Topoisomerase 1 inhibitors are a class of targeted therapies used in the treatment of various types of cancer. These inhibitors specifically target the enzyme topoisomerase I, which is involved in DNA replication and repair. The mechanism of action involves binding to the enzyme and preventing its normal function, leading to the accumulation of DNA strand breaks and subsequent cell death in cancer cells. Topoisomerase I inhibitors have shown efficacy in several disease indications, including colorectal, lung, and ovarian cancers. By disrupting DNA replication and inducing DNA damage, these inhibitors exhibit selective cytotoxicity against cancer cells with high topoisomerase I expression levels. According to the World Health Organization (WHO), colorectal cancer is the third most common cancer globally, with Europe and the United States having significant incidence rates. In Europe, there were approximately 375,000 new cases of colorectal cancer in 2020, and it accounted for over 170,000 deaths. In the United States, colorectal cancer is the third leading cause of cancer-related deaths, with an estimated 53,200 deaths in 2020. Lung cancer is also a major concern, with Europe accounting for about 458,000 new cases and 405,000 deaths in 2020. In the United States, lung cancer is the leading cause of cancer-related deaths, with an estimated 135,720 deaths in 2020. Ovarian cancer affects women worldwide, with Europe reporting around 65,000 new cases and 45,000 deaths in 2020.
The growth drivers of the Topoisomerase I inhibitor market include the increasing incidence of cancer, the demand for targeted therapies, advancements in research and development, collaborations between pharmaceutical companies and research institutions, favorable reimbursement policies, and the growing awareness of personalized medicine. Companies such as Daiichi Sankyo, Bio-Thera Solutions, AstraZeneca, DualityBio, BioNTech, Generic mfg., Gibson Oncology, Luye Group, MediLink, Minghui Pharma, ProfoundBio, Shanghai Fudan-Zhangjiang, Gilead, Ipsen, Merck (MSD), Sichuan Kelun Pharma, 3T Ophthalmics, and AbbVie cater to this category. Moreover, many companies are coming up with new molecules in this space. For instance, Lees Pharma is currently conducting a clinical trial of the drug CPT-184 for the treatment of idiopathic pulmonary fibrosis.
Key Developments
- In June 2023, Everest medicine’s Sacituzumab govitecan receives positive opinion from the CHMP of the EMA for HER2-negative-breast-cancer
- In June 2023, US FDA assigned PDUFA action date of (13/02/2024) for irinotecan Sucrosofate for Pancreatic cancer
Approved Topoisomerase I Inhibitor molecules
- Irinotecan
- Topotecan
- Onivyde (nanoliposomal irinotecan)
- Enhertu (fam-trastuzumab deruxtecan-nxki)
- Trodelvy (sacituzumab govitecan-hziy)
- Onzeald (etirinotecan pegol)
- Karenitecin (cositecan)
- Camtobell (belotecan)
- Irinotecan liposomal
- HA-irinotecan
- Simmitecan
- Brakiva (topotecan liposomal)
- Topotecan episcleral
Topoisomerase I Inhibitor Pipeline Molecules
- Datopotamab deruxtecan (DS-1062a)
- Gimatecan (CPT-184)
- Davamotecan pegadexamer (EP0057)
- Patritumab deruxtecan (U3-1402)
- MK-2870
- Labetuzumab govitecan (IMMU-130)
- Lipotecan (TLC388)
- NK012
- Silatecan (AR-67)
- PLX038
- Indotecan (LMP400)
- ELU001
- ESG401
- HS-20093
- JSKN003
- Alphalex-exatecan (CBX-12)
- Ifinatamab deruxtecan (DS-7300)
- Irinotecan hydrochloride liposome injection (LY01610)
- Locnartecan (PEN-866)
- ABBV-706
- AZD5335
- AZD8205
- AZD9592
- BAT8006
- BAT8007
- BAT8008
- BAT8009
- BAT8010
- BNT323
- BNT324
- CEB-01
- DAN-222
- DB-1305
- DB-1310
- DS-6000
- DS-6157
- FDA018
- FDA022-BB05
- IBI354
- IT-141
- LMP744
- M9140
- MHB036C
- MHB088C
- PEGylated camptothecin (PEEL-224)
- PRO1160
- SKB-315
- T-1201
- YL201
- YL202
- Elomotecan (BN 80927)
- Liposomal topotecan (FF-10850)
- Rinatabart sesutecan (PRO1184)
Clinical Activity and Development of Topoisomerase I Inhibitor
In the Topoisomerase I Inhibitor space, more than 60 companies are conducting more than 900 clinical trials in this category of drugs. For instance,
- In June 2023, Gilead Sciences released efficacy and adverse events data from a phase III TROPICS-02 trial of Trodelvy for Her2-negative breast cancer
- In June 2023, Ispen got pre-registration for the drug Onivyde for pancreatic cancer in the USA
|
Product Name |
Total Studies |
|
Datopotamab deruxtecan (DS-1062a) |
20 |
|
Gimatecan (CPT-184) |
17 |
|
Davamotecan pegadexamer (EP0057) |
15 |
|
Patritumab deruxtecan (U3-1402) |
12 |
|
MK-2870 |
8 |
|
Labetuzumab govitecan (IMMU-130) |
8 |
|
Lipotecan (TLC388) |
6 |
|
NK012 |
5 |
|
Silatecan (AR-67) |
5 |
|
PLX038 |
3 |
|
Indotecan (LMP400) |
3 |
|
ELU001 |
2 |
|
ESG401 |
2 |
|
HS-20093 |
2 |
|
JSKN003 |
2 |
|
Alphalex-exatecan (CBX-12) |
2 |
|
Ifinatamab deruxtecan (DS-7300) |
2 |
|
Irinotecan hydrochloride liposome injection (LY01610) |
2 |
|
Locnartecan (PEN-866) |
2 |
|
ABBV-706 |
1 |
Target Indication Analysis of Topoisomerase 1 Inhibitor
Topoisomerase 1 inhibitors are targeted therapies that selectively inhibit the activity of the enzyme topoisomerase I, which plays a crucial role in DNA replication and repair. These inhibitors have shown promising results in the treatment of various types of cancer, including colorectal, lung, and ovarian cancers. By preventing the unwinding of DNA during replication and causing DNA strand breaks, topoisomerase I inhibitors disrupt cancer cell growth and induce cell death. They are particularly effective against tumors that exhibit high levels of topoisomerase I expression. These inhibitors hold great potential as targeted therapies for cancer treatment and continue to be an active area of research and development.
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- The report provides a plethora of information about market entry strategies, regulatory framework, and reimbursement scenario
Frequently Asked Questions
Topoisomerase I inhibitors drugs are used in the management of various types of cancer, including colorectal, lung, and ovarian cancers.
The growth drivers of the Topoisomerase I inhibitor market include the increasing incidence of cancer, the demand for targeted therapies, advancements in research and development, collaborations between pharmaceutical companies and research institutions, favorable reimbursement policies, and the growing awareness of personalized medicine. As the prevalence of cancer continues to rise globally, the need for effective and targeted treatment options becomes paramount.
The major players in this space are Daiichi Sankyo, Bio-Thera Solutions, AstraZeneca, DualityBio, BioNTech, Generic mfg., Gibson Oncology, Luye Group, MediLink, Minghui Pharma, ProfoundBio, Shanghai Fudan-Zhangjiang, Gilead, Ipsen, Merck (MSD), Sichuan Kelun Pharma, 3T Ophthalmics, and AbbVie.
One of the restraints of Topoisomerase I inhibitor market is the emergence of resistance to these inhibitors, limiting their efficacy over time. Additionally, the high cost of development and production of these inhibitors can pose a financial constraint for patients and healthcare systems.
- Daiichi Sankyo
- Bio-Thera Solutions
- AstraZeneca
- DualityBio
- BioNTech
- Generic mfg.
- Gibson Oncology
- Luye Group
- MediLink
- Minghui Pharma
- ProfoundBio
- Shanghai Fudan-Zhangjiang
- Gilead
- Ipsen
- Merck (MSD)
- Sichuan Kelun Pharma
- 3T Ophthalmics
- AbbVie
- Alphamab
- Athenex
- BioNumerik
- CSPC Pharma
- Cebiotex
- Chong Kun Dang
- Cybrexa Therap
- Dantari
- EMD Serono
- Ellipses Pharma
- Elucida Oncology
- Equisnzaroo
- Escugen Biotechnology
- Everest Medicines
- Exelixis
- Fujifilm Holdings
- Guangzhou Xiangxue Pharma
- HaiHe Biopharma
- Hanmi
- Innovent Biologics
- Intezyne
- Jazz
- Jiangsu Hansoh Pharma
- Lees Pharm
- Lumos Pharma
- Madrigal Pharma
- Mersana
- National Cancer Institute
- National Cancer Institute - Bethesda
- Nektar Therap
- Neovia Oncology
- Nippon Kayaku
- PEEL Therap
- PharmaEngine
- PharmaEssentia
- ProLynx
- Purdue University
- Roche
- SciClone
- Servier
- Sorrento
- Spectrum Pharma
- Taivex Therapeutics Corporation
- Taiwan Liposome Company
- Takeda
- Tarveda Therap
- Upstryve
- Vivacitas
- Yakult Honsha