Nelipepimut-S (NeuVax)_Dosage, benefits & legal status
Also known as NeuVax, nelipepimut, E75, E75 peptide, HER2 369-377, ZZ-143, nelipepimut-S acetate
A peptide cancer vaccine given by clinic staff to women with a matching tissue type: nine residues of HER2 mixed with GM-CSF, aimed at cells left behind after breast cancer treatment. The phase 3 found no difference in recurrence.
Common vial size is what vendors typically sell, not a recommendation. Enter your own vial in the calculator.
What is Nelipepimut-S (NeuVax)?
Plain language first. The technical label stays, but it never stands alone.Overview
Most breast cancer deaths come from cells left behind after surgery and chemotherapy, so a vaccine that teaches killer T cells to hunt those cells was worth testing, especially for tumors with too little HER2 for trastuzumab. In PRESENT, 758 women received either the vaccine with GM-CSF or GM-CSF alone, and an interim analysis found no significant difference in recurrence, so the trial was stopped; no hazard ratio for that endpoint has ever been published. The encouraging figures still quoted for it, 89.7% against 80.2% recurrence-free survival at five years, come from an earlier study whose comparison group was not randomized and whose p value was 0.08. It was never approved, and the only people who received it were enrolled in trials and tissue-typed first.
Nelipepimut-S is the nine-residue peptide KIFGSLAFL, residues 369 to 377 of human HER2, an HLA-A2 and HLA-A3 restricted class I epitope used as the acetate salt with no carrier protein and no chemical modification. Trial staff injected 1,000 mcg into the skin, mixed at the bedside with 250 mcg of sargramostim (GM-CSF), to expand HER2-specific CD8 T cells in women whose tumors carried too little HER2 to qualify for trastuzumab. The 758-patient PRESENT phase 3 was stopped for futility in June 2016, and the compound no longer appears in its owner's pipeline.
What it's used for
Nothing in medicine. It was an experimental breast cancer vaccine, injected by clinic staff only, and its last trials finished without a result that carried it forward.
How does Nelipepimut-S (NeuVax) work?
What it does in the body, and where.A peptide vaccine holds no drug: it holds a short fragment of a protein, injected so that killer T cells learn to destroy cells displaying that fragment.
- 01Nine residues is exactly the right lengthThe groove of an HLA class I molecule holds a peptide of about nine residues, and KIFGSLAFL is that length already, so it can load straight onto HLA-A2 or HLA-A3 at the injection site with no processing. It is a native stretch of HER2, residues 369 to 377, with no ring, no fatty chain and no carrier protein. Peptides do other jobs in cancer treatment too: zelenectide pevedotin is a peptide used as a delivery vehicle for chemotherapy rather than as an immune lesson.
- 02GM-CSF does the recruitingThe peptide on its own would be ignored, so 1,000 mcg of it was mixed at the bedside with 250 mcg of sargramostim, a manufactured form of GM-CSF, and injected into the skin as four small doses on the upper thigh. GM-CSF draws dendritic cells to the site and matures them, so they carry the peptide to the lymph nodes and show it to T cells.
- 03What limits the ideaT cells trained this way are meant to find residual cells carrying HER2, including the faintly positive tumors trastuzumab is not used for. Three things narrow the odds. Only women with a matching tissue type can respond, the target is present at low levels by definition, and a measurable T cell response is not the same as fewer recurrences. In the ductal carcinoma in situ trial the T cell response itself did not appear at all (p=0.71).
A schematic of the compound's mechanism, not a diagnostic image.
What else is it used for?
Each group carries its own evidence level.Approved means regulators have cleared it for that purpose. Investigational means it is in trials. Early research means it is being studied and is not established.
The phase 3 (PRESENT)
tested-and-failed- Human trial758 women randomized to the vaccine with GM-CSF or GM-CSF alone: no significant difference in disease-free survival at the interim analysis, median follow-up 16.8 months, and the trial stopped for futility in June 2016.
- No dataNo hazard ratio or confidence interval for disease-free survival has appeared in the publication or in any sponsor release, so any number quoted for it is unsourced.
- No dataThe control arm received GM-CSF alone rather than an inert placebo, and the event count at the interim analysis is given as 73 in the paper against 70 triggering and 71 reviewed in the sponsor's release.
How the recurrences were counted
tested-and-failed- Human trialProtocol-mandated annual imaging counted new abnormalities as recurrence events without requiring a biopsy, and 54.1% of the events in the vaccine arm came from scans in women with no symptoms against 29.2% in the control arm (P=0.069).
- No dataThe authors concluded that the mandated scans and image-detected events hastened the interim analysis and contributed to the early stop, so the trial design shaped the result as well as the vaccine.
The early figures that still circulate
Early research- human-early187 assessable patients: 5-year disease-free survival 89.7% in the 108 vaccinated against 80.2% in the 79 controls, P=0.08.
- No dataThe controls were women whose tissue type did not match, enrolled prospectively and never randomized, and 65% of the vaccinated patients got less than the dose later judged optimal; among those optimally dosed it was 94.6% (P=0.05) and among the rest 87.1%. Of 21 patients given the full booster program, 1 recurred.
With trastuzumab
tested-and-failed- Human trialPhase 2b, 275 randomized in HER2-low disease: 24-month disease-free survival 89.8% against 83.8%, hazard ratio 0.62 (95% CI 0.31 to 1.25), P=0.18, so the primary endpoint was missed; 36-month figures were 86.7% against 80.8%.
- No dataA prespecified exploratory triple-negative subgroup favored the vaccine (hazard ratio 0.26, 95% CI 0.08 to 0.81, P=0.01) on small numbers. The authors called for a phase 3 and it was never run.
- No dataA separate 100-patient phase 2 in HER2-positive disease posted bare counts of 42 of 50 against 47 of 50 with no analysis, no p value and no publication, so it supports nothing either way.
Ductal carcinoma in situ (VADIS)
tested-and-failed- Human trialThe NCI's phase 2 measured the change in peptide-specific killer T cells a month after surgery as its primary endpoint: 0.09% in controls against 0.02% with the vaccine, p=0.71, so no immune response was detected.
- No dataTumor-infiltrating lymphocytes and HER2 expression also showed no significant change, and the record's enrollment field (43) disagrees with the 13 patients randomized in the posted results, so its other numbers are not worth quoting.
The numbers that travel furthest are the weakest ones. The 89.7% against 80.2% five-year recurrence-free survival often reported for it comes from a phase 1/2 in which the comparison group was women whose tissue type did not match, enrolled prospectively but never randomized, and the difference was not significant (P=0.08). The 94.6% figure is narrower still: it describes the subgroup that received the dose later judged optimal, in a study where 65% of patients got less than that. The triple-negative hazard ratio of 0.26 is a prespecified exploratory subgroup of the 275-patient phase 2b whose primary endpoint failed, and the phase 3 its authors called for was never run. A hazard ratio is sometimes quoted for PRESENT itself; none has been published, so the correct statement is that there was no significant difference in disease-free survival. Event counts for that interim analysis disagree, at 73 in the publication against 70 triggering the analysis and 71 reviewed in the sponsor's release. The dose is 1,000 mcg with 250 mcg of GM-CSF; the 1.5 mg/mL seen in the registry is the concentration of the solution. The registry record for PRESENT describes the peptide as HER2/neu p366-379, a 14-residue span, and that is wrong: it is the 9-residue stretch at 369 to 377, checked against the human HER2 entry in UniProt. Names cause the rest of the trouble. E75 also names a fruit fly nuclear receptor and a European road, so it only makes sense written as nelipepimut-S or HER2 369-377; NeuVax was never an approved brand; nelipepimut-S is not galinpepimut-S, the same company's WT1 vaccine, nor the related HER2 peptides GP2 and AE37 from the same research program. Three peptide vaccines get mixed up with one another: this one is a bare 9-mer given with GM-CSF, rindopepimut is a 14-mer tied to a carrier protein, and tertomotide is a 16-mer from telomerase. The free nine-residue peptide is listed by life-science reagent suppliers for laboratory work, not by the vendors this site's readers use, and what those catalogs ship is not the trial product: PRESENT used the acetate salt mixed with GM-CSF and injected by clinic staff into tissue-typed women.
The published record
Papers and trials about Nelipepimut-S (NeuVax)
29 papers tagged human · 16 not reviews or lab · 13 clinical trial publications
4 registered trials · 3 with posted results
Furthest stage reached: Phase 3, completed, no results posted
Counted from Europe PMC indexing, not read by a person; a human tag can land on reviews, commentary or lab papers; clinical trial publications is the narrower count.
At a glance
Four things to know about Nelipepimut-S (NeuVax)
Evidence
Investigational
Category
Immune support
Common vial
Varies
Half-life
Not established
How much, and do you cycle it?
The range, and whether you take breaks.1,000 mcg with 250 mcg GM-CSF (PRESENT phase 3), monthly for 6 months, then boosters every 6 months (trial). Six monthly injections, then boosters every 6 months through 36 months Trial dose
PRESENT set a fixed course of six priming doses and five boosters rather than open-ended treatment. The program is dormant, so there is no schedule to plan around.
Not establishedNo figure
No pharmacokinetic data were published, and none would be expected: a nine-residue peptide injected into the skin is taken up on the spot by antigen-presenting cells rather than circulating as a drug. The trials measured the immune response instead, as peptide-specific T cell frequency and skin test reactions.
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How is it given?
Dosing context and source notes.Given in hospital from a prepared product, so there is nothing to mix.
Trial dose: 1000 mcg per dose. ClinicalTrials.gov, PRESENT (NCT01479244)
Injected into the skin by clinic staff, never by a patient. In PRESENT, 1,000 mcg of nelipepimut-S acetate, supplied at 1.5 mg/mL in water for injection, was mixed with 250 mcg of sargramostim immediately before use and given as four divided injections at four sites on the upper thigh, monthly for 6 months and then as boosters every 6 months through 36 months. The control arm received the 250 mcg of sargramostim alone. That 1.5 mg/mL is the concentration of the solution, not the dose. The trastuzumab combination trials used the same 1,000 mcg with 250 mcg of GM-CSF every 3 weeks for 6 doses, then 4 boosters 6 months apart. Entry required a matching tissue type, HLA-A2 or HLA-A3 in PRESENT and HLA-A2, A3, A24 or A26 in the trastuzumab trials, there was never a commercial presentation, strength or form, and no adjustment data exist, so the calculator has no dose to draw.
How do you store it?
Before mixing, and after.Given in a hospital or trial clinic, so the pharmacy stores it.
Nelipepimut-S (NeuVax) is prepared and given by hospital, clinic or trial staff, following the product label or the trial protocol. Some products like this arrive ready to use and others are mixed just before the dose, often with hours rather than weeks of shelf life once prepared. It is not a medicine people store at home.
What are the side effects and cautions?
Known cautions and warnings for this compound.Solubility, computed: 33% charged residues, 67% hydrophobic. Water usually sufficient.
A first-pass rule from peptide manufacturers' guidance. It does not account for disulfide bridges, salt form or how the powder was dried, and it predicts what should be easy rather than what will happen in your vial.
Who should avoid it
- Not studied in anyone with an autoimmune disease or an immune deficiency
- Not studied in anyone on long-term steroids or other immune-suppressing treatment
- Not studied in anyone with severe heart failure (New York Heart Association class 3 or 4) or grade 2 or worse nerve damage
- The phase 3 and the HER2-low phase 2b excluded anyone who had already had trastuzumab, or who had bilateral or inflammatory breast cancer or an earlier breast cancer; the HER2-positive phase 2 required prior trastuzumab instead
- Trials enrolled only women with a matching tissue type: HLA-A2 or HLA-A3 in the phase 3, with HLA-A24 or HLA-A26 also accepted in the trastuzumab trials, since a peptide vaccine does nothing without a matching tissue type
- Never available outside a clinical trial: nothing was ever marketed anywhere
Stop and get help
- Hives, swelling of the lips or face, or trouble breathing after an injection
- An injection site that grows hot, hard and more painful over days instead of settling
Common effects
- In PRESENT, injection-site redness in 84.3%, firm swelling in 55.8% and itching in 54.9%; the per-arm split was not published
- In the 275-patient phase 2b with trastuzumab, the authors reported no extra overall or heart toxicity against the control arm, and heart pumping measurements at 24 months were no different from the start (p=0.58), and no different between the arms (p=0.91)
- In the 100-patient HER2-positive phase 2, serious adverse events were 3 of 50 against 5 of 50 on GM-CSF alone, with one death in the control arm and none in the vaccine arm
- In the earlier phase 1/2, followed for 60 months, toxicity was described as minimal
Where this page says nothing is established, that means nobody has studied it, not that a compound is safe.
Is Nelipepimut-S (NeuVax) approved?
And where the numbers on this page come from.No. Nelipepimut-S (NeuVax) was never approved, and no development has been reported in recent years. There is no legal route to obtain it as a medicine.
- Approval statusInvestigational
- RouteInto the skin (intradermal), mixed with GM-CSF
- Checked21 October 2026
- DoseFrom published clinical trials. Not approved by a regulator for this dose.
- Vial sizeFrom what vendors typically list; not a recommendation.
- SourcesUniProt P04626, human HER2 (ERBB2) sequenceFDA GSRS substance record, nelipepimut-S (UNII 7M0A29CD8B)ClinicalTrials.gov, PRESENT (NCT01479244)Mittendorf EA et al., Clinical Cancer Research 2019;25:4248-4254 (PRESENT)Galena Biopharma, PRESENT discontinuation (SEC exhibit, June 29, 2016)Galena Biopharma, second-quarter 2016 report (SEC exhibit, August 9, 2016)Mittendorf EA et al., Annals of Oncology 2014;25:1735-1742 (phase 1/2 final report)Clifton GT et al., Clinical Cancer Research 2020;26:2515-2523 (phase 2b with trastuzumab)ClinicalTrials.gov, phase 2b with trastuzumab (NCT01570036)ClinicalTrials.gov, HER2-positive phase 2 (NCT02297698)ClinicalTrials.gov, VADIS in ductal carcinoma in situ (NCT02636582)SELLAS Life Sciences Group, annual report for 2017SELLAS Life Sciences Group, 2024 prospectus supplementSELLAS Life Sciences Group, pipeline page
What has happened recently
Never approved by any agency and never marketed. Apthera developed it as NeuVax, a development name that was never an approved brand, and Galena Biopharma held the program when the PRESENT phase 3 began in November 2011 under an FDA special protocol assessment. The FDA granted fast track designation, announced on June 1, 2016, for nelipepimut-S with GM-CSF in early-stage, node-positive breast cancer with HER2 at 1+ or 2+. No orphan designation and no breakthrough therapy designation have been documented for it, so claims of either are unsupported. The lead trial collapsed three weeks after the fast track news: the independent data monitoring committee met on June 24, 2016, dated its letter recommending a futility stop on June 27, and Galena announced the recommendation and halted the trial on June 29. On August 9, 2016, Galena reported that its own investigation had confirmed the committee's finding and had turned up no evidence of a systemic reversal of the treatment arms, a possibility the committee's letter had raised. The Galena and SELLAS business combination completed on December 29, 2017, renaming the company SELLAS Life Sciences Group and moving it to Nasdaq as SLS on January 2, 2018; its 2017 annual report still described investigator-sponsored phase 2 work and a plan to seek FDA guidance on the triple-negative indication. SELLAS's 2024 prospectus and its current pipeline list only galinpepimut-S and SLS009, with no mention of nelipepimut-S, and no formal termination of the program followed the June 2016 discontinuation of the phase 3, so it counts as inactive rather than discontinued.
You can compare this against the whole library, or read how to check a seller.
What else is like Nelipepimut-S (NeuVax)?
Others in Immune support, side by side.If you're weighing Nelipepimut-S (NeuVax), it's worth reading Tertomotide (GV1001), Darobactin A, and Thymalin in the same class.
A peptide cancer vaccine given by clinic staff to women with a matching tissue type: nine residues of HER2 mixed with GM-CSF, aimed at cells left behind after breast cancer treatment. The phase 3 found no difference in recurrence.
- Dose
- 1,000 mcg with 250 mcg GM-CSF (PRESENT phase 3)
- How often
- Monthly for 6 months, then boosters every 6 months (trial)
A 16-amino-acid piece of telomerase, injected with GM-CSF to make T cells attack tumors. It is the rare investigational peptide that was approved, in South Korea, and then had the approval taken away.
- Dose
- 0.56 to 1.12 mg per dose (phase 2a trial)
- How often
- Weekly for 4 weeks, then every 2 weeks
Seven amino acids stitched into two fused rings by bacteria that live inside insect-killing nematodes. It blocks the machine that builds the outer wall of Gram-negative bacteria, a target nothing in the clinic hits.
- Dose
- No human dose exists: no person has received it
- How often
- Not applicable
A thymus peptide taken in courses to refresh immune function and aging.
- Dose
- 5 up to 10 mg per day (start low, increase slowly)
- How often
- 10-day courses
Guides for this compound
- How to Reconstitute a Peptide
Mix peptide powder with bacteriostatic water, step by step.
- How to Read an Insulin Syringe
Read the units, convert to millilitres, and draw the exact dose.
- mcg vs mg: The Peptide Dosing Mistake to Avoid
Your vial says mg and your protocol says mcg. Here is the conversion and how to check it.
- How to Read a Peptide COA
What the purity number does and does not tell you, and how to spot an edited report.
- How to Vet a Peptide Vendor
Independent COAs, HPLC purity, and the red flags that mean walk away.
Sources
- UniProt P04626, human HER2 (ERBB2) sequence(2026)Residues 361 to 420 read IQEFAGCKKIFGSLAFLPESF..., confirming residue by residue that 369 to 377 is KIFGSLAFL.
- FDA GSRS substance record, nelipepimut-S (UNII 7M0A29CD8B)(2026)Nine-residue subunit KIFGSLAFL, recorded as a human T-cell antigen peptide with no modifications; a second record, UNII HAB4B44DVX, is the acetate; USAN code ZZ-143; CAS 160212-35-1 for the free peptide and 1361396-07-7 for the acetate.
- ClinicalTrials.gov, PRESENT (NCT01479244)(2016)758 enrolled; node-positive, HER2 1+ or 2+ without amplification, HLA-A2 or HLA-A3 positive; acetate at 1.5 mg/mL with 250 mcg sargramostim against sargramostim alone; disease-free survival as the primary endpoint; no posted results.
- Mittendorf EA et al., Clinical Cancer Research 2019;25:4248-4254 (PRESENT)(2019)Interim analysis after 73 disease-free survival events: no significant difference between arms at a median follow-up of 16.8 months, with no hazard ratio published; redness 84.3%, firm swelling 55.8%, itching 54.9%; image-detected events in symptom-free patients 54.1% against 29.2% (P=0.069).
- Galena Biopharma, PRESENT discontinuation (SEC exhibit, June 29, 2016)(2016)Committee letter dated June 27, 2016, recommending a futility stop; interim triggered at 70 events with 71 reviewed; final analysis had been planned at 141 events with at least 3 years of follow-up; PRESENT ran under an FDA special protocol assessment.
- Galena Biopharma, second-quarter 2016 report (SEC exhibit, August 9, 2016)(2016)Committee met June 24, 2016; the company's own investigation found no evidence of a reversal of treatment arms and the trial was closed; FDA fast track designation announced June 1, 2016.
- Mittendorf EA et al., Annals of Oncology 2014;25:1735-1742 (phase 1/2 final report)(2014)187 assessable patients, 108 vaccinated against 79 non-randomized controls whose tissue type did not match: 5-year disease-free survival 89.7% against 80.2%, P=0.08; 65% received less than the dose later judged optimal; optimally dosed 94.6% (P=0.05), suboptimally dosed 87.1%.
- Clifton GT et al., Clinical Cancer Research 2020;26:2515-2523 (phase 2b with trastuzumab)(2020)275 randomized: 24-month disease-free survival 89.8% against 83.8%, hazard ratio 0.62 (95% CI 0.31 to 1.25), P=0.18; triple-negative subgroup hazard ratio 0.26 (95% CI 0.08 to 0.81), P=0.01; no extra overall or heart toxicity.
- ClinicalTrials.gov, phase 2b with trastuzumab (NCT01570036)(2020)Doses and schedule; 36-month disease-free survival 86.7% against 80.8%; posted grade 3 reaction rates that read backward against the control arm, with p values that do not match the percentages.
- ClinicalTrials.gov, HER2-positive phase 2 (NCT02297698)(2023)100 patients, 50 per arm: the posted primary outcome is bare counts of 42 of 50 against 47 of 50, with no hazard ratio, p value or definition of what is counted; serious adverse events 3 of 50 against 5 of 50; no publication cited.
- ClinicalTrials.gov, VADIS in ductal carcinoma in situ (NCT02636582)(2023)NCI-sponsored; primary endpoint, the change in peptide-specific T cell response a month after surgery, was 0.09% in controls against 0.02% with the vaccine, p=0.71; enrollment field 43 against 13 randomized in the posted results.
- SELLAS Life Sciences Group, annual report for 2017(2018)Galena and SELLAS combination completed December 29, 2017, trading as SLS from January 2, 2018; fast track designation held; investigator-sponsored phase 2 work described; orphan designations belong to galinpepimut-S, not to this compound.
- SELLAS Life Sciences Group, 2024 prospectus supplement(2024)Lists only galinpepimut-S and SLS009 as product candidates, with no mention of nelipepimut-S or NeuVax.
- SELLAS Life Sciences Group, pipeline page(2026)Current programs are galinpepimut-S and SLS009; nelipepimut-S does not appear.
Beyond these, 34 records are indexed. Browse the records