On August 19, the pharmaceutical company Merck and the biotechnology firm Moderna reported that a personalized mRNA vaccine against melanoma has reached the primary and one of the key secondary endpoints in phase III clinical trials. The experimental therapy used the drug intismeran autogene, also known as V940 or mRNA‑4157, in combination with Merck’s antitumor drug Keytruda. The INTerpath-001 study involved 1,137 patients with stage IIB–IV melanoma who had undergone complete tumor removal. They were divided into two groups: the first received intismeran autogene together with Keytruda, the second received Keytruda alone. The combination showed statistically significant improvement in two indicators: time without disease recurrence and the appearance of distant metastases. This is the first positive result of the third phase for personalized neoantigen therapy and mRNA therapy against cancer. The company has not yet disclosed specific performance indicators; the results are planned to be presented at one of the international medical conferences. In the second phase, the combination also demonstrated an advantage: after five years of observation, the risk of recurrence or death decreased by 49 percent, and the risk of developing distant metastases or death decreased by 59 percent.

Unlike a conventional vaccine, intismeran autogene is created separately for each patient. First, specialists sequence tumor and blood samples, then Moderna’s algorithms analyze the detected mutations and select up to thirty‑four neoantigens – potential targets for the immune system. Based on these, the company produces a personalized mRNA vaccine, which, after administration, should teach the immune system to recognize tumor‑specific targets and attack cancer cells. Moderna uses several built‑in AI tools for this purpose; they evaluate genetic data and predict which neoantigens are most likely to trigger an immune response. Artificial intelligence is also used in production management: algorithms allocate production capacity and plan the output of thousands of individual batches. Keytruda works differently – the drug blocks the mechanism by which tumor cells suppress the immune response. In combination, one therapy helps the immune system identify the target, while another helps it attack it more actively.

After the results were published, Moderna shares rose by approximately 131 percent – to $163, which was a record one‑day increase for the company’s securities. By the time the material was prepared, the quotes had adjusted by almost 15 percent. The sharp rise hit traders who had bet on Moderna’s decline: according to the ORTEX analytical platform, the unrealized losses of market participants reached approximately four and eight‑tenths of a billion dollars. Until that point, about thirteen and a half percent of the company’s shares in free float were held in short positions. Merck and Moderna plan to present the results to regulators and discuss submitting an application to register the combination of intismeran autogene and Keytruda, while the therapy remains experimental and has not been approved for use. Companies are also studying the drug for other types of cancer, including lung, bladder, and kidney tumors. It should be recalled that in October 2025, Google’s AI model predicted a combination of drugs that makes “cold” tumors visible to the immune system, and earlier, Redmod’s neural network learned to detect pancreatic cancer on computed tomography scans on average 475 days before the diagnosis was made.