CureVac intends to expand its COVID-19 vaccine candidate clinical trial in order to be able to determine efficacy for select variants.
International biopharmaceutical firm CureVac, developing a new class of transformative therapies based on messenger ribonucleic acid (mRNA), announced on Monday it intends to expand and further specify the protocols of its ongoing late-stage clinical trials with its CVnCoV COVID-19 vaccine candidate.
Determining CureVac’s vaccine candidate efficacy for select COVID-19 variants
At present, CVnCoV efficacy is being evaluated in the pivotal HERALD Phase 2b/3 trial conducted in Europe and Latin America. Rapid distribution of new virus variants in the countries where the study is conducted underpins the need for further analysis specification for the anticipated case-driven interim analysis. This enables the determining CureVac’s vaccine candidate efficacy for select variants. The company has ongoing discussions with the European Medicines Agency (EMA) to potentially include an amendment related to select virus strains in the study.
For its Phase 2a dose-confirmation trial in older adults in Peru and Panama, CureVac has filed a protocol amendment to include a secondary objective for vaccine efficacy. The study initially intended to evaluate the safety, reactogenicity and immunogenicity of CVnCoV in adults. An expanded trial analysis is expected to allow for the collection of relevant efficacy data which includes the key group of approximately 270 participants above the age of 60, treated with 12µg of CVnCoV.
Ulrike Gnad-Vogt, Interim Chief Development Officer of CureVac commented:
“Our goal is to offer the public and especially the vulnerable older age groups the best possible protection against the virus and its variants with our vaccine candidate. The additional efficacy analysis in Phase 2a is intended to leverage the data we can collect from older adults, and will represent important complementary data to the statistically relevant efficacy data from our HERALD trial. At the same time we need to make sure that our efficacy data are meaningful in view of the emergence of new virus variants. We are therefore aiming to specify what type of virus we are dealing with in the HERALD trial.”
CureVac anticipates data readouts from both clinical trials in the second quarter of this year. It also reaffirms its intention to file for formal marketing authorization within the second quarter 2021.
About the CVnCoV COVID-19 vaccine candidate
CureVac started the development of its mRNA-based COVID-19 vaccine candidates in January 2020. The first vaccine candidate selected for 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 commenced 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 the 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 the HERALD study, a pivotal Phase 2b/3, with a 12µg dose of CVnCoV. In February 2021 CureVac initiated a rolling submission with the European Medicines Agency (EMA) for CVnCoV.
Notably, CureVac has entered into several important strategic partnerships for the further development, manufacturing and commercialization of the CVnCoV COVID-19 vaccine. The biopharmaceutical company signed a collaboration agreement with German pharmaceutical giant Bayer in January 2021 relating to CVnCoV production. In February 2021 CureVac and the British pharmaceutical company GlaxoSmithKline (GSK) agreed to jointly develop next-generation multi-valent mRNA vaccines against COVID-19.
The development of novel vaccine candidates is further boosted by a partnership with the United Kingdom Government and its Vaccines Taskforce, which CureVac also entered in February 2021. GSK may potentially also contribute to this collaboration.
Clinical trial and commercial material are provided by CureVac’s substantial production capacities for mRNA vaccines at its headquarters in Tübingen, Germany, strengthened by the current expansion of manufacturing capacities in Europe, allowing broad-scale manufacturing of CVnCoV for potential commercial supply preparedness.
About the Phase 2a Clinical Trial
In September 2020, CureVac launched its Phase 2a Clinical Trial with CVnCoV. The dose-confirmation study has been conducted in Peru and Panama and enrolled a total of 670 participants in two distinct groups: older adults ages 61 and above, and younger participants 18 to 60 years old. The study participants received two vaccinations at intervals of 28 days with the aim to evaluate the safety, reactogenicity and immunogenicity in healthy adults.
CureVac is a global biopharmaceutical company focusing on messenger RNA (mRNA) technology, with more than two decades 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 patented 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 600 people at its sites in Tübingen, Frankfurt, and Boston, USA.
Further information can be found at www.curevac.com.
Source: CureVac Press Release https://www.curevac.com/en/2021/03/22/curevac-expands-cvncov-covid-19-vaccine-candidate-clinical-trial-analyses-to-include-phase-2b-3-variant-specification-and-efficacy-secondary-endpoint-to-phase-2a/