nPSC TECHNOLOGY - Directed Cell Lines
Tithon's science team has successfully demonstrated the ability to differentiate the nPSCs recovered from human peripheral blood, utilizing the nPSC Technology, into the following cells through a proprietary culture medium:
- osteoblasts (bone)
- chondrocytes (cartilage)
- dermal papilla (hair)
- oocytes (primitive ovum)
- cardiomyocytes (heart)
nPSC Technology - In Vitro Production of 3D Organoid Tissue
Tithon's science team is currently engaged in the development of in vitro generated 3D organ tissue buds (“3D organoids”) utilizing the peripheral blood derived pluripotent stem cells recovered utilizing its nPSC Technology both for supply of various organ tissues for drug discovery and laboratory research and testing and as a promising approach toward regenerating functional and vascularized organs including intestine, kidney, pancreas, heart, lung, and brain.
AD-MSC-CM Technology - Product Candidate
Tithon's science team has completed and reviewed initial findings resulting from animal testing of its AD-MSC-CM product candidate. Evaluation of these reported results has lead to the Company's commencement of steps to undertake submission of its AD-MSC-CM product candidate to the FDA for approval as a therapeutic product for addressing Idiopathic Pulmonary Fibrosis ("IPF").
The Company is also planning to conduct further safety and efficacy testing of its AD-MSC-CM for use in treating animals through a limited pre-clinical animal study to be conducted by participating veterinarians with whom Tithon's science team possesses existing relationships. This early testing will be followed by the conduct of multi-site clinical pilot studies under an FDA issued INAD (Investigational New Animal Drug).
Establishment of cGMP/cGTP Facility
To simultaneously advance commercialization of the nPSC Technology, while also preserving the proprietary nature of the methods, processes and procedures required to recover the nPSC population utilizing the nPSC Technology, the Company’s management has determined that the optimal commercialization strategy is to develop and utilize a single point of processing of peripheral blood submitted by human and animal health care providers for recovery of the nPSC cell population, utilizing the nPSC Technology. This strategy requires the processing be performed at a cGMP/cGTP FDA licensed facility within each geographic market in which the Company intends to offer the cells recovered utilizing the nPSC Technology, including for cell banking, therapeutics, diagnostics and tissue engineering - including the in vitro production of 3D organoids, to be commercialized through a biobank.
To this end, the Company has recently entered into a human cell banking agreement with a large U.S. blood bank and the necessary SOPs and protocols have been completed (“cGMP/cGTP Facility”). Technicians at this facility are being trained and are supported by Tithon’s science team in performing the Company’s proprietary methods, processes and procedures related to blood collection, processing and nPSC cell recovery, cell storage, thawing and distribution of cell materials. This cGMP/cGTP Facility possesses state of the art lab processing and cryopreservation facilities and the necessary FDA licensing to provide all of the Company’s currently planned products and/or services for the foreseeable future, although only cell banking and related services has currently been negotiated.
It is further contemplated that upon arriving at suitable commercial terms, this cGMP/cGTP Facility will be utilized to produce the Company's AD-MSC-CM product candidate in the United States.
