2023-12-14 19:58:40
The company also announced Monday the start of a “phase 3” trial for an mRNA vaccine once morest lung cancer and is studying other types of tumors.
Moderna CEO Stéphane Bancel told AFP that his company’s experimental melanoma vaccine might be available in just two years, marking a historic step once morest the most serious form of skin cancer.
It is estimated that in 2020 there were 325,000 new cases and 57,000 deaths from the disease worldwide.
“We believe that in some countries the product might be launched with accelerated approval around 2025,” he said in an interview.
Unlike conventional vaccines, so-called therapeutic vaccines treat a disease rather than prevent it. But they also act by training the human body’s immune system once morest the invading agent.
Therapeutic vaccines today represent true hope in oncology, an “immunotherapy 2.0”, according to Bancel.
Moderna’s pipeline received a boost on Thursday with the latest clinical trial results showing an improvement in survival chances thanks to the vaccine.
The technology used is messenger RNA (mRNA), which proved to be very effective once morest severe forms of covid-19.
In a study involving 157 people with advanced melanoma, Moderna’s vaccine, in combination with Merck’s immunotherapy drug Keytruda, reduced the risk of recurrence or death by 49% over a three-year period, compared with administration of Keytruda only.
In 2022, Moderna had already announced two-year follow-up results that showed a 44% risk reduction.
“The difference in survival is growing. The more time goes by, the more you see that advantage,” Bancel said, noting that the rate of side effects had not increased.
“We have one in two people, compared to the best product on the market, who survive,” he said, “which in oncology is huge.”
Seeking early approval
Existing clinical trials might thus form the basis for conditional approval of the vaccine, known for now as mRNA-4157, Bancel said.
In this scenario, a larger “phase 3” study, in which a thousand people will participate and which Moderna will be carrying out in 2024, might confirm the previous conditional authorization.
Both the US Food and Drug Administration (FDA) and the European Medicines Agency have placed the therapy on an accelerated review track.
Vaccine development begins with sequencing the genome of each patient’s tumor and identifying specific mutations to code for.
It is, consequently, an example of “individualized” medicine adapted “only to the person being treated,” Bancel stated.
To prepare for bringing the vaccine to market, Moderna is building a new factory in Massachusetts to have an abundant supply, an FDA requirement.
The company also announced Monday the start of a “phase 3” trial for an mRNA vaccine once morest lung cancer and is studying other types of tumors.
Bancel’s hope is to combine these cancer vaccines with “liquid biopsies,” innovative tests that detect signs of tumors through blood tests, and which have begun to become available in the United States.
The faster cancer can be detected, the better Moderna’s new drugs will work, Bancel thinks.
Other companies, such as BioNTech, are also working on individualized therapeutic cancer vaccines.
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