mRNA cancer vaccine obtains FDA fast track qualification to treat melanoma

On November 19, 2021, BioNTech announced that the US FDA has granted BNT111 Fast Track status

BioNTech’s FixVac technology platform uses mRNA to express shared tumor-associated antigens, which can target antigen-presenting cells and activate antigen-specific T cell responses

▲Introduction to FixVac technology platform (picture source: BioNTech official website)

BNT111 is a ready-to-use therapeutic vaccine manufactured using the FixVac technology platform

▲BNT111 has shown gratifying results in phase 1 clinical trials (Image source: BioNTech official website)

This phase 2 clinical trial aims to evaluate the efficacy of BNT111 in combination with the anti-PD-1 monoclonal antibody drug Libtayo (cemiplimab)

“The FDA’s grant of Fast Track status underscores the potential of our FixVac platform, which is expected to solve the current treatment challenges faced by melanoma patients

Reference materials:

[1] BioNTech Receives FDA Fast Track Designation for its FixVac Candidate BNT111 in Advanced Melanoma.