Introduction to Chiauranib
Chiauranib, developed by Shenzhen Chipscreen Biosciences, is a novel drug candidate that has garnered significant attention in the oncology sector due to its innovative multi-pathway pharmacological mechanism. This drug is designed to target various types of cancer, including small cell lung cancer (SCLC), ovarian cancer, liver cancer, and breast cancer, among others.
Mechanism of Action
Chiauranib is a highly selective inhibitor of Aurora B, VEGFRs, CSF1R, and other kinases. Its mechanism involves inhibiting tumor angiogenesis, preventing tumor cell mitosis, and modulating the tumor microenvironment. This triple-pathway approach enhances antitumor immunity and inhibits the rapid proliferation of tumor cells, making it a potent anti-tumor agent[4][5].
Clinical Trial Progress
Phase 1b/2 Clinical Trials in the USA
Chiauranib has received Investigational New Drug (IND) clearance from the US FDA for a Phase 1b/2 clinical trial. This trial aims to evaluate the safety, tolerability, and efficacy of Chiauranib as a monotherapy in patients with SCLC. The primary objective is to assess its performance in 24 to 36 patients[1].
Phase III Clinical Trials in China
In China, Chiauranib has been approved for Phase III clinical trials for the first-line treatment of extensive stage small cell lung cancer (ES-SCLC) when combined with PD-(L)1 monoclonal antibody and standard chemotherapy. Additionally, Phase III trials for Chiauranib monotherapy in later-line treatment of SCLC have been completed, and the Pre-NDA is under communication[2][5].
Other Ongoing Trials
Chiauranib is also being evaluated in various other clinical trials, including:
- Phase III trials combined with chemotherapy for ovarian cancer.
- Phase II trials for single or combined treatment of triple negative breast cancer, soft tissue sarcoma, and pancreatic cancer[2][5].
Breakthrough Designations and Regulatory Approvals
Chiauranib has been designated as a "breakthrough therapy" by the National Medical Products Administration (NMPA) of China for its treatments in SCLC and ovarian cancer. This designation highlights its potential to significantly improve treatment outcomes for these conditions[1].
Global Development Strategy
The clearance of the US FDA IND application for Chiauranib is a significant step in Chipscreen Biosciences' global development strategy. According to Dr. Xianping Lu, Chairman and President of Chipscreen, this clearance will enhance the success of their global development strategy based on early efficacy and safety data obtained from China trials[1].
Market Projections
Given its comprehensive anti-tumor effects and the progress in clinical trials, Chiauranib is poised to make a significant impact in the oncology market.
Competitive Advantage
Chiauranib's unique mechanism of action, which outperforms similar drugs in overall efficacy and safety profile, positions it as a competitive candidate in the market. Its ability to target neuroendocrine tumors, such as SCLC, with high selectivity against Aurora B and other kinases, sets it apart from existing treatments[4][5].
Market Potential
The global market for cancer treatments is vast and growing, driven by the increasing incidence of cancer and the need for more effective therapies. With its approval for Phase III trials and breakthrough designations, Chiauranib is likely to capture a substantial share of this market, particularly in the segments of SCLC and ovarian cancer.
Economic Impact
The economic impact of Chiauranib could be substantial, given the high costs associated with cancer treatments and the potential for improved patient outcomes. By offering a more effective and safer treatment option, Chiauranib could reduce healthcare costs in the long term and improve the quality of life for patients.
Expert Insights
"Chiauranib's unique triple-pathway mechanism and its ability to target neuroendocrine tumors make it a promising candidate in the fight against cancer," said Dr. Xianping Lu, Chairman and President of Chipscreen Biosciences. "We are optimistic about its potential to enhance long-term survival and improve treatment outcomes for patients with various types of cancer."
Statistics and Data
- Clinical Trial Enrollment: As of October 9, 2020, a total of 42 subjects entered the safety analysis and 41 subjects entered the efficacy analysis in the Phase Ib/II trial for SCLC[3].
- Efficacy: Preliminary results from clinical trials have shown promising efficacy of Chiauranib in treating patients with relapsed or refractory SCLC[3].
Conclusion
Chiauranib represents a significant advancement in oncology, with its innovative mechanism of action and promising clinical trial results. As it progresses through various stages of clinical trials and regulatory approvals, it is poised to become a key player in the treatment of several types of cancer, particularly SCLC and ovarian cancer.
Key Takeaways
- Innovative Mechanism: Chiauranib inhibits tumor angiogenesis, prevents tumor cell mitosis, and modulates the tumor microenvironment.
- Clinical Trials: Approved for Phase III trials in China and Phase Ib/II trials in the USA.
- Breakthrough Designations: Designated as a "breakthrough therapy" by the NMPA of China for SCLC and ovarian cancer.
- Global Development: Part of Chipscreen Biosciences' global development strategy.
- Market Potential: Significant potential in the oncology market, especially for SCLC and ovarian cancer.
FAQs
What is Chiauranib?
Chiauranib is a novel drug candidate developed by Shenzhen Chipscreen Biosciences, designed to treat various types of cancer through its multi-pathway pharmacological mechanism.
What types of cancer is Chiauranib being tested for?
Chiauranib is being tested for small cell lung cancer (SCLC), ovarian cancer, liver cancer, breast cancer, triple negative breast cancer, soft tissue sarcoma, and pancreatic cancer.
What is the current stage of clinical trials for Chiauranib?
Chiauranib is in Phase III clinical trials in China for the first-line treatment of ES-SCLC and in Phase Ib/II clinical trials in the USA for SCLC.
What are the breakthrough designations for Chiauranib?
Chiauranib has been designated as a "breakthrough therapy" by the NMPA of China for its treatments in SCLC and ovarian cancer.
How does Chiauranib work?
Chiauranib works by inhibiting tumor angiogenesis, preventing tumor cell mitosis, and modulating the tumor microenvironment through its selective inhibition of Aurora B, VEGFRs, CSF1R, and other kinases.
Sources
- Chipscreen Biosciences: "Chipscreen Received a Phase 1b/2 Clinical Trial of Chiauranib/CS2164 from US FDA" - April 16, 2021.
- BioPharma Asia: "Chipscreen Biosciences Secures NMPA Approval for Phase III Trial of Chiauranib in ES-SCLC Treatment" - November 4, 2024.
- Veeva Systems: "Phase 3 Clinical Study of Chiauranib Capsule in Patients With Small Cell Lung Cancer".
- Business Wire: "Aurora Kinase Inhibitor Pipeline Report 2021 - ResearchAndMarkets.com" - July 6, 2021.
- PR Newswire: "The Phase III Clinical Trial Application for First-Line Treatment of Extensive Disease Small Cell Lung Cancer with Chiauranib Has Been Approved" - November 1, 2024.
Last updated: 2025-01-02