Moderna's cancer vaccine trial with Merck in Phase 2, results by year’s end

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Moderna Inc., the company that shot to fame after developing the vaccine for COVID-19, has teamed up with the pharmaceutical giant, Merck, to develop a personalized vaccine against skin cancer, CNBC reported. If successful, the vaccine will be used in high-risk patients of melanoma, the deadliest known skin cancer.

The two companies have had an agreement in place since 2016 to develop and sell a vaccine based on mRNA technology and have made significant progress in using the personalized cancer vaccine (PCV) mRNA-4157/V940 as an investigational treatment option in combination with Merck's FDA-approved monoclonal antibody therapy, KEYTRUDA.

Now, Merck has exercised its option by agreeing to pay a sum of $250 million to Moderna, which will pave the way for further development and commercialization of the vaccine, a Merck press release said.

How will the vaccine work?

Cancerous cells can have mutations — changes in their DNA sequence that make conventional treatment ineffective. By using a personalized cancer vaccine, the patient's immune system can be prepared to generate a mutation-specific anti-tumor response.

Moderna's mRNA-4517/V940 is designed to generate Tcell responses based on the mutational signature of the tumor in the patient. T cells are a type of white blood cell that are tasked with defending the body in the event of an infection.

Merck's KEYTRUDA is an anti-programmed death receptor-1 (PD-1) therapy that targets the PD-1 protein that cells can use to evade detection by T cells. Since both healthy as well as cancerous cells use this mechanism to evade T cell attack, using KEYTRUDA even puts healthy cells in the firing line.

In combination with Moderna's vaccine, the treatment can aim to specifically target tumor cells.

Moderna teams up with Merck for personalized vaccine against skin cancer — iStock/FatCamera

KEYNOTE-942 trial

Merck's KEYTRUDA is currently being used in over 1,600 trials across a wide range of cancers. Through these trials, Merck is trying to understand the various factors that might affect the effectiveness of the treatment in patients.

KEYNOTE 942 is one such trial studying the effectiveness of KEYTRUDA in high-risk melanoma patients. Currently, in Phase 2, the trial has enrolled 157 patients who have been randomized into two groups following the surgical removal of their tumors.

One group receives nine doses of Moderna's mRNA vaccine every three weeks, along with 200 mg KEYTRUDA, while the other receives only KEYTRUDA. This open-label trial is scheduled to run for one year to see if the disease recurs or drug toxicity becomes unacceptable. The researchers are looking for recurrence-free survival in patients, alongside metastasis-free and overall survival as endpoints. The results of the clinical trial are expected by the end of the year.

Moderna will look keenly toward the trial result to demonstrate that its technology can be used for other diseases as well. Even as the company is expected to bring in $21 billion in revenues after rolling out its Omicron-specific booster shot, the COVID vaccine is its sole commercial product on the market, CNBC said in its report.