Organ transplantation can be a lifesaving treatment option, but the immune system continues to pose the greatest challenge to transplantation becoming a routine medical treatment due to the rejection that occurs when the recipient’s immune system recognizes the transplanted organ as foreign.
A New Approach
The discovery of immunosuppressants (anti-rejection drugs) over 40 years ago, such as cyclosporine, has allowed survival of transplanted organs by preventing acute or early rejection. However, immunosuppressants fail to prevent the chronic or long-term rejection that occurs years after the initial transplantation procedure. About 40% of transplanted organs survive for no more than 5 years. Furthermore, immune suppression leads to significant undesirable side effects such as increased susceptibility to life-threatening infections and cancers because it is not specifically targeted towards the transplanted organs; rather, it indiscriminately and broadly suppresses immune function throughout the body.
New, focused therapeutic approaches are needed that modulate only the portion of immune cells that are involved inrejection of a transplanted organ, as this will be safer for patients than indiscriminate immune suppression. Such approaches are known as immune tolerance, and when therapeutically induced, may not only be safer for patients, but could also potentially allow long-term survival of transplanted tissues and organs.
In the late 1990s, academic research on these approaches was conducted at the Transplant Center at Loma Linda University (LLU) in connection with a project that secured initial grant funding from the U.S. Department of Defense (DOD). The focus of that project was skin grafting for burn victims. Twenty years of research at LLU and an affiliated incubator led to a series of discoveries that have been translated into a large patent portfolio of therapeutic approaches that may be applied to the modulation of the immune system in order to induce tolerance to self and transplanted organs.
We have an exclusive worldwide license for commercializing this nucleic acid-based technology called Apoptotic DNA Immunotherapy™ (ADi™), which utilizes a novel approach that mimics the way our bodies naturally induce tolerance to our own tissues (“therapeutically induced immune tolerance”).
While immune suppression requires continuous administration to prevent acute or early rejection of transplanted organs, induction of tolerance has the potential to retrain the immune system to accept the organ for longer periods of time. Thus, ADi™ may allow patients to live with transplanted organs with significantly reduced dependence on immune suppression.
We are developing a novel approach utilizing the body’s natural process to train the recipient’s immune system to accept transplanted tissues and organs without indiscriminately suppressing the immune system.
Reduce Chronic Rejection
Preclinical studies have demonstrated that ADi™ treatment significantly and substantially prolongs graft survival, in addition to successfully “reversing” other established immune-mediated inflammatory processes.
Reduce Immune Suppression
We believe that with ADi™ treatment, recipients can be conditioned/desensitized ahead of transplantation, to more readily accept the organ and also reduce the levels of immunosuppressive drugs needed post-transplantation.
Studies have shown that hypersensitivity increases the rate of organ rejection. We believe that ADi™ may have the potential to address this hypersensitivity issue.
ADi™ is a nucleic acid-based technology ( e.g. , plasmid DNA-based) which we believe selectively suppresses only those immune cells involved in the rejection of tissue and organ transplants. It does so by tapping into the body’s natural process of cell death (apoptosis) to reprogram the immune system to stop unwanted attacks on self or transplanted tissues. In short, it retrains the immune system to become accepting of the organ much like how natural apoptosis reminds our immune system to be tolerant to our own “self” tissues.
Ease of Delivery
Better Safety Profile
Cost of Goods Advantage
Simplified Therapy Delivery System
The ADi™ technology and its various components are protected by multiple families of patents and patent applications, including several U.S. and non-U.S. issued patents.
Apoptotic DNA Immunotherapy™ (ADi™) Technology
Designed to harness the body’s natural processes to therapeutically induce immune tolerance to transplanted tissues and organs.