Moderna Inc. (MRNA) and Merck Inc. (MRK) shares experienced a boost in after-hours trading on Wednesday, following the announcement that a cancer-vaccine candidate of the two pharmaceutical companies had been granted the “breakthrough therapy” designation from the Food and Drug Administration (FDA). This designation allows for expedited review of a candidate, and was granted after a Phase 2b study of the personalized vaccine – known as mRNA-4157/V940 – in combination with Merck’s Keytruda.
Moderna President Steven Hoge expressed his enthusiasm for the breakthrough, saying in a statement that “mRNA-4157/V940 in combination with KEYTRUDA provided the first demonstration of efficacy for an investigational mRNA cancer treatment in a randomized clinical trial and potentially represents a new frontier in treating melanoma and other cancers.” He went on to say that they were looking forward to “publishing the full data set and sharing the results at an upcoming oncology medical conference, as well as continuing discussions with health authorities.”
The Phase 3 study focusing on melonoma is set to begin this year, and the news of the breakthrough therapy designation has already had a positive effect on the stocks of both companies. Moderna shares rose 3% and Merck shares increased about 0.5% in late trading.
The development of mRNA-4157/V940 is a major breakthrough in the field of cancer treatment, and could potentially revolutionize the way in which cancer is treated. mRNA-4157/V940 is a personalized vaccine, meaning that it is tailored to the individual patient, and is designed to work in combination with Merck’s Keytruda. Keytruda is an immunotherapy drug, meaning that it works by stimulating the body’s own immune system to fight cancer.
The combination of these two treatments has the potential to be hugely effective in treating melanoma and other cancers. The Phase 2b study showed that the combination of mRNA-4157/V940 and Keytruda was able to produce positive results in a randomized clinical trial, and the Phase 3 study is expected to further demonstrate the effectiveness of the combination.
The breakthrough therapy designation from the FDA is a major step forward for the development of mRNA-4157/V940, and could potentially lead to the drug being approved for use in the near future. The expedited review process could mean that the drug is available to patients sooner than expected, and could potentially save countless lives.
The news of the breakthrough therapy designation has already had a positive effect on the stocks of both Moderna and Merck, and the future of the drug looks bright. The Phase 3 study is set to begin this year, and the results of this study will be eagerly anticipated by both the medical community and investors alike. If the results of the study are positive, then mRNA-4157/V940 could become a major player in the fight against cancer, and could potentially revolutionize the way in which cancer is treated.
