CureVac Announces Promising Phase 2 Interim Data from Seasonal Influenza Vaccine Development Program in Collaboration with GSK
- Positive interim data from ongoing Phase 2 study
- Boosted antibody titers against all encoded flu strains
- Geometric mean titers for influenza A strains exceeded comparator vaccines
- Acceptable safety profile reported
- Plans for further optimizations to enhance immune responses against influenza B strains
- None.
Insights
The interim data from CureVac's ongoing Phase 2 study of its seasonal influenza vaccine candidate presents a mixed bag of results. While the vaccine shows promise in eliciting strong immune responses against influenza A strains, it appears to lag behind licensed comparator vaccines in its effectiveness against influenza B strains. This differentiation is significant as it suggests that the mRNA technology used by CureVac may require further refinement to achieve balanced protection against all prevalent flu strains.
From a medical research perspective, the success of a multivalent vaccine is measured not just by its immunogenicity but also by its ability to provide broad coverage. The fact that the vaccine candidate is multivalent and encodes antigens for all four WHO-recommended flu strains is commendable. However, the lower geometric mean titers for influenza B strains indicate a potential area for improvement. The planned optimizations for the upcoming Phase 2 study will be critical in determining the vaccine's future potential.
The acceptable safety profile is encouraging, as it suggests that the vaccine could have a favorable risk-benefit ratio if it proves to be effective. The use of the second-generation mRNA backbone could be a key factor in the vaccine's safety and tolerability, which are important for public acceptance and widespread use.
In the context of the pharmaceutical market, the development of a new seasonal flu vaccine by CureVac, particularly one based on mRNA technology, has the potential to disrupt the current market. The ability to rapidly match WHO-recommended flu strains could provide CureVac with a competitive edge, assuming the vaccine reaches commercialization with satisfactory efficacy.
However, the market response to these interim results will likely be tempered by the mixed efficacy profile. Investors and stakeholders will be closely monitoring the upcoming optimizations and subsequent Phase 2 study results. The success in improving immune responses against influenza B strains could significantly influence the market potential of the vaccine. Market acceptance is predicated not only on safety but also on efficacy that is at least on par with existing vaccines.
Furthermore, the vaccine's performance in both younger and older adults is a key consideration since these demographics are critical target markets for flu vaccines. The ability to elicit higher geometric mean titers in younger adults compared to licensed vaccines is a positive indicator, but the overall market viability will depend on consistent results across all age groups.
With the release of Phase 2 interim data, investors will be scrutinizing the financial implications for CureVac. The company's stock performance on Nasdaq (CVAC) may experience volatility as the market digests the potential of the vaccine candidate. If the subsequent optimizations prove successful and the vaccine demonstrates improved efficacy against influenza B strains, there could be a positive impact on CureVac's market valuation.
It is important to note that the development of vaccines is a capital-intensive process with significant financial risk. The investment in R&D and subsequent clinical trials represents a substantial financial commitment from CureVac and its collaborators. The eventual return on investment hinges on the vaccine's ability to secure regulatory approval and achieve market penetration.
Long-term financial prospects for CureVac also depend on the scalability of their mRNA platform and the ability to adapt quickly to changes in flu virus strains. The strategic collaboration with GSK could provide additional financial and operational support, which might be necessary to navigate the competitive landscape and regulatory hurdles ahead.
- Seasonal flu vaccine candidate boosted antibody titers at all dose levels and for all encoded seasonal influenza strains across younger and older adults
- Potentially differentiated, multivalent candidate encodes antigens matched to all four WHO-recommended flu strains
- For influenza A strains, geometric mean titers numerically exceeded those elicited by the licensed comparator vaccines consistently across all tested dose levels and age groups
- For influenza B strains, geometric mean titers were lower than those elicited by the licensed comparator vaccines, in line with expectations and other initial mRNA-based clinical flu development programs
- Further optimizations to enhance immune responses against influenza B strains will be tested in additional Phase 2 study
- Candidate showed acceptable safety profile, confirming previous findings that the proprietary platform elicits strong overall antibody titers at well-tolerated dose levels
TÜBINGEN, GERMANY and BOSTON, MA / ACCESSWIRE / April 4, 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 interim data from an ongoing Phase 2 part of the combined Phase 1/2 study of its seasonal influenza vaccine candidate, conducted in collaboration with GSK. The multivalent candidate was selected from a comprehensive Phase 1 part, which tested vaccine candidates with up to eight separate mRNA constructs per candidate. It was designed for broad antigen coverage, encoding antigens matched to all four WHO-recommended flu strains.
Results from the planned interim analysis showed that the multivalent vaccine candidate using CureVac's proprietary second-generation mRNA backbone boosted antibody titers against all encoded flu strains and across all age groups and tested dose levels, including the lowest tested dose. The vaccine candidate was shown to have an acceptable safety and tolerability profile, with the majority of solicited adverse events reported as either grade 1 (mild) or grade 2 (moderate) within seven days of dosing. The results confirm previous findings that the platform elicits strong overall antibody titers at well-tolerated dose levels.
Among younger and older adults, geometric mean titers generated by the vaccine candidate against influenza A strains numerically exceeded the geometric mean titers of the licensed comparator vaccines consistently across all tested dose levels. For influenza B strains geometric mean titers were lower than those elicited by the licensed comparator vaccines across both age groups and tested dose levels. Targeted optimizations to further improve immune responses against influenza B strains will be tested in an additional Phase 2 study.
"The Phase 2 interim data show that CureVac's highly effective and flexible mRNA technology platform puts us on the right track to advance our joint seasonal influenza vaccine program," said Dr. Myriam Mendila, Chief Development Officer of CureVac. "Results regarding influenza A strains were strong. Immunogenicity for B strains was in line with our expectations also in view of other initial mRNA-based clinical flu development programs. We are confident that planned optimizations will improve performance against these historically challenging influenza strains."
The Phase 2 dose-confirmation study assesses the reactogenicity, safety, and immunogenicity of different dose levels of a modified, multivalent vaccine candidate, encoding antigens matched to all four WHO-recommended flu strains. Reactogenicity, safety, and immunogenicity were assessed in 480 healthy younger adults aged 18 to 64 and 480 healthy older adults aged 65 to 85. In each age group, three different dose levels were tested in comparison to an age-appropriate, licensed comparator vaccine. For younger adults, immune responses were compared to a standard dose seasonal vaccine. For older adults, immune responses were compared to a high dose seasonal flu 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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FAQ
What company announced the interim data from the Phase 2 study of a seasonal flu vaccine candidate?
What were the results of the interim analysis regarding the antibody titers of the vaccine candidate?
Did the geometric mean titers for influenza A strains exceed those of the licensed comparator vaccines?
Were the geometric mean titers for influenza B strains higher or lower than those of the licensed comparator vaccines?
What plans are in place to enhance immune responses against influenza B strains?
