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DRUG CLASS:

Telomerase 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)
17d
Combined Inhibition of telomerase and mitochondria synergistically promote apoptosis in AML cell lines. (PubMed, Med Oncol)
This investigation assessed the impact of concurrently targeting telomerase with BIBR1532 and mitochondrial function with Tigecycline on inducing apoptosis in AML cell models. Also, TI/MI significantly changed Bax and Bcl-2 protein levels and reduced telomere length. In conclusion, the combined use of TI/MI induced anti-proliferative effects and induction of apoptosis by down-regulation of anti-apoptotic and up-regulation of pro-apoptotic genes and proteins levels and shortening of telomere length on AML cells.
Preclinical • Journal • IO biomarker
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BCL2 (B-cell CLL/lymphoma 2) • BCL2L1 (BCL2-like 1) • BAX (BCL2-associated X protein) • ANXA5 (Annexin A5)
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BIBR1532
24d
All-Trans Retinoic Acid (ATRA) and Atezolizumab for the Treatment of Recurrent or Metastatic Non-Small Cell Lung Cancer (clinicaltrials.gov)
P1, N=18, Active, not recruiting, Dwight Owen | Suspended --> Active, not recruiting | Trial completion date: Oct 2025 --> Jan 2026 | Trial primary completion date: Oct 2025 --> Jan 2026
Enrollment closed • Trial completion date • Trial primary completion date
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PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase)
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Tecentriq (atezolizumab) • Vesanoid (tretinoin)
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)
1m
Enrollment closed
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hydroxyurea • Rytelo (imetelstat)
1m
Myelodysplastic syndromes: Updates on Genomic Landscape, Molecular Subtypes, & Targeted Therapies. (PubMed, Curr Hematol Malig Rep)
Several recent targeted drug approvals including luspatercept and imetelstat have greatly expanded the treatment arsenal for lower-risk MDS. Standard of care therapy options for high-risk MDS, in particular TP53-mutated, remain limited beyond HMAs and transplant and are an active area of investigation.
Review • Journal
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TP53 (Tumor protein P53) • IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2) • SF3B1 (Splicing Factor 3b Subunit 1)
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TP53 mutation • IDH1 mutation • Chr del(5q)
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Reblozyl (luspatercept-aamt) • Rytelo (imetelstat)
2ms
Trial suspension
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PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase)
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Tecentriq (atezolizumab) • Vesanoid (tretinoin)
2ms
Gadd45B Deficiency Drives Radio-Resistance in BRAFV600E-Mutated Differentiated Thyroid Cancer by Disrupting Iodine Metabolic Genes. (PubMed, Cancers (Basel))
Gadd45B plays a pivotal role in regulating the differentiation status and RAI sensitivity of BRAFV600E-mutated thyroid cancer. These findings identify Gadd45B as a promising therapeutic target for restoring RAI responsiveness in RAIR-DTC patients.
Journal
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MYC (V-myc avian myelocytomatosis viral oncogene homolog) • GADD45B (Growth Arrest And DNA Damage Inducible Beta)
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BRAF V600E • BRAF V600
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PLX4720 • BIBR1532
2ms
Outcomes with imetelstat in myelofibrosis: a systematic review and meta-analysis. (PubMed, Leuk Lymphoma)
The pooled SVR of 10%, 20% and 35% was 22.40 (95% CI 0.0-50.76, p = 0.0001), 11.44 (95% CI 0.00-30.95, p = 0.0006), and 4.42 (95% CI 0.0-14.31, p = 0.0152), respectively, while the pooled reduction of more than one grade in BM fibrosis was reported in 14.79% (95% CI: 4.70-24.88, p = 0.04, I2=67.5%). This meta-analysis demonstrates the efficacy of Imetelstat in MF patients who have relapsed on or are refractory to JAK inhibitors.
Retrospective data • Journal
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JAK2 (Janus kinase 2)
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Rytelo (imetelstat)
2ms
Novel agents and evolving strategies for anemia management in lower-risk myelodysplastic syndromes. (PubMed, Blood Res)
Erythropoiesis-stimulating agents (ESAs) and lenalidomide are the standard therapies; however, their effectiveness is limited by resistance and patient selection criteria. Additionally, the real-world use of these new agents remains limited in some regions owing to issues with local introduction and reimbursement. This review summarizes recent clinical data on luspatercept and imetelstat, highlights their current limitations, and discusses areas for future research based on recent trial outcomes and evolving clinical practices.
Review • Journal • Tumor mutational burden
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TMB (Tumor Mutational Burden)
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lenalidomide • Reblozyl (luspatercept-aamt) • Rytelo (imetelstat)
2ms
A Phase III Study With THIO + Cemiplimab vs Chemotherapy as 3rd Line Treatment in Advanced/Metastatic NSCLC (clinicaltrials.gov)
P3, N=300, Not yet recruiting, Maia Biotechnology | Initiation date: Jul 2025 --> Nov 2025
Trial initiation date • IO biomarker
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PD-L1 (Programmed death ligand 1)
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gemcitabine • docetaxel • Libtayo (cemiplimab-rwlc) • vinorelbine tartrate • ateganosine (THIO)