Drug intelligence / Profile preview

recMAGE-A3 + AS01B

Development stage
Discontinued
Lead developer
GSK
Modality
Recombinant Proteins and Enzymes, Vaccines & Immunotherapeutics
Administration
Intramuscular
01

Overview

recMAGE-A3 + AS01B is an investigational antigen-specific cancer immunotherapeutic (ASCI) developed by GSK. It consists of a recombinant MAGE-A3 fusion protein—comprising the MAGE-A3 cancer-testis antigen fused to a portion of Protein D from *Haemophilus influenzae* B and a polyhistidine tail—formulated with the AS01B adjuvant system. The AS01B adjuvant is a liposomal formulation containing two immunostimulants: monophosphoryl lipid A (MPL) and the saponin QS-21. The vaccine was designed to elicit a robust Th1-biased cellular immune response and humoral immunity against tumor cells expressing MAGE-A3, which is frequently found in melanoma and non-small cell lung cancer (NSCLC) but absent in normal tissues. Despite showing promise in Phase II trials, the program was discontinued after failing to meet primary endpoints in two major Phase III trials: the DERMA trial for resected Stage III melanoma and the MAGRIT trial for NSCLC.

Other names
MAGE-A3 ASCIMAGE-A-3 ASCIMAGE-A 3 ASCIMAGE-A3 antigen-specific cancer immunotherapeuticMAGE-A-3 antigen-specific cancer immunotherapeuticMAGE-A 3 antigen-specific cancer immunotherapeuticrecMAGE-A3 + AS01BProtein D-MAGE-A3-His fusion protein + AS01B
02

Targets

MAGEA3 (Melanoma-associated antigen 3)

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