CureVac Reports Positive Interim Phase 1 Data for its COVID-19 Vaccine Candidate CVnCoV
TÜBINGEN, Germany / BOSTON, USA - November 2, 2020 -- CureVac NV (Nasdaq: CVAC), a biopharmaceutical company developing a new class of drugs based on messenger ribonucleic acid (mRNA) in clinical trials, announced today positive interim data from its ongoing Phase 1 dose escalation study. This study investigated the safety, reactogenicity, and immunogenicity of the SARS-CoV-2 vaccine candidate CVnCoV. The vaccine candidate showed a generally good tolerance in all tested dose strengths between 2 and 12 µg. In addition, it induced strong binding and neutralizing antibody reactions in addition to the first signs of T-cell activation. In the coming weeks, CureVac will prepare a detailed overview of the Phase 1 data and publish it in a scientific publication.
“The interim phase 1 dates are very encouraging. They represent a decisive milestone in our COVID-19 vaccine program and emphatically support the further development of our vaccine candidate, "explains Dr. Franz-Werner Haas, CEO of CureVac. "After a further selection of the data and discussions with the approval authorities, we feel that our development program has been confirmed and we are sticking to the start of the approval-relevant phase 2b / 3 study before the end of 2020."
More than 250 healthy volunteers between the ages of 18 and 60 took part in the phase 1 clinical study. Various study participants were vaccinated intramuscularly with CVnCoV in escalating dose strengths of 2, 4, 6, 8 and 12 µg on day 1 and day 29. Up to ten people who had tested positive for COVID-19 (seropositive) took part per dose strength in order to evaluate the safety and immunogenicity of CVnCoV for this cohort as well.
The data support the decision to conduct the upcoming approval-relevant phase 2b / 3 study with a dose of 12 µg.
The immunogenicity data showed a dose-dependent increase in the binding antibodies, which also resulted in an increase in virus-neutralizing antibody titers at all dose levels tested. The geometric mean titers (Geometric Mean Titers, GMT) of the binding and neutralizing antibodies were compared with the peak serum titers of 67 symptomatic Covid-19 patients and recovered (Human Convalescent Sera, or HCS). This HCS panel was compiled as a medically relevant benchmark for validating the effectiveness of CVnCoV. The panel was representative of immune activation in critically ill patients with multiple symptoms, approximately 24 percent of whom were hospitalized.
At a dose of 12 µg, the GMT of the binding antibodies increased to the level measured in the HCS panel. Virus-neutralizing antibodies also increased to HCS levels at 12 µg and were measured using a live virus micro-neutralization test. Analysis of T cell-generated immunity continues. Initial data show evidence of functional T cells that confirm activation of the cellular immune response.
“These initial data show a robust and highly efficient immune response to our natural mRNA-based CVnCoV vaccine candidates. It includes antibody and initial T cell responses at the level of a relevant panel of symptomatically convalescent patients, ”said Dr. Mariola Fotin-Mleczek, Chief Technology Officer of CureVac. "We are grateful to all study participants who have helped to enable the development of a vaccine that offers people the best possible protection."
CVnCoV's unique mechanism of action mimics the natural immune response to the infection seen in recovered COVID-19 patients. This is reflected in the relative ratio of neutralizing to binding antibody levels, which are similar in vaccinated individuals and convalescent patients.
The reactogenicity of CVnCoV was continuously monitored by a data and safety monitoring board. The vaccine candidate showed generally good tolerability at all tested doses. No serious side effects were observed. At 12 µg, grade 3 adverse events occurred primarily after administration of the second dose and included fatigue, headache, chills, muscle pain and, to a lesser extent, fever. All events reported were transient and resolved quickly, usually within 24 to 48 hours.
The formulation of CVnCoV is based on lipid nanoparticle technology (LNP) licensed from Acuitas Therapeutics, a longstanding partner of CureVac.
CureVac began developing its mRNA-based vaccine candidate COVID-19 in January 2020. The active ingredient is based on optimized, chemically unmodified mRNA that codes for the prefusion-stabilized full spike protein of the SARS-CoV-2 virus. In June 2020, the company started a clinical phase 1 study with CVnCoV in clinical study centers in Germany and Belgium in collaboration with the Coalition for Epidemic Preparedness Innovations (CEPI). At the end of September 2020, the vaccine candidate started a phase 2a clinical trial in Peru and Panama, in which clinical investigations were extended to older adults and regions with a high incidence of COVID-19 infections. The company plans to initiate a pivotal phase 2b / 3 clinical trial by the end of 2020. The material for the clinical studies is provided thanks to the company's extensive production capacities for mRNA vaccines at its headquarters in Tübingen. CureVac is currently expanding this manufacturing capacity to prepare the large-scale manufacture of CVnCoV for possible commercial delivery.
CureVac is a global biopharmaceutical company in the field of mRNA technology (messenger RNA) with more than 20 years of experience in the development and optimization of this versatile biological molecule for medical purposes. The principle of CureVac's proprietary technology is based on the use of chemically unmodified mRNA as a data carrier to guide the human body to produce the correspondingly encoded proteins with which a variety of diseases can be combated. Based on its proprietary technology, the company has built an extensive clinical pipeline in the areas of prophylactic vaccines, cancer therapies, antibody therapies and the treatment of rare diseases. CureVac has been listed on the New York Nasdaq since August 2020. The company is headquartered in Tübingen, Germany, and employs around 500 people in Tübingen, Frankfurt and Boston, USA. For more information, seewww.curevac.com .
Posted: November 2020
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