Aditxt Inc (NASDAQ: ADTX) reported on Monday that its wholly owned subsidiary Adimune Inc announced positive results from preclinical studies conducted by the Mayo Clinic, supporting the safety and immunomodulatory profile of its lead therapeutic candidate, ADI-100. The data will support upcoming regulatory submissions in the US and Germany for clinical trials targeting type 1 diabetes, psoriasis, and stiff person syndrome.

Led by Dr Sean Pittock and Dr Charles Howe, the Mayo Clinic study demonstrated that ADI-100 induces immune tolerance to glutamic acid decarboxylase (GAD), a key autoantigen in several autoimmune conditions. Key findings include a favorable safety profile, enhanced tolerogenic markers in dendritic cells and antigen-specific suppression of proinflammatory T cell responses.

ADI-100 is an investigational gene therapy leveraging Apoptotic DNA Immunotherapy, which reprograms immune responses by combining a pro-apoptotic BAX DNA molecule with a methylated, modified GAD antigen. The therapy aims to restore immune tolerance without immunosuppression, potentially offering a durable and targeted treatment for autoimmune diseases.

Preclinical efficacy and safety studies have concluded, and GMP manufacturing is complete. Stability testing is underway, with regulatory filings planned for the second half of 2025, followed by potential first-in-human trials.

Aditxt operates as a social innovation platform advancing health solutions across immune and precision health. The company is also pursuing merger and acquisition strategies, including agreements with Appili Therapeutics Inc (TSX: APLI) (OTCPink: APLIF) and Evofem Biosciences Inc (OTCQB: EVFM), contingent on financing and shareholder approvals.