CureVac Announces Dosing of First Participant in a Phase 2 Study in Seasonal Influenza; Development in Collaboration with GSK
CureVac has commenced dosing of the first participant in a Phase 2 study for its multivalent seasonal influenza vaccine candidate, developed in collaboration with GSK. This follows interim data from a Phase 2 part of a combined Phase 1/2 study, which showed the vaccine candidate elicited stronger immune responses against influenza A strains but weaker responses against influenza B strains compared to licensed vaccines. The Phase 2 study's design has been updated to match the three flu strains recommended by the WHO, excluding the B/Yamagata lineage. The study will evaluate the safety, reactogenicity, and immunogenicity of the vaccine in 500 healthy adults, split between younger (18-64) and older (65-85) participants.
- Initiation of Phase 2 study indicates progress in CureVac's vaccine development.
- Collaboration with GSK adds credibility and resources to the project.
- Positive interim data showed strong immune responses against influenza A strains.
- Updated vaccine candidate aligns with WHO's latest recommendations.
- Phase 2 study will test the reactogenicity, safety, and immunogenicity in a diverse age group of 500 healthy participants.
- Interim data indicated weaker immune responses against influenza B strains compared to licensed vaccines.
- Exclusion of B/Yamagata lineage may limit the coverage of the vaccine.
- The need for an updated formulation suggests prior versions were insufficient.
Insights
The initiation of the Phase 2 study for CureVac's seasonal influenza vaccine candidate signifies an essential step in its development pipeline, particularly within the broader effort to combat influenza B strains, which have historically been challenging to target effectively. Notably, the vaccine's reformulation to match the WHO-recommended flu strains—two influenza A strains and one B strain—addresses the recent exclusion of the B/Yamagata lineage.
Given the promising interim data from the Phase 2 part of the combined Phase 1/2 study, demonstrating strong antibody responses against influenza A strains, the current study's focus on improving the immune response to influenza B is critical. Medical researchers will closely monitor the vaccine's reactogenicity (the tendency for a vaccine to produce adverse reactions), safety and immunogenicity (the ability to provoke an immune response).
This initiative is particularly relevant as mRNA technology platforms, such as those used by CureVac, have shown significant potential in developing vaccines with robust and adaptive immunogenic profiles. The study's structure, involving 500 participants across different age groups and dose levels, will provide a comprehensive data set to assess the modified vaccine's efficacy in a diverse population.
For retail investors, it's important to understand that while the initiation of a Phase 2 study is a positive indicator of progress, it still represents an intermediary step in the lengthy and rigorous vaccine development process. The outcomes of this study will significantly influence the future value and commercial viability of CureVac’s mRNA-based flu vaccine candidates.
From a market perspective, the collaboration between CureVac and GSK in developing this multivalent seasonal influenza vaccine candidate signals a strategic alliance aimed at leveraging both companies' strengths. CureVac's mRNA platform combined with GSK's extensive experience in vaccine development and distribution could potentially yield a competitive advantage in the flu vaccine market.
The positive interim results from earlier studies are encouraging, particularly concerning the strong performance against influenza A strains. However, the vaccine's relatively lower efficacy against influenza B strains, compared to licensed competitors, underscores the necessity of the current Phase 2 study's targeted optimizations.
For investors, the collaboration reflects a calculated risk-reward scenario. On one hand, successful development and subsequent regulatory approval of this vaccine could position CureVac and GSK favorably within the seasonal flu vaccine market, which is valued significantly. On the other hand, any setbacks in the Phase 2 study could delay progress and impact investor confidence.
Investors should also consider the broader context: the competitive landscape, where several established companies dominate and the potential for CureVac's mRNA platform to innovate within this space. Monitoring updates from this study will be critical to gauging future market performance and investment potential.
- Phase 2 study to assess updated formulations for improved immune responses of multivalent vaccine candidate against influenza B strain
- Study initiated following previously reported interim data from Phase 2 Part of combined Phase 1/2 study in seasonal influenza
- Composition of vaccine candidate changed to match all three WHO-recommended flu strains, following recommendation to exclude B/Yamagata lineage
TÜBINGEN, GERMANY AND BOSTON, MA / ACCESSWIRE / May 28, 2024 / CureVac N.V. (Nasdaq:CVAC) ("CureVac"), a global biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid ("mRNA"), today announced dosing of the first participant in a Phase 2 study of the multivalent seasonal influenza vaccine candidate developed in collaboration with GSK. The study will assess targeted optimizations for improved immune responses of the vaccine candidate against the relevant influenza B strain.
This new Phase 2 study in the joint CureVac/GSK seasonal influenza program has been initiated following interim data from the Phase 2 part of the ongoing combined Phase 1/2 study in seasonal influenza reported on April 4, 2024 . The reported data showed that among younger and older adults, serum hemagglutinin inhibition (HAI) geometric mean titers elicited by the vaccine candidate against influenza A strains numerically exceeded those of the applied licensed comparator vaccines consistently across all tested dose levels. For influenza B strains, serum HAI geometric mean titers were lower than those elicited by the licensed comparator vaccines across tested age groups and dose levels.
For the now initiated Phase 2 study, the design of the multivalent vaccine candidate has been changed to address all three World Health Organization (WHO)-recommended influenza strains, following its recommendation from February 2024 to exclude the influenza B/Yamagata lineage and apply a trivalent vaccine format going forward. The three remaining influenza strains include two influenza A strains and one influenza B strain.
"The previously reported positive interim data of the Phase 2 part of the combined Phase 1/2 study in seasonal influenza confirmed that our technology platform elicits strong overall antibody titers at well-tolerated dose levels, underscoring the potential of our second-generation mRNA backbone in our collaborative seasonal influenza vaccine program," said Dr. Myriam Mendila, Chief Scientific Officer of CureVac. "Historically, it's been challenging to target influenza B strains with a potent vaccine strategy. We are making progress in adapting and optimizing our clinical approach to address this challenge and improve performance against the remaining B strain."
The Phase 2 study assesses the reactogenicity, safety, and immunogenicity of different dose levels of a modified, multivalent vaccine candidate, encoding antigens matched to all three WHO-recommended flu strains. The study will include 250 healthy younger adults aged 18 to 64 and 250 healthy older adults aged 65 to 85. In each age group, different dose levels will be tested in comparison to an age-appropriate, licensed comparator vaccine.
About CureVac
CureVac (Nasdaq: CVAC) is a global biopharmaceutical company in the field of messenger RNA (mRNA) technology, with more than 20 years of expertise in developing, optimizing, and manufacturing 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 N.V. has its headquarters in Tübingen, Germany, and has more than 1,100 employees across its sites in Germany, the Netherlands, Belgium, Switzerland, and the U.S. Further information can be found at www.curevac.com.
CureVac Media Contact
Patrick Perez, Junior Manager Public Relations
CureVac, Tübingen, Germany
T: +49 7071 9883-1831
patrick.perez@curevac.com
CureVac Investor Relations Contact
Dr. Sarah Fakih, Vice President Corporate Communications and Investor Relations
CureVac, Tübingen, Germany
T: +49 7071 9883-1298
M: +49 160 90 496949
sarah.fakih@curevac.com
Forward-Looking Statements CureVac
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SOURCE: CureVac
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FAQ
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