Adimune, Inc., a subsidiary of Aditxt (NASDAQ: ADTX), has reached a significant milestone in advancing its innovative autoimmune disease therapy toward clinical trials. The company is preparing to ship drug substances for its lead candidate ADI-100, marking a crucial step in the development of a novel treatment approach for multiple autoimmune conditions.
Promising Preclinical Results
Comprehensive preclinical studies of ADI-100 have demonstrated encouraging outcomes in restoring immune tolerance, particularly in Type 1 Diabetes studies spanning 10 months. The studies revealed several key findings:
- No drug toxicity observed
- Absence of antibody formation to the drug product
- No persistence in evaluated organs
- Maintained immune system functionality against infections and cancer
- Preserved effectiveness of checkpoint inhibitors
Manufacturing Progress and Regulatory Preparation
The company has successfully manufactured GMP clinical-grade drug substances through a qualified contract manufacturer. Dr. Friedrich Kapp, Co-CEO of Adimune, emphasized the significance of this development: "With the shipment of ADI-100 drug substance soon underway, we are moving toward clinical trials and remain focused on executing the necessary steps to ensure the highest standards of safety, efficacy and regulatory compliance."
The company has already engaged in pre-submission meetings with German regulatory authorities and completed additional requested studies. Parallel efforts include:
- Collaboration with a Contract Research Organization for German clinical trials
- Partnership with Mayo Clinic for FDA IND package preparation
- Anticipated pre-IND meeting in Q2 2024
Innovative Therapeutic Approach
ADI-100 represents a novel approach to treating autoimmune diseases through antigen-specific gene therapy. The treatment consists of two DNA molecules designed to restore immune tolerance without immunosuppression. Key features include:
- Targets Glutamic Acid Decarboxylase (GAD), implicated in multiple autoimmune conditions
- Utilizes precision immune reprogramming
- Demonstrates potential for bystander effect in reducing aggressive T cells
- Shows promise in restoring GABA levels
The therapy aims to address multiple autoimmune conditions, including:
- Type 1 Diabetes
- Psoriasis
- Stiff Person Syndrome
"Adimune is committed to developing a transformative approach to autoimmunity—one that focuses on restoring immune tolerance rather than suppressing the immune system," stated Dr. Kapp. This development represents a potential paradigm shift in autoimmune disease treatment, offering hope for patients seeking alternatives to traditional immunosuppressive therapies.
