U.S. Department of Health & Human Services Divider Arrow National Institutes of Health Divider Arrow NCATS
Nelipepimut-S (formerly known as E75) is an immunogenic peptide from the HER2 protein that is highly expressed in breast cancer. The NeuVax™ (Galena, OR, USA) vaccine, nelipepimut-S plus granulocyte-macrophage colony-stimulating factor, is designed for the prevention of clinical recurrences in high risk, disease-free breast cancer patients. Nelipepimut-S is being developed by Sellas Life Sciences Group. When combined with the immunoadjuvant granulocyte-macrophage colony-stimulating factor (GM-CSF), nelipepimut-S has been used as a vaccine that is capable of eliciting a robust anti-HER2 immune response. Early-phase clinical trials that enrolled women with node-positive or high-risk node-negative breast cancer who had been rendered disease free with standard of care therapy but were at risk for recurrence, demonstrated the vaccine to be safe with a suggestion of clinical benefit. Nelipepimut-S is currently being evaluated in a Phase III clinical trial.

Approval Year

PubMed

PubMed

TitleDatePubMed
Efficacy and Safety Analysis of Nelipepimut-S Vaccine to Prevent Breast Cancer Recurrence: A Randomized, Multicenter, Phase III Clinical Trial.
2019-07-15
The development and use of the E75 (HER2 369-377) peptide vaccine.
2016-06

Sample Use Guides

Breast Cancer: Patients received 1,000 ug Nelipepimut-S + 250 ug GM-CSF or placebo + GM-CSF monthly for 6 months, then every 6 months through 36 months.
Route of Administration: Other
Name Type Language
NELIPEPIMUT-S ACETATE
Common Name English
L-Leucine, L-lysyl-L-isoleucyl-L-phenylalanylglycyl-L-seryl-L-leucyl-L-alanyl-L-phenylalanyl-, acetate (1:1)
Preferred Name English
Code System Code Type Description
FDA UNII
HAB4B44DVX
Created by admin on Wed Apr 02 19:48:30 GMT 2025 , Edited by admin on Wed Apr 02 19:48:30 GMT 2025
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CAS
1361396-07-7
Created by admin on Wed Apr 02 19:48:30 GMT 2025 , Edited by admin on Wed Apr 02 19:48:30 GMT 2025
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