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Since the 1990s, mRNA has been used in therapeutic vaccines, but it wasn't until the COVID-19 pandemic in 2020 that mRNA vaccines gained significant attention, making the technology a candidate for a new generation of vaccines. On October 2, 2023, the Nobel Prize in Physiology or Medicine was awarded for two major discoveries. The laureates, Dr. Katalin Karikó and Dr. Drew Weissman, jointly received this prestigious global scientific honor for their groundbreaking contributions to mRNA vaccines.
mRNA vaccines are being applied in various fields at an unprecedented pace, reigniting enthusiasm and interest in mRNA technology. Due to its advantages in flexibility, cost, and development speed, this technology also holds great promise for cancer treatment and personalized medicine.
BOC RNA provides specialized mRNA custom synthesis services, offering tailored solutions for your mRNA vaccine development pipelines. Our high-quality, scalable production ensures precise and reliable mRNA for your research and preclinical needs.
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On May 31, 2024, Moderna announced that its mRNA respiratory syncytial virus (RSV) vaccine, mRESVIA (mRNA-1345), has been approved by the FDA for market release. This marks the second commercialized mRNA vaccine worldwide, following the COVID-19 vaccine, further advancing the application of mRNA technology in non-COVID vaccine development. The vaccine is primarily used to prevent RSV-related lower respiratory tract disease (RSV-LRTD) and acute respiratory disease (ARD) in adults aged 60 and older. Notably, this is the first RSV mRNA vaccine and the only "pre-filled syringe" vaccine available on the market. This approval also marks the first mRNA vaccine approved for use in diseases other than COVID-19.
RSV is a highly contagious seasonal respiratory virus that is a major cause of lower respiratory tract infections and pneumonia, particularly posing a significant disease burden on infants and the elderly. In the United States, approximately 60,000 to 160,000 older adults are hospitalized each year due to RSV infection, with 6,000 to 10,000 deaths.
The FDA approval of mRESVIA is based on positive data from the Phase 3 ConquerRSV trial, a global study conducted in 22 countries with approximately 37,000 adults aged 60 and older. The results were published in The New England Journal of Medicine. The primary analysis had a median follow-up time of 3.7 months. When RSV-LRTD was defined as the occurrence of two or more symptoms, 55 cases of RSV-LRTD were found in the placebo group, compared to 9 cases in the mRNA-1345 group, resulting in a vaccine efficacy (VE) of 83.7%. When defined by "three or more symptoms," the VE for RSV-LRTD was 82.4%. The vaccine's efficacy against RSV-related acute respiratory disease was 68.4%. Additionally, mRNA-1345 demonstrated good safety, with most adverse reactions being mild or moderate. Additional long-term analysis showed that the vaccine provided sustained protection against RSV LRTD during a median follow-up period of 8.6 months.
Although the vaccine's approval was delayed due to FDA "administrative restrictions," it has finally been approved for market release. This suggests that the RSV vaccine may become the next blockbuster product in the mRNA vaccine field. Meanwhile, domestic vaccine development is progressing rapidly, with some pipelines already entering clinical or IND application stages.
On December 14, 2023, Moderna and Merck announced the latest data from their Phase II clinical trial of the mRNA vaccine combined with Keytruda (pembrolizumab). The impressive study results suggest it could become the first mRNA cancer vaccine to be marketed, potentially as early as 2025!
In the KEYNOTE-942 study, data showed that the jointly developed personalized mRNA-4157/V940 vaccine, based on patients' tumor DNA, significantly improved recurrence-free survival (RFS). It reduced the risk of recurrence or death by 49% and the risk of distant metastasis or death by 62% in high-risk stage III/IV melanoma patients. When used in combination with Keytruda, compared to Keytruda alone, the reported adverse events and safety were consistent with previous findings. Earlier this year, preliminary data from this trial were reported at AACR and ASCO, where it was shown that, with a median follow-up time of about 2 years, the combination of mRNA-4157 and Keytruda reduced the risk of recurrence or death by 44% and the risk of distant metastasis or death by 65%.
The results of the ongoing randomized, open-label Phase IIb trial were first announced in December 2022. These results were significant enough for the U.S. Food and Drug Administration (FDA) to grant the combination breakthrough therapy designation and for the European Medicines Agency (EMA) to grant it PRIME (Priority Medicines) designation. The two companies plan to initiate a Phase III study in 2023 to investigate this combination as adjuvant therapy for high-risk melanoma patients. These results further illustrate the potential of personalized neoantigen therapies to become a new frontier in the treatment of melanoma and other cancers.
As early as February 23, 2023, Merck announced that the investigational mRNA cancer vaccine mRNA-4157/V940 in combination with Keytruda had been granted breakthrough therapy designation by the FDA for adjuvant treatment of high-risk melanoma patients following complete resection. Compared to Keytruda alone, the combination therapy reduced the risk of recurrence or death by 44%.
Therapeutic vaccines for cancer have undergone years of development and represent a revolutionary advancement in the field of oncology. Neoantigens are poised to open a new chapter in personalized cancer immunotherapy, enabling patients' immune cells, such as T cells, to autonomously track and precisely attack tumor cells like guided missiles. Various approaches, including peptide vaccines, dendritic cell vaccines, and mRNA vaccines, have demonstrated clinical efficacy in treating malignant melanoma, lung cancer, glioblastoma, and other cancers, showcasing promising application prospects.
To date, the National Institutes of Health (NIH) clinical trials website lists over 7,000 cancer vaccines in development, with 640 of these being mRNA vaccines. Among them, 197 are neoantigen vaccines. There are 7 mRNA vaccines focusing on immunomodulation, 11 targeting tumor-associated antigens (TAAs), and 10 targeting neoantigens, with most in Phase I/II clinical trials. With the advancement of mRNA cancer vaccines for neoantigens and targeted TAAs, supported by AI-assisted development, antigen design is becoming more intelligent, and delivery systems targeting cells and tissues are maturing. The likelihood of mRNA cancer vaccines receiving clinical approval is increasing, with several expected to enter clinical treatment applications in the coming years.
Currently, clinical trials for cancer vaccines are progressing rapidly, with promising breakthroughs in various tumor types. New cancer vaccines, including personalized neoantigen vaccines, dendritic cell vaccines, mRNA vaccines, and DNA vaccines, have shown significant potential in extending the survival of patients with advanced solid tumors.
Global Supplier of High-Quality RNA / DNA Products & Services.
