In Britain, they began to test a new “tailored vaccine” on melanoma patients

Steve had a “lump” on his head for 10 years that was long misdiagnosed. But then the specialists found out that it was malignant melanoma, a less common but very dangerous form of skin cancer. Last August, doctors cut out a mass from his scalp, but the fight against melanoma usually does not end completely with this procedure, because there is a risk of the return of this malignant disease, through scattered and hardly visible cancer cells in the body.

Now Steve has joined the clinical trials associated with the phase 3 study, where he was administered a so-called personalized mRNA vaccine as part of the experimental therapy.

The trial therapy is part of a study led by University College London Hospitals (UCLH) NHS Foundation Trust. A personalized melanoma mRNA vaccine has been developed by Moderna, with immunotherapy administered to patients in parallel – namely the drug Keytruda (pembrolizumab), developed by Merck Sharp and Dohme (MSD).

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According to The Guardian, the world’s first mRNA vaccines for the treatment of melanoma are being tested, among other things, on British patients. The anti-cancer agent is tailored for each person in just eight weeks and works by telling the body to make proteins that will eventually prevent this deadly skin cancer from returning.

A phase 2 study involving pharmaceutical companies Moderna and MSD has already found that the vaccine dramatically reduces the risk of cancer returning in melanoma patients.

So now the final phase 3 of experimental vaccination therapy has started. Patients who participated in phase 3 had to have their high-risk melanoma surgically removed within the last 12 weeks to ensure the best possible outcome. A control sample of patients receives a placebo, and these patients do not know whether they are receiving the drug or a placebo in the injections.

It is the first personalized mRNA vaccine against melanoma cancer in the world, which, according to experts, as The Independent wrote last week, allegedly also has the potential to stop lung, bladder and kidney cancer. The vaccine works by “tutoring” the human body to kill cancer cells more consistently – thereby preventing the deadly disease from returning. This treatment is known under the technical name of individualized neoantigen therapy (INT).

Heather Shaw, the study’s national coordinating investigator, said: “This is a really fine-tuned tool. These things are extremely technical and delicately generated for the patient. Patients are really excited about them.”

The vaccine is designed to prime the immune system with a precise focus to fight against a specific type of tumor of a particular patient. The injection is known as mRNA-4157 (V940). It is designed to target so-called tumor neoantigens, which are produced by tumors in a specific patient. These are some kind of individual marks on the tumor that can potentially be recognized by the immune system.

The injection carries the code of up to 34 of these neoantigens and thus activates an anti-tumor immune response based on the unique code or “signature” of a specific patient’s cancer. In order to create this injection, a tumor sample is first taken from the patient, followed by DNA sequencing and the use of artificial intelligence. The result is a personalized anti-cancer injection that is specific to each patient’s tumor. The vaccine uses similar technology to current covid vaccines.

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“The goal is primarily to cure patients of their current cancer,” Shaw noted. “But since the immune system is already trained by the vaccine, with this therapy we also deal with the theoretical risk that the cancer could return if some cells escaped and were not seen on the scans, which reduces the possibility of later recurrence,” she added, adding that according to her about a revolutionary change in immunotherapy.

Phase 2 data, published in December 2023, found that people with severe, high-risk melanomas who received the injection along with MSD’s Keytruda immunotherapy were nearly half (49 percent) less likely to die or have their cancer return after three years compared to those given only keytruda.

Patients received one milligram of mRNA vaccine every three weeks (a total of up to nine doses) and 200 milligrams of keytruda every three weeks (a maximum of 18 doses, for about a year).

The global Phase 3 trial will now include a wider range of patients, including in some other countries including Australia, with experts hoping to include around 1,100 people in total. The UK branch aims to recruit at least 60 to 70 patients across eight centres, including London, Manchester, Edinburgh and Leeds. A similar combination therapy is also being tried for lung, bladder and kidney cancer.

Shaw said side effects of the vaccine include fatigue and a sore arm where the injection was given. “So it seems to be a relatively tolerable procedure for most patients and in fact no worse than a flu or covid vaccination,” she stated, according to the BBC news station.

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According to Lawrence Young of the University of Warwick, this is one of the “most exciting discoveries in modern cancer treatment”.

“The combination of a personalized cancer vaccine to boost a patient’s tumor-specific immune response, along with the use of an agent that releases the brake on the body’s immune response, has already shown great promise in patients who have had their original skin cancer (melanoma) removed. Interest in cancer vaccines has been revived in recent years by a deeper understanding of how the body controls immune responses and the advent of mRNA vaccines, which make it much easier to develop a vaccine based on the immune profile of a patient’s own tumor. We hope that this approach could be extended to other types of cancer as well, such as lung and colon cancer,” said the mentioned expert.

MSD Vice President of Research Laboratories Vassiliki Karantza said that MSD is “committed to advancing research into innovative therapies at the early stages of cancer, when they can have the most meaningful impact on patients.”

“This study demonstrates progress in new treatment options for melanoma patients, and we look forward to expanding our comprehensive clinical development program to other tumor types,” she concluded.

What is melanoma

Melanoma is a type of skin cancer that arises from the uncontrolled growth of melanocytes, which are cells that produce the pigment melanin. Melanoma is one of the most aggressive and potentially life-threatening forms of skin cancer, although it represents only a small part of its manifestations. It occurs mainly on the skin, but sometimes also in the intestine and in the eye.

Causes and risk factors: The main cause of melanoma is excessive exposure to ultraviolet (UV) radiation, which can come from the sun or from man-made sources such as tanning beds. After all, the World Health Organization (WHO) points out that tanning beds are responsible for 10,000 malignant melanomas in the population of Europe, Australia and the USA every year. If people start using tanning beds before the age of 35, their risk of developing melanoma increases by 60 percent.

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Other risk factors include fair skin, the presence of multiple birthmarks, a family history of melanoma, a weakened immune system, and genetic factors.

Symptoms: Melanoma often presents as a change in the skin, which may include the growth of a new mole or a change in an existing mole. Warning signs include asymmetry, irregular edges, uneven color, enlargement or change in size, and itching or bleeding from the mole site.

Diagnosis: Diagnosis of melanoma usually involves a physical examination of the skin and a biopsy of the suspicious area. Pathologists analyze the tissue sample to confirm the presence of cancer cells.

Therapy: Melanoma treatment depends on its stage and includes surgical removal of the tumor, possibly supplemented with chemotherapy, radiotherapy or immunotherapy. In stages where melanoma has spread to other parts of the body, treatment can be more complex and include multiple types of therapy. The earlier melanoma is caught, the easier it is to treat – and the more likely it is to be successful.

Prevention and early detection: The best prevention is UV protection, including using sunscreen, wearing protective clothing, and avoiding tanning beds. Early detection is key, so it’s important to regularly check your skin for unusual changes and see a dermatologist if warning signs appear.

Melanoma is a serious disease, but with early detection and treatment, the chances of a successful cure can be increased.

Incidence of melanoma

Melanoma is rarer than other forms of skin cancer, but it is much more dangerous because of its aggressiveness and ability to metastasize quickly. Melanoma incidence statistics vary by region, age, gender, and other factors such as UV exposure.

It is most common in men and Caucasians living in sunny climates. Melanoma affects about 160,000 people worldwide every year and is the biggest killer among different forms of skin cancer. The incidence of malignant melanoma has also been increasing rapidly in recent years. According to a WHO report, around 48,000 people worldwide die from melanoma every year. It accounts for 75 percent of all skin cancer-related deaths.

It is estimated that about 1-2% of all cancer deaths are from melanoma. This may seem like a small percentage, but because melanoma is more serious and can metastasize quickly, it is a significant health problem.

It is the seventh most common malignant tumor in the Czech Republic, and its incidence is increasing. In 1994, over a thousand cases of melanoma were diagnosed in the Czech Republic, and in 2014, over 2,400 cases. Approximately 350 to 400 patients die from this tumor in the Czech Republic every year.

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