Nelipepimut-S
Also known as: E75, HER2/neu peptide (E75), HER2/neu peptide vaccine, KIFGSLAFL, Nelipepimut‑S, NPS
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Summary
Nelipepimut‑S (E75) is a 9‑amino‑acid peptide derived from the HER2/neu extracellular domain, investigated as an adjuvant vaccine for HER2‑positive breast and ovarian cancers.
Mechanism of Action
elicits HER2/neu‑specific cytotoxic T‑lymphocyte responses by presenting the E75 epitope (aa 369‑377) on MHC class I molecules
Routes of Administration
Goals & Uses
- Prevention of breast cancer recurrenceOncology / Cancer PreventionModerate
- Adjuvant therapy in node-positive breast cancerOncologyLow
- Combination with trastuzumab for HER2-low breast cancerCombination ImmunotherapyModerate
- HER2-specific immune activationImmunotherapyModerate
- Adjuvant therapy for HER2‑positive breast cancerOncologyModerate
Contraindications
- HLA-A2 or HLA-A3 negativityGenetic/ImmunologicHigh
- Immunosuppressive therapyPharmacologicalModerate
- Known hypersensitivity to GM-CSF or vaccine componentsAllergicHigh
- Active autoimmune diseaseAutoimmunityModerate
Adverse Effects
- Flu-like symptomsSystemic/ImmunologicalUncommon
- Flu‑like symptomsSystemicUncommon
- Local Injection Site ReactionsDermatologicalCommon
- FatigueGeneralCommonLow energy or tiredness
- Allergic/hypersensitivity reactionsImmunologicalRare
- Injection‑site erythemaLocalCommon
- LymphadenopathyLymphoreticularUncommon
Drug Interactions
- Chemotherapy agentsModerate
- TrastuzumabLow
- CorticosteroidsModerate
Population Constraints
- PregnancyReproductive SafetyRelative
- Pregnant or breastfeeding womenReproductiveRelative
- Severely immunocompromised patientsImmunologicalRelative
- HER2-overexpressing (3+) breast cancerOncologicRelative
- HLA-A2 or HLA-A3 negative patientsGeneticAbsolute
Regulatory Status
- European UnionInvestigationalClinical trials conducted under EU Clinical Trial Regulation; no marketing authorization.
- United StatesInvestigationalInvestigational New Drug (IND) application filed; not FDA‑approved.
- United KingdomInvestigationalNo MHRA approval; investigational only.
Investigational vaccine studied in phase I/II trials; not approved in any jurisdiction.
Evidence & Sources
No sources recorded yet.
Frequently Asked Questions
What is Nelipepimut-S?
Nelipepimut‑S (E75) is a 9‑amino‑acid peptide derived from the HER2/neu extracellular domain, investigated as an adjuvant vaccine for HER2‑positive breast and ovarian cancers.
What is Nelipepimut-S used for?
Nelipepimut-S is educationally associated with: Prevention of breast cancer recurrence, Adjuvant therapy in node-positive breast cancer, Combination with trastuzumab for HER2-low breast cancer, HER2-specific immune activation, Adjuvant therapy for HER2‑positive breast cancer. Educational only — not medical advice.
How is Nelipepimut-S administered?
Recorded routes of administration: Intradermal, Subcutaneous.
What are the potential side effects of Nelipepimut-S?
Reported adverse effects include: Flu-like symptoms, Flu‑like symptoms, Local Injection Site Reactions, Fatigue, Allergic/hypersensitivity reactions, Injection‑site erythema, Lymphadenopathy. This list is not exhaustive — consult a qualified clinician.
Who should avoid Nelipepimut-S?
Recorded contraindications: HLA-A2 or HLA-A3 negativity, Immunosuppressive therapy, Known hypersensitivity to GM-CSF or vaccine components, Active autoimmune disease. Consult a qualified clinician before use.