Mountain View, California-based Aditx Therapeutics (NASDAQ: ADTX) is developing technologies specifically focused on improving the health of the immune system through immune monitoring and reprogramming. The Company’s immune monitoring technology is designed to provide a personalized comprehensive profile of the immune system. The Company’s immune reprogramming technology is designed to retrain the immune system to induce tolerance with an objective of addressing rejection of transplanted organs, autoimmune diseases, and allergies.
On March 24th, Aditxt announced that its AditxtReprogrammingTM Therapeutics Division is preparing its therapeutic program for psoriasis for First-In-Human clinical trials. The trials, which are planned to begin in Q4 2021, will evaluate clinical safety and efficacy of Aditxt’s new approach to reprogramming and retraining the immune system.
The Trials will be evaluating a nucleic acid-based technology named Apoptotic DNA Immunotherapy™ (ADi™). Aditxt’s ADi™ technology utilizes a novel approach that mimics the way the body naturally induces tolerance to its own tissues (therapeutically induced immune tolerance) and is protected with approximately 90 U.S. and international patents. ADi™ has demonstrated efficacy in several pre-clinical disease models including psoriasis in which a reduction in skin thickening and scaling, and modulation of key protein markers were observed.
Aditxt has signed an agreement with a regulatory consultant based in Munich, Germany, which will play a central role in navigating the first AditxtReprogrammingTM therapeutic program through the clinical trial and regulatory process. The firm will work with the Aditxt’s AditxtReprogrammingTM team to submit an Investigational New Drug application (IND) to the regulatory agency in Germany. Psoriasis is the first indication being targeted for clinical trial in the AditxtReprogrammingTM therapeutics pipeline. Other candidates that are advancing toward clinical trials include ADi™ for type 1 diabetes and skin allografting.
Co-Founder, President and CEO at Aditx Therapeutics, Inc. (NASDAQ: ADTX)
Amro Albanna, co-founder and Chief Executive Officer of Aditxt, stated, “this agreement represents a major step forward as we begin advancing ADi™ for psoriasis through the regulatory process and towards the start of clinical trials. Our co-founder and Chief Innovation Officer, Dr. Shahrokh Shabahang, and his product development team have experience working within the regulatory framework of both the U.S. and Europe and are leading all preparation, execution, regulatory and budgetary matters relating to Aditxt’s planned 2021 Phase I/IIA clinical trials for psoriasis. We are excited to begin this phase of Aditxt’s development after our initial focus on launching the AditxtScoreTM platform for monitoring the immune system.”
