Telomerase is a reverse transcriptase enzyme, responsible for the replication of telomeres. Telomeres are important for ensuring chromosomal integrity. However, sometimes due to the inability of DNA polymerase to replicate the end of the chromosome during lagging strand synthesis, cells fail to undergo senescence, progressive telomere shortening can lead to the formation of chromosome fusions, genomic instability, and eventually loss of cell viability and tumor development, which could be overcome by targeting enzyme telomerase. Telomerase overexpression is related to cancer development, thus telomerase inhibitors enable a more specific treatment of cancers such as breast cancer, lung cancer, solid tumors, pancreatic cancers, and others compared with conventional chemotherapy drugs, whereas telomerase inhibition is combined with age-related diseases, hence telomerase activators can be potent drugs against age-related diseases associated with telomere shortening. Roche and GemVax & KAEL are the key players with their approved telomerase inhibitors in the market. Geron Corporation, Ultimovacs, Race Oncology, and Merck (MSD) are some of the pharmaceutical companies with telomerase analogs in their pipeline.
Key Market Developments:
- In Nov 2022, GemVax’s Tertomotide (LucaVax) was under clinical trial approval procedures in France, Italy, Portugal, the Netherlands, Poland, and Finland.
- In Nov 2022, GemVax’s Tertomotide (LucaVax) received approval for Alzheimer’s disease from Spanish Agency for Pharmaceuticals and Hygiene Products.
- In Apr 2023, the Ultimovacs ASA received a Notice of Intention to Grant from the European Patent Office for UV1 in combination with CTLA-4, PD-1, or PD-L1 checkpoint inhibitors for the treatment of cancer.
Approved Telomerase Analogues:
- Vesanoid (Tretinoin) -Roche
- LucaVax (Tertomotide) -GemVax and KAEL
Pipeline Drugs - Telomerase Analogues:
- Imetelstat (GRN163L)
- UV1
- Telomelysin (Suratadenoturev)
- AAV-hTERT
- Zantrene (Bisantrene)
- Transgenic Lymphocyte Immunization (CB-10-01)
- 6-thio-2′-Deoxyguanosine (THIO)
- GX301
- V934 Vaccine
- V935 Vaccine
- VAC2
Clinical Activity and Developments of Telomerase Analogues:
Currently, there are 2 approved telomerase inhibitors in the market and more than 10 drug molecules are in clinical trials.
- In Jul 2022, Race Oncology conducted Phase-I clinical trials in acute myeloid leukemia and chronic myelomonocytic leukemia patients in Australia for Zantrene (Bisantrene).
- In Jun 2023, Ultimovacs ASA released the efficacy and adverse event data for UV1 (Synthetic peptide vaccine) from the phase-II NIPU trial in malignant pleural mesothelioma patients.
|
Molecule Name |
Number of Studies |
|
Imetelstat (GRN163L) |
22 |
|
UV1 |
11 |
|
Telomelysin (Suratadenoturev) |
7 |
|
AAV-hTERT |
3 |
|
Zantrene (Bisantrene) |
3 |
|
Transgenic Lymphocyte Immunization (CB-10-01) |
2 |
|
6-thio-2′-Deoxyguanosine (THIO) |
1 |
|
GX301 |
1 |
|
V934 Vaccine |
1 |
|
V935 Vaccine |
1 |
|
VAC2 |
1 |
Target Indication Analysis of Telomerase Analogues:
Roche’s Vesanoid (Tretinoin) is currently in the market for indications such as acne vulgaris, and acute promyelocytic leukemia. GemVax & KAEL’s LucaVax (Tertomide) is being indicated for patients with pancreatic cancer. Moreover, LucaVax is also in a phase-III clinical trial for benign prostatic hyperplasia. Geron Corporation’s Imetelstat is in clinical trial Phase-III for myelodysplastic syndromes and myelofibrosis. Some of the drug molecules are in clinical trial phase II for treatment of head and neck cancer, malignant melanoma, non-small cell lung cancer, ovarian cancer, gastric cancer, esophageal cancer, malignant melanoma, and others.
Frequently Asked Questions
Vesanoid (Tretinoin), LucaVax (Tertomotide) are the FDA-approved Telomerase analogs.
Roche and GemVax & KAEL are the major market players with their approved telomerase inhibitors in the market.
Some of the telomerase analogs are in clinical trial phase II for the treatment of head and neck cancer, malignant melanoma, non-small cell lung cancer, ovarian cancer, gastric cancer, esophageal cancer, malignant melanoma, and others.
There are a total of 11 molecules in the Phase-I/II clinical trial for telomerase analogues.
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- Novartis AG (Switzerland)
- Roche (Switzerland)
- Geron Corporation (USA)
- GemVax & KAEL Ltd. (South Korea)
- Ultimovacs ASA (Norway)
- Oncolys BioPharma (Japan)
- Libella Gene Therapeutics (USA)
- Race Oncology (Australia)
- Merck (MSD) (USA)