Drug intelligence / Profile preview

BNT116

Development stage
Phase 2
Lead developer
BioNTech
Modality
mRNA Therapeutics → RNA Therapeutics → Nucleic Acid Therapeutics, Cancer Vaccines → Therapeutic Vaccines → Vaccines & Immunotherapeutics
Administration
Intravenous
01

Overview

BNT116 is an intravenously administered mRNA-based therapeutic cancer vaccine developed for the treatment of non-small cell lung cancer (NSCLC). It consists of six RNA molecules, each encoding a tumor-associated antigen (TAA) frequently expressed in NSCLC. Delivered as an RNA-lipoplex formulation, BNT116 is designed to educate cytotoxic T cells to recognize and eradicate malignant cells by presenting these TAAs to the immune system. The drug leverages BioNTech's FixVac platform and aims to induce strong T cell responses against shared tumor antigens in NSCLC. Clinical trials are evaluating its safety and efficacy both as monotherapy and in combination with other agents such as cemiplimab (a PD-1 inhibitor), docetaxel, carboplatin/paclitaxel, anti-CTLA-4 antibody (BNT316), anti-B7-H3 ADCs, or anti-HER3 ADCs[1][3][5][7][8].

Brand names
FixVac Lung
Other names
FixVac Lung Cancer Vaccine
02

Targets

MAGEC1 (Melanoma antigen family C1)CLDN6 (Claudin-6)MAGEA4 (Melanoma-associated antigen A4)MAGEA3 (Melanoma-associated antigen 3)CT83 (Kita-Kyushu lung cancer antigen 1)PRAME (Preferentially expressed antigen in melanoma)

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