Aditxt Subsidiary Adimune Completes Preclinical Studies for ADI-100, Advances Toward Human Clinical Trials

Immune Modulation Gains Momentum with Industry Focus and High-Value Collaborations

Aditxt, Inc. (NASDAQ: ADTX) announced that its subsidiary, Adimune, Inc., has successfully completed all preclinical efficacy and safety studies for its antigen-specific gene therapy, ADI-100. This milestone positions Adimune to submit a Clinical Trial Application (CTA)/Investigational New Drug (IND) application for regulatory approval to initiate first-in-human clinical trials in H2 2025. The trials will target Type 1 Diabetes, Psoriasis, and Stiff-Person Syndrome in collaboration with Mayo Clinic.

Dr. Friedrich Kapp, Co-CEO of Adimune commented, “The treatment of autoimmune diseases will see a fundamental change in the next few years, a paradigm shift, which has been awaited since the processes were understood by which immune tolerance normally is being maintained. Restoring immune tolerance will replace immunosuppressants in the treatment of autoimmune diseases, and insulin eventually will become a mere rescue medication in type 1 diabetes. With the recent deal between Roche/Genentech and Cour on autoimmune treatments, the race is on and will be won by the drug which best fulfils three main criteria: safety, effectiveness, and durability of response. Adimune’s ADI-100 is well positioned in this competitive endeavor. We are one of the front runners because we believe our drug candidate will meet all three criteria in a perfect manner.”

Preclinical results demonstrated antigen-specific immune tolerization without impairing the immune system’s overall responsiveness. Safety studies confirmed no significant adverse effects, paving the way for the therapy’s next phase of development.

For more information and to view the corporate presentation, visit adimune.com.