Aditxt®, Inc. (NASDAQ: ADTX) (“Aditxt” or the “Company”), a
global innovation company focused on innovation and activation of
precision medicine therapeutics and technologies that monitor and
modulate the immune system, is pleased to provide an important
update regarding its innovation programs and strategic M&A
initiatives.
At Aditxt, our DNA is focused on bringing some of the most
needed and promising health innovations and solutions to life in a
faster, more efficient way. We believe strongly in the power of
precision medicine, precision diagnostics and monitoring, precision
prevention, and precision treatment. People deserve better than a
one-size-fits-all approach to disease prevention, diagnostics, and
treatments—in every area of health, including autoimmune diseases,
oncology, neurology, and viral infections.
As we near the end of the third quarter of 2023 and look ahead
to 2024, we are focused on expanding our portfolio to include:
- 2 current programs in monitoring and treating autoimmunity and
organ transplantation: Adimune and Pearsanta.
- a human clinical trial with Mayo Clinic studying the central
nervous system disorder Stiff-Person Syndrome using our proprietary
ADI-100™.
For Q2 2023 and the first half of the Q3 2023, we have been
heavily focused on ongoing conversations around promising
innovations. We also mutually agreed to terminate the non-binding
letter of intent with Natural State Genomics and Natural State
Laboratories.
Since the founding of Aditxt, we have believed that
commercializing health innovations deserves a new approach driven
by stakeholders. For far too long, game-changing innovations never
see the light of day. Highly promising innovations, drug molecules,
therapeutics, screening devices, or pieces of hardware or software,
are tabled due to lack of critical infrastructure, expertise, and
resources needed to survive and thrive—including, operations,
finance, M&A, global partnerships, content and marketing,
access to labs and research facilities, and more. We believe that
the Aditxt model offers the foundation innovations needed to
succeed.
Finally, Aditxt was built and designed to harness the power of
global capital markets and partners—from medical research
institutions to software and hardware companies, manufacturing, and
commercialization. As we expand, so does our ability to accelerate
innovation. We are committed to advancing healthcare through
innovation and precision medicine. At Aditxt, we strive to make
promising innovations possible, together.
Leadership Weighs In
“Aditxt takes a stakeholder-driven approach to developing and
deploying some of the most promising health innovations such as
Pearsanta’s immune monitoring platform, and Adimune’s immune
modulation therapeutic,” says Amro Albanna, Aditxt CEO, Chairman
and Co-Founder. “Our goal is to get our current programs to reach
key clinical or commercial stage and expand our portfolio of
innovations to address additional markets such as oncology and
neurology.”
Aditxt Portfolio Updates
Adimune™, Inc. Immune modulation
program
Adimune, Inc.’s immune modulation technologies are designed to
retrain the immune system to restore tolerance in autoimmune
diseases and allergies, and to induce tolerance in allogeneic skin
transplantation.
Program Highlights and Next
Steps
- Adimune and Mayo Clinic signed a clinical trial agreement to
test ADI-100™ in patients with Stiff-Person Syndrome, a rare
central nervous system autoimmune disease mediated by a target
antigen also implicated in T1D. - U.S. human trials are expected to
be underway in Q4 2023. - Mayo Clinic is currently working to
enroll 15 to 20 patients and initial screenings have begun.
- ADI-100™ prevented checkpoint-inhibitor-induced T1D without
preventing its effectiveness in reducing cancer tumor size,
demonstrating selective upregulation of regulatory cells.
- Clinical trial applications for psoriasis and T1D are expected
to be filed with the German Health Authority in Q1 2024.
- Clinical grade manufacturing of clinical grade drug substances
(DNA plasmids) has been completed and GMP formulation of clinical
grade ADI-100™, to be used for the first-in-human studies in
subjects with psoriatic lesions, is expected to be initiated.
- Completed the in-life portion of the toxicology studies. Safety
data are recorded and Adimune is awaiting immunotoxicology
data.
Leadership Weighs In
“This is an exciting time for Adimune. ADI-100™ is now part of
an investigator sponsored study at the Mayo Clinic this year in
patients with Stiff-Person Syndrome, a very severe progressive
central nervous system autoimmune disorder,” says Adimune co-CEO
Joachim-Friedrich Kapp, M.D., Ph.D. “Once the stability program is
completed, we intend to finalize the CTA documents and apply for
regulatory approval to perform clinical trials in two additional
indications, T1D and psoriasis. We are optimistic that the findings
in the human trials will confirm what has been established in the
vast number of animal safety and efficacy studies.”
Pearsanta™, Inc. “Lab testing anytime
and anywhere”
Pearsanta, Inc. is committed to building a “lab testing anytime
and anywhere” model through three channels: Traditional lab
developed tests (“LDT”s); Point of Care (“POC”) devices (i.e., “lab
on a chip,”); and Direct to Consumers (“DTC”) offerings.
Program Highlights and Next
Steps
- Established immune monitoring center in Richmond, VA in 2021,
for centralized and decentralized lab services. An advanced
multi-spectral sensor technology platform for at-home testing is
currently under development for decentralized lab services. Market
roll out for at-home testing is expected to begin in Q2 2024
through brick-and-mortar retailers along with a DTC eCommerce
online marketing strategy coupled with social media
influencers.
- Continuing to expand product pipeline, research, and
development, and have wider commercial reach with patients with a
POC testing platform.
- Working to identify M&A opportunities to access new
territories and markets for additional innovation expertise in the
field of genetics, products, and services to deliver Pearsanta’s
“Health by the Numbers” for improved health outcomes.
- Exploring future partnerships for the development,
implementation, and distribution of a rapid PCR-based testing
platform. Rapid test results will have the potential to enable
almost real-time clinical decision making in prescribing the most
appropriate treatment protocol for Covid, influenza, respiratory
syncytial virus (RSV), urinary tract infections (UTIs), sexually
transmitted Infections (STIs), strep throat, and others.
Leadership Weighs In
“Pearsanta’s lab testing platform is a paradigm shift in how
consumers can access their healthcare on demand for immediate
care,” says Ernie Lee, Head of Pearsanta. “As an example, positive
lab test results from UTIs, Covid, flu, RSV, and STIs respond most
effectively when treatments are started within a few days of
symptoms. Through the platform, you could potentially be tested,
see a health care provider, receive a prescription for a
medication, if one is needed, and have the prescription filled—all
in one encounter.”
Adivir™, Inc. Antiviral
therapeutics
Adivir, Inc. is focused on catalyzing discoveries that prevent
and cure infectious diseases.
Program Highlights and Next
Stage
- Continue to work towards completing the transaction for the
acquisition of 50 percent ownership in G Response Aid FZCO, which
includes the license to develop and commercialize 200MG Avigan®
(Favipiravir), an antiviral that may be used as a mono treatment or
in combination therapies.
About Aditxt, Inc.
Aditxt®, Inc. (NASDAQ: ADTX) is a global innovation company
focused on innovation and activation of precision medicine
therapeutics and technologies that monitor and modulate the immune
system. Headquartered in Richmond, Virginia, with operations in
Silicon Valley, California, and New York, Aditxt’s mission of
“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.,
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 offers 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 finance and execute on its strategic
M&A initiatives; the Company’s ability 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; 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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version on businesswire.com: https://www.businesswire.com/news/home/20230818690162/en/
Media and Investor Relations Contact: ir@aditxt.com
www.aditxt.com
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