Moderna CEO Stephane Bancel told AFP that his company’s experimental vaccine against melanoma could be available in just two years, amounting to a groundbreaking step against the most serious form of skin cancer.
Globally, there were an estimated 325,000 new cases of melanoma and 57,000 deaths from the disease in 2020.
“We expect that the product could come to market in some countries with accelerated approval by 2025,” he said in an interview.
Unlike traditional vaccines, so-called therapeutic vaccines treat rather than prevent a disease. But they also work by training the body’s immune system against the invader.
Therapeutic vaccines now represent a real hope in oncology, an “immunotherapy 2.0,” says Bancel.
Moderna’s ambitions got a boost on Thursday when the latest clinical trial results showed that survival chances have improved over time thanks to the vaccine, which uses the same messenger RNA technology that has proven highly effective against severe forms of Covid-19 has proven.
In a study of 157 people with advanced melanoma, the Moderna vaccine combined with Merck’s immunotherapy drug Keytruda reduced the risk of recurrence or death by 49 percent over three years compared to Keytruda alone.
Moderna had already announced two-year monitoring results last year that showed a risk reduction of 44 percent.
“The difference in survival is increasing. The more time passes, the more this benefit becomes apparent,” Bancel said, noting that the rate of side effects has not increased.
“Compared to the best product on the market, one in two people survive,” he said, “which is huge in oncology.”
I’m looking for approval soon
The existing clinical evidence could therefore form the basis for conditional approval of the vaccine, initially known as mRNA-4157, said Bancel.
In this scenario, a larger, thousand-person “Phase 3” trial that Moderna is conducting in 2024 could confirm the earlier conditional approval.
Both the US Food and Drug Administration and the European Medicines Agency have subjected the therapy to an accelerated review process.
Development of the vaccine begins with sequencing the genome of each patient’s tumor and identifying specific mutations to code against. It is therefore an example of “individualized” medicine that is “tailored just for you,” said Bancel.
To prepare for the launch, Moderna is building a new factory in Massachusetts to ensure sufficient supply, an FDA requirement.
On Monday, the company also announced that it would start a phase 3 trial for an mRNA vaccine against lung cancer. Other types of tumors are also being investigated.
Bancel’s hope is to eventually combine these cancer vaccines with “liquid biopsies” – groundbreaking tests that use blood tests to detect signs of tumors earlier and are gradually becoming available in the United States.
Bancel believes that the faster you can detect cancer, the better Moderna’s new drugs will work.
Other companies such as BioNTech are also working on individualized therapeutic cancer vaccines.
© Agence France Press
Originally posted 2023-12-18 05:44:26.