Aditxt, Inc. Successfully Completes Preclinical Toxicity Study of Its Psoriasis Drug Candidate ADI™-100 Advancing it Closer to First-in-Human Trials

Rhea-AI Summary

Aditxt, Inc. (NASDAQ: ADTX) announces positive results from a toxicology study for its immunotherapeutic drug ADI™-100, aimed at treating autoimmune diseases and organ transplantation rejection. The study demonstrated a robust safety profile with no premature deaths or adverse clinical signs. These findings will support an upcoming Investigational New Drug (IND) application. Aditxt's commitment to advancing innovative solutions in the biotech sector is emphasized by the encouraging results, positioning ADI™-100 for potential human trials.

Positive

• Successful toxicology study for ADI™-100, indicating a robust safety profile.
• No adverse clinical signs were reported, supporting a favorable outlook for human trials.
• The drug does not exhibit immunosuppressive effects, which is advantageous for patient outcomes.

Negative

• None.

RICHMOND, Va.--(BUSINESS WIRE)-- Aditxt, Inc. (Nasdaq: ADTX) (“Aditxt” or the "Company"), a biotech innovation company developing and commercializing technologies focused on monitoring and reprogramming the immune system, today announces that its therapeutic program Adimune™, has successfully completed a toxicology study that indicates the safety profile of ADI™-100, the Company’s immunotherapeutic technology drug that addresses rejection of transplanted organs, skin allografting, autoimmune diseases and allergies.

The toxicology findings will provide vital supporting evidence when the Company files an Investigational New Drug (IND) application with the regulatory agencies.

“Our drug is truly antigen-specific in the treatment of autoimmune diseases,” said Joachim-Friedrich Kapp, M.D., Ph.D., Aditxt senior vice president of Clinical Development-Autoimmunity. “In preparation of the clinical study, we performed a toxicology study and found: no premature death, no signs of local intolerance, no test item-related influence on clinical signs, body weight and body weight gains, food consumption, biochemistry or urinalysis. No anti-nuclear antibodies, no macroscopic post-mortem findings, no changes in histopathology were noted, confirming the safety profile of our drug product, which we have seen in all pre-clinical experiments before.”

ADI™-100 consists of two DNA molecules, which together restore immune tolerance in autoimmune disease and establish tolerance in allogeneic skin transplantation applied in large skin wounds. Modulating the immune system by restoring/inducing tolerance is a unique mechanism of action, with a potentially huge efficacy and safety benefit for the patients affected because there is no immunosuppression involved.

“These findings are very promising,” said Dr. Kapp.

Amro Albanna, co-founder and CEO of Aditxt, said the encouraging toxicology results of ADI™-100 illustrate the Company’s commitment to advancing promising technologies to address rising unmet needs of patients with autoimmune diseases and those needing life-saving organ transplantation procedures.

“We are excited about the progress Adimune™ is making towards human trials, which represents a significant inflection point for the program and Aditxt as a whole,” Albanna said. “Adimune™ is an example of our business model accelerating promising innovation into commercialization and monetization.”

“In addition, and separately, we clearly demonstrated that our drug does not display any general immunosuppressive effect,” Dr. Kapp explains. “This was shown in safety studies, when using a Listeria model for infection and a melanoma model for potential effects on tumor growth. As one could have predicted, considering the mechanism of action, there was no interference with the immune system and its capacity to fight infection or tumor disease, at all. These findings are very promising and certainly will support our story when filing the IND.”

About Aditxt

Aditxt is a biotech innovation company developing and commercializing technologies focused on monitoring and reprogramming the immune system. Aditxt’s immune monitoring technologies are designed to provide a personalized immune profile. Aditxt’s immune reprogramming technologies, currently preclinical, are being developed to retrain the immune system to induce tolerance to address rejection of transplanted organs, autoimmune diseases, and allergies.

For more information, visit the company’s websites at www.Aditxt.com and www.AditxtScore.com.

Forward-Looking Statements

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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220708005062/en/

Media and Investor Relations Contact:

ir@aditxt.com

www.aditxt.com

Source: Aditxt, Inc.

FAQ

What were the results of Aditxt's ADI™-100 toxicology study?

The toxicology study for ADI™-100 showed a strong safety profile with no premature deaths or adverse clinical signs.

When will Aditxt file the IND application for ADI™-100?

Aditxt plans to file the Investigational New Drug (IND) application soon, supported by the toxicology study results.

What is the purpose of Aditxt’s ADI™-100 drug?

ADI™-100 is designed to treat autoimmune diseases and prevent rejection in organ transplants.

Does ADI™-100 have immunosuppressive effects?

No, the toxicology study confirmed that ADI™-100 does not display any general immunosuppressive effects.

What is Aditxt's focus as a biotech company?

Aditxt focuses on developing technologies for monitoring and reprogramming the immune system.