Delta-Fly Pharma Inc.: Abstracts submission for Phase I Clinical Trial of DFP-14927 to 2024 ASCO annual meeting

TOKUSHIMA, Japan

Following the previous information on Jan. 5th. in 2024, we are excited to share our latest development status.

A Phase I clinical dose-finding study of DFP-14927 in patients with solid tumors has been completed at MD Anderson Cancer Center and the University of California, Los Angeles in the United States. Subsequently, the concentration of DFP-10917, the active component of DFP-14927, delivering into cancer tissue in patients treated with DFP-14927 is being measured to confirm PK/PD relationship for the clinical efficacy of DFP-14927.

On 6^th Feb. 2024, we are pleased to announce that we have submitted an abstract to the 2024 ASCO annual meeting to be held from May 31^st this year in Chicago.

DFP-14927 is an amide bond of DFP-10917 to a carboxylic acid at the end of polyethylene glycol (PEG) with a molecular weight of 40,000, and it is extremely stable in human blood after intravenous administration, allowing for weekly treatment regimen. DFP-14927 is a drug delivery system (DDS) with a mechanism that allows selective release of DFP-10917 into cancer tissues by amidolysis of proteases that are highly expressed in them.

Compared to high molecular weight antibody-drug conjugates (ADCs), medium-sized PEG covalent conjugates are known to have retention in blood vessels around cancer and cancer cell membranes and higher permeability into tumors, and therefore, the concentration of DFP-10917 in cancer tissue can be measured by conventional analysis without the use of radioisotope technology.

Soon after the expected effective concentration of DFP-10917 in cancer tissue is confirmed in the study, we plan to conduct an expanded Phase I study, equivalent to a Phase II clinical trial, in patients with colorectal cancer who have failed existing approved drugs.

The composition of matter patent for DFP-14927 has been granted in the United States, Europe, Asian countries and others, which will enable global marketing of DFP-14927.

In collaboration with leading oncology hospitals in the U.S., we are considering the development of DFP-14927 in haematological cancers such as acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) in addition to solid tumors.

For our future global development and marketing strategy, we are considering collaboration with a major global pharmaceutical company that has strength and expertise in the oncology.

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