The Company has been granted rights, authorizing it, within the designated Territory (as defined below), to commercially market, sell, and distribute applications of a proprietary Adipose Derived Mesenchymal Stem Cell Conditioned Medium (“AD-MSC-CM”), a product under development by its parent company, Tithon and its subsidiaries and affiliates, including Paspa Pharmaceuticals Pty. Ltd. (collectively "Tithon"), for use in treating detrimental overactive immune response in the human body.
The AD-MSC-CM product under development by Tithon’s science team is the result of years of research and testing conducted by Tithon and its predecessor regarding therapeutic applications of Mesenchymal Stem Cells in both humans and animals.
Additionally, Tithon's science team and collaborators, in an effort to provide new therapeutic solutions, are continuing in an ongoing effort to advance research and to develop new and useful applications of the AD-MSC-CM product candidate, with the objective of commercialization, in full compliance with regulatory standards and requirements.
AD-MSC-CM Product Candidate
Tithon’s science team has developed a novel Adipose Derived Mesenchymal Stem Cell Conditioned Medium (“AD-MSC-CM”) demonstrated to inhibit inflammatory conditions, in the human body. This AD-MSC-CM contains the secretions of immuno-regulatory factors present in the culture medium of a proprietary line of Immortalized Mesenchymal Stem Cells (“IMSC”) that were carefully screened and selected due to their verified disease-free-state and high level of desired immuno-regulatory secretory factors.
The Condition Medium is produced by activating the IMSCs to produce the optimal secretion of immuno-regulatory factors in the medium by exposing the IMSCs to specific light frequencies, utilizing a proprietary and patented Light Activation Technology (the “AdiLight-2”).
AD-MSC-CM Product Therapeutic Applications
The Company’s AD-MSC-CM product candidate has been demonstrated to possess broad applications due to its demonstrated ability to reduce inflammation by modulating immune response in the human body, attenuating excessive immune response exhibited in conditions such as Acute Respiratory Distress Syndrome, Acute Lung Injury, Asthma, Chronic Obstructive Pulmonary Disease and Idiopathic Pulmonary Fibrosis.
Several previously conducted clinical trials and more recent animal studies suggest that administration of the Company's AD-MSC-CM product is well tolerated and that AD-MSC-CM based therapy is a safe therapeutic approach, since only a limited number of side effects (mainly related to the MSC-based excessive suppression of immune response in the injured lungs) were reported. Accordingly, it can be concluded that, due to its potent immuno-regulatory properties, the Company’s AD-MSC-CM product candidate represents a new therapeutic alternative, effective in addressing numerous inflammatory conditions.
Mesenchymal Stem Cells – Developing the Optimal Therapeutic Potential
Current and compelling scientific evidence suggests that the therapeutic mechanism of action of mesenchymal stem cells (“MSCs”) is not in their ability to differentiate into a target tissue, as initially believed, but rather in their ability to secrete immuno-regulatory factors, including cytokines and exosomes, that lead to their observed immuno-regulatory effect.
Despite the demonstrated ability of MSCs to produce these desirable immuno-regulatory factors, ongoing laboratory testing and clinical in vivo administration of both autologous and allogeneic derived MSCs, have clearly demonstrated the limited availability of the desired immuno-regulatory factors, due to an attack by the recipient’s immune system of the in vivo administered MSCs, thereby limiting the MSCs survivability and therefore viability to produce the desired immuno-regulatory factors within the target area into which they have been placed.
To address this shortcoming, and obtain the optimal demonstrated therapeutic value of AD-MSCs, Tithon’s science team, developed a method and process to harvest and commercially produce these immuno-regulatory factors in vitro, in a cell medium, utilizing a proprietary line of Immortal Mesenchymal Stem Cells (“IMSCs”) that were carefully screened and selected due to their verified disease-free-state and high level of secreted immuno-regulatory factors into the AD-MSC-CM. Upon completion of the proprietary process of harvesting these immuno-regulatory factors, the Conditioned Medium is processed in such a way as to eliminate all cell material and sterilize the CM, leaving only the desired immuno-regulatory factors for therapeutic use.
Obtaining and Maintaining the Optimal Immuno-Regulatory Factors derived from Mesenchymal Stem Cells.
Tithon’s science team has developed an optimal MSC cell line, means of harvesting from this MSC cell line high counts of immune-regulatory factors through a proprietary method and process that assures consistent CM possessing optimal therapeutic value and means of efficient storage and delivery:
Mesenchymal Stem Cells (MSC’s) were originally harvested from healthy young human fat tissue
The MSC’s where then turned into a dedicated immortalized cell-line thereby assuring they can be indefinitely expanded without losing their vitality and viability
A dedicated, immortalized cell line, under the same manufacturing parameters, allows for the same constituent protein and exosome secretions per batch i.e., no batch-to-batch differences
The MSC secretions consisting of active proteins and secreted exosomes can be stored frozen for two years or lyophilized allowing for simple logistics and future use.
Proprietary Methods produced under USA FDA cGMP manufacturing conditions
Consistency per batch due to dedicated MSC cell line
Tithon’s science team utilizes a proprietary and patented photo-activation device developed and patented by Adistem Pty, Ltd. and Dr. Paspaliaris (published April 3, 2014) (the “AdiLight-2”) that has been demonstrated to activate the IMSCs utilized in developing the AD-MSC-CM product, thereby maximizing the immuno-regulatory factors excreted into the CM. The IMSCs are activated by irradiating them with one or more specific wavelengths of light, tested and demonstrated by members of the Tithon’s science team to “awaken” the IMSCs, thereby stimulating the paracrine function and level of excretion of the desired immuno-regulatory factors into the CM. The use of light frequencies to stimulate MSCs has been utilized over the last ten years and has been commercially utilized by physicians worldwide to stimulate these immuno-regulatory factors in both MSCs and Platelet Rich Plasma (“PRP”), prior to injection.
The Finished Conditioned Medium (CM) Product
Animal studies using a mouse population chemically induced to exhibit the condition of lung damage resulting from over active immune response was undertaken by Summa in 2020, and final results have shown both safety and significant efficacy in addressing conditions such as Idiopathic Pulmonary Fibrosis (“IPF”), an incurable fatal medical condition, unless a suitable lung transplant is performed. It is estimated that approximately 5,000,000 people are affected globally, with new cases occurring in about 12 individuals per 100,000 population.
Preparation of Manuscript For Submission to Publisher of Peer Reviewed Articles.
To advance the awareness of both the scientific and medical communities regarding the development and potential therapeutic applications of the Company’s AD-MSC-CM product, Tithon’s science team has prepared a manuscript entitled Stem Cell-Derived Conditioned Media as a Potential Therapeutic Tool in Regenerative Medicine, that will be submitted in a Special Issue to be published October 1, 2021 in Stem Cells International.
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