Submission for Regulatory Approval to Initiate
Human Trials for Type 1 Diabetes, Psoriasis, and Stiff-Person
Syndrome Targeted for H2 2025
Aditxt, Inc. (NASDAQ: ADTX) (“Aditxt” or the “Company”), a
social innovation platform dedicated to accelerating promising
health innovations, today announced that its subsidiary, Adimune,
Inc. (“Adimune”), has successfully completed all preclinical
efficacy and safety studies for its antigen-specific gene therapy,
ADI-100. This achievement represents a major milestone as Adimune
prepares to submit a Clinical Trial Application
(CTA)/Investigational New Drug (IND) application to initiate
first-in-human clinical trials for ADI-100 in the treatment of Type
1 Diabetes (T1D), Psoriasis, and in collaboration with Mayo Clinic,
Stiff-Person Syndrome (SPS).
Preclinical Data Highlight: Antigen specific immune
tolerization without impairment of the overall immune
responsiveness: ADI-100 is an innovative immune modulation
therapy designed to restore immune tolerance in autoimmune diseases
and induce tolerance for transplanted organs by leveraging the
body’s natural immune homeostasis mechanisms. Preclinical studies
demonstrated the therapy's potential to achieve antigen-specific
tolerization without impairing the immune system's ability to fight
infections or to suppress tumor growth.
In preclinical models, ADI-100 demonstrated efficacy in
reversing hyperglycemia in Type 1 Diabetes, restoring islet cell
mass, and transferring protective immune modulation to animals that
were not treated with ADI-100. In separate preclinical experiments
ADI-100 did not show any impairment of immune responses to
infections or tumor growth. In Non-Obese Diabetic (NOD) mice (prone
to spontaneous type 1 diabetes) treated with anti-PD-1 checkpoint
inhibitors, which markedly hastened disease progression, ADI-100
prevented hyperglycemia in 70% of treated mice and provided durable
protection lasting over 300 days. In a study conducted using tumor
bearing mice, ADI-100 did not impede the ability of the checkpoint
inhibitor, anti-PD1, to shrink the tumor.
Preclinical toxicology data confirmed the therapy’s safety, with
no detectable persistence of plasmids in tissues and organs, no
formation of anti-plasmid antibodies, and no significant adverse
effects.
Advancing Toward IND Submission: Adimune has successfully
completed all preclinical efficacy and safety studies for ADI-100,
with GMP drug substances manufactured and stability studies
underway. These steps position ADI-100 for first-in-human clinical
trials, marking a significant milestone in transforming the
treatment landscape for autoimmune diseases.
Dr. Friedrich Kapp, Co-CEO of Adimune commented, “The treatment
of autoimmune diseases will see a fundamental change in the next
few years, a paradigm shift, which has been awaited since the
processes were understood by which immune tolerance normally is
being maintained. Restoring immune tolerance will replace
immunosuppressants in the treatment of autoimmune diseases, and
insulin eventually will become a mere rescue medication in type 1
diabetes. With the recent deal between Roche/Genentech and Cour on
autoimmune treatments, the race is on and will be won by the drug
which best fulfils three main criteria: safety, effectiveness, and
durability of response. Adimune’s ADI-100 is well positioned in
this competitive endeavor. We are one of the front runners because
we believe our drug candidate will meet all three criteria in a
perfect manner.”
The autoimmune disease market represents a significant and
growing unmet medical sector, with a total addressable market (TAM)
of $84.12 billion. Autoimmune diseases affect approximately 8% of
the U.S. population, with prevalence increasing year over year.
Recent industry developments underscore the demand for innovative
therapies in this space.
Adimune’s ADI-100 stands out in this competitive landscape with
its innovative mechanism of action, broad therapeutic potential,
and very strong preclinical data.
Amro Albanna, Co-Founder, Chairman, and CEO of Aditxt and Co-CEO
of Adimune, added, “Adimune represents an opportunity for a
fundamental shift in the way we treat autoimmunity where reliance
on immunosuppressants could be reduced or eliminated. With the
successful completion of ADI-100’s preclinical efficacy and safety
study, Adimune is closer to bringing this therapy to human trials
advancing its mission of addressing autoimmune diseases as one of
the most pressing health challenges we face.”
About ADI-100
ADI-100 is an innovative antigen-specific gene therapy that
consists of two DNA molecules designed to restore immune tolerance
in autoimmune diseases or to induce tolerance to transplanted
organs. This approach should retrain the immune system to recognize
antigens as "self" without relying on immunosuppression, offering
the possibility of significant safety and efficacy benefits.
The therapy consists of a pro-apoptotic DNA molecule (BAX),
which has been shown in preclinical models to induce localized
apoptotic cell death combined with a methylated sGAD55 DNA molecule
that encodes a modified form of GAD to retrain the immune system to
become tolerant to the antigen.
ADI-100 is designed to work through precision immune
reprogramming, downregulating pro-inflammatory cytokines while
upregulating anti-inflammatory cytokines in an antigen-specific
manner. It tolerizes to GAD, which is a target of autoimmunity,
directly or indirectly involved in Type 1 Diabetes, Psoriasis, and
certain CNS autoimmune disorders. In the mouse model for type 1
diabetes, ADI-100 demonstrated a reduction in the number of
aggressive T cells directed against insulin, which is another
antigen in the pancreas that is a target of autoimmune attack. This
bystander effect is an important factor to counteract a phenomenon
often observed where autoimmunity spreads to other regions of a
protein or to other proteins in a cell. Another potential benefit
of downregulating anti-GAD antibodies by ADI-100 is restoration of
GABA levels, further enhancing the tolerization process.
To learn more and view the corporate presentation, please visit
adimune.com.
About Aditxt, Inc.
Aditxt, Inc.® is a social innovation platform dedicated to
accelerating promising health innovations. Aditxt’s ecosystem of
research institutions, industry partners, and shareholders
collaboratively drives their mission to "Make Promising Innovations
Possible Together." The innovation platform is the cornerstone of
Aditxt’s strategy, where multiple disciplines drive disruptive
growth and address significant societal challenges. Aditxt operates
a unique model that democratizes innovation, ensures every
stakeholder’s voice is heard and valued, and empowers collective
progress.
Aditxt currently operates two programs focused on immune health
and precision health. The Company plans to introduce two additional
programs dedicated to public health and women’s health. For these,
Aditxt has entered into an Arrangement Agreement with Appili
Therapeutics, Inc. (“Appili”) (TSX: APLI; OTCPink: APLIF), which
focuses on infectious diseases, and a Merger Agreement with Evofem
Biosciences, Inc. (“Evofem”) (OTCQB: EVFM). Each program will be
designed to function autonomously while collectively advancing
Aditxt’s mission of discovering, developing, and deploying
innovative health solutions to tackle some of the most urgent
health challenges. The closing of each of the transactions with
Appili and Evofem is subject to several conditions, including but
not limited to approval of the transactions by the respective
target shareholders and Aditxt raising sufficient capital to fund
its obligations at closing. These obligations include cash payments
of approximately $17 million for Appili and $17 million for Evofem,
which includes approximately $15.2 million required to satisfy
Evofem's senior secured noteholder; should Aditxt fail to secure
these funds, Evofem's senior secured noteholder is expected to seek
to prevent the closing of the merger with Evofem. No assurance can
be provided that all of the conditions to closing will be obtained
or satisfied or that either of the transactions will ultimately
close.
For more information, www.aditxt.com.
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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 finance and execute its strategic M&A
initiatives; the Company’s ability to obtain the necessary funding
and partner to commence clinical trials; 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
Company’s ability to raise additional capital; expected usage of
the Company’s ELOC and ATM facilities; 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 Aditxt’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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version on businesswire.com: https://www.businesswire.com/news/home/20241212322796/en/
Aditxt, Inc. Corporate
Communications Jeff Ramson, PCG Advisory, Inc. T: 646-863-6893
contactus@aditxt.com
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