Aditxt Subsidiary Adimune Signs Clinical Trial Agreement with Top Research Institution to Study Stiff Person Syndrome

Rhea-AI Summary

Aditxt's subsidiary Adimune has signed a clinical trial agreement with Mayo Clinic to advance clinical studies targeting autoimmune diseases of the central nervous system (CNS), starting with Stiff Person Syndrome (SPS). The collaboration aims to restore immune tolerance in patients with progressive autoimmune CNS disorders. The clinical trial is expected to begin in 2023 with enrollment of approximately 10-15 patients.

Positive

• Aditxt's subsidiary Adimune signed a clinical trial agreement with Mayo Clinic to advance clinical studies targeting autoimmune diseases of the CNS, starting with Stiff Person Syndrome. The collaboration will help advance the full pre-clinical and clinical programs of ADI-100, Aditxt's immune modulation product candidate. The clinical trial is expected to begin in 2023 with enrollment of approximately 10-15 patients.

Negative

• None.

• Adimune, Inc. is nearing completion of its pre-clinical package for the immunotherapy clinical study drug candidate ADI-100
• Collaboration will initially target Stiff Person Syndrome, a rare, central nervous system disease frequently associated with other autoimmune diseases such as type-1 diabetes
• Clinical trial at Mayo Clinic is planned with enrollment of approximately 10-15 patients

RICHMOND, Va.--(BUSINESS WIRE)-- Aditxt®, Inc. (NASDAQ: ADTX) (“Aditxt” or the “Company”), a global innovation company focused on therapeutics and technologies that modulate and monitor the immune system, today announces that its subsidiary Adimune™, Inc. (“Adimune”), has signed a clinical trial agreement with Mayo Clinic to advance clinical studies targeting autoimmune diseases of the central nervous system (“CNS”) with the initial focus on the rare, but debilitating, autoimmune disease Stiff Person Syndrome (“SPS”). Adimune was founded earlier this year to lead Aditxt’s immune modulation therapeutic programs.

For the past 18 months, Aditxt has been preparing to launch its first immune modulation product candidate, ADI™-100, targeting several clinical trials to demonstrate its safety and indications of efficacy. ADI-100 is designed to tolerize against an antigen known as glutamic acid decarboxylase (“GAD”), which is implicated in type-1 diabetes, psoriasis, and in many autoimmune diseases of the CNS.

“We are extremely pleased about having the opportunity to work with Mayo Clinic on trying to restore immune tolerance in patients suffering from devastating progressive autoimmune central nervous system disorders,” said Dr. Joachim Friedrich Kapp, the co-CEO of Adimune. “The collaboration will include both pre-clinical and clinical studies and builds on Adimune’s current efforts to advance the full pre-clinical and clinical programs of ADI-100. We believe that the pre-clinical studies will help us to expand on the understanding of the technology, specifically the mechanism of action which induces antigen-specific immune tolerance without impairing the responsiveness of the immune system to fight infections and cancers.”

Adimune plans to initiate clinical studies using ADI-100, targeting autoimmune diseases of the CNS that are mediated by GAD, starting with SPS. According to the National Organization of Rare Diseases, the exact incidence and prevalence of SPS is unknown; however, one estimate places the incidence at approximately 1 in 1 million individuals in the general population. The clinical trial is expected to begin in 2023 with enrollment of approximately 10-15 patients, some of whom may also suffer from type-1 diabetes.

“With autoimmune disorders of the central nervous system, including multiple sclerosis and other rare diseases affecting millions of people, this step supports our mission of ‘Making Promising Innovations Possible, Together,’” says Adimune Co-CEO and Aditxt Co-Founder, CEO and Chairman, Amro Albanna.

About Aditxt, Inc.

Aditxt®, Inc. (NASDAQ: ADTX) is a global innovation company focused on therapeutics and technologies that monitor and modulate the immune system. Headquartered in Richmond, Virginia, with operations in Silicon Valley, California, and New York, New York. Aditxt’s mission “Making Promising Innovations Possible, Together” is defined by our growing ecosystem of research institutions, global industry partners and shareholders who inform and inspire our mission. Aditxt’s diverse innovation portfolio includes: Adimune™, Inc., aimed at developing and designing a new class of therapeutics for retraining the immune system to address organ rejection, autoimmunity, and allergies; Adivir™, Inc., focused on identifying, developing and commercializing new ways to treat infectious diseases; and Pearsanta, Inc., which intends to offer personalized immune monitoring for a wide range of health conditions, including hereditary cancer, wounds and cardiomyopathy.

For more information, visit the Company’s websites at www.Aditxt.com, www.Adimune.com and www.Pearsanta.com. Follow us on LinkedIn for the latest company news.

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 ability to secure the capital necessary to satisfy its obligations under the clinical trial agreement with the Mayo Clinic; the Company’s ability to enroll qualifying patients in the study; 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

Source: Aditxt, Inc.

FAQ

What is Aditxt's subsidiary Adimune focusing on?

Adimune is focusing on advancing clinical studies targeting autoimmune diseases of the CNS, starting with Stiff Person Syndrome (SPS).

What is the purpose of the clinical trial agreement with Mayo Clinic?

The purpose of the clinical trial agreement is to restore immune tolerance in patients with progressive autoimmune CNS disorders.

What is the estimated enrollment for the clinical trial?

The clinical trial is expected to enroll approximately 10-15 patients.