Delta-Fly Pharma Inc.: Update on the R&D status of DFP-10917 and DFP-14927, a novel PEG Drug Conjugate, in the patients with R/R AML

TOKUSHIMA, Japan--(BUSINESS WIRE)--Following the previous information on June 30^th in 2023, we are excited to share our latest development status.

1. A Phase III study of DFP-10917 in patients with recurrent or refractory acute myeloid leukemia (R/R AML) at multicenter in the US is undergoing of the interim analysis.
2. A Phase I/II study of DFP-10917 in the combination with Venetoclax (VTX) in patients with R/R AML in the U.S. is in preparation.
3. A patent has been granted in the U.S. for the combination therapy of DFP-10917 and VTX based on the animal study’s data by using of animal model of AML in addition to Japan and Taiwan.
4. Pharmacology studies of DFP-14927, which is a 4 arm PEG conjugate of DFP-10917 by amido bond, can be selectively activated by the amidase activity of protease highly expressed in the tumor, is ongoing at a major university in the US for a Phase I/II study of DFP-14927 in the patients with R/R AML.
5. A Phase I study of DFP-14927 in the patients with advanced solid cancers in the US has been completed with an extraordinary safe profile and also long stable diseases over 5 months in the three patients in advance for the next expansion study, which likes early Phase II study. The PK profile of DFP-10917 (active form) in the tumors of the cancer patients treated with DFP-14927 is under investigation for establishing of the good relationship with efficacy to confirm a useful drug delivery system likes ADC (antibody-drug conjugate).
6. Both the patents of PEGylated VTX and DFP-14927 have been granted in worldwide, and their pharmacological data have been published in the leading oncology journals.

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