Moderna boss hopes to have a therapeutic vaccine against skin

Moderna boss hopes to have a therapeutic vaccine against skin cancer by 2025

The head of Moderna, Stéphane Bancel, told AFP that it is possible that the therapeutic vaccine against skin cancer developed by the company will be approved as early as 2025, after new positive results were announced on Thursday.

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“It is expected that the product could potentially be launched with accelerated approval in some countries by 2025,” he said in an interview.

This therapeutic vaccine is not intended to prevent the disease from developing, like a traditional vaccine, but to treat it once it occurs. However, it is based on the same principle: it helps the patient's immune system defend itself against diseases.

Therapeutic vaccines today represent a real hope in oncology, an “immunotherapy 2.0”, says Stéphane Bancel. “Immunotherapy 1.0” is particularly represented by increasingly used drugs such as Keytruda, developed by Merck (MSD outside the US and Canada).

This timeline is particularly reinforced by the results published on Thursday by Moderna, which show an improvement in survival over time thanks to the treatment that uses messenger RNA technology, which has proven effective against Covid-19.

In a study of about 160 people with advanced melanoma, taking the vaccine at the same time as the cancer drug Keytruda reduced the risk of the disease coming back by 49% over three years. cancer or death compared to patients treated with the cancer drug alone.

Moderna had already announced two-year monitoring results last year with a 44% reduction in risks.

“The difference in survival is increasing. The more time passes, the more one realizes that the benefit of the Moderna treatment is “significant,” Mr. Bancel said.

A treatment that works for “one in two people,” compared to those who have received “the best treatment on the market” in oncology, is “tremendous,” he emphasized.

“Individualized” treatment

In his opinion, these data could therefore allow treatment to be started without having to wait for the results of a phase 3 study. This began in July with more than 1,000 people and recruitment was expected to be completed “in the second half of 2024”.

“At this point we can begin discussions with regulators to accelerate the conditional approval of the product,” explained Stéphane Bancel. The prerequisite for confirmation of approval would then be “a success of phase 3, which would confirm the data we see today”.

The treatment has already been designated as an “innovative therapy” by the United States Food and Drug Administration (FDA), a designation intended to accelerate its development. The European Medicines Agency (EMA) has also given it a similar designation (“Priority Medicines”).

A recent study estimates that around 57,000 people worldwide died from melanoma, one of the most serious forms of skin cancer, in 2020.

Moderna's therapeutic vaccine is developed from mutations read in the DNA of the patient's tumor – who undergoes surgery to remove it before treatment.

Detect earlier

So it's more than a personalization of the vaccine, it's an “individualization,” emphasized Mr. Bancel. Moderna “physically manufactures a product” made “just for you.”

To prepare for commercialization, the company is building a factory in Massachusetts for these customized cancer treatments.

Other types of tumors also come into consideration. The company announced Monday that it is starting a Phase 3 trial for lung cancer.

According to Stéphane Bancel, another key to saving more lives in the future will be early detection of cancer.

He wants to combine studies with the innovative technology of “liquid biopsies,” thanks to which “you can see small pieces of DNA from the tumor in the blood.”

By being able to detect cancer earlier, the patient's immune system would be less weakened. However, therapeutic vaccines rely on this immune system.

Other companies such as BioNTech are also working on individualized therapeutic cancer vaccines.

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