Moderna's melanoma shot could be approved in MONTHS

World’s first cancer vaccine one step closer to reality: Moderna’s melanoma shot is given ‘breakthrough’ drug status by the FDA — meaning it could be approved in MONTHS

  • The shot plus Keytruda reduces the risk of skin cancer’s recurrence or death 44%
  • Breakthrough status was granted to the therapy by the FDA yesterday 
  • Moderna gets more contact with the FDA and application response in 6 months 

A cancer vaccine made by Moderna has been given ‘breakthrough therapy’ status by health chiefs, paving the way for a fast-tracked approval.

The shot, given alongside an immunotherapy drug, is used to treat patients recovering from advanced melanoma who are at risk of tumors returning.

A phase two trial showed the combination reduced the chance of relapse or death in sufferers after surgery by 44 percent, compared to the immunotherapy drug on its own.

The promising results prompted the Food and Drug Administration (FDA) to upgrade its approval status yesterday – which could slash the time it takes to be approved to six months.

More than one million Americans are living with melanoma, the most serious form of skin cancer, roughly 4 percent of whom have advanced forms of the disease.

The new shot, designed for people with high-risk melanoma, harnesses mRNA technology that delivers pieces of genetic code from patients’ tumors into their cells and teaches the body to fight off the cancer. The vaccine is given to people post-surgery to prevent the tumor from returning, and it is tailored to each patient, meaning no two shots will be the same

The experimental therapy is comprised of Moderna’s shot and Merck’s immunotherapy drug Keytruda.

The new ‘breakthrough’ tag means the FDA believes the vaccine may ‘address unmet medical need in the treatment of serious or life-threatening conditions’.

In practical terms it means the agency will hold frequent meetings with Moderna about the progress of the shot throughout its development.

The move also makes the therapy eligible for accelerated approval and priority review by the FDA. This means the regulator will make a decision on applications within six months, rather than 10 months under standard review. has approached Moderna and the FDA for a timeline on when it could be approved.

Most drugs or vaccines need to go through phase three trials before they can be approved for mass use. 

But in special circumstances, if the treatment appears to be both safe and effective in phase one and two trials, it can be authorized before that point. 

The new vaccine harnesses mRNA technology that uses pieces of genetic code from patients’ tumors to teach the body to fight off the cancer.

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A vaccine — developed at the famous Mount Sinai hospital in Manhattan, New York — rapidly melts away the primary tumor and teaches the body to hunt and kill cancer cells that have spread elsewhere.

The vaccine is given to people post-surgery to prevent the tumor from returning, and it is tailored to each patient, meaning no two shots will be the same.

Merck and Moderna said they plan to initiate a phase three study into the therapy this year, where it will be tested on potentially thousands of patients.

They will also ‘rapidly expand’ to looking at other cancers, including non-small cell lung cancer.

In the ongoing phase two study, 157 patients were given personalized vaccines alongside Merck’s immunotherapy drug Keytruda.

They are being compared to a control group who also have high-risk melanoma but are only being given Keytruda. The trial has been going on for the past year. 

If it works, the vaccine will be trialed in a much larger group involving thousands of patients. 

Moderna was able to develop, trial and seal approval of its Covid shot within the space of a year. The vaccine uses DNA taken from each patient’s tumor.

This genetic snippet is then inserted into messenger RNA — the molecule that carries a cell’s instructions for making proteins.

Once inside the body, the mRNA delivers this piece of code to human cells, teaching them to recognize cancer cells and attack them if it returns.

The hope is that the body will be able to recognize and destroy them before they can start to multiply and form tumours. 

The vaccine is being given in nine doses every three weeks, along with one course of Keytruda every three weeks.

The American Cancer Society said the rates of melanoma have been growing significantly over the past years.

It estimates that about 99,780 new melanomas will be diagnosed (around 57,180 in men and 42,600 in women) in the US in 2022.

And about 7,650 people are expected to die of melanoma (roughly 5,080 men and 2,570 women).

You are more than 20 times more likely to get melanoma if you are White compared to if you are African Americans.

The lifetime risk of contracting melanoma is about 2.6 per cent (one in 38) for Whites, 0.1 per cent (one in 1,000) for Blacks, and 0.6 per cent (one in 167) for Hispanics.

The type of cancer is more common in men, but before age 50 it is more prevalent in women.

How mRNA tech could cure cancer

For over a decade, cancer researchers have been working on individualized cancer vaccines, using technology including mRNA.

Messenger RNA, or mRNA, is genetic material which tells the body how to make proteins.

The mRNA Covid vaccine teaches cells in the body how to make a protein which sets off an immune response.

The immune response generates antibodies, so that if the body is exposed to the real virus later, the body will recognize it and know how to fight it off.

With a cancer vaccine, researchers aim to bring out an immune response to fight abnormal proteins, known as neoantigens, made by cancer cells.

The manufacturing process for the vaccine begins by identifying the genetic mutations in a patient’s tumor cells that could release neoantigens.

The patient will have had the tumor surgically removed, meaning scientists can easily look at the tumor’s cells.

Computer algorithms judge which neoantigens are most likely to latch onto receptors on white blood cells and trigger an immune response.

The personalized shot can hold genetic sequences for up to 34 different neoantigens.

It is hoped that the mRNA vaccine will then activate white blood cells which can recognize individual cancer cells thanks to the cancer cells’ neoantigens.

The vaccine will effectively teach the immune system that cancer cells are different to the rest of the body.

This will hopefully not be too hard, as neoantigens do not form on normal cells.

Once tissue samples have been gathered from a patient, it takes between one and two months to make a personalized mRNA cancer vaccine.

A previous Moderna-sponsored study of a personalized cancer vaccine on patients with head and neck cancer saw the biotech company produce each individualized shot in around six weeks.

Because of the specialized nature of the vaccines, each one can cost up to $100,000.

Source: National Cancer Institute, CDC 

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