On August 19, pharmaceutical company Merck and biotech firm Moderna announced that their personalized mRNA vaccine for melanoma has met the primary and one of the key secondary endpoints in Phase 3 clinical trials.
The experimental therapy used the drug intismeran autogene (also known as V940 or mRNA-4157) in combination with Merck’s cancer treatment Keytruda.
Trial Results
The INTerpath-001 study involved 1,137 melanoma patients in stages IIB-IV, who had their tumors completely removed. They were divided into two groups: one received intismeran autogene with Keytruda, and the other received only Keytruda.
The combination showed a statistically significant improvement in two measures: recurrence-free survival and distant metastasis-free survival.
This marks the first positive Phase 3 result for personalized neoantigen and mRNA cancer therapies.
Specific efficacy metrics have not yet been disclosed by the companies. The results are expected to be presented at an upcoming international medical conference.
The study will continue to assess overall survival and other parameters. No new safety risks were identified compared to previous trials.
In Phase 2, the combination also showed an advantage over Keytruda alone. After five years of observation, the risk of recurrence or death was reduced by 49%, and the risk of distant metastasis or death by 59%.
AI in Vaccine Development
Unlike conventional vaccines, intismeran autogene is created individually for each patient.
Initially, specialists sequence tumor and blood samples. Moderna’s algorithms then analyze the detected mutations and select up to 34 neoantigens—potential targets for the immune system.
Based on these, the company produces a personalized mRNA vaccine. Once administered, it is intended to train the immune system to recognize tumor-specific targets and attack cancer cells.
Moderna employs several built-in AI tools for this process. They evaluate genetic data and predict which neoantigens are most likely to elicit an immune response.
The company also uses artificial intelligence in production management. Each vaccine is unique, so Moderna utilizes algorithms to allocate manufacturing resources and plan the production of thousands of individual batches.
Keytruda works differently: it blocks a mechanism that tumor cells use to suppress the immune response. In combination, one therapy helps the immune system identify the target, while the other enhances the attack.
Moderna Shares Surge 130%
Following the release of the results, Moderna’s shares rose approximately 131% to $163, marking a record one-day increase for the company.
By the time of writing, the stock had corrected by nearly 15%.
The sharp rise impacted traders betting against Moderna, writes Reuters citing analytics platform ORTEX. Unrealized market losses reached approximately $4.8 billion. Before this, about 13.5% of the company’s publicly traded shares were in short positions.
Merck and Moderna plan to present the results to regulators and discuss filing for approval of the intismeran autogene and Keytruda combination. The therapy remains experimental and is not yet approved for use.
The companies are also exploring intismeran autogene for other cancer types, including lung, bladder, and kidney tumors.
In October 2025, a Google AI model predicted a drug combination that makes “cold” tumors visible to the immune system. The hypothesis was confirmed in laboratory experiments.
Previously, a neural network from Redmod learned to detect pancreatic cancer in CT scans an average of 475 days before diagnosis.
