CureVac Partner GSK Announces Positive Phase 2 Data from Seasonal Influenza mRNA Vaccine Program
CureVac N.V. (Nasdaq: CVAC) announced that its partner GSK reported positive Phase 2 data from their seasonal influenza mRNA vaccine program. The vaccine candidate, based on CureVac's second-generation mRNA backbone, demonstrated positive immune responses against influenza A and B strains compared to current standards, meeting all predefined success criteria in both older and younger adult groups. The data suggests an acceptable safety and reactogenicity profile.
GSK confirmed that the data supports advancing the program to Phase 3, which would trigger a significant milestone payment for CureVac. This development follows the July 2024 agreement where GSK assumed full control of the influenza vaccine program. The Phase 2 study involved 500 participants across two age groups, testing different dose levels against licensed comparator vaccines.
CureVac N.V. (Nasdaq: CVAC) ha annunciato che il suo partner GSK ha riportato dati positivi della Fase 2 dal loro programma di vaccino mRNA per l'influenza stagionale. Il candidato vaccinale, basato sul backbone mRNA di seconda generazione di CureVac, ha mostrato risposte immunitarie positive contro i ceppi di influenza A e B rispetto agli standard attuali, soddisfacendo tutti i criteri di successo predefiniti sia nei gruppi di adulti più giovani che in quelli più anziani. I dati suggeriscono un profilo di sicurezza e reattogenicità accettabile.
GSK ha confermato che i dati supportano l'avanzamento del programma alla Fase 3, il che comporterebbe un pagamento significativo di milestone per CureVac. Questo sviluppo segue l'accordo di luglio 2024, in cui GSK ha assunto il pieno controllo del programma del vaccino per l'influenza. Lo studio di Fase 2 ha coinvolto 500 partecipanti suddivisi in due gruppi di età, testando diversi livelli di dosaggio contro vaccini comparatori autorizzati.
CureVac N.V. (Nasdaq: CVAC) anunció que su socio GSK informó datos positivos de la Fase 2 de su programa de vacunas mRNA contra la influenza estacional. El candidato a la vacuna, basado en la plataforma de mRNA de segunda generación de CureVac, demostró respuestas inmunitarias positivas contra los virus de influenza A y B en comparación con los estándares actuales, cumpliendo todos los criterios de éxito predefinidos en grupos de adultos tanto jóvenes como mayores. Los datos sugieren un perfil de seguridad y reactivación aceptable.
GSK confirmó que los datos respaldan el avance del programa a la Fase 3, lo que desencadenaría un pago significativo por hitos para CureVac. Este desarrollo sigue al acuerdo de julio de 2024, donde GSK asumió el control total del programa de la vacuna contra la influenza. El estudio de la Fase 2 involucró a 500 participantes en dos grupos de edad, probando diferentes niveles de dosis contra vacunas comparadoras autorizadas.
CureVac N.V. (Nasdaq: CVAC)는 파트너 GSK가 계절성 독감 mRNA 백신 프로그램의 2상 긍정적 데이터를 보고했다고 발표했습니다. CureVac의 2세대 mRNA 백본을 기반으로 한 백신 후보는 현재 기준에 비해 인플루엔자 A 및 B 균주에 대해 긍정적인 면역 반응을 나타내었으며, 모든 사전 정의된 성공 기준을 충족했습니다. 이 데이터는 수용 가능한 안전성과 반응성 프로필을 제안합니다.
GSK는 이 데이터가 프로그램을 3상으로 발전시키는 것을 지원한다고 확인했으며, 이는 CureVac에게 중요한 마일스톤 지급을 촉발할 것입니다. 이 개발은 GSK가 독감 백신 프로그램의 전체 제어권을 인수한 2024년 7월의 계약 이후 이루어졌습니다. 2상 연구에는 두 개의 연령 그룹에서 500명의 참가자가 포함되어 있으며, 허가된 비교 백신에 대해 다양한 용량 수준을 테스트했습니다.
CureVac N.V. (Nasdaq: CVAC) a annoncé que son partenaire GSK avait rapporté des données positives de la Phase 2 de son programme de vaccin mRNA contre la grippe saisonnière. Le candidat vaccin, basé sur le backbone mRNA de deuxième génération de CureVac, a montré des réponses immunitaires positives contre les souches de grippe A et B par rapport aux normes actuelles, satisfaisant à tous les critères de succès prédéfinis tant chez les adultes plus jeunes que plus âgés. Les données suggèrent un profil de sécurité et de réactogénicité acceptable.
GSK a confirmé que les données soutiennent l'avancement du programme à la Phase 3, ce qui déclencherait un paiement de jalon significatif pour CureVac. Ce développement fait suite à l'accord de juillet 2024 où GSK a pris le contrôle total du programme de vaccin contre la grippe. L'étude de Phase 2 a impliqué 500 participants répartis sur deux groupes d'âge, testant différents niveaux de doses par rapport à des vaccins comparateurs autorisés.
CureVac N.V. (Nasdaq: CVAC) gab bekannt, dass ihr Partner GSK positive Phase-2-Daten aus ihrem saisonalen Influenza-mRNA-Impfstoffprogramm gemeldet hat. Der Impfstoffkandidat, basierend auf CureVacs mRNA-Rückgrat der zweiten Generation, zeigte positive Immunantworten gegen die Influenza-A- und B-Stämme im Vergleich zu den aktuellen Standards und erfüllte alle zuvor festgelegten Erfolgskriterien in Gruppen von älteren und jüngeren Erwachsenen. Die Daten deuten auf ein akzeptables Sicherheits- und Reaktogenitätsprofil hin.
GSK bestätigte, dass die Daten die Weiterführung des Programms in die Phase 3 unterstützen, was eine signifikante Meilensteinzahlung für CureVac auslösen würde. Diese Entwicklung folgt auf die Vereinbarung im Juli 2024, bei der GSK die vollständige Kontrolle über das Influenza-Impfstoffprogramm übernommen hat. Die Phase-2-Studie umfasste 500 Teilnehmer in zwei Altersgruppen und testete verschiedene Dosen gegen zugelassene Vergleichsimpfstoffe.
- Positive Phase 2 data meeting all predefined success criteria
- Acceptable safety and reactogenicity profile observed
- Potential advancement to Phase 3, triggering significant milestone payment for CureVac
- Positive immune responses against both influenza A and B strains
- Successful application of CureVac's second-generation mRNA technology
- None.
Insights
The Phase 2 data for GSK's seasonal influenza mRNA vaccine, based on CureVac's technology, shows promising results. The vaccine demonstrated positive immune responses against both influenza A and B strains, which is particularly noteworthy for the B strain. The acceptable safety profile and meeting of all pre-defined endpoints are encouraging signs for the vaccine's potential.
The success of this candidate, utilizing CureVac's second-generation mRNA backbone, further validates the platform's capability in developing effective vaccines. The potential advancement to Phase 3 trials signifies confidence in the vaccine's performance and could accelerate its path to market. This progress could position GSK and CureVac as strong competitors in the evolving mRNA vaccine landscape, potentially challenging established flu vaccine manufacturers.
This news is financially positive for CureVac. The successful Phase 2 results pave the way for a significant milestone payment if the program advances to Phase 3. Moreover, GSK's full control of development, manufacturing and commercialization, as per the July 2024 agreement, could lead to substantial royalties for CureVac if the vaccine reaches the market.
Investors should note that while this progress is promising, it's still a mid-stage development. The
The seasonal influenza vaccine market is highly competitive and valuable, with annual global sales exceeding
The positive results against influenza B strains are particularly noteworthy, as this has been a challenge for existing vaccines. If these results translate to Phase 3 and eventual approval, it could give GSK a significant edge in the market. However, competitors like Moderna and Pfizer are also developing mRNA flu vaccines, so the race to market will be crucial. The success of this program could also boost confidence in mRNA technology for other vaccine applications, potentially expanding the total addressable market for companies like CureVac.
Phase 2 data demonstrated positive immune responses to A and B strains, with acceptable safety and reactogenicity profile, meeting all pre-defined study endpoints
Vaccine candidate based on CureVac's proprietary second-generation mRNA backbone
GSK confirmed data support advancing program to Phase 3; dosing of first Phase 3 participant is associated with a significant milestone payment for CureVac
In July 2024, GSK assumed full control for the development, manufacturing and commercialization of influenza vaccines through new licensing agreement
TÜBINGEN, GERMANY and BOSTON, MA / ACCESSWIRE / September 12, 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 that GSK has reported positive Phase 2 headline data from the seasonal influenza mRNA vaccine program. The program was fully licensed to GSK under the terms of a licensing agreement announced on July 3, 2024.
According to GSK, the data demonstrated positive immune responses against influenza A and B strains compared to the current standard of care, meeting all predefined success criteria in the tested age groups of older and younger adults. The interim data further suggests the tested vaccine candidate has an acceptable safety and reactogenicity profile. The vaccine candidate is based on CureVac's second-generation mRNA backbone.
"The positive Phase 2 results once again highlight the immense potential of our second-generation mRNA backbone to develop best in class vaccines against influenza and other infectious diseases," said Dr. Myriam Mendila, Chief Scientific Officer of CureVac. "We are strongly encouraged by a positive response against influenza A strains but particularly excited about adequate immune responses against influenza B. We look forward to seeing advanced data from the study and potential transition of the program to Phase 3, which would be associated with a significant milestone payment for CureVac."
The Phase 2 study was initiated following interim data reported on April 4, 2024, from the Phase 2 part of the ongoing combined Phase 1/2 study in seasonal influenza. It 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 includes 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 pioneering multinational biotech company founded in 2000 to advance the field of messenger RNA (mRNA) technology for application in human medicine. In more than two decades of developing, optimizing, and manufacturing this versatile biological molecule for medical purposes, CureVac has introduced and refined key underlying technologies that were essential to the production of mRNA vaccines against COVID-19, and is currently laying the groundwork for application of mRNA in new therapeutic areas of major unmet need. CureVac is leveraging mRNA technology, combined with advanced omics and computational tools, to design and develop off-the-shelf and personalized cancer vaccine product candidates. It also develops programs in prophylactic vaccines and in treatments that enable the human body to produce its own therapeutic proteins. Headquartered in Tübingen, Germany, CureVac also operates sites in the Netherlands, Belgium, Switzerland, and the U.S. Further information can be found at www.curevac.com.
CureVac Media and 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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