Mayo Clinic study bolsters ADI-100 autoimmune therapy

MOUNTAIN VIEW, Calif. - Aditxt, Inc. (NASDAQ: ADTX), a health innovation platform, announced today that its subsidiary Adimune’s lead therapeutic candidate, ADI-100, has shown promising results in a study conducted by the Mayo Clinic. The study supports the safety profile and immunomodulatory effects of ADI-100, which is designed to induce immune tolerance in patients with autoimmune diseases.

The independent research, spearheaded by Dr. Sean Pittock and Dr. Charles Howe from the Mayo Clinic’s neuroimmunology team, confirmed that ADI-100 prompts immune tolerance to glutamic acid decarboxylase (GAD), an autoantigen involved in various autoimmune conditions such as type 1 diabetes and stiff person syndrome.

Amro Albanna, CEO of Aditxt, expressed optimism about ADI-100’s potential to offer targeted treatments for autoimmune diseases without broad immunosuppression. The study’s key findings include a confirmation of ADI-100’s safety, evidence of immune modulation at the cellular level, and antigen-specific suppression of T cell activation in GAD-sensitive patients.

Dr. Friedrich Kapp, Co-CEO of Adimune, emphasized the importance of the study’s results in supporting the selection of ADI-100 for clinical testing. The study’s findings were presented at the American Academy of Neurology Annual Meeting, and a peer-reviewed manuscript is in development. These results will also be used to support regulatory submissions in the U.S. and Germany. InvestingPro analysis reveals the company is rapidly burning through cash, with revenue of just $0.09 million in the last twelve months. Subscribers to InvestingPro can access 6 additional key financial tips about Aditxt’s current position.

Dr. Charles Howe highlighted the potential impact of ADI-100 on patients with neurological impairments caused by GAD autoreactive T cells and the possibility of developing tailored tolerization trials for a range of neurological disorders.

Adimune is preparing for clinical studies, with stability testing of ADI-100 underway and regulatory submissions planned for the second half of 2025. Aditxt aims to launch first-in-human clinical trials following these submissions.

ADI-100 is an investigational gene therapy that combines a pro-apoptotic DNA molecule with a methylated sGAD55 DNA molecule to retrain the immune system. This approach could offer significant safety and efficacy benefits over current treatments.

This news is based on a press release statement and reflects the ongoing efforts of Aditxt and its subsidiary, Adimune, to advance innovative treatments for autoimmune diseases. Investors tracking this development should note that Aditxt’s next earnings report is scheduled for June 25, 2025, which may provide further insights into the company’s research and development progress.

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