Following our previous update on January 5, 2024, we are delighted to share the latest advancements with you.
A Phase I dose-ranging clinical trial investigating DFP-14927 in patients with solid tumors has been successfully conducted at MD Anderson Cancer Center and the University of California, Los Angeles, in the United States. Subsequent to this trial, the concentration of DFP-10917, the active component of DFP-14927, administered to the cancerous tissue of treated patients will be assessed to validate the pharmacokinetic/pharmacodynamic (PK/PD) ratio crucial for the clinical efficacy of DFP-14927.
We are thrilled to announce that as of February 6, we have submitted an abstract for the 2024 ASCO Annual Meeting, scheduled to take place in Chicago on May 31 of this year.
DFP-14927, comprising an amide bond of DFP-10917 to a carboxylic acid at the terminus of polyethylene glycol (PEG) with a molecular weight of 40,000, exhibits remarkable stability in human blood post intravenous administration, thereby facilitating a weekly treatment regimen. DFP-14927 serves as a drug delivery system (DDS) featuring a mechanism allowing selective release of DFP-10917 into cancerous tissue via amidolysis of proteases highly expressed in these tissues.
In contrast to high molecular weight antibody conjugates (ADCs), medium-sized covalent PEG conjugates demonstrate excellent retention in the blood vessels surrounding the cancer and in cancer cell membranes, coupled with increased permeability into the tumor. Consequently, the concentration of DFP-10917 in cancerous tissue can be assessed using conventional analytical methods, obviating the need for radioisotope technology.
Following confirmation of the anticipated effective concentration of DFP-10917, we intend to proceed with an expanded Phase I study, tantamount to a Phase II clinical trial, targeting colorectal cancer patients who have shown resistance to currently approved medications.
Patents covering the composition of DFP-14927 have been granted in the United States, Europe, Asia, and other regions, facilitating its global marketability.
In collaboration with leading oncology clinics in the US, we are exploring the potential development of DFP-14927 for hematological malignancies such as acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS), in addition to its application in solid tumors.
As part of our forthcoming global development and marketing strategy, we are evaluating partnerships with prominent global pharmaceutical companies possessing extensive capabilities and expertise in the oncology domain.
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