Aditxt Subsidiary Adimune Signs Clinical Trial Agreement with Top Research Institution to Study Stiff Person Syndrome
May 05 2023 - 7:05AM
Business Wire
- 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
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.
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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
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