CureVac Doses First Participant in Phase 1 Study With Multivalent Influenza Vaccine Candidate Based on Second-Generation mRNA Backbone Developed in Collaboration With GSK

CureVac N.V. recently announced it has dosed the first participant in a Phase 1 study of its seasonal influenza second-generation mRNA vaccine candidate, CVSQIV, developed in collaboration with GSK. The differentiated multivalent vaccine candidate features multiple non-chemically modified mRNA constructs to induce immune responses against relevant targets of four different influenza strains. The use of customizable and rapidly produced mRNAs to address influenza could enable faster development and delivery of potentially improved vaccine candidates, featuring even short-term strain updates for the approaching influenza season.

“Providing seasonally updated yet highly effective influenza vaccines has historically been challenging. The successful implementation of mRNA technology to address the global COVID-19 pandemic has demonstrated a tremendous opportunity for this platform,” said Dr. Klaus Edvardsen, Chief Development Officer of CureVac. “Leveraging the inherent flexibility of our mRNA platform together with our fast manufacturing, we have successfully combined multiple different mRNAs in a single candidate with the goal to develop a potentially improved vaccine for seasonal influenza. We believe this represents an important advancement of this key technology.”

The Phase 1 dose-escalation study is being conducted in Panama and is expected to enroll up to 240 healthy adult participants to evaluate the safety, reactogenicity and immunogenicity of CVSQIV. In line with the mRNA development strategy in collaboration with GSK, both companies are also working on chemically modified mRNA technologies with clinical programs for influenza and COVID-19 expected to start later this year.

The CureVac-GSK infectious disease collaboration was first announced in July 2020 and focuses on the development of new products based on CureVac’s mRNA technology for different targets in the field of infectious diseases.

CVSQIV is the first seasonal influenza vaccine candidate in clinical development based on an advanced mRNA backbone developed by CureVac and is one of the second-generation mRNA vaccine candidates from the infectious disease program developed in collaboration with GSK. The differentiated candidate combines multiple separate non-chemically modified mRNAconstructs encoding for antigens that address four different influenza strains. The Phase 1, open-label, dose-escalation study will assess the safety, reactogenicity and immunogenicity of CVSQIV in the dose range of 3 to 28μg in the predefined age groups of 18-55 years and 65 years and above. The study is expected to enroll up to 240 healthy participants and is being conducted in Panama. A clinical study to test the use of chemically modified mRNA is expected to begin later this year.

CureVac is a global biopharmaceutical company in the field of messenger RNA (mRNA) technology, with more than 20 years of expertise in developing and optimizing this versatile biological molecule for medical purposes. The principle of CureVac’s proprietary technology is the use of optimized mRNA as a data carrier to instruct the human body to produce its own proteins capable of fighting a broad range of diseases. In July 2020, CureVac entered in a collaboration with GSK to jointly develop new products in prophylactic vaccines for infectious diseases based on CureVac’s second-generation mRNA technology. This collaboration was later extended to the development of second-generation COVID-19 vaccine candidates, and modified mRNA vaccine technologies. Based on its proprietary technology, CureVac 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 900 people at its sites in Tübingen, Frankfurt, and Boston, MA.