Moderna’s melanoma vaccine poised for 2025 launch

Moderna’s CEO, Stephane Bancel, has announced that their experimental vaccine targeting melanoma could hit the market as early as 2025, with potential accelerated approval in some countries by 2025.

Globally, melanoma claimed 57,000 lives among the 325,000 new cases reported in 2020. Bancel expressed optimism in an interview, stating, “We think that in some countries the product could be launched under accelerated approval by 2025.”

Unlike traditional vaccines, therapeutic vaccines like Moderna’s focus on treating diseases, training the body’s immune system against the invader.

Bancel dubbed these vaccines as “immunotherapy 2.0,” representing a beacon of hope in oncology.

Moderna’s recent clinical trial results unveiled a significant advancement in survival rates over time. In a study involving 157 individuals with advanced melanoma, the combination of Moderna’s vaccine and Merck’s immunotherapy drug Keytruda exhibited a 49 percent reduction in the risk of recurrence or death over three years, outperforming Keytruda alone.

“The more time passes, the more you see that advantage,” noted Bancel, highlighting the growing disparity in survival rates compared to existing products on the market.

The promising results from ongoing clinical trials could pave the way for conditional approval of the vaccine, currently known as mRNA-4157.

Moderna is set to conduct a larger phase three study in 2024, involving a thousand participants, to solidify the earlier conditional authorization.

Both the US Food and Drug Administration (FDA) and the European Medicines Agency have expedited the review process for this groundbreaking therapy, marking a significant step toward its swift introduction.

Moderna’s commitment to ensuring an ample vaccine supply is evidenced by the construction of a new factory in Massachusetts, aligning with FDA requirements.

The company has also initiated a phase 3 trial for an mRNA vaccine targeting lung cancer, with ongoing studies exploring vaccines for various tumor types.

Bancel’s vision extends beyond treatment, aiming to integrate cancer vaccines with “liquid biopsies” that detect tumor signs through blood tests. This innovative approach aligns with the belief that early cancer detection enhances the efficacy of Moderna’s drugs.

In the race against cancer, Moderna is not alone. Companies like BioNTech are also delving into individualized therapeutic cancer vaccines, collectively contributing to the evolving landscape of oncological treatments.