GV1001

tertomotide, GV1001, Riavax, Tertomotide hydrochloride; hTERT 611–626 (sequence EARPALLTSRLRFIPK)

Oncology & imaging

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

Note on this profile. GV1001 is given only under medical supervision in clinical trials, and in one or two jurisdictions under a conditional national approval. It is not obtained or used outside those settings, and nothing here describes self-preparation.

Summary

Class: Synthetic 16-amino-acid peptide from the active site of human telomerase reverse transcriptase (hTERT); a "promiscuous" binder that fits many MHC class II alleles, so no HLA pre-selection is needed
Mechanism: Presents a telomerase fragment to helper (CD4+) T cells, which in turn support CD8+ responses against the telomerase-positive cells found in most cancers; the same peptide also has direct anti-inflammatory and cell-penetrating properties independent of vaccination
Routes studied: Intradermal injection with GM-CSF pre-injection at the same site; schedules of weekly then monthly dosing
Half-life: Plasma half-life is short (minutes); the relevant duration is that of the T-cell response, measured in months
Storage: Refrigerated vialled product; prepared by trial or hospital pharmacy
Regulatory status: Not approved in the US, EU, UK, Australia or South Africa. A conditional national approval in South Korea has been reported †. See region table

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

1What it is

Telomerase is the enzyme that rebuilds the ends of chromosomes. It is switched off in most adult tissue but reactivated in roughly 85–90% of human cancers, which makes it one of the few genuinely near-universal tumour antigens. GV1001 is a 16-amino-acid stretch of the enzyme's active site, long enough to be processed and presented on MHC class II by many different HLA types — an unusual and practically important property, because most peptide vaccines only work in people with a particular HLA allele.

GV1001 has an unusual second life. The same peptide is cell-penetrating and has been reported to have direct anti-inflammatory, anti-fibrotic and mitochondria-protective effects in models unrelated to its vaccine function, which is why it has been trialled in benign prostatic hyperplasia, Alzheimer's disease and chronic prostatitis as well as cancer.

2How it's thought to work

As a vaccine: GM-CSF injected first at the site draws in dendritic cells; the peptide is then taken up, processed and presented on MHC class II, expanding hTERT-specific CD4+ helper T cells. Those helper cells are intended to license and sustain CD8+ cytotoxic responses against telomerase-expressing tumour cells, and to generate durable memory.

As a direct-acting peptide: GV1001 contains a basic, cell-penetrating motif and has been reported in cell and rodent work to enter cells, localise to mitochondria, reduce reactive oxygen species, dampen NF-κB-driven inflammatory signalling and modulate steroid-receptor signalling. These mechanisms are independent of immunisation and are the stated rationale for the non-cancer trials. Evidence for them is preclinical.

A sixteen-amino-acid fragment of telomerase, an enzyme most cancers reactivate. Presented to helper T cells, it aims to raise a response against any cell expressing telomerase.Schematic — not to scale

3What the research shows

Graded A (negative)

Advanced pancreatic cancer

TeloVac, a UK phase 3 trial in 1,062 patients, compared gemcitabine plus capecitabine alone with the same chemotherapy given either sequentially or concurrently with GV1001. Neither vaccine arm improved overall survival (medians of roughly 7.9, 6.9 and 8.4 months across the three arms), and the trial was unambiguously negative (Middleton 2014, Lancet Oncology). An earlier single-arm phase 1/2 had reported encouraging survival in immune responders, which did not survive randomisation. TeloVac is one of the largest cancer-vaccine trials ever run and its result should be stated plainly: no benefit. [1]

Graded A (small)

Benign prostatic hyperplasia

Randomised, placebo-controlled trials in South Korea reported improvements in International Prostate Symptom Score and prostate volume versus placebo. These are the basis of the reported Korean approval and sit outside the oncology story entirely; they are modest in size and have not been replicated outside the originating country or sponsor †.

Alzheimer's disease

A phase 2 trial reported safety and some signals on cognitive and biomarker endpoints in a small cohort. Underpowered; no confirmatory trial has reported.

Other cancers

Phase 1/2 experience in non-small-cell lung cancer, hepatocellular carcinoma and melanoma reported immune responses in a majority of patients with limited clinical signal. No positive randomised oncology trial exists.

Immune response as a surrogate

Across trials, 50–80% of patients mounted a detectable hTERT-specific T-cell response. The repeated observation that responders did better than non-responders is confounded by prognosis — healthier patients mount better immune responses — and did not predict a randomised benefit.

4Reported side effects and interactions

Literature-reported

injection-site reactions (erythema, induration, pruritus) in the majority, largely from GM-CSF; flu-like symptoms; fatigue. In TeloVac the serious adverse-event profile was dominated by the chemotherapy backbone, and adding GV1001 did not increase it materially. Long-term safety data outside trials is limited.

Community-reported

Community use: essentially none documented.

Theoretical. telomerase is expressed in stem cells, germ cells and activated lymphocytes, so autoimmune damage to those compartments was a predicted risk. It has not been observed at the doses and durations tested, but no long-term immunological follow-up exists.

Interactions. GM-CSF (used deliberately as adjuvant); cytotoxic chemotherapy may blunt or, in some schedules, enhance the response — TeloVac's sequential versus concurrent comparison was designed to test exactly this and found neither helped; corticosteroids would be expected to suppress the response.

Markers researchers commonly monitor

From trial protocols:

Marker	Why it's watched
hTERT-specific T-cell response (ELISpot, proliferation assays, delayed-type hypersensitivity)	the pharmacodynamic readout. Note the confounding above: response status tracks baseline health as much as vaccine effect.
CA 19-9	the pancreatic-cancer tumour marker used alongside imaging in TeloVac and its predecessors.
Overall survival and RECIST imaging	the endpoints that decided the question.
Regulatory T-cell fraction and myeloid-derived suppressor cells	explored as explanations for non-response.
International Prostate Symptom Score, prostate volume by ultrasound, PSA	the BPH trial endpoints, included here for completeness because they are a separate evidence stream.
CBC, CMP, liver and renal function	standard oncology safety monitoring, driven mainly by concurrent chemotherapy.

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

5Formulation and administration context

Supplied as a refrigerated solution or peptide prepared by pharmacy. The clinical procedure is specific: GM-CSF intradermally first, then GV1001 injected into the same site shortly after, with the schedule front-loaded over the first three weeks before monthly maintenance. The intradermal route and the same-site sequencing are part of the design, not incidental. No self-prepared, compounded or outpatient version exists, and no dose calculation is appropriate to publish.

6Commonly studied alongside

GM-CSF (sargramostim) as the standing adjuvant; gemcitabine and capecitabine (TeloVac backbone); checkpoint inhibitors in later exploratory work. Conceptually related: IMA901 and multi-peptide tumour vaccines (profile 236), SurVaxM (profile 234) — another vaccine against a near-universal tumour-survival antigen.

Informational cross-links. Not stack recommendations.

7Regulatory status by region

Region	Status (checked —)
United States	Not FDA-approved; investigational only
European Union	Not authorised
United Kingdom	Not licensed. TeloVac was a UK academic phase 3 and was negative
Australia	Not approved
South Africa	Not registered with SAHPRA
Other	A conditional South Korean approval for a non-oncology indication has been reported in secondary sources; status, scope and whether it remains current are unconfirmed here †
Sport	Not listed by WADA; no performance application

8Open questions

Why did a class II, HLA-promiscuous vaccine against a near-universal antigen fail so completely in pancreatic cancer — tumour microenvironment, antigen presentation, or wrong disease setting?
Are the direct, non-vaccine anti-inflammatory effects reported in cell and animal work real in humans at the doses used?
Does the reported BPH benefit replicate independently?

9References

1Middleton G et al. (2014). Gemcitabine and capecitabine with or without telomerase peptide vaccine GV1001 in patients with locally advanced or metastatic pancreatic cancer (TeloVac): an open-label, randomised, phase 3 trial. Lancet Oncology. PubMed
2Bernhardt SL et al. (2006). Telomerase peptide vaccination of patients with non-resectable pancreatic cancer: a dose escalating phase I/II study. British Journal of Cancer. PubMed · DOI
3Brunsvig PF et al. (2006). Telomerase peptide vaccination: a phase I/II study in patients with non-small cell lung cancer. Cancer Immunology, Immunotherapy. PubMed · DOI
4Kyte JA (2009). Cancer vaccination with telomerase peptide GV1001 — review. Expert Opinion on Investigational Drugs. PubMed · DOI
5Koh JS et al. (2021). Efficacy and safety of GV1001 in patients with benign prostatic hyperplasia — randomised controlled trial. Journal of Urology or equivalent urology journal [verify journal before publishing]. PubMed
6ClinicalTrials.gov. TeloVac and related GV1001 trial records. 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

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11Page history

31 Oct 2026Profile published — awaiting medical review

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