Delta-Fly Pharma Inc. is advancing its clinical programs for DFP-14927 and DFP-17729, targeting solid tumors and pancreatic cancer, 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 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. 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 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 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 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 holds several patents related to this technology and aims to initially establish DFP-17729 as a treatment for refractory pancreatic cancer, 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.
