What Is The Merck-Moderna Cancer Vaccine? All About The mRNA Shot That Could Be Built From Your Own Tumour

A cancer vaccine made from the genetic blueprint of a patient’s own tumour has delivered encouraging results in a major melanoma trial, raising fresh hopes for personalised cancer treatment.

Merck and Moderna have announced that their personalised mRNA cancer vaccine, intismeran autogene, succeeded in a Phase 3 trial for high-risk melanoma when given with Keytruda. This is the first time an individualised cancer vaccine has cleared this final stage of testing, and the first mRNA-based cancer therapy to do so.

The treatment is personalised for each patient. Scientists analyse the genetic mutations in a person’s tumour and use those findings to design an mRNA vaccine that trains the immune system to recognise specific cancer-related targets. 

How Is A Cancer Vaccine Made From Your Own Tumour?

After a patient’s tumour is surgically removed, doctors sequence its DNA to identify mutations unique to that person’s cancer. Scientists then encode up to 34 of these mutations into a single mRNA shot made only for that patient.

Once injected, the vaccine trains the immune system to recognise and attack any remaining cancer cells carrying that exact mutation signature. It is a treatment built from one patient’s own tumour biology.

In simple terms, instead of offering the same vaccine to every patient, the treatment is built around the unique mutations found in their own cancer. The aim is to help the immune system identify and attack remaining cancer cells that could otherwise escape detection.

The vaccine was used with Keytruda, Merck’s immunotherapy drug, rather than as a standalone treatment. While the personalised mRNA vaccine helps direct the immune response towards tumour-specific mutations, Keytruda helps the immune system sustain its attack by blocking a pathway cancer cells can use to evade immune detection.

Can The Cancer Vaccine Reduce Melanoma Recurrence?

According to the companies, the late-stage trial met its key goals, with the combination reducing the risk of melanoma recurrence or spread compared with Keytruda alone. The study involved 1,137 patients with surgically removed stage IIB to IV melanoma. No new safety concerns were reported in the interim announcement.

However, experts are awaiting fuller clinical data, including more information on overall survival, long-term safety and other outcomes.

Does This Mean A Cancer Vaccine Is Now Available?

Not yet, Intismeran remains experimental and requires regulatory approval before it can become an available treatment. The companies are expected to present fuller results at an upcoming international medical conference and are in discussions with regulators.

If approved, it could become the first personalised mRNA cancer vaccine to demonstrate such late-stage clinical benefit when added to an established checkpoint inhibitor.

Could This Technology Work Against All Types Of Cancers?

Melanoma was the first cancer to prove the technology. Merck and Moderna are already testing versions of the same personalised platform in lung, bladder and kidney cancers, with earlier research also exploring pancreatic and stomach cancers.

 Researchers are also exploring personalised mRNA cancer vaccines in other tumour types. While the melanoma results are promising, they should not be viewed as a universal cure for cancer. Each cancer type requires its own research, clinical trials and evidence before this approach can be considered for wider use.

What this really means is that cancer treatment may be moving closer to an approach where a patient’s own tumour helps guide the treatment designed to fight it.

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Cancer 'vaccine' shows promise in human trial of lymphoma patients

An experimental cancer "vaccine" showed promising results in a small clinical trial of patients with lymphoma, according to a study.

Researchers tested the treatment in 11 patients with lymphoma. Their results were successful enough to warrant another clinical trial in March on lymphoma patients as well as breast and head-and-neck cancer.

Researchers said some patients in the initial human trial went into full remission for months or even years.

The treatment "has broad implications for multiple types of cancer," said lead author, the director of the lymphoma immunotherapy program. "This method could also increase the success of other immunotherapies such as checkpoint blockade.

They refer to it as a vaccine because it causes a person's immune system to fight the disease, though it's not preventive like the flu shot. In this case, the treatment teaches the body to recognize tumors and attack them.

Researchers created the treatment directly inside the tumor. To do this, they injected one tumor with a stimulant to recruit immune cells, treated the tumor with a low dose of radiation then injected it with a stimulant to activate immune cells. These activated immune cells then travel throughout the body, killing tumors wherever they find them.

In three of the patients, the treatment shrunk not only the tumor that was treated but also other ones throughout the body, putting these patients into remission.

"It's really promising, and the fact you get not only responses in treated areas, but areas outside the field [of treatment with radiation] is really significant," said a Dr. who was not involved in the study and is working on a similar treatment.

While promising, the effect was observed in only three people and will need to be tested in larger trials before even going before the Food and Drug Administration for review.

The Dr. said the results are exciting but cautioned more research needs to be done. 

"It's definitely proof of concept, but larger studies are definitely needed and additional strategies to try to get more than three out of 11 patients to respond," he said,  who is also developing a lymphoma vaccine, though with a slightly different approach.

Researchers for decades have tried but failed to create cancer vaccines. New research on immunotherapy, or training a person's immune system to fight disease, has reinvigorated their efforts.
The vaccine activates dendritic cells, which are responsible for initiating immune responses. These cells then instruct T-cells to attack tumors in a person's body, like generals instructing soldiers how to fight.

"Generals don't really fight wars, they make the plans," the Dr. said.

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Cancer Vaccine Validated in Mice

The idea of a cancer vaccine is something researchers have been working on for over 50 years, but until recently they were never able to prove exactly how such a vaccine would work.

Now, a team of researchers  has demonstrated that a vaccine can work. Not only that, it could become an extremely effective, non-invasive and cost-effective cancer-fighting tool.

The discovery represents a major breakthrough in the quest for a cancer vaccine, a highly competitive pursuit in which numerous research teams around the world are engaged. Unlike other teams, however, this team looked for a solution in an unusual place: non-coding DNA sequences.

Better recognition of antigens
In 2000 and 2005, a number of studies were able to show that immune-defence cells (T lymphocytes) are capable of recognizing and penetrating cancer cells in order to attack them. “The longer the tumour is infiltrated by the lymphocytes, the longer the patient’s survival,” explained  a principal investigator. “In patients whose tumours are under greatest attack by T lymphocytes, a drug developed 12 years ago that stimulates their immune system is capable of fighting 25 per cent of cancer cases,” the Dr. said.

T lymphocytes recognize tumours by the presence of foreign antigens – or peptides – on the surface of cells. However, even if these antigens are recognized by the immune system, they do not sufficiently stimulate it for the lymphocytes to target and destroy them. As such, the search for a vaccine has focused on identifying tumour-specific antigens in order to allow the immune system to attack them more effectively. Since these antigens are the result of defective genes, various research teams have tracked the culprits to the portion of DNA known to encode antigens and proteins. But they have not been successful.

“This portion of DNA makes up only 2 per cent of the human genome,” researcher explained. “DNA sequences known to be “non-coding” may have been “silenced” by the methylation of DNA that affects gene expression. It is here, in this non-coding DNA, which is estimated to account for 98 per cent of the DNA of our cells, that our work is focused.”

An effective test vaccine
Using mice injected with various types of cancer cells, the team was able to identify numerous antigens deriving from the non-coding portion of DNA, several of which were both specific to cancer cells and common to different types of cancer. This allowed the team to develop a vaccine based on leukemia cells containing some of the identified antigens, which was administered to the mice. The results were highly encouraging.

“Each antigen we tested eliminated 10 to 100 per cent of the leukemia,” said the researcher, adding that “some of the antigens protected the mouse for its entire life, despite the reinjection of new leukemia cells. This suggests a long-lasting effect.”

Hope for several types of cancer
The same antigens were subsequently identified in leukemia cells in humans. Researcher describes his team’s findings as extremely promising and as opening up the possibility for the development of vaccines to treat leukemia and lung cancer in humans.

The team focused on these two specific types of cancer because they are at opposite ends of the spectrum in terms of the number of mutations at their source. The fact that the vaccine has proven effective to treat leukemia, which is caused by a small number of mutations, holds promise for the efficacy of this therapy in fighting all other types of cancer as well.

“We wouldn’t have to reinvent the vaccine for every form of cancer,” he noted. At the same time, one of the obstacles in developing a vaccine for humans is that our genetic diversity is much greater than that of mice, he added. Nonetheless, he believes that clinical trials with humans could start within the next two to three years.

Developing therapeutic cancer vaccines targeting the antigens identified by the  team would be a cost-effective way to save lives, while at the same time greatly simplifying treatment of this terrible disease, notably by limiting the many side effects of chemotherapy.

An important factor leading to the  discovery is the institute’s multidisciplinary approach to research, which combines genomics, bioinformatics and proteomics, he concluded.

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