Aditxt Subsidiary Adimune Announces Positive Results from Mayo Clinic Pre-Clinical Studies to Support FDA and European Regulatory Submissions for Type 1 Diabetes, Psoriasis, and Stiff Person Syndrome Human Trials
Aditxt (NASDAQ: ADTX) announced positive results from Mayo Clinic pre-clinical studies for its subsidiary Adimune's lead therapeutic candidate ADI-100. The study, led by Mayo Clinic's neuroimmunology team, validated that ADI-100 induces immune tolerance to glutamic acid decarboxylase (GAD), a key autoantigen in multiple autoimmune conditions.
Key findings include:
- Confirmation of ADI-100's safety profile with no increased T cell reactivity to GAD
- Dendritic cells treated with ADI-100 showed increased tolerogenic markers
- ADI-100-induced tolerogenic dendritic cells reduced activation of T cells from GAD-sensitive patients
The findings were presented at the American Academy of Neurology Annual Meeting. With pre-clinical efficacy and safety studies complete and GMP manufacturing finalized, Adimune plans regulatory submissions for the second half of 2025, targeting subsequent first-in-human clinical trials.
Aditxt (NASDAQ: ADTX) ha annunciato risultati positivi da studi pre-clinici della Mayo Clinic per il suo candidato terapeutico principale ADI-100, sviluppato dalla sussidiaria Adimune. Lo studio, condotto dal team di neuroimmunologia della Mayo Clinic, ha confermato che ADI-100 induce tolleranza immunitaria all'acido glutammico decarbossilasi (GAD), un autoantigene chiave in diverse condizioni autoimmuni.
I risultati chiave includono:
- Conferma del profilo di sicurezza di ADI-100 senza aumento della reattività delle cellule T verso il GAD
- Le cellule dendritiche trattate con ADI-100 hanno mostrato marcatori tollerogenici aumentati
- Le cellule dendritiche tollerogeniche indotte da ADI-100 hanno ridotto l'attivazione delle cellule T da pazienti sensibili al GAD
I risultati sono stati presentati all'American Academy of Neurology Annual Meeting. Con studi di efficacia e sicurezza pre-clinici completati e la produzione GMP finalizzata, Adimune prevede di presentare richieste normative nella seconda metà del 2025, mirando a successivi trial clinici di prima in umani.
Aditxt (NASDAQ: ADTX) anunció resultados positivos de estudios preclínicos de la Clínica Mayo para su candidato terapéutico principal ADI-100, desarrollado por su subsidiaria Adimune. El estudio, dirigido por el equipo de neuroinmunología de la Clínica Mayo, validó que ADI-100 induce tolerancia inmune a la descarboxilasa del ácido glutámico (GAD), un autoantígeno clave en múltiples condiciones autoinmunes.
Los hallazgos clave incluyen:
- Confirmación del perfil de seguridad de ADI-100 sin aumento de la reactividad de células T hacia el GAD
- Las células dendríticas tratadas con ADI-100 mostraron marcadores tolerogénicos aumentados
- Las células dendríticas tolerogénicas inducidas por ADI-100 redujeron la activación de células T de pacientes sensibles al GAD
Los hallazgos se presentaron en la Reunión Anual de la Academia Americana de Neurología. Con los estudios de eficacia y seguridad preclínicos completados y la fabricación GMP finalizada, Adimune planea presentaciones regulatorias para la segunda mitad de 2025, apuntando a ensayos clínicos de primera en humanos posteriores.
Aditxt (NASDAQ: ADTX)는 자회사 Adimune의 주요 치료 후보인 ADI-100에 대한 Mayo Clinic의 전임상 연구에서 긍정적인 결과를 발표했습니다. Mayo Clinic의 신경면역학 팀이 주도한 이 연구는 ADI-100이 여러 자가면역 질환에서 주요 자가 항원인 글루탐산 탈카복실화 효소(GAD)에 대한 면역 관용을 유도한다는 것을 검증했습니다.
주요 발견 사항은 다음과 같습니다:
- GAD에 대한 T 세포 반응성이 증가하지 않은 ADI-100의 안전성 프로필 확인
- ADI-100으로 처리된 수지상 세포에서 관용성 마커 증가
- ADI-100에 의해 유도된 관용성 수지상 세포가 GAD 민감 환자의 T 세포 활성화를 감소시킴
이 발견은 미국 신경학회 연례 회의에서 발표되었습니다. 전임상 효능 및 안전성 연구가 완료되고 GMP 제조가 최종화됨에 따라, Adimune은 2025년 하반기에 규제 제출을 계획하고 있으며, 이후 인간을 대상으로 하는 임상 시험을 목표로 하고 있습니다.
Aditxt (NASDAQ: ADTX) a annoncé des résultats positifs d'études précliniques menées par la Mayo Clinic pour son candidat thérapeutique principal ADI-100, développé par sa filiale Adimune. L'étude, dirigée par l'équipe de neuro-immunologie de la Mayo Clinic, a validé qu'ADI-100 induit une tolérance immunitaire à la glutamate décarboxylase (GAD), un autoantigène clé dans plusieurs maladies auto-immunes.
Les résultats clés incluent :
- Confirmation du profil de sécurité d'ADI-100 sans augmentation de la réactivité des cellules T envers le GAD
- Les cellules dendritiques traitées avec ADI-100 ont montré des marqueurs tolérants augmentés
- Les cellules dendritiques tolérantes induites par ADI-100 ont réduit l'activation des cellules T chez les patients sensibles au GAD
Les résultats ont été présentés lors de la réunion annuelle de l'American Academy of Neurology. Avec des études d'efficacité et de sécurité précliniques complètes et une fabrication GMP finalisée, Adimune prévoit des soumissions réglementaires pour la deuxième moitié de 2025, visant des essais cliniques ultérieurs chez l'homme.
Aditxt (NASDAQ: ADTX) gab positive Ergebnisse aus präklinischen Studien der Mayo Clinic für den Haupttherapiekandidaten ADI-100 seiner Tochtergesellschaft Adimune bekannt. Die Studie, die vom Neuroimmunologie-Team der Mayo Clinic geleitet wurde, bestätigte, dass ADI-100 eine Immunverträglichkeit gegenüber der Glutamat-Decarboxylase (GAD) induziert, einem Schlüsselautoantigen bei mehreren Autoimmunerkrankungen.
Wichtige Ergebnisse umfassen:
- Bestätigung des Sicherheitsprofils von ADI-100 ohne erhöhte T-Zell-Reaktivität gegenüber GAD
- Mit ADI-100 behandelte dendritische Zellen zeigten erhöhte tolerogene Marker
- ADI-100-induzierte tolerogene dendritische Zellen reduzierten die Aktivierung von T-Zellen bei GAD-sensiblen Patienten
Die Ergebnisse wurden auf dem Jahresmeeting der American Academy of Neurology präsentiert. Mit abgeschlossenen präklinischen Wirksamkeits- und Sicherheitsstudien sowie finalisierter GMP-Produktion plant Adimune regulatorische Einreichungen für die zweite Hälfte des Jahres 2025, mit dem Ziel, anschließende klinische Studien am Menschen durchzuführen.
- Pre-clinical studies at Mayo Clinic validated ADI-100's safety and efficacy
- Successful completion of GMP manufacturing
- Clear regulatory pathway with submissions planned for 2025
- Demonstrated immune tolerance induction without broad immunosuppression
- Clinical trials won't begin until after second half of 2025
- Still requires regulatory approval before human trials can commence
Insights
Aditxt's wholly-owned subsidiary Adimune has achieved significant preclinical validation through Mayo Clinic-led independent studies for their lead candidate ADI-100, representing meaningful progress in their autoimmune disease platform. The data demonstrates ADI-100's ability to induce immune tolerance to glutamic acid decarboxylase (GAD), a critical autoantigen in multiple conditions including type 1 diabetes and stiff person syndrome.
The findings reveal three crucial elements: 1) a favorable safety profile with no increased T cell reactivity, 2) successful immune modulation with dendritic cells showing increased tolerogenic markers, and 3) antigen-specific suppression even under inflammatory conditions. These results are particularly notable because they suggest ADI-100 may achieve targeted immune tolerance without broad immunosuppression - addressing a significant unmet need in autoimmune treatment.
From a development standpoint, Adimune has completed GMP manufacturing and preclinical efficacy/safety studies, with stability testing underway. This positions the company for regulatory submissions in both the U.S. and Germany by H2 2025, potentially advancing to first-in-human trials thereafter. The Mayo Clinic collaboration adds substantial credibility, with study data presented at the American Academy of Neurology Annual Meeting and a peer-reviewed manuscript in development.
For a company with Aditxt's modest
Findings Further Support the Safety Profile and Immunomodulatory Effects of ADI-100, Adimune’s Lead Therapeutic Candidate for Autoimmune Diseases
The independent study, led by Dr. Sean Pittock and Dr. Charles Howe of the Mayo Clinic’s neuroimmunology team, confirmed that ADI-100 induces immune tolerance to glutamic acid decarboxylase (GAD)—a key autoantigen implicated in multiple autoimmune conditions, including type 1 diabetes, stiff person syndrome, cerebellar ataxia, and autoimmune epilepsy.
“These results mark an important milestone not only for Adimune’s platform but also for Aditxt’s broader vision of transforming the way we approach autoimmune diseases,” said Amro Albanna, co-founder and CEO of Aditxt. “We believe that autoimmunity represents one of the most underserved and challenging areas of medicine. ADI-100’s potential ability to restore immune tolerance without broad immunosuppression is a meaningful step toward safer, more targeted treatments.”
Key Findings from the Mayo Clinic Study Include:
- Encouraging Safety Profile: ADI-100 did not increase T cell reactivity to GAD, reinforcing the product candidate’s preclinical safety profile.
- Immune Modulation at the Cellular Level: Dendritic cells treated with ADI-100 apoptotic bodies displayed increased tolerogenic markers.
- Antigen-Specific Suppression: ADI-100-induced tolerogenic dendritic cells reduced activation of T cells from GAD-sensitive patients, even in the presence of proinflammatory stimuli.
“Selection of a product candidate for clinical testing must demonstrate preclinical safety above all. The recent findings by Mayo Clinic using patient derived T cells corroborate Adimune’s preclinical findings showing an absence of disease exacerbation,” said Dr. Friedrich Kapp, Co-CEO of Adimune. “Demonstrating that ADI-100 treatment of patient-derived immune cells downregulates anti-GAD aggressive immune response is extremely reassuring as we prepare for clinical studies. It is our goal to restore immune tolerance and address both treatment and prevention needs of intervention. Treatment and prevention aspects will be key especially in Type 1 Diabetes where it is well established that people develop anti-GAD activity well prior to full disease manifestation. In other anti-GAD dependent disorders, we will have to see if we can halt or heal the disease.”
These findings were presented in abstract form at the American Academy of Neurology (AAN) Annual Meeting, with a peer-reviewed manuscript in development to include Mayo Clinic and Adimune datasets. The data will also support upcoming regulatory submissions in both the
“Our recent findings verifying the ability of ADI-100 to effectively tolerize a patient’s own ‘immune-system-in-a-dish’ against GAD and the observation that ADI-100 alters human T cell function in a manner that appears to be safe and non-inflammatory, really suggests that this therapy will make an impact in patients with anti-GAD autoimmunity. We are excited about moving ADI-100 forward into clinical testing in patients suffering from severe neurological impairments precipitated by GAD autoreactive T cells. Critically, we are also quite hopeful that the application of ADI-100 in these patients will open up the future development of tailored tolerization trials in patients with an array of neurological disorders, including neurodegenerative diseases in which CD8+ T cells have been implicated,” said Dr. Charles Howe, Chair of the Division of Experimental Neurology at Mayo Clinic and Director of Research for the Mayo Clinic Center for Multiple Sclerosis and Autoimmune Neurology.
With pre-clinical efficacy and safety studies complete and GMP manufacturing finalized, Adimune is working to advance ADI-100 toward the clinic. Stability testing is currently underway, and regulatory submissions are planned for the second half of 2025, potentially paving the way for first-in-human clinical trials shortly thereafter.
About Adimune
Adimune is a pre-clinical stage biopharmaceutical company pioneering a new class of immune modulation therapies designed to restore natural immune tolerance. Our mission is to advance immune health by providing targeted, long-term solutions that minimize reliance on chronic immunosuppression—transforming treatment for autoimmune diseases and organ transplantation.
At the core of Adimune’s innovation is ADI-100™, a first-in-class Apoptotic DNA Immunotherapy™ that mimics the body’s natural mechanisms for maintaining immune tolerance. This proprietary platform uses nucleic acid technology to deliver two coordinated signals: one encoding BAX, a protein that promotes targeted apoptosis, and another encoding a modified disease-specific antigen to re-establish immune tolerance.
To learn more and view the corporate presentation, please visit adimune.com .
About ADI-100
ADI-100 is an investigational, 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 is designed to 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.
About Aditxt, Inc.
Aditxt, Inc.® is a social innovation platform 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
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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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Aditxt, Inc.
Corporate Communications
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T: 646-863-6893
contactus@aditxt.com
Source: Aditxt, Inc.
FAQ
What are the key findings of Mayo Clinic's pre-clinical study for ADTX's ADI-100?
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How does ADTX's ADI-100 differ from current autoimmune treatments?
