2025/1/31
TaiRx’s orally administered anticancer drug, CVM-1118 (Foslinanib), was officially granted Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration (FDA) on January 31, 2025, for the treatment of pancreatic neuroendocrine tumors (PNETs). Upon receiving market approval, CVM-1118 will enjoy seven years of market exclusivity in the United States.
PNETs are a rare type of pancreatic tumor, with a prevalence of fewer than 200,000 patients in the U.S. to date. The five-year overall survival rates for localized, regional, and metastatic PNETs are 83%, 67%, and 28%, respectively. However, most patients are diagnosed only after metastasis has occurred, leaving them with limited treatment options such as somatostatin analog therapy, oral targeted drugs, and conventional chemotherapy, which often result in poor prognosis.
According to Data Bridge Market Research (2023), the global neuroendocrine cancer market was valued at $3.23 billion in 2023 and is projected to reach $7.13 billion by 2031, with a compound annual growth rate (CAGR) of 10.4% from 2024 to 2031.
CVM-1118 (Foslinanib) is a mitochondrial protein TRAP1 inhibitor that promotes cell apoptosis, inhibits tumor growth, and suppresses vasculogenic mimicry (VM). In preclinical PNET animal models, CVM-1118 demonstrated significant anticancer activity. Furthermore, in a Phase II clinical trial (CVM-005), the drug not only exhibited a favorable safety profile but also extended progression-free survival (PFS) in PNET patients, with one patient achieving partial response (PR). These promising results highlight CVM-1118’s potential clinical benefits in PNET treatment, offering patients an additional therapeutic option.
TaiRx is currently in discussions with the U.S. FDA regarding the next phase of clinical trials, aiming to accelerate the drug development to market approval.