The immune system is a complex organ system, but the way it works is quite straightforward. For every functional immune cell, there is a reciprocal cell called a regulatory cell to control it. This is because excessive immune stimulation will cause tissue damage. Importantly, because we all have cells that cause autoimmune diseases, the regulatory cells constantly keep these potentially pathologic self-reactive cells silent. In six percent of Americans, however, the self-reactive immune cells will escape the control of the regulatory cells and trigger an autoimmune disease. Regardless of the cause, if one can increase the numbers of functional regulatory cells to numbers that again predominate over the self-reactive cells, they will regain control, silence them and thereby induce remission of the autoimmune disease.
General Nanotherapeutics has a strategy to induce remission using very tiny nanoparticles that target three different populations of immune cells in the body and provides them with two critical growth factors that induce them to become regulatory cells and then expands them. Although in large doses these growth factors would have serious adverse side effects, their localization around the targeted cells and their functional specificity minimizes adverse side effects. One of these growth factors has been structurally altered so that at all doses it only induces and expands the protective therapeutic cells. Thus, the remission-inducing strategy we have developed safely resets the immune system back to normal where the regulatory cells keep the pathologic cells silent. Importantly, this reset is achieved using only agents made by the immune system. Pharmacological drugs are avoided. This contrasts with the immunosuppressive drugs in use today can have severe adverse side effects and none can achieve remission.
Besides reversing established autoimmune diseases, our therapeutic nanoparticles can prevent these diseases from occurring in subjects with a strong genetic predisposition to develop them. In addition, besides their use in autoimmune diseases, these nanoparticles can be used to treat and prevent graft versus host disease and solid organ graft rejection.
General Nano has chosen lupus as the first autoimmune disease to treat because it is well known that the growth factors needed for functional protective regulatory cells are decreased. We believe that the repair of this production defect by our targeted nanoparticles will lead to long-term remission of established disease and prevent lupus from developing in highly susceptible subjects.
Finally, the current nanoparticles we are using need to be delivered by injection. General Nanotherapeutics was spun off Toralgen, Inc, another company that Dr. Horwitz co-founded. Toralgen has developed oral nanoparticles with potent intrinsic anti-inflammatory properties that can carry biological agents without intestinal degradation and is scaling up these nanoparticles for clinical trials. The ultimate objective of Dr. Horwitz is to switch the present injectable nanoparticle formulation to an oral nanopill.
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