For oral delivery of insulin
APH-0907 is a nanoencapsulation of insulin in biodegradable polymer nanospheres [US Patent].
Nanoencapsulation is being used to protect the protein macromolecules/nanoparticles during the stomach passage; the residence time in the stomach will be short compared to the protein release rate from the polymer nanospheres. Animal data demonstrates that nanoencapsulated insulin was protected in the stomach and then transported to the blood. When protein nanoparticles reach the gut, they are transported across the lining, which may be mediated by M cells in the lymphatic tissue of the gut. Alternatively, the protein can be mobilized from nanospheres and rapidly transported to systemic circulation by the epithelial cells. Both the polymer "shell" and the protein macromolecules/nanoparticles are intended to enable and regulate this stage of drug transport.
With the optimal combination of the biodegradable polymer nanospheres, shell properties and protein characteristics, we anticipate a significant improvement in oral bioavailability of protein therapeutics. We believe that our oral delivery nanotechnology will be applicable to large as well small protein molecules since we have demonstrated that our protein nanoparticles technology is independent of size and molecular weight (MW).
Proprietary Nanoencapsulation ProcessAPH-0907 is manufactured by Aphios' proprietary and patented PNS process. In PNS, a biodegradable biopolymers is dissolved in SuperFluids™, mixed with the target in solution or as a slurry of nanoparticles at operating pressures, and the mixture is decompressed into an aqueous solution, liquid nitrogen or an empty vessel (spray dryer); as result of decompression, polymer nanospheres are formed, encapsulating the therapeutic target.
In Vitro Characteristics of PNS
In Vivo Characteristics of PNS
Partnering OpportunityWe are seeking a strategic corporate partner to continue the development of APH-0907 as an oral insulin product for diabetics.