SurVaxM

SVN53-67/M57-KLH, SurVaxM, survivin peptide mimic vaccine

Oncology & imaging

Awaiting medical reviewEN ES DE FR PT ZH+ Follow for updates

Note on this profile. SurVaxM is an investigational vaccine given only inside clinical trials under neuro-oncology supervision. It is not available outside trials, and nothing here describes self-preparation.

Summary

Class: Synthetic 15-amino-acid survivin peptide with an engineered anchor substitution (M57), conjugated to keyhole limpet haemocyanin (KLH) as a carrier protein; given emulsified in Montanide ISA-51 with GM-CSF
Mechanism: Raises CD8+ and CD4+ T-cell and antibody responses against survivin, a protein that blocks cell death and is strongly expressed by glioblastoma and many other cancers but almost absent from normal adult tissue
Routes studied: Subcutaneous injection of the peptide–KLH conjugate in Montanide emulsion with GM-CSF, four priming doses two weeks apart then maintenance every 8–12 weeks
Half-life: Not a meaningful figure; the conjugate–adjuvant depot and the resulting immune memory are the relevant durations
Storage: Refrigerated trial product, emulsified by pharmacy before each dose
Regulatory status: Not approved anywhere. FDA orphan drug and fast track designations have been reported for glioma indications †. See region table

Doses are as reported in studies or by the community — never recommendations.

1What it is

Survivin (BIRC5) is a small protein that suppresses apoptosis and is needed for cell division. Normal adult tissues express very little of it; glioblastoma, and a long list of other cancers, express a great deal. That contrast makes it an attractive vaccine target — arguably a better one than a differentiation antigen like gp100, because there is less normal tissue to damage.

SurVaxM is not the native survivin sequence. It is a 15-amino-acid region (residues 53–67) with one residue deliberately substituted to improve HLA class I binding, then chemically conjugated to keyhole limpet haemocyanin, a large and strongly immunogenic carrier protein from a sea snail that is widely used to turn small peptides into robust immunogens. The construct is designed to raise helper T cells, cytotoxic T cells and antibodies at once, and it is not restricted to a single HLA type.

2How it's thought to work

The KLH carrier supplies strong, non-tumour helper T-cell epitopes, which is what allows a short tumour peptide to generate a durable response rather than tolerance.

Montanide ISA-51 forms a depot; GM-CSF recruits dendritic cells.

The modified class I epitope is presented to CD8+ T cells, which can kill survivin-expressing glioma cells.

Anti-survivin antibodies are also produced; their contribution is unclear, since survivin is mainly intracellular.

Because survivin is required for tumour-cell survival, the hypothesis is that antigen loss — the usual escape route from a single-antigen vaccine — is harder for the tumour to tolerate.

A survivin peptide vaccine for glioblastoma. Survivin is expressed by the tumour and barely by normal adult tissue, which is what makes it a target.Schematic — not to scale

3What the research shows

Newly diagnosed glioblastoma

A multicentre single-arm phase 2 study added SurVaxM to standard temozolomide maintenance after surgery and radiotherapy in 63 patients with newly diagnosed glioblastoma. Reported outcomes were a median progression-free survival of roughly 11.4 months and median overall survival of roughly 25.9 months, with a high proportion alive at 12 months (Ahluwalia 2023, Clinical Cancer Research). Those figures compare favourably with the historical ~15–16 month median overall survival for standard care, but this was a single-arm trial in a selected population, and selection effects in glioblastoma trials are large and well documented. Grade B, not A. [1]

Graded B (ongoing)

Newly diagnosed glioblastoma, randomised

A randomised, double-blind, placebo-controlled phase 2b trial (the SURVIVE trial) is running in newly diagnosed glioblastoma. A pre-specified interim analysis in 2025 allowed the trial to continue and was described by the sponsor as showing a survival signal; that is a sponsor announcement about an interim look, not a published result, and it carries no more than grade B weight until the full randomised data are published. Final results are pending †.

Recurrent glioblastoma and other settings

Phase 1 experience in recurrent malignant glioma reported safety and immune responses (Fenstermaker 2016, Cancer Immunol Immunother). Early studies in multiple myeloma, neuroendocrine tumours and paediatric diffuse midline glioma have reported immunogenicity in small numbers. [2]

Immunogenicity

Survivin-specific CD8+ T-cell and IgG responses were induced in the large majority of vaccinated patients across studies, and in the phase 2 the magnitude of the antibody response was reported to associate with outcome. Association, not proof of mechanism.

4Reported side effects and interactions

Literature-reported

injection-site reactions are the most common event — erythema, induration and, as with any Montanide product, occasional persistent nodules or sterile abscesses. Fatigue, flu-like symptoms, low-grade fever, myalgia. Serious events in the glioblastoma trials were overwhelmingly attributable to the disease and to temozolomide (cytopenias, seizures, thromboembolism) rather than the vaccine. No autoimmune toxicity signal has been reported, which is consistent with survivin's low expression in normal adult tissue.

Community-reported

Community use: essentially none documented.

Theoretical. survivin is expressed in haematopoietic progenitors and some regenerating tissue, so marrow or mucosal autoimmunity is the mechanistically predicted risk. Not observed to date. KLH conjugates can cause hypersensitivity reactions.

Interactions. temozolomide and dexamethasone are the important ones — both are lymphodepleting or immunosuppressive, and dexamethasone in particular, which almost all glioblastoma patients receive at some point, would be expected to blunt a vaccine response. Trial protocols cap steroid doses for this reason.

Markers researchers commonly monitor

From trial protocols:

Marker	Why it's watched
Survivin-specific CD8+ T-cell frequency and anti-survivin IgG titre	the pharmacodynamic readouts; antibody titre has been reported to associate with survival, which is unusual for a peptide vaccine and worth watching in the randomised data.
Anti-KLH antibody titre	confirms the carrier worked and the patient is not profoundly immunosuppressed.
Progression-free and overall survival; MRI with standardised RANO criteria	the endpoints. Pseudoprogression after immunotherapy makes MRI interpretation genuinely difficult in glioblastoma.
Dexamethasone dose	tracked as a covariate, not a safety marker: high steroid exposure both predicts worse disease and suppresses the vaccine.
Lymphocyte count and CD4 count	temozolomide-induced lymphopenia directly limits what a vaccine can do.
MGMT promoter methylation and IDH status	baseline prognostic markers; they dominate outcome and must be balanced before any survival claim means anything.
CBC, CMP, liver function	routine safety, driven mainly by temozolomide.

Free for everyone. Safety information is never behind a paywall.

5Formulation and administration context

Supplied as a refrigerated peptide–KLH conjugate, emulsified by pharmacy with Montanide ISA-51 and combined with GM-CSF immediately before each injection. The priming schedule is four doses at two-week intervals, followed by maintenance injections every 8–12 weeks for as long as the patient remains on study. Montanide emulsion quality and injection-site rotation are practical handling points in the protocols. There is no self-prepared, compounded or outpatient form of this product and no dose calculation appropriate to publish.

6Commonly studied alongside

Temozolomide and radiotherapy (the standard glioblastoma backbone); GM-CSF and Montanide ISA-51 as adjuvants; pembrolizumab in exploratory combination work. Conceptually related: GV1001 (profile 233) — another vaccine against a near-universal tumour-survival protein; neoantigen peptide vaccines (profile 238).

Informational cross-links. Not stack recommendations.

7Regulatory status by region

Region	Status (checked —)
United States	Not FDA-approved; investigational. Orphan drug and fast track designations in glioma have been reported †
European Union	Not authorised
United Kingdom	Not licensed
Australia	Not approved
South Africa	Not registered with SAHPRA
Sport	Not listed by WADA; no performance application

8Open questions

Will the randomised phase 2b confirm the single-arm survival figures, or will they shrink the way most glioblastoma single-arm results do?
Is the antibody response mechanistically important for an intracellular antigen, or a bystander marker of a competent immune system?
Can steroid exposure be reduced enough in real-world glioblastoma care for a vaccine to work outside a trial population?

9References

1Ahluwalia MS et al. (2023). Phase IIa study of SurVaxM plus adjuvant temozolomide for newly diagnosed glioblastoma. Journal of Clinical Oncology / Clinical Cancer Research [verify which journal before publishing]. PubMed · DOI
2Fenstermaker RA et al. (2016). Clinical study of a survivin long peptide vaccine (SurVaxM) in patients with recurrent malignant glioma. Cancer Immunology, Immunotherapy. PubMed · DOI
3Ciesielski MJ, Fenstermaker RA et al. (2010). Antitumor cytotoxic T-cell response induced by a survivin peptide mimic. Cancer Immunology, Immunotherapy. PubMed · DOI
4Altieri DC (2008). Survivin, cancer networks and pathway-directed drug discovery. Nature Reviews Cancer. PubMed · DOI
5MimiVax (2025). Interim analysis of the randomised phase 2b SURVIVE trial — sponsor announcement [verify; interim, unpublished]. PubMed
6ClinicalTrials.gov. SURVIVE — randomised phase 2b trial of SurVaxM in newly diagnosed glioblastoma. PubMed

References are being resolved to PubMed/DOI identifiers; links search PubMed for the citation until then.

† Being confirmed by our reviewers against current sources.

10Community

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Self-reported side effects Phase 2

Not enough data yet. 0 of the 50 members needed have logged this compound for 4+ weeks. We don't show anything below 50, so no one can be identified.

11Page history

31 Oct 2026Profile published — awaiting medical review

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