Moderna has made a breakthrough in cancer treatment—the stock market reacted with a record surge
20 August 06:21
Shares of the American biotechnology company Moderna nearly tripled following the announcement of positive results from a trial of a personalized mRNA therapy for melanoma. This was reported by "Komersant Ukrainian", citing Reuters.
At the close of trading on August 19 , the company’s shares rose 176.97% to $174.38 per share. This turned out to be even higher than initially reported during the trading session, when the increase was estimated at 150–160%, according to final stock exchange data.
The sharp rise in share prices was a reaction to the results of the Phase 3 trial of the personalized therapy Intismeran autogene, which Moderna is developing in collaboration with the pharmaceutical company Merck.
According to Reuters, the positive news added tens of billions of dollars to Moderna’s market value. Merck’s shares also rose by approximately 12.6%.
What the Moderna vaccine trial showed
The international Phase 3 INTerpath-001 trial involved 1,137 patients with Stage IIB–IV skin melanoma. Before treatment began, their tumors were completely removed surgically.
Patients received:
- personalized Intismeran mRNA therapy in combination with Keytruda;
- or Keytruda alone and a placebo.
The combination of Intismeran and Keytruda demonstrated statistically significant and clinically meaningful improvements in two primary endpoints.
The therapy extended the period without disease recurrence and reduced the risk of distant metastases compared to using Keytruda alone.
The study met its primary endpoint—relapse-free survival—as well as one of the key secondary endpoints—distant metastasis-free survival, according to an official statement from Merck and Moderna.
However, the companies have not yet disclosed the exact risk reduction figures from the Phase 3 trial. They plan to present detailed results at an upcoming international medical conference.
Why Intismeran Is Called a Personalized Vaccine
Intismeran differs from conventional vaccines, which are mass-produced using a standardized formula.
The drug is created individually for each patient. First, specialists analyze a sample of the removed tumor and identify a set of mutations unique to that tumor.
Based on this data, synthetic mRNA is produced that can encode up to 34 tumor neoantigens. After the drug is administered, the immune system receives a kind of “portrait” of the cancer cells and learns to recognize them.
Keytruda, in turn, blocks the mechanism by which the tumor hides itself from the immune system. The combination of these two technologies is designed to help the body more accurately locate and attack residual cancer cells.
This is not a preventive cancer vaccine
Despite the common term “cancer vaccine,” Intismeran is not intended for vaccinating healthy people and does not prevent the initial onset of melanoma.
It is an experimental personalized therapy for patients who have already been diagnosed with melanoma and had the tumor removed. Its goal is to reduce the risk of the disease returning or spreading to other organs.
The drug has not yet been approved for general use. Moderna and Merck plan to submit the results to regulatory authorities and discuss filing a registration application.
In an optimistic scenario, the therapy could become available as early as 2027, though this will depend on the regulators’ decision.
What data is currently missing
The Phase 3 results are interim, and the study itself is ongoing.
The companies have not yet reported:
- the exact percentage reduction in the risk of recurrence;
- the exact percentage reduction in the risk of distant metastases;
- results regarding overall survival;
- the future cost of personalized therapy;
- the estimated time required to manufacture the drug for a single patient.
No new safety signals were identified during the trial. The safety profile was generally consistent with that observed in previous studies of this combination.
What the previous phase of the study showed
Investors’ additional optimism stems from the results of an earlier Phase 2 study.
After five years of follow-up, Intismeran combined with Keytruda reduced the risk of recurrence or death by 49% and the risk of distant metastases or death by 59% compared with Keytruda alone without mRNA therapy.
These results cannot be automatically extrapolated to the third phase. A new, larger study has confirmed the combination’s advantage, but the company has yet to present specific figures.
Why This Could Save Moderna After COVID-19
For Moderna, the success of Intismeran has not only medical but also strategic significance. After the pandemic ended, the company’s revenue from COVID-19 vaccines plummeted, and investors were waiting for proof that mRNA technology could be successfully applied in other areas.
The positive Phase 3 results mark the first such achievement for a personalized mRNA therapy against cancer.
Barclays analysts estimate Intismeran’s potential annual sales—for the treatment of melanoma alone—at approximately $3 billion by 2035. JPMorgan considers the drug’s launch one of the key factors in Moderna’s potential return to profitability.
However, a sharp rise in stock prices does not guarantee further increases in their value. The companies still need to release full results, obtain regulatory approval, establish rapid personalized production, and set a price for the therapy.
What types of cancer is Intismeran being tested for?
Moderna and Merck are conducting a total of nine Phase II and III trials using Intismeran.
In addition to melanoma, the technology is being studied for the treatment of:
- non-small cell lung cancer;
- kidney cancer;
- bladder cancer;
- pancreatic cancer;
- certain stomach cancers.
Success with melanoma does not yet prove the therapy’s effectiveness against other tumors. However, it confirms that the personalized mRNA platform can be effective in a large Phase III trial.
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