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DRUG:

LucaVax (tertomotide)

i
Other names: GV1001, hTERT RNA vaccine, telomerase peptide vaccine, GV-1001
Company:
GemVax & KAEL, Samsung Pharm
Drug class:
Telomerase inhibitor, Viral replication inhibitor, HBsAg release inhibitor
13d
Administration of GV1001 for the Treatment of Progressive Supranuclear Palsy Who Completed Study GV1001-PSP-CL2-011 (clinicaltrials.gov)
P2, N=67, Completed, GemVax & Kael | Active, not recruiting --> Completed | Trial completion date: Dec 2025 --> Sep 2025
Trial completion • Trial completion date
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LucaVax (tertomotide)
15d
Evaluation of the Safety, Tolerability and PK Characteristics of GV1001 in Healthy Subjects (clinicaltrials.gov)
P1, N=59, Completed, GemVax & Kael | Recruiting --> Completed | Trial completion date: Dec 2025 --> Aug 2025
Trial completion • Trial completion date
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LucaVax (tertomotide)
1m
Therapeutic effects of telomerase-derived peptide GV1001 in experimental autoimmune encephalomyelitis: Inhibiting neuroinflammation and promoting remyelination. (PubMed, Biochem Pharmacol)
Co-culture assays confirmed that GV1001 blunts microglial neurotoxicity and facilitates remyelination during inflammation. Collectively, the data indicate that GV1001 modulates microglial activity to attenuate neuroinflammation and foster spinal cord repair, underscoring its promise as a multitarget therapy for inflammatory demyelinating diseases such as multiple sclerosis.
Journal
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TERT (Telomerase Reverse Transcriptase) • IGF1 (Insulin-like growth factor 1) • PRMT1 (Protein Arginine Methyltransferase 1)
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LucaVax (tertomotide)
3ms
GV1001 Subcutaneous(SC) for the Treatment of Mild to Moderate Alzheimer's Disease (AD) (clinicaltrials.gov)
P2, N=199, Completed, GemVax & Kael | Active, not recruiting --> Completed | Trial completion date: Mar 2026 --> Apr 2025
Trial completion • Trial completion date
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LucaVax (tertomotide)
1year
Administration of GV1001 for the Treatment of Progressive Supranuclear Palsy Who Completed Study GV1001-PSP-CL2-011 (clinicaltrials.gov)
P2, N=67, Active, not recruiting, GemVax & Kael | Recruiting --> Active, not recruiting | Trial completion date: Jul 2025 --> Dec 2025 | Trial primary completion date: Dec 2024 --> Nov 2025
Enrollment closed • Trial completion date • Trial primary completion date
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LucaVax (tertomotide)
1year
GV1001 Subcutaneous(SC) for the Treatment of Progressive Supranuclear Palsy (PSP) (clinicaltrials.gov)
P2, N=78, Completed, GemVax & Kael | Recruiting --> Completed | Trial completion date: May 2024 --> Oct 2024 | Trial primary completion date: Dec 2023 --> Oct 2024
Trial completion • Trial completion date • Trial primary completion date
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LucaVax (tertomotide)
1year
Enrollment open
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LucaVax (tertomotide)
1year
New P1 trial
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LucaVax (tertomotide)
over1year
The Cell-Penetrating Peptide GV1001 Enhances Bone Formation via Pin1-Mediated Augmentation of Runx2 and Osterix Stability. (PubMed, Biomolecules)
GV1001 demonstrated protective effects against bone loss in OVX mice by upregulating osteogenic differentiation via the Pin1-mediated protein stabilization of Runx2 and Osterix. GV1001 could be a potential candidate with anabolic effects for the prevention and treatment of osteoporosis.
Journal
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PIN1 (Peptidylprolyl Cis/Trans Isomerase, NIMA-Interacting 1) • RUNX2 (RUNX Family Transcription Factor 2)
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LucaVax (tertomotide)
over1year
hTERT Peptide Fragment GV1001 Prevents the Development of Porphyromonas gingivalis-Induced Periodontal Disease and Systemic Disorders in ApoE-Deficient Mice. (PubMed, Int J Mol Sci)
GV1001 also suppressed the accumulation of AD biomarkers in the brains of mice with periodontal disease. Overall, these findings suggest that GV1001 holds promise as a preventive agent in the development of atherosclerosis and AD-like conditions associated with periodontal disease.
Preclinical • Journal
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APOE (Apolipoprotein E)
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LucaVax (tertomotide)
over1year
GV1001 Subcutaneous(SC) for the Treatment of Mild to Moderate Alzheimer's Disease (AD) (clinicaltrials.gov)
P2, N=180, Active, not recruiting, GemVax & Kael | Trial primary completion date: Sep 2025 --> Apr 2025
Trial primary completion date
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LucaVax (tertomotide)
over1year
GV1001 Subcutaneous(SC) for the Treatment of Mild to Moderate Alzheimer's Disease (AD) (clinicaltrials.gov)
P2, N=180, Active, not recruiting, GemVax & Kael | Recruiting --> Active, not recruiting | Trial completion date: Sep 2024 --> Mar 2026 | Trial primary completion date: Jul 2023 --> Sep 2025
Enrollment closed • Trial completion date • Trial primary completion date
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LucaVax (tertomotide)