ADI-100 consists of two DNA molecules, which together restore immune tolerance in autoimmune disease and establish tolerance in allogeneic skin transplantation applied in large skin wounds.

Aditxt, Inc.’s therapeutic program Adimune has successfully completed a toxicology study that indicates the safety profile of ADI-100, the Company’s immunotherapeutic technology drug that addresses rejection of transplanted organs, skin allografting, autoimmune diseases and allergies.

The toxicology findings will provide vital supporting evidence when the Company files an Investigational New Drug (IND) application with the regulatory agencies.

“Our drug is truly antigen-specific in the treatment of autoimmune diseases,” says Joachim-Friedrich Kapp, M.D., Ph.D., Aditxt senior vice president of Clinical Development-Autoimmunity, in a news release. “In preparation of the clinical study, we performed a toxicology study and found: no premature death, no signs of local intolerance, no test item-related influence on clinical signs, body weight and body weight gains, food consumption, biochemistry or urinalysis. No anti-nuclear antibodies, no macroscopic post-mortem findings, no changes in histopathology were noted, confirming the safety profile of our drug product, which we have seen in all pre-clinical experiments before.”

ADI-100 consists of two DNA molecules, which together restore immune tolerance in autoimmune disease and establish tolerance in allogeneic skin transplantation applied in large skin wounds. Modulating the immune system by restoring/inducing tolerance is a unique mechanism of action, with a potentially huge efficacy and safety benefit for the patients affected because there is no immunosuppression involved.

“These findings are very promising,” says Dr. Kapp.

Amro Albanna, co-founder and CEO of Aditxt, said the encouraging toxicology results of ADI-100 illustrate the Company’s commitment to advancing promising technologies to address rising unmet needs of patients with autoimmune diseases and those needing life-saving organ transplantation procedures.

“We are excited about the progress Adimune is making towards human trials, which represents a significant inflection point for the program and Aditxt as a whole,” Albanna said. “Adimune™ is an example of our business model accelerating promising innovation into commercialization and monetization,” Albanna says. 

“In addition, and separately, we clearly demonstrated that our drug does not display any general immunosuppressive effect,” Dr. Kapp explains. “This was shown in safety studies, when using a Listeria model for infection and a melanoma model for potential effects on tumor growth. As one could have predicted, considering the mechanism of action, there was no interference with the immune system and its capacity to fight infection or tumor disease, at all. These findings are very promising and certainly will support our story when filing the IND.”