Kipspharma Receives IND Approval for Phase 2 Trial of Idetrexed
核心洞察
Kipspharma (搜索) received Ministry of Food and Drug Safety IND approval on September 11 for a domestic Phase 2 trial of its small molecule FRα-targeted anticancer candidate Idetrexed.
The trial will enroll 50 patients with platinum-resistant high-grade serous ovarian, fallopian tube or primary peritoneal cancer (搜索) showing moderate or higher folate receptor alpha (搜索) expression.
Idetrexed is positioned against AbbVie's FRα-directed ADC Elahere, which recorded $690 million in sales last year but carries ocular toxicity and thrombocytopenia (搜索) risks.
Kipspharma (搜索) has received approval from the Ministry of Food and Drug Safety for a domestic Phase 2 investigational new drug application for Idetrexed, its next-generation targeted anticancer candidate. The approval was granted on September 11 and announced on September 14. The company said it will accelerate clinical development in line with its scheduled timeline.
The Phase 2 trial will enroll 50 patients with platinum-resistant high-grade serous ovarian cancer (搜索), fallopian tube cancer (搜索) or primary peritoneal cancer (搜索) that shows moderate or higher expression of folate receptor alpha (搜索) (FRα). Kipspharma (搜索) noted that more than 90% of ovarian cancer patients display FRα overexpression, which it cites as the basis for market potential in targeted therapy.
Idetrexed is expected to compete directly with Elahere, AbbVie's FRα-targeting antibody-drug conjugate and currently the only approved therapy in that class for ovarian cancer (搜索). Elahere recorded $690 million in sales last year but has faced continued criticism over side effects including ocular toxicity and thrombocytopenia (搜索). Kipspharma (搜索) differentiates Idetrexed as a small molecule-based delivery agent, which it expects to reduce toxicities and support indication expansion or combination use. In earlier Phase 1 studies, Idetrexed achieved an objective response rate of 36%, including responses in patients with moderate FRα expression; Elahere achieved 42.3% ORR in the FRα-high subgroup of the Phase 3 MIRASOL study. The company also reported positive initial results from an ongoing UK combination trial led by the Institute of Cancer Research evaluating Idetrexed with AstraZeneca's PARP inhibitor Olaparib (Lynparza).
Kipspharma (搜索) said it aims to confirm safety and efficacy in this Phase 2 trial and to pursue subsequent trials and business opportunities including global technology licensing deals.
Source: The Asia Business Daily