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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
Substance Class Protein
Created
by admin
on Wed Apr 02 19:48:30 GMT 2025
Edited
by admin
on Wed Apr 02 19:48:30 GMT 2025
Protein Type PEPTIDE
Protein Sub Type T-CELL ANTIGEN
Sequence Origin HUMAN
Sequence Type COMPLETE
Record UNII
HAB4B44DVX
Record Status Validated (UNII)
Record Version
  • Download
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
PRIMARY
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
PRIMARY
Related Record Type Details
PARENT -> SALT/SOLVATE
Related Record Type Details
ACTIVE MOIETY

Structural Modifications

Modification Type Location Site Location Type Residue Modified Extent Fragment Name Fragment Approval
MOIETY ACETATE ION 569DQM74SC
Name Property Type Amount Referenced Substance Defining Parameters References
Molecular Formula CHEMICAL
MOL_WEIGHT:NUMBER(CALCULATED) CHEMICAL