Business
Aditxt Forms Adimune, Inc. as a Wholly Owned Subsidiary with a Focus on Immune Modulation Therapies and Appoints Dr. Friedrich Kapp, Former President of the Therapeutic Business Unit at Schering AG, as its Chairman and CEO
Completion of GMP Drug Substances in January for Clinical Trials in H2, 2023 RICHMOND, Va.--(BUSINESS WIRE)-- Aditxt, Inc. (NASDAQ: ADTX) (“Aditxt” or the
About this update from Aditxt, Inc.
[{"type":"text","content":"\nCompletion of GMP Drug Substances in January for Clinical Trials in H2, 2023\n\n RICHMOND, Va.--(BUSINESS WIRE)--\nAditxt, Inc. (NASDAQ: ADTX) (“Aditxt” or the “Company”), a biotech innovation company developing and commercializing technologies with a focus on monitoring and modulating the immune system, today announces the formation of a U.S.-based subsidiary Adimune, Inc. (“Adimune™) and its plans towards submission of a Clinical Trial Application (“CTA”) for its immunotherapeutic technology drug candidate, ADI™-100 (“ADI™-100” or “ADI™”). The CTA application will request approval for Adimune™ to conduct the first-in-human study in psoriasis patients, beginning in the second half of 2023. A second study is also planned for type 1 diabetes.\n\nJoachim-Friedrich Kapp, M.D., Ph.D., a 30-year veteran of the pharmaceutical industry and former president of the Therapeutics Business Unit at the multinational pharmaceutical company Schering AG, will serve as CEO of Adimune™ and chairman of the board. Among his responsibilities as CEO of Adimune™, Dr. Kapp will be tasked with leading and developing the ADI™ immune modulation technology toward clinical trials.\n\n“My vision for Adimune™ is to advance our program and effectively demonstrate that ADI™ technology is designed to restore immune health in patients with autoimmune diseases such as psoriasis and type 1 diabetes,” said Dr. Kapp. “We believe 2023 will be a pivotal year for us as we prepare and implement CTA approved clinical human trials featuring our drug candidate, ADI™-100, which we believe to be extremely promising.”\n\nGMP drug substances of the product candidate ADI™-100 are slated to enter the product stability testing program in January 2023. Encouraging toxicology study results for ADI™-100 in 2022 confirmed the safety profile of the drug candidate. The ADI™ technology, which restores/induces immune tolerance, is based on a unique mechanism of action with a potentially profound efficacy benefit without immune suppression.\n\nPsoriasis, caused when the immune system attacks skin cells, triggers chronic production of itchy, inflamed, thick scaly skin patches that can be very painful. Treatments currently range from creams and ointments to ultraviolet light therapy to systemic drugs. More than 125 million people worldwide are afflicted with psoriasis. Adimune’s™ product a...