mRNA cancer vaccine milestone! Moderna (MRNA.US) collaborates with Merck & Co., Inc. (MRK.US) for successful melanoma trial, pre-market stock price surges 80%.

Moderna Inc. (MRNA.US) and Merck & Co., Inc. (MRK.US) announced that their personalized cancer vaccine successfully reduced the risk of melanoma recurrence in a large late-stage trial, marking a significant milestone for mRNA-based cancer therapies. The trial met its primary endpointdata showed that the vaccine, when used in combination with Merck & Co., Inc.'s immunotherapy Keytruda, was able to lower the melanoma recurrence rate compared to the use of Keytruda alone. The two companies stated in a Wednesday announcement that the study also achieved a critical secondary endpoint, demonstrating that the vaccine helps prevent the spread of tumors to other parts of the body. The companies noted that this is the first time any mRNA-based cancer therapy has achieved positive results in a late-stage trial. Following this news, Moderna's stock surged over 100% in pre-market trading in New York. As of the time of writing, it had increased by 80%, while Merck & Co., Inc.'s stock rose by approximately 7.2%. Detailed data on the specific improvement in the duration of disease-free survival (i.e., the length of time without cancer recurrence) for this vaccine has not yet been released. The trial is ongoing to evaluate whether vaccinated patients can achieve longer overall survival. Melanoma is the most severe form of skin cancer. According to the American Cancer Society, approximately 112,000 people are diagnosed with it in the U.S. each year, resulting in about 8,500 deaths. In the statement, the two companies indicated that they would discuss plans for filing for regulatory approval and announce related data at an upcoming medical conference. Moderna CEO Stphane Bancel stated in an interview that, depending on the regulatory review process, the product could be approved for market as early as 2027. Bancel remarked, This is an extraordinary milestone for mRNA science. The underlying science behind the development of the vaccine (named intismeran autogene) has been in progress for over a decade. The vaccine utilizes the same messenger RNA technology used in Moderna's COVID-19 vaccine and is customized based on specific tumor mutations in patients. In the trial, patients received the mRNA vaccine combined with Merck & Co., Inc.'s Keytruda treatment after tumor surgical removal. Controls in the study received only Keytruda monotherapy, which is the standard treatment protocol for preventing recurrence in high-risk patients. The aim is to have both drugs work synergistically to train the body's immune system to attack any remaining cancer cells. Thanks to the promising outlook for this cancer vaccine, Moderna's stock has risen by a total of 113% from the beginning of the year to Tuesday's close. The melanoma trial is viewed as a critical early test to validate this approach. Merck & Co., Inc. and Moderna are testing it in other cancer types, including lung cancer, but research related to melanoma is the furthest along. Scientists have long sought a vaccine that can enable the body's own defense system to fight cancer, teaching the immune system to recognize the molecular fingerprints of tumors and destroy remaining cells. However, it has proven extremely challenging to make such vaccines work until now. Jane Hily, head of early oncology development at Merck & Co., Inc., stated in an interview weeks before the data was released, Therapeutic vaccines have been the Holy Grail in the field of cancer. People have been trying to make this work in various ways for over a century. She noted that one of the potential advantages of such vaccines is to extend survival without significantly increasing side effects. Earlier this year, both companies stated that in a mid-stage trial, skin cancer patients receiving mRNA vaccine combined with Keytruda had a 49% lower risk of death or cancer recurrence five years later compared to those receiving Keytruda alone.