- Aditxt recently announced the formation of a U.S.-based wholly owned subsidiary, Adimune, Inc., and appointed Joachim-Friedrich Kapp, M.D., Ph.D., a 30-year veteran of the pharmaceutical industry, as its Chairman and CEO
- Dr. Kapp will be tasked with leading and developing the Apoptotic DNA Immunotherapy(TM) (“ADI(TM)”) technology toward clinical trials
- Aditxt also plans to submit a Clinical Trial Application (“CTA”) for immunotherapeutic technology drug candidate ADI(TM)-100, seeking approval for Adimune(TM) to conduct the first-in-human study in psoriasis patients, beginning in the second half of 2023
- ADI(TM) is a nucleic acid-based technology platform that utilizes a novel antigen-specific approach to induce immune tolerance by mimicking the way the body naturally induces tolerance to its own tissues
Aditxt (NASDAQ: ADTX), a biotech innovation company developing and commercializing technologies with a focus on monitoring and modulating the immune system, on January 3, 2023 announced the formation of a U.S.-based wholly owned subsidiary, Adimune, Inc. (“Adimune(TM)”). The company also announced the appointment of Dr. Joachim-Friedrich Kapp, M.D., Ph.D., as the CEO of Adimune(TM) and Chairman of the board. A pharmaceutical industry veteran whose career spans 30 years, Dr. Kapp is the former president of the Therapeutics Business Unit at Schering AG, a multinational pharmaceutical company. As CEO of Adimune(TM), Dr. Kapp will be tasked with leading and developing the ADI(TM) immune modulation technology and ADI(TM)-100, Aditxt’s unique and potent antigen-specific immunotherapeutic technology drug candidate, toward clinical trials (https://ibn.fm/LFvTt).
“For the past two and a half years, acceleration of the ADI(TM) technology toward clinical trials has been a leading objective of Aditxt, and we now have reached a pivotal milestone by forming a subsidiary with its own dedicated team to advance the commercialization of one of our technologies – ADI(TM),” commented Amro Albanna, Co-Founder, Chairman, and CEO of Aditxt.
Short for Apoptotic DNA Immunotherapy(TM), ADI(TM) is a nucleic acid-based technology platform that utilizes a novel antigen-specific approach to induce immune tolerance by mimicking the way the body naturally induces tolerance to its own tissues. The technology, the company believes, selectively suppresses only those immune cells involved in either an autoimmune process or rejection of tissue and organ transplants. “It does so by tapping into the body’s natural process of cell death (apoptosis) to reprogram the immune system to stop unwanted attacks on self or transplanted tissues,” the Adimune website reads (https://ibn.fm/O6PVD).
It is this technology platform on which the company based the creation of the ADI(TM)-100 drug candidate, which is set to be evaluated in the planned clinical trials. So far, Aditxt has successfully completed a toxicology study that confirmed the safety profile of ADI(TM)-100. As part of the study, no premature death, no signs of local intolerance, and no test item-related influence on clinical signs, body weight and body weight gains, food consumption, biochemistry, or urinalysis were observed. Additionally, no anti-nuclear antibodies, no macroscopic post-mortem findings, and no changes in histopathology were noted, supporting the safety profile of the drug product (https://ibn.fm/TPQxb).
In addition to animal studies in type 1 diabetes, which demonstrated a long-term pronounced treatment effect, the company has also conducted non-clinical studies evaluating ADI(TM)-100 in a stringent model of skin transplantation using genetically mismatched donor and recipient animals, demonstrating a 3x increase in the survival of the skin graft in animals treated with ADI(TM)-100 compared to animals that only received immune suppression drugs. The formulation also prolonged graft life despite the discontinuation of immune suppression after the first five weeks. Moreover, in a short-term induced non-clinical model for psoriasis – a condition caused when the immune system attacks skin cells, triggering chronic production of itchy, inflamed, thick, scaly skin patches – ADI(TM) treatment resulted in down-regulation of pro-inflammatory cytokines and up-regulation of anti-inflammatory cytokines in addition to affecting skin thickness and skin flaking. (all of the parameters assessed during the clinical evaluation of psoriasis skin lesions) (https://ibn.fm/t4vG4).
Next, per an October 2022 news release, Aditxt initiated the GMP manufacturing of the drug candidate as a key milestone toward the goal of commencing the first-in-human trials (https://ibn.fm/9eRHh). And to further bolster this goal, the company recently announced its plans to submit within H1, 2023 a CTA for ADI(TM)-100. The CTA application will seek approval for Adimune to conduct the first-in-human study in psoriasis patients, beginning in the second half of 2023. Aditxt also plans to undertake a second study for type 1 diabetes.
Aditxt is a biotech innovation company developing and commercializing technologies focused on monitoring and modulating the immune system. Aditxt’s immune monitoring technologies are designed to provide a personalized immune profile. Aditxt’s immune modulating technologies, currently preclinical, are being developed to retrain the immune system to induce tolerance to address rejection of transplanted organs, autoimmune diseases and allergies.
NOTE TO INVESTORS: The latest news and updates relating to ADTX are available in the company’s newsroom at https://ibn.fm/ADTX
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