Drug intelligence / Profile preview

GP2 + AE37

Development stage
Unknown
Lead developer
Generex Biotechnology
Modality
Peptides, Vaccines & Immunotherapeutics
Administration
Subcutaneous
01

Overview

GP2 + AE37 is a combination of two HER2-derived peptide cancer vaccines administered with the GM-CSF adjuvant sargramostim to induce complementary anti-tumor immunity in breast cancer. AE37 is an Ii-Key–modified HER2 776–790 class II peptide designed to elicit a CD4+ T-helper response, while GP2 is a HER2 654–662 class I peptide that elicits a CD8+ cytotoxic T-cell response; together they aim to enhance immunologic control of micrometastatic disease and reduce recurrence risk after standard therapy. A large randomized, single-blind, multi-center phase II trial tested AE37+GM-CSF and GP2+GM-CSF versus GM-CSF control in disease-free, node-positive or high-risk node-negative breast cancer; overall disease-free survival was not significantly improved, but subgroup signals were observed: AE37 showed benefit trends in advanced stage, HER2 under-expression, and triple-negative subsets, and GP2 showed a trend toward improved DFS with no recurrences among HER2-positive patients who completed vaccination. Further evaluation including potential combination of AE37 and GP2 has been suggested based on these findings.[1][2][3][4]

Other names
GP2 vaccine + AE37 vaccineHER2 peptide vaccine combinationHER-2 peptide vaccine combinationHER 2 peptide vaccine combination
02

Targets

MHC I (MHC class I})

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