Psoriasis First-in-Human (Phase I/IIa) program is slated for 2022
Type 1 Diabetes and Skin Allografting are planned to enter clinical trials in 2022
Pre-clinical investigational work has started in Multiple Sclerosis
Aditxt, Inc. (the “Company” or “Aditxt”) (Nasdaq: ADTX), a biotech innovation company with a mission to improve the health of the immune system, today announced its Psoriasis clinical program will now be slated for 2022 instead of December 2021 as previously announced. The updated timeline is due to a lengthier large scale clinical grade manufacturing and approval process for initiating toxicology studies. Meanwhile, Aditxt has continued to strengthen the data set that will be supporting regulatory submissions for the Apoptotic DNA Immunotherapy™ (ADi™) platform for evaluation of ADi in clinical studies for skin allografting and type 1 diabetes in addition to the trials planned for psoriasis.
The Company is also announcing the expansion of its preclinical ADi program to include antigen-specific immune cell modulation for multiple sclerosis (MS), alongside its existing projects focused on type 1 diabetes and skin allografting. Broadening the therapeutic programs to include MS is intended to address an important clinical need in addition to demonstrating the utility of ADi as an antigen-specific immune tolerance platform.
‘’We’ve chosen to target our research into MS because there is a significant clinical unmet need for therapies that aid repair of damage caused by MS that impacts nerve cells in the central nervous system,” said Amro Albanna, Co-founder and Chief Executive Officer of Aditxt. “This development is a natural evolution of our business model for therapeutics, which is focused on early-stage clinical development in partnership with life sciences leaders and partners.”
ADi is a nucleic acid-based technology, which utilizes a novel approach that mimics the way a person’s body naturally induce tolerance to their own tissues (“therapeutically induced immune tolerance”). ADi is designed and being developed to retrain the immune system to become tolerant to transplanted tissues, allergens and self-tissues that have become the target of autoimmunity. This therapeutic approach is designed to modulate the immune cells that specifically attack the target tissues rather than indiscriminately suppressing or blind folding the immune response.
Aditxt is continuing to build its patent portfolio protecting ADi with the addition of new patent families in 2021. To date, Aditxt’s worldwide exclusively licensed ADi intellectual property portfolio is comprised of 96 issued patents, and 22 pending applications.
Aditxt is developing technologies specifically focused on improving the health of the immune system through immune monitoring and reprogramming. Aditxt’s immune monitoring technology is designed to provide a personalized comprehensive profile of the immune system. Aditxt’s immune reprogramming technology is designed to retrain the immune system to induce tolerance with an objective of addressing rejection of transplanted organs, autoimmune diseases, and allergies. For more information, please visit: www.aditxt.com.
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 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.
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