Completion of GMP Drug Substances in January for Clinical Trials in H2, 2023
RICHMOND, Va., January 03, 2023--(BUSINESS WIRE)--Aditxt, 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.
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," 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."
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," continued Amro Albanna.
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.
Certain statements in this press release constitute "forward-looking statements" within the meaning of federal securities laws. Forward-looking statements include statements regarding the Company's intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things, the Company's ongoing and planned product and business development; the Company's intellectual property position; the Company's ability to develop commercial functions; expectations regarding product launch and revenue; the Company's results of operations, cash needs, spending, financial condition, liquidity, prospects, growth and strategies; the industry in which the Company operates; and the trends that may affect the industry or the Company. Forward-looking statements are not guarantees of future performance and actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, as well as market and other conditions and those risks more fully discussed in the section titled "Risk Factors" in the Company's most recent Annual Report on Form 10-K, as well as discussions of potential risks, uncertainties, and other important factors in the Company's other filings with the Securities and Exchange Commission. All such statements speak only as of the date made, and the Company undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
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