The company plans to submit a CTA for ADI-100, which consists of two DNA molecules that restore immune tolerance in autoimmune disease.

Aditxt, Inc. has formed Adimune, Inc.,  a U.S.-based subsidiary, and plans to submit a Clinical Trial Application (CTA) for ADI-100, which consists of two DNA molecules that restore immune tolerance in autoimmune disease.

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.

Joachim-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.

“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,” says Dr. Kapp in a news release. “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.”

GMP 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.

“The formation of Adimune around ADI technology demonstrates Aditxt’s business model of building businesses around promising innovations. For the past two and half years, acceleration of the ADI 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,” says Amro Albanna, co-founder, chairman and CEO of Aditxt.

“Under Dr. Kapp’s leadership, we believe Adimune is rapidly nearing that goal. We are confident that 2023 will provide tangible progress, illustrating Aditxt’s determination to meet important milestones that will benefit our company and stakeholders.”