COVID-2019 infections (Prevention) in Germany (IM, Injection) , (NCT04652102) Updated 08 Dec 2020
16 Nov 2020 Regulatory Status CureVac announces intention to launch coronavirus vaccine for COVID-2019 infections Updated 27 Nov 2020
02 Nov 2020 Scientific Update Immunogenicity and adverse events data from a phase-I trials in COVID-2019 infections released by CureVac [23] Updated 09 Nov 2020
23 Oct 2020 Scientific Update Pharmacodynamics and immunogenicity data from preclinical studies in COVID-2019 infections released by CureVac [29] Updated 28 Oct 2020
28 Sep 2020 Phase Change - II Phase-II clinical trials in COVID-2019 infections (Prevention) in Panama, Peru (IM) (NCT04515147) [20] Updated 01 Oct 2020
17 Aug 2020 Trial Update CureVac plans a phase II trial for COVID-2019 infections (Prevention) (IM) (NCT04515147) Updated 19 Aug 2020
10 Aug 2020 Trial Update CureVac plans a phase III trial for COVID-2019 infections [35] Updated 18 Aug 2020
18 Jun 2020 Phase Change - I Phase-I clinical trials in COVID-2019 infections (Prevention) in Belgium (IM) (NCT04449276) Updated 10 Jul 2020
18 Jun 2020 Phase Change - I Phase-I clinical trials in COVID-2019 infections (Prevention) in Germany (IM) (NCT04449276) Updated 10 Jul 2020
17 Jun 2020 Regulatory Status German Health Authority Paul-Ehrlich-Institute and the Belgian Federal Agency for Medicines and Health Products approved a phase I clinical trial for COVID-2019 infection (Prevention) [25] Updated 23 Jun 2020
17 Jun 2020 Trial Update CureVac plans a phase I trial for COVID-2019 infections (Prevention) in Germany and Belgium [25] Updated 23 Jun 2020
14 May 2020 Trial Update CureVac plans a phase I/IIa trial for COVID 2019 infections (In volunteers) in June 2020 [33] Updated 10 Jul 2020
14 May 2020 Phase Change - Preclinical Preclinical trials in COVID-2019 infections (Prevention) in Germany (unspecified route) before May 2020 [33] Updated 20 May 2020
06 Feb 2020 Licensing Status Coronavirus vaccine - CureVac is available for licensing as of 31 Jan 2020. https://www.curevac.com/partnering Updated 06 Feb 2020
31 Jan 2020 Licensing Status CureVac and Coalition for Epidemic Preparedness Innovations (CEPI) entered into a research and development agreement to develop Coronavirus vaccine in Germany for COVID-2019 infections [10] Updated 06 Feb 2020
31 Jan 2020 Phase Change Early research in COVID-2019-infections (Prevention) in Germany (unspecified route) [10] Updated 05 Feb 2020

References

  1. GSK and CureVac announce strategic mRNA technology collaboration.

    Media Release
  2. GSK and CureVac to develop next generation mRNA COVID-19 vaccines.

    Media Release
  3. CureVac and GSK begin clinical development of second-generation COVID-19 vaccine candidate, CV2CoV.

    Media Release
  4. Novartis signs initial agreement to reserve capacity and implement the technology transfer for the production of the active pharmaceutical ingredient for Roche's Actemra/RoActemra(Rm).

    Media Release
  5. CureVac and Rentschler Biopharma ramp up Manufacturing of COVID-19 Vaccine, CVnCoV - joint press release.

    Media Release
  6. CureVac and Bayer collaborate on COVID-19 vaccine candidate CVnCoV - joint press release.

    Media Release
  7. CureVac and Bayer join forces on COVID-19 vaccine candidate CVnCoV.

    Media Release
  8. CureVac and WACKER Sign Manufacturing Contract for CureVac's COVID-19 Vaccine Candidate, CVnCoV - joint press release.

    Media Release
  9. CEPI awards US$ 34M contract to CureVac to advance The RNA Printer(Tm)a disruptive, transportable mRNA vaccine manufacturing platform that can rapidly combat multiple diseases.

    Media Release
  10. CureVac and CEPI extend their Cooperation to Develop a Vaccine against Coronavirus nCoV-2019.

    Media Release
  11. CureVac publishes financial results for the first quarter of 2021 and provides information on its business development.

    Media Release
  12. CureVac Expands CVnCoV COVID-19 Vaccine Candidate Clinical Trial Analyses to Include Phase 2b/3 Variant Specification and Efficacy Secondary Endpoint to Phase 2a.

    Media Release
  13. COVID-19: A Phase 3 Multicenter Clinical Trial to Evaluate the Safety, Reactogenicity and Immunogenicity of the Investigational SARS-CoV-2 mRNA Vaccine CVnCoV in Adults 18 Years of Age and Above With Co-morbidities

    ctiprofile
  14. COVID-19: A Phase 3, Randomized, Observer-Blinded, Placebo-Controlled Clinical Study Evaluating the Safety and Immunogenicity of Investigational SARS-CoV-2 mRNA Vaccine CVnCoV in Adult Health Care Workers in Mainz (Germany)

    ctiprofile
  15. CureVac publishes financial results for the fourth quarter and the full year 2020 and provides information on its business development.

    Media Release
  16. COVID-19: A Phase 2b/3, Randomized, Observer-Blinded, Placebo-Controlled, Multicenter Clinical Study Evaluating the Efficacy and Safety of Investigational SARS-CoV-2 mRNA Vaccine CVnCoV in Adults 18 Years of Age and Older

    ctiprofile
  17. According to the DSMB recommendation, CureVac's first-generation vaccine candidate, CVnCoV, continues to demonstrate efficacy in a variant-based environment in phase 2b / 3.

    Media Release
  18. CureVac Provides Update on Phase 2b/3 Trial of First-Generation COVID-19 Vaccine Candidate, CVnCoV.

    Media Release
  19. CureVac Establishes European-Based Network to Ramp Up Manufacturing of its COVID-19 Vaccine Candidate, CVnCoV.

    Media Release
  20. CureVac Initiates Phase 2a Clinical Trial of COVID-19 Vaccine Candidate.

    Media Release
  21. COVID-19: 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

    ctiprofile
  22. CureVac and European Commission in advanced talks to deliver up to 405 million doses of a potential mRNA-based COVID-19 vaccine.

    Media Release
  23. CureVac Reports Positive Interim Phase 1 Data for its COVID-19 Vaccine Candidate, CVnCoV.

    Media Release
  24. COVID-19: A Phase 1, 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

    ctiprofile
  25. CureVac Receives Regulatory Approval from German and Belgian Authorities to Initiate Phase 1 Clinical Trial of its SARS-CoV-2 Vaccine Candidate.

    Media Release
  26. COVID-19 (CoviCompareCV): A Phase 3, Non-randomized, Open Label Clinical Trial to Evaluate the Immunogenicity and Safety of the Investigational SARS-CoV-2 mRNA Vaccine CVnCoV Administered Intramuscularly in Adults Aged 65 Years or Above Compared to Younger Adults Aged 18-45 Years

    ctiprofile
  27. COVID-19: A Phase 3, Randomized, Observer-blinded, Multicenter Clinical Study Evaluating the Immunogenicity, Safety, and Reactogenicity of the Investigational SARS-CoV-2 mRNA Vaccine CVnCoV, When Co-administered With a Licensed Quadrivalent Influenza Vaccine Versus Separate Administration of the Two Vaccines in Adults 60 Years of Age and Older

    ctiprofile
  28. CureVac's COVID-19 Vaccine Candidate, CVnCoV, Suitable for Standard Fridge Temperature Logistics.

    Media Release
  29. CureVac reports positive preclinical data for its COVID-19 vaccine candidate CVnCoV.

    Media Release
  30. Gebre M, Rauch S, Roth N, Yu J, Chandrashekar A, Mercado NB, et al. OPTIMIZATION OF NONCODING REGIONS IMPROVES mRNA SARS-CoV-2 VACCINE IN NHPs. CROI-2022 2022; abstr. 254.

    Available from: URL: http://www.croiconference.org/
  31. CureVac's COVID-19 Vaccine Candidate, CVnCoV, Demonstrates Protection Against SARS-CoV-2 B.1.351 Variant (South African Variant) in Preclinical Challenge Study.

    Media Release
  32. CureVac's COVID-19 Vaccine Candidate, CVnCoV, Demonstrated Efficient Protection of Non-Human Primates During SARS-CoV-2 Challenge Infection.

    Media Release
  33. CureVac##180##s Optimized mRNA Platform Provides Positive Pre-Clinical Results at Low Dose for Coronavirus Vaccine Candidate.

    Media Release
  34. CureVac is expected to receive up to 252 million euros from the Federal Ministry of Research for further COVID-19 vaccine development and expansion of production capacities.

    Media Release
  35. CureVac Announces Proposed Initial Public Offering of Common Shares.

    Media Release
  36. Germany: EIB and European Commission provide CureVac with a EUR75 million financing for vaccine development and expansion of manufacturing.

    Media Release
  37. CureVac CEO Daniel Menichella Discusses Coronavirus Vaccine Development with U.S. President Donald Trump and Members of Coronavirus Task Force.

    Media Release
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