According to reports, Moderna plans to launch an mRNA-based skin cancer vaccine mRNA-4157 as early as next year. The vaccine is combined with MSD PD-1 Therapy K to treat melanoma.
The Zhitong Finance App learned that, according to reports, Moderna (MRNA.US) plans to launch an mRNA-based skin cancer vaccine as early as next year. According to reports, Moderna has released interim data on its individualized cancer vaccine called mRNA-4157. The vaccine is used in combination with MSD (MRK.US) PD-1 therapy K (Keytruda, pabolizumab) to treat melanoma.
Moderna CEO Stephane Bancel said, “Phase 2 data is available. Our factory is almost complete. Typically, such products are ready within 6 months, not 12 months. That's why mRNA-4157 is still likely to be available in 2025.”
According to the data, mRNA-4157 is a novel individualized novel antigen therapy (INT) based on messenger RNA (mRNA), composed of synthetic mRNA coding for up to 34 new antigens. In June of this year, the first three-year follow-up data from a phase IIb study of mRNA-4157 combined with pabolizumab for high-risk stage III/IV melanoma after complete resection was released. The data showed that the risk of recurrence or death was reduced by 49%, and the risk of distant metastasis or death was reduced by 62%.
The 2.5-year recurrence-free survival rate of mRNA-4157 combined with pabolizumab was 74.8%, while the 2.5-year recurrence-free survival rate of pabolizumab alone was 55.6%. Furthermore, compared with pabolizumab alone, the exploratory endpoints of overall survival (OS) of mRNA-4157 (V940) combined with pabolizumab were more favorable, with 2.5-year OS rates of 96.0% and 90.2%, respectively.
No serious adverse effects were reported from mRNA-4157 in combination with pabolizumab. The results of the three-year mid-term follow-up showed that the number of patients reporting adverse events between the two groups was close. The reported rate of adverse events with mRNA-4157 in combination with pabolizumab was 25%, and the reported rate of adverse events with pabolizumab alone was 20%. Specifically, the most common adverse effects of mRNA-4157 were fatigue (60.6%), pain at the injection site (56.7%), and chills (49%).
It is worth noting that the so-called cancer vaccine does not mean that tumors can be prevented after vaccination, but rather a cancer treatment with a mechanism of vaccine action, targeting people who have already had cancer.
In February of this year, Moderna announced that mRNA-4157 was granted breakthrough therapy certification by the US Food and Drug Administration (FDA), making it the first mRNA tumor vaccine in the world to receive this certification. However, Moderna added that based on available data, discussions on the possibility that mRNA-4157 may be approved by the FDA at an accelerated pace have yet to bear fruit. “The company and its partner MSD will continue to engage with regulators about the plan and continue to focus on implementing phase III trials,” the company said.