Stiff-Person Syndrome

RICHMOND, Va.--(BUSINESS WIRE)-- 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 , , and 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.

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 , and 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.

MINNEAPOLIS , July 6, 2022 /PRNewswire/ -- Stiff person syndrome spectrum disorders are rare autoimmune and neurological disorders that most often cause muscle stiffness and spasms in the torso and limbs. According to a small, preliminary study released today, a blood treatment called plasmapheresis, also known as therapeutic plasma exchange, may be a safe way to treat stiff person syndrome spectrum disorders. The research will be presented at the new American Academy of Neurology Summer Conference: Autoimmune Neurology and Neurology Year in Review in San Francisco, July 15 to 16, 2022. Researchers also found that many study participants also experienced an improvement in symptoms or function, or both, while being treated with this therapy. For people with these disorders, symptoms may come and go early in the disease, but eventually become constant. Stiffness and spasms usually begin in the leg and torso muscles and over time can affect the arms and even the face. Other symptoms such as gait unsteadiness and unexplained falls can occur. Most people with these disorders are women. "Stiff person syndrome spectrum disorders are rare, and while there are some treatments for varying forms of these disorders, they are not always effective at reducing symptoms or preventing worsening of function," said study author Scott D. Newsome, DO, of Johns Hopkins University in Baltimore, Maryland, and Fellow of the American Academy of Neurology. "Finding a new way to treat a debilitating and painful disease that has few side effects or risks is a big win. The findings of our research help promote awareness of a treatment that may lead to relief for some people living with stiff person syndrome spectrum disorders." For the study, researchers looked at the medical records of 36 people with stiff person syndrome spectrum disorders who underwent plasmapheresis. This process cleans the blood by removing and replacing a person's blood plasma with albumin, a product manufactured from donated plasma to treat certain diseases. Of the participants, the majority had classic stiff person syndrome. Researchers found that this therapeutic plasma exchange process was both a safe and tolerable form of treatment for people with stiff person syndrome spectrum disorder. Four of the people studied, or 11%, had complications from the treatment, such as catheter infection or hemorrhage, but no deaths or anaphylaxis were reported. Additionally, 20 people, or 56%, saw improvement with these treatments. Twelve people needed fewer medications to treat their symptoms three months after the treatment. Researchers also reviewed other cases and identified an additional 42 people with stiff person syndrome who underwent the same treatment and found 69% reported a temporary improvement in their condition. "While the main focus of the study was safety, and we showed that complications from this treatment in people with stiff person syndrome are rare and manageable, it's very important that many people saw improvements or maintained the same level of function," Newsome said. "Further studies could confirm these results and help inform doctors when to use this treatment for stiff person syndrome spectrum disorders." One limitation of this study was that it was retrospective, meaning that researchers looked back at medical records rather than following study participants in real time. Another limitation was that it included a small number of participants. Newsome noted this is the largest case series to date. Learn more about stiff person syndrome at BrainandLife.org, home of the American Academy of Neurology's free patient and caregiver magazine focused on the intersection of neurologic disease and brain health. Follow Brain & Life® on Facebook, Twitter and Instagram. When posting to social media channels about this research, we encourage you to use the hashtags #Neurology, #AANscience, and the Summer Conference hashtag #AANSC. The American Academy of Neurology is the world's largest association of neurologists and neuroscience professionals, with over 38,000 members. The AAN is dedicated to promoting the highest quality patient-centered neurologic care. A neurologist is a doctor with specialized training in diagnosing, treating and managing disorders of the brain and nervous system such as Alzheimer's disease, stroke, migraine, multiple sclerosis, concussion, Parkinson's disease and epilepsy. For more information about the American Academy of Neurology, visit AAN.com or find us on Facebook, Twitter, Instagram, LinkedIn and YouTube. SOURCE American Academy of Neurology