Skin cancer vaccine succeeds in late-stage trial

Moderna’s mRNA vaccine combined with Merck’s immunotherapy Keytruda succeeded in a late-stage trial for skin cancer, the companies said on Wednesday, sending shares of the vaccine maker up 60% in premarket ​trading.

The study is ongoing, but interim results found the treatment, Intismeran, met ​both its primary target of reducing cancer recurrence and its secondary ⁠goal of keeping cancers from spreading to other parts of the body.

Moderna has been ​diversifying its portfolio beyond its COVID-19 vaccine. The company recently added an FDA-approved flu ​vaccine while developing experimental shots for diseases including norovirus and Lyme disease.

Analysts had noted the cancer vaccine data could be an important catalyst for the company and potentially strengthen investor sentiment. Last ​month Barclays analysts said they expect the therapy could generate about $3 billion for treating ​melanoma by 2035.

Shares of Moderna were trading at $103.60, while Merck climbed 7.5% before the bell.

The cancer ‌treatment ⁠combines Merck’s Keytruda with a made-to-order mRNA vaccine from Moderna that is based on an analysis of mutations found in the patients’ own tumors.

The trial enrolled 1,137 high-risk patients with stage IIB-IV melanoma that had been surgically removed.
Volunteers were randomized to receive ​up to nine doses ​of Keytruda plus ⁠the personalized vaccine or Keytruda alone for about one year. The companies said no new safety signals have emerged in the ​trial.

In January, the companies announced results of a mid-stage trial of the ​treatment showing ⁠that it reduced the risk of recurrence or death by 49% after five years.

The companies said they will present their results at an upcoming medical meeting and share them ⁠with ​regulators.

Melanoma is the deadliest form of skin cancer. In ​2023, there were more than 1.5 million people in the U.S. living with melanoma, according to the National ​Cancer Institute.

About Intismeran Autogene

Intismeran autogene (intismeran; V940 or mRNA-4157) is a novel, potential first-in-class investigational messenger RNA (mRNA)-based individualized neoantigen therapy (INT) jointly developed by Merck and Moderna.

Intismeran is designed and produced using a patient’s tumor sample to identify the unique mutational signature, or “fingerprint,” of their cancer and generate an anti-tumor immune response. Each therapy consists of a synthetic mRNA coding for up to 34 neoantigens and is tailored to the unique biology of an individual patient’s tumor.

Upon administration, the RNA-encoded neoantigen sequences are translated in the body and presented to the immune system, a key step in generating specific T-cell responses against cancer cells. Individualized neoantigen therapies are designed to train and activate an anti-tumor immune response based on the unique mutational signature of a patient’s tumor.