Landmark melanoma vaccine may be available in just two years: ScienceAlert
Moderna CEO Stephane Bancel told AFP that his company’s experimental vaccine against skin cancer may be available in less than two years, in what could be a historic step against the most dangerous forms of skin cancer.
Globally, there were an estimated 325,000 new melanoma cases and 57,000 deaths from the disease in 2020.
“We believe the product could be launched in some countries under accelerated approval by 2025,” he said in an interview.
Unlike conventional vaccines, so-called therapeutic vaccines treat the disease rather than prevent it. But they also work by training the body’s immune system against invaders.
Today, therapeutic vaccines represent a real hope in treating tumors, which is “immunotherapy 2.0,” according to Bancel.
Moderna’s aspirations received a boost on Thursday, as the latest clinical trial results showed improvement over time in chances of survival thanks to the vaccine, which uses the same messenger RNA technology that has proven highly effective against serious forms of Covid-19.
In a study of 157 people with advanced melanoma, the Moderna vaccine combined with Merck’s immunotherapy drug Keytruda reduced the risk of disease recurrence or death by 49 percent over three years, compared with Keytruda alone.
Moderna had already announced results from two-year surveillance last year, which showed a 44 percent reduction in risk.
“The difference in survival is increasing. The more time goes by, the more you see that advantage,” Bancel said, noting that the rate of side effects has not increased.
“We have about one in two people, compared to the best products on the market, surviving, which is huge in oncology,” he said.
Seek early approval
Bancel said current clinical evidence could form the basis for conditional approval of the vaccine, now known as mRNA-4157.
Under this scenario, a larger “Phase III” study involving 1,000 people, which Moderna will conduct in 2024, could confirm the previous conditional authorization.
Both the US Food and Drug Administration and the European Medicines Agency have put the treatment on an accelerated review track.
Vaccine development begins with sequencing each patient’s tumor genome and identifying specific mutations to code against. It is therefore an example of “individualized” medicine designed “just for you,” Bancel said.
To prepare for its market launch, Moderna is building a new factory in Massachusetts in order to obtain abundant supplies, a requirement of the US Food and Drug Administration.
It also announced on Monday that it had begun a phase 3 trial of an mRNA vaccine against lung cancer. Other types of tumors are also being studied.
Bancel eventually hopes to pair these cancer vaccines with “liquid biopsies” — pioneering tests that detect tumor markers early, via blood tests, and are beginning to become 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 individual therapeutic cancer vaccines.
© Agence France-Presse