基于FixVac的BNT111获得FDA的Fast Track Designation

t
tlexander
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如果能成功,感觉是肿瘤治疗的突破性成就

BNT111 Melanoma Vaccine Description

BNT111 Melanoma vaccine candidate is based upon BioNTech's FixVac platform
that targets a fixed combination of mRNA-encoded, tumor-associated antigens with the objective of triggering a strong and precise immune response
against cancer.

BioNTech's BNT111 is an intravenous therapeutic cancer vaccine candidate
encoding for a fixed set of four cancer-specific antigens optimized for
immunogenicity and delivered as an RNA-lipoplex formulation. More than 90%
of melanomas in patients express at least one of the four tumor-associated
antigens encoded in BNT111 (NY-ESO-1, MAGE-A3, tyrosinase, and TPTE).

BNT111 is one of the most advanced of five clinical-stage FixVac product
candidates within BioNTech's development pipeline. The FixVac platform
candidates consist of a fixed combination of mRNA-encoded non-mutated
antigens shared within specific cancer types. In addition, they feature
BioNTech's proprietary RNA-lipoplex delivery formulation, which is designed to enhance stability and translation of the mRNA cargo and specifically
target dendritic cells. Thus, the vaccine candidate aims to trigger a strong and precise innate and adaptive immune response against cancer cells
overexpressing the respective antigen.