Delta-Fly Pharma Advances Solid Tumor and Pancreatic Cancer Programs
核心洞察
Delta-Fly Pharma (搜索)'s DFP-14927, a drug delivery formulation of DFP-10917, is undergoing an expanded Phase I study in R/R colorectal cancer (搜索) patients at MD Anderson and UCLA.
DFP-17729, in combination with TS-1, receives PMDA approval for a Phase II/III clinical trial in pancreatic cancer (搜索) patients after third-line treatment.
Phase I/II data suggests DFP-17729 with TS-1 may prolong median overall survival in third-line or later pancreatic cancer (搜索) patients treated for over 6 weeks.
Delta-Fly Pharma (搜索) Inc. is advancing its clinical programs for DFP-14927 and DFP-17729, targeting solid tumors and pancreatic cancer (搜索), respectively. The company announced an update on the expanded Phase I study of DFP-14927 and the approval for a Phase II/III trial of DFP-17729.
DFP-14927: Expanded Phase I Study in Colorectal Cancer
DFP-14927, a drug delivery formulation of DFP-10917 selective to solid tumors, has demonstrated promising safety and efficacy in an initial Phase I study. Based on these findings, Delta-Fly Pharma (搜索) has initiated an expanded Phase I study of DFP-14927 at a weekly dose of 3200 mg/m2 in patients with relapsed or refractory (R/R) colorectal cancer (搜索). The study is being conducted at MD Anderson Cancer Center and UCLA. The primary efficacy endpoint for this expanded Phase I study is the Disease Control Ratio (DCR), with overall survival (OS) to be evaluated in a subsequent registration study for potential NDA approval.
DFP-17729: Phase II/III Trial Approved for Pancreatic Cancer
Following consultation with the Pharmaceuticals and Medical Devices Agency (PMDA) on December 3, 2024, Delta-Fly Pharma (搜索) received approval to proceed with a Phase II/III clinical trial of DFP-17729 in combination with TS-1 (tegafur/gimeracil/oteracil) versus TS-1 alone. This trial will enroll patients with pancreatic cancer (搜索) who have progressed after third-line treatment.
Previous Phase I/II study results of DFP-17729 in combination with TS-1 in patients with end-stage pancreatic cancer (搜索) did not show a significant difference compared to the control treatment (TS-1 or gemcitabine) in the overall population. However, a stratified analysis indicated that in patients receiving third-line or later treatment for more than 6 weeks, the combination of DFP-17729 and TS-1 showed a predominant median overall survival (mOS) prolongation (9.0 months vs. 6.1 months). Furthermore, a significant correlation was observed between urinary alkalinization and mOS in pancreatic cancer patients treated with DFP-17729, suggesting a potential mechanism of action related to neutralizing the acidic cancer microenvironment.
DFP-17729 represents a novel approach to cancer treatment by targeting the acidic tumor microenvironment. Delta-Fly Pharma (搜索) holds several patents related to this technology and aims to initially establish DFP-17729 as a treatment for refractory pancreatic cancer (搜索), where effective therapies are lacking. The company plans to explore expanding the drug's indication to other cancer types through partnerships with major global pharmaceutical companies.