Aditxt, Inc. Successfully Completes Preclinical Toxicity Study of Its Psoriasis Drug Candidate ADI™-100 Advancing it Closer to First-in-Human Trials
July 08 2022 - 7:30AM
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.
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Media and Investor Relations Contact: ir@aditxt.com
www.aditxt.com
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