Aditxt, Inc., a biotech innovation company developing and commercializing technologies with a focus on monitoring and modulating the immune system, has formed a U.S.-based subsidiary Adimune, Inc.
The plan is to submit a clinical trial application (CTA) for its immunotherapeutic technology drug candidate, ADI-100 (ADI). The CTA 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, 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, 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,” Kapp said.
“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.
Psoriasis, 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 aims to prevent immune attacks by restoring immune tolerance and addressing the root cause of inflammation in skin.
“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,” said 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.”