Moderna (MRNA.US) skin cancer vaccine mRNA-4157 is expected to be on the market as early as 2025.

It is reported that Moderna (MRNA.US) plans to launch an mRNA-based skin cancer vaccine as early as next year. Moderna has announced the mid-term data of its personalized cancer vaccine named mRNA-4157, which is used in combination with Merck & Co., Inc.'s (MRK.US) PD-1 therapy Keytruda for the treatment of melanoma. Moderna CEO Stephane Bancel said, "The data from Phase 2 is available. Our factory is almost complete. Typically, this type of product is ready within 6 months, not 12 months. That's why mRNA-4157 still has the potential to be on the market in 2025." Data shows that mRNA-4157 is a novel personalized new antigen therapy (INT) based on messenger RNA (mRNA), consisting of synthetic mRNA encoding up to 34 new antigens. In June of this year, the three-year follow-up data of a Phase IIb study of mRNA-4157 in combination with Keytruda for completely resected high-risk stage III/IV melanoma was released for the first time, showing a 49% reduction in the risk of recurrence or death and a 62% reduction in the risk of distant metastasis or death. The 2.5-year recurrence-free survival rate with mRNA-4157 in combination with Keytruda was 74.8%, while the rate with Keytruda alone was 55.6%. Furthermore, the exploratory endpoint of overall survival (OS) with mRNA-4157 (V940) in combination with Keytruda was more favorable compared to Keytruda alone, with 2.5-year OS rates of 96.0% and 90.2% respectively. No serious adverse events were reported with the combination of mRNA-4157 and Keytruda. The interim follow-up results over three years showed a comparable number of patients reporting adverse events between the two groups. The rate of adverse events with mRNA-4157 in combination with Keytruda was 25%, while with Keytruda alone it was 20%. The most common adverse reactions with mRNA-4157 were fatigue (60.6%), pain at the injection site (56.7%), and chills (49%). It is worth noting that the so-called tumor vaccine does not refer to preventing tumors after vaccination, but rather a tumor treatment method based on the mechanism of vaccine action, targeting individuals already diagnosed with cancer. In February of this year, Moderna announced that mRNA-4157 had received breakthrough therapy designation from the FDA, becoming the world's first mRNA tumor vaccine to receive this designation. However, Moderna added that discussions regarding the potential for accelerated approval of mRNA-4157 by the FDA based on existing data have not yet yielded results. The company stated, "The company and its partner Merck & Co., Inc. will continue to engage with regulatory authorities on this plan and remain focused on executing Phase III trials."