Cancer vaccine shows promise in early trial

Pharmaceutical companies Moderna and Merck are set to launch the first phase three trial of a messenger RNA cancer vaccine after a study suggested it could be used to treat an aggressive type of skin cancer.

Data released by Moderna on Tuesday showed that a combination of the company’s experimental cancer vaccine and Merck’s immunotherapy drug Keytruda reduced the risk of death or recurrence of melanoma in high-risk patients by 44%. compared to treatment using only Keytruda.

The randomized phase two trial recruited 157 patients who had already undergone melanoma-related surgery and followed them for one year. Some participants received nine doses of the cancer vaccine, codenamed mRNA-4157/V940, along with Keytruda. Others only received Keytruda, which is the standard treatment for high-risk melanoma.

Stéphane Bancel, Moderna’s chief executive, said the results encouraged Merck and Moderna to embark on a larger phase three study that regulators tend to require before approving a new treatment.

The vast majority of drugs that were successful in phase two studies failed in the next stage of testing.

The companies would also test the combination on other types of cancer. “We believe this should work in many tumor types, not just melanoma,” Bancel said in an interview.

Moderna shares rose as much as 25% to $207.37 in early trading after the earnings release, while Merck shares rose nearly 1%.

Scientists have long studied the potential of using mRNA technology — which is best known for having been used successfully in vaccines against Covid — to deliver a vaccine that teaches the body’s immune system to target cancerous tumors.

Jeffrey Weber, principal investigator of the study and deputy director of the Perlmutter Cancer Center at New York University Langone, said the findings provided the first randomized evidence that a personalized vaccine approach with neoantigens could be beneficial in melanoma. Weber is a paid consultant for Merck and Moderna.

However, some analysts urged caution, noting that Moderna had released only a small amount of test data and the results had not yet been peer-reviewed by independent scientists.

Daina Graybosch, an analyst at SVB Securities, said the phase two results were impressive, but a detailed reading of the results would be needed to build confidence that they could be repeated in a larger test.

Julie Bauman, director of the George Washington University Cancer Center, said mRNA cancer vaccines were specifically tailored to target each individual’s cancer.

“You take tissue from a tumor, sequence it, and over a period of six weeks, you make a vaccine that matches the top 10 to 20 mutations,” she said.

Bauman said the vaccine stimulates the person’s immune system to selectively target these cancer cells.

The clinical trial is part of a six-year collaboration between Merck and Moderna in the field of developing personalized cancer vaccines. In October, Merck agreed to pay Moderna $250 million to exercise an option to jointly develop and commercialize mRNA-4157/V940.

According to Dean Li, president of Merck Research Laboratories, the positive test results represent an important milestone in the company’s collaboration with Moderna.

“We look forward to moving this program into the next phase of development,” he said.

_{Translated by Luiz Roberto M. Gonçalves}