Aditxt’s (Nasdaq: ADTX) Adimune™ Program Has Initiated the Manufacturing Process of Immunotherapeutic Drug Candidate, ADI™-100 in Preparation for Planned Psoriasis First-in-Human Trials

Rhea-AI Summary

Aditxt, Inc. (NASDAQ: ADTX) announced the commencement of GMP manufacturing for its drug candidate ADI™-100 under the Adimune™ program, aiming to start first-in-human trials in the second half of 2023, pending regulatory approvals. Targeting autoimmune diseases, it will initially focus on psoriasis. Previous toxicology studies confirm ADI™-100's safety. The global psoriasis treatment market is projected to grow from $26.37 billion in 2022 to $47.24 billion by 2029, reflecting a strong potential for Adimune’s innovative approach that restores immune tolerance rather than suppressing it.

Positive

• Initiation of GMP manufacturing for ADI™-100 marks a key milestone.
• Potential to begin first-in-human trials in the second half of 2023.
• Encouraging toxicology results confirm safety for ADI™-100.
• Target market for psoriasis treatment projected to grow significantly from $26.37 billion in 2022 to $47.24 billion by 2029.
• ADI™ technology offers a novel approach by restoring immune tolerance.

Negative

• None.

RICHMOND, Va.--(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 that its program Adimune™ has initiated the GMP manufacturing of drug candidate ADI™-100 as a key milestone toward its goal to begin first-in-human trials during the second half of 2023. Pending regulatory approvals, these trials will be performed in autoimmune diseases, with psoriasis as the first indication to be studied. Adimune’s™ nucleic acid-based technology, called Apoptotic DNA Immunotherapy™ (“ADI™”), restores/induces immune tolerance in an antigen-specific way, and is based on a unique mechanism of action with a potentially profound efficacy benefit without immune suppression. Encouraging toxicology study results for ADI™-100 earlier established the safety profile of the drug candidate in the treatment of autoimmune diseases.

Dr. 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, is leading Adimune’s™ ADI™ immune modulation technology development toward clinical trials.

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 drugs. Many of those suffering with psoriasis also have serious health conditions such as diabetes, heart disease and depression. Some psoriasis sufferers also have an inflammatory condition called psoriatic arthritis that affects their joints.

Adimune’s™ solution aims to prevent the immune system attacks by restoring immune tolerance and addressing the root cause of skin cell build-ups. Treatment with ADI™-100 reduced skin thickening by 69% and scaling by 38% over a 10-day study period in an established psoriasis model.

“The impact of Adimune’s™ approach to treating autoimmune disease may have a game changing impact in a worldwide market estimated at more than 1.2 million Type 1 diabetes patients under the age of 20 and another 125 million psoriasis patients,” said Dr. Kapp. “The ADI™ technology is very different from immunosuppressant drugs in that it restores immune tolerance. Our proof-of-concept trials are designed to demonstrate just that.”

“Aditxt’s vision is dedicated to a new era of precision medicine through individual immune monitoring and modulation,” said Amro Albanna, co-founder, chairman and CEO of Aditxt, Inc. “We are laser focused on advancing each of our innovation programs toward commercialization. Adimune’s initiation of ADI™-100 manufacturing is measurable progress of Adimune™ toward our 2023 strategic goals.”

The global psoriasis treatment market size is projected to grow from $26.37 billion in 2022 to $47.24 billion by 2029, exhibiting a CAGR of 8.7% during the forecast period, according to Fortune Business Insights.

Adimune™ is planning to develop the ADI™ technology platform to address a wide variety of indications.

About Aditxt Inc.

Aditxt is a biotech innovation company developing and commercializing technologies with a focus 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.

For more information, please visit: www.Aditxt.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 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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Media and Investor Relations Contact:

ir@aditxt.com

www.aditxt.com

Source: Aditxt, Inc.

FAQ

What is Aditxt's recent press release about ADI™-100?

Aditxt announced the start of GMP manufacturing for ADI™-100, with plans for first-in-human trials in autoimmune diseases, particularly psoriasis.

When does Aditxt plan to begin human trials for ADI™-100?

Aditxt aims to begin first-in-human trials for ADI™-100 in the second half of 2023, pending regulatory approvals.

What does Aditxt's ADI™ technology aim to achieve?

ADI™ technology is designed to restore immune tolerance to treat autoimmune diseases without immune suppression.

What are the market prospects for psoriasis treatment?

The global psoriasis treatment market is expected to grow from $26.37 billion in 2022 to $47.24 billion by 2029.