GV1001
aka GV1001 vaccine · hTERT peptide vaccine · telomerase vaccine
A 16-amino acid peptide derived from the active site of human telomerase reverse transcriptase (hTERT). Originally developed as a cancer immunotherapy vaccine, now investigated for anti-inflammatory and anti-aging properties.
Sequence
EARPALLTSRLRFIPK
Glu-Ala-Arg-Pro-Ala-Leu-Leu-Thr-Ser-Arg-Leu-Arg-Phe-Ile-Pro-Lys-OH
Mechanism of action
GV1001 is a promiscuous MHC class II-binding peptide that induces CD4+ and CD8+ T-cell responses against hTERT-expressing cells. Beyond immunotherapy, GV1001 has been shown to have direct anti-inflammatory effects by inhibiting NF-kB signaling, anti-apoptotic properties, and neuroprotective effects. It can penetrate cells via heat shock protein (HSP) pathways and modulate intracellular signaling independent of immune response.
What the evidence actually shows
Phase 3 clinical trials completed for pancreatic cancer (TeloVac trial). Anti-inflammatory and neuroprotective effects demonstrated in preclinical models. Multiple studies on immune response induction.
Regulatory status
Pharmacokinetics
Dosing — what backs each figure
GV1001 has genuine published oncology trial dosing: 0.112-1.87 mg intradermally with 30 mcg GM-CSF adjuvant on a fixed seven-injection schedule over 10 weeks in phase I/II pancreatic cancer, taken forward at the intermediate dose into the phase 3 TeloVac trial, which was negative. It is not approved anywhere and there is no established therapeutic dose.
Three dose levels of GV1001 by intradermal injection in the right para-umbilical area: 0.112 mg (low), 0.560 mg (intermediate), 1.87 mg (high). Each vaccination preceded 5-15 minutes earlier by 30 mcg GM-CSF intradermally at the same site. Schedule: three injections in week 1 (Mon/Tue/Fri) then one weekly injection in weeks 2, 3, 4, 6 and 10 (seven injections over the 10-week treatment period), followed by optional monthly boosters for up to one year
48 patients with non-resectable pancreatic cancer (dose-escalating phase I/II) · intradermal
GV1001 telomerase peptide vaccine given sequentially or concurrently with gemcitabine and capecitabine chemotherapy in a randomised open-label phase 3 trial (TeloVac); the trial did not demonstrate a survival benefit for adding GV1001
Patients with locally advanced or metastatic pancreatic cancer · intradermal (with GM-CSF)
Handling and storage
Safety
References (3)
- Middleton 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 ↗The Lancet OncologyPMID 24954781DOI
Three-group open-label randomised phase 3 trial in 51 UK hospitals; adding sequential or concurrent GV1001 to gemcitabine/capecitabine did not improve overall survival in advanced pancreatic ductal adenocarcinoma.
- Koh SH, et al. (2021) Efficacy and safety of GV1001 in patients with moderate-to-severe Alzheimer's disease already receiving donepezil: a phase 2 randomized, double-blind, placebo-controlled, multicenter clinical trial ↗Alzheimer's Research & TherapyPMID 33771205DOI
96 patients with moderate-to-severe Alzheimer's disease at 13 South Korean centres were randomised 1:1:1 to placebo, subcutaneous GV1001 0.56 mg or 1.12 mg over 6 months.
- Shin TJ, et al. (2025) A randomized, active-controlled, multicenter, phase 3 clinical trial to evaluate the efficacy and safety of GV1001 in patients with benign prostatic hyperplasia ↗Prostate InternationalPMID 40620871DOI
423 men aged 50 or over with prostate volume above 30 mL were randomised to GV1001 0.56 mg, GV1001 1.12 mg or finasteride 5 mg, with study drug given at clinic visits every 2 weeks from week 0 to 22.
Data provenance
Chemistry and citations on this page were checked against primary sources on 2026-08-14. Values that could not be verified were left blank rather than filled with a plausible guess.
Could not verify
storage.lyophilized, storage.reconstituted, storage.lightSensitive, reconstitution.solvent