MNC Invests Over $15 Billion in mRNA Influenza Vaccines as the Next Hotspot Emerges
GSK
Pharmaceutical R&D Manufacturer
CureVac
mRNA Drug Developer
July 5, 2024
eMedClub News
Recently,GSKAndCureVacReformulatedmRNAVaccine Cooperation License Agreement,GSKWill have the development, production, and commercialization of influenza andCOVID-19All rights to the candidate vaccine (including combination vaccines)，CureVacRetain the rights to undisclosed projects from previous collaborations that have been preclinically validated and target infectious diseases, with the right to independently or collaboratively develop treatments for any other infectious diseases or indications.mRNAThe right to vaccines. Meanwhile,CureVacWill Obtain4EUR billion as an upfront payment, and up to10.5€1.6 billion in milestones and royalties (equivalent to RMB 11.39 billion)。
It is reported that GSK and CureVac reached a cooperation agreement in July 2020 to research, develop, manufacture, and commercialize up to five mRNA vaccines and monoclonal antibodies targeting infectious diseases. This collaboration will transfer full rights to multiple vaccines, including a seasonal flu vaccine in Phase 2 clinical trials and an avian flu vaccine in Phase 1 clinical trials, to GSK. This move will further optimize GSK’s strategic positioning in the mRNA field and consolidate its leading position in the global infectious disease vaccine market.
At the same time, CureVac also underwent a significant strategic adjustment,Aimed at focusing resources on high-value mRNA pipeline opportunities, planning to cut 30% of its workforce, reduce operating costs by more than 30% starting next year, and refocus on early-stage research and development. As CureVac CEO Alexander Zehnder stated, "bringing CureVac back to its roots in the research, development, and innovation of mRNA vaccines."
Flu Vaccine Could Be the Next Breakthrough for mRNA
eMedClub
mRNA has always been a technology with promising prospects, and it has already demonstrated exciting potential in the fight against COVID-19. In May this year, Moderna's RSV mRNA vaccine mRNA-1345 was approved by the FDA for market launch to prevent RSV-associated lower respiratory tract disease (RSV-LRTD) and acute respiratory disease (ARD) in adults aged 60 years or older. This is the world’s first RSV mRNA vaccine and also the only “pre-filled syringe” vaccine available on the market. The approval of mRNA-1345 also signifies that mRNA vaccines have successfully navigated the path to becoming a viable drug and reaching the market beyond the context of COVID-19.In China, Afana Bio, Jiachen Xihai, Sirnaomics, and Shenzhen Biotechnology,CSPC Group, and others like StarRidge Medicine have also made arrangementsRSV mRNAVaccine. Undoubtedly,RSV mRNAVaccine ismRNAOne of the hot topics in vaccines.
Moreover, on July 2, Moderna announced that it had received up to$176 millionThe funding support aims toAccelerate the late-stage clinical trial development of its pandemic candidate vaccine mRNA-1018 targeting H5/H7 avian influenza strains.This funding not only supports Moderna in advancing its vaccine development process but also covers preparations and rapid response measures for future public health threats.
According to a report by the U.S. Centers for Disease Control and Prevention, since the beginning of this year, there have been three cases in the United States of humans contracting the H5N1 avian influenza virus after coming into contact with dairy cows. Since avian influenza viruses typically do not spread easily between people, the increase in such cross-species infection cases has undoubtedly heightened concerns about a potential outbreak of avian influenza. Although there is currently no conclusive evidence that H5N1The virus has already possessed the ability to spread widely among the population, but the emergence of these cases should not be overlooked.
Moderna's mRNA-1018 is a pandemic candidate mRNA vaccine targeting H5/H7 avian influenza strains, encoding the antigen proteins of avian influenza strains H5 and H7. It is currently in Phase 1/2 trials to test its protective efficacy. Meanwhile, Moderna stated that its research results will support the development plan for Phase 3.
The moves of the industry leader often serve as a "bellwether," capable of guiding industry trends. Perhaps mRNA vaccines targeting influenza will be the next hotspot., quite a few companies have already made their moves and achieved progress. As for Moderna, it has another candidate, mRNA-1083, which is composed of Moderna's seasonal flu vaccine mRNA-1010 and its next-generation COVID-19 vaccine mRNA-1283. In June this year, Moderna announced that the Phase III clinical trial of this candidate had met its primary endpoint, demonstrating good protective efficacy and safety.
In May this year, a multivalent modified candidate mRNA seasonal influenza vaccine jointly developed by CureVac and GSK completed the first patient dosing in a Phase 1 clinical trial. This candidate mRNA vaccine covers four influenza virus strains recommended by the WHO, including the influenza A virus strains H1N1 and H3N2, as well as the influenza B virus strains Yamagata and Victoria.
An article titled "An mRNA-based broad-spectrum vaccine candidate confers cross-protection against heterosubtypic influenza A viruses" reportedShanghai Institute of Biological Products, China National Biotec GroupProof-of-Concept Results for a Novel Broad-Spectrum Influenza mRNA Vaccine from the Vaccine Development Team. The research team utilized bioinformatics to screen for conserved influenza antigens and combined mRNA-LNP technology to innovatively design an antigen combination strategy expressing a fusion of the extracellular domain of the influenza virus M2 protein (M2e) in tandem sequences, the long alpha-helical region of the HA stalk domain (LAH) in tandem sequences, and the viral nucleoprotein (NP), leading to the development of a novel broad-spectrum influenza mRNA vaccine.
Immunogenicity studies in mouse models showed that the vaccine induced high-titer M2e and LAH-specific antibody responses in mice, which effectively neutralized the virus and mediated antibody-dependent cell-mediated cytotoxicity (ADCC). The vaccine also elicited a strong cellular immune response, characterized by a significant increase in多功能CD4+ and CD8+ T cells secreting various cytokines, particularly NP protein-specific T-cell responses, which play an important role in mediating cross-protective immunity.
Last July,JC West SeaThe IND for its self-developed mRNA quadrivalent seasonal influenza vaccine JCXH-107 has been approved by the FDA. This is Jiaming West Sea's third RNA infectious disease vaccine, and also China's first mRNA influenza vaccine approved for clinical trials. JCXH-107 utilizes Jiaming West Sea’s RTU delivery technology, addressing the shortcomings of mRNA vaccines that require ultra-low temperature storage and have a short shelf life. The RTU delivery vector boasts high transfection efficiency, low side effects, and a long shelf life under 2-8°C conditions. Additionally,Jinfar PharmaceuticalsAlso laid out the influenza mRNA vaccine.
Summary
eMedClub
Currently, the development of influenza mRNA vaccines is entering a brand-new stage. International leading pharmaceutical companies such as Moderna, CureVac, GSK, as well as domestic enterprises like Shanghai Institute of Biological Products of China National Biotec Group and Jiachen West Sea, have all entered the field, focusing on the development of mRNA vaccines targeting the influenza virus. This is also expected to provide new solutions for global influenza prevention and control.
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