Tiziana Life Sciences Announces Groundbreaking Study Published in Nature Neuroscience Demonstrating Positive Results for Nasal Anti-CD3 Therapy in Traumatic Brain Injury
Tiziana Life Sciences (NASDAQ: TLSA) has published a groundbreaking study in Nature Neuroscience demonstrating significant positive results for their nasal anti-CD3 therapy in treating traumatic brain injury (TBI). The study shows that nasal administration of Tiziana's anti-CD3 monoclonal antibody, foralumab, effectively reduced neuroinflammation and improved recovery.
The research, led by Dr. Saef Izzy at Brigham and Women's Hospital, revealed that the therapy induces IL-10 producing regulatory T cells that migrate to the brain and modulate microglia activity. Key improvements observed in the preclinical model included:
- Reduced anxiety
- Less cognitive decline
- Improved motor skills
The study validates the mechanism of action of foralumab and its potential application in treating various neuroinflammatory conditions, including Multiple Sclerosis, Alzheimer's disease, and ALS. This breakthrough is particularly significant as there are currently no effective treatments available for TBI, which remains a major unmet medical need.
Tiziana Life Sciences (NASDAQ: TLSA) ha pubblicato uno studio innovativo su Nature Neuroscience che dimostra risultati positivi significativi per la loro terapia nasale anti-CD3 nel trattamento del trauma cranico (TBI). Lo studio mostra che la somministrazione nasale dell'anticorpo monoclonale anti-CD3 di Tiziana, foralumab, ha ridotto efficacemente la neuroinfiammazione e migliorato il recupero.
La ricerca, condotta dal Dr. Saef Izzy presso il Brigham and Women's Hospital, ha rivelato che la terapia induce cellule T regolatorie produttrici di IL-10 che migrano verso il cervello e modulano l'attività della microglia. I principali miglioramenti osservati nel modello preclinico includevano:
- Riduzione dell'ansia
- Minore declino cognitivo
- Miglioramento delle abilità motorie
Lo studio convalida il meccanismo d'azione di foralumab e il suo potenziale utilizzo nel trattamento di varie condizioni neuroinfiammatorie, tra cui la sclerosi multipla, la malattia di Alzheimer e la SLA. Questa scoperta è particolarmente significativa poiché attualmente non esistono trattamenti efficaci disponibili per il TBI, che rimane un'importante necessità medica insoddisfatta.
Tiziana Life Sciences (NASDAQ: TLSA) ha publicado un estudio innovador en Nature Neuroscience que demuestra resultados positivos significativos para su terapia nasal anti-CD3 en el tratamiento de lesiones cerebrales traumáticas (TBI). El estudio muestra que la administración nasal del anticuerpo monoclonal anti-CD3 de Tiziana, foralumab, redujo eficazmente la neuroinflamación y mejoró la recuperación.
La investigación, liderada por el Dr. Saef Izzy en el Brigham and Women's Hospital, reveló que la terapia induce células T reguladoras productoras de IL-10 que migran al cerebro y modulan la actividad de la microglía. Las mejoras clave observadas en el modelo preclínico incluyeron:
- Reducción de la ansiedad
- Menor deterioro cognitivo
- Mejora de las habilidades motoras
El estudio valida el mecanismo de acción de foralumab y su potencial aplicación en el tratamiento de diversas condiciones neuroinflamatorias, incluyendo la esclerosis múltiple, la enfermedad de Alzheimer y la ELA. Este avance es particularmente significativo, ya que actualmente no hay tratamientos efectivos disponibles para el TBI, que sigue siendo una gran necesidad médica insatisfecha.
티지아나 라이프 사이언스(Tiziana Life Sciences) (NASDAQ: TLSA)는 자연 신경과학(Nature Neuroscience)에서 외상성 뇌 손상(TBI) 치료를 위한 비강 항-CD3 요법에 대한 중요한 긍정적 결과를 보여주는 획기적인 연구를 발표했습니다. 이 연구는 티지아나의 항-CD3 단클론 항체인 포랄루맙(foralumab)의 비강 투여가 신경 염증을 효과적으로 감소시키고 회복을 개선했다는 것을 보여줍니다.
브리검 여성 병원(Brigham and Women's Hospital)의 세프 이지(Dr. Saef Izzy) 박사가 이끄는 연구는 이 요법이 IL-10을 생성하는 조절 T 세포를 유도하여 뇌로 이동하고 미세아교세포(microglia)의 활동을 조절한다는 것을 밝혔습니다. 전임상 모델에서 관찰된 주요 개선 사항은 다음과 같습니다:
- 불안 감소
- 인지 저하 감소
- 운동 능력 향상
이 연구는 포랄루맙의 작용 메커니즘을 검증하고 다발성 경화증, 알츠하이머병 및 ALS와 같은 다양한 신경 염증 질환 치료에 대한 잠재적 적용 가능성을 보여줍니다. 이 획기적인 발견은 현재 TBI에 대한 효과적인 치료법이 없다는 점에서 특히 중요하며, 이는 여전히 큰 의학적 필요로 남아 있습니다.
Tiziana Life Sciences (NASDAQ: TLSA) a publié une étude révolutionnaire dans Nature Neuroscience démontrant des résultats positifs significatifs pour leur thérapie nasale anti-CD3 dans le traitement des lésions cérébrales traumatiques (TBI). L'étude montre que l'administration nasale de l'anticorps monoclonal anti-CD3 de Tiziana, foralumab, a réduit efficacement la neuroinflammation et amélioré la récupération.
La recherche, dirigée par le Dr Saef Izzy à l'hôpital Brigham and Women's, a révélé que la thérapie induit des cellules T régulatrices productrices d'IL-10 qui migrent vers le cerveau et modulent l'activité des microglies. Les améliorations clés observées dans le modèle préclinique comprenaient:
- Réduction de l'anxiété
- Moins de déclin cognitif
- Amélioration des compétences motrices
L'étude valide le mécanisme d'action du foralumab et son application potentielle dans le traitement de diverses conditions neuroinflammatoires, y compris la sclérose en plaques, la maladie d'Alzheimer et la SLA. Cette percée est particulièrement significative car il n'existe actuellement aucun traitement efficace disponible pour le TBI, qui reste un besoin médical majeur non satisfait.
Tiziana Life Sciences (NASDAQ: TLSA) hat eine bahnbrechende Studie in Nature Neuroscience veröffentlicht, die signifikante positive Ergebnisse für ihre nasale Anti-CD3-Therapie zur Behandlung von traumatischen Hirnverletzungen (TBI) zeigt. Die Studie zeigt, dass die nasale Verabreichung des Anti-CD3-Monoklonalen Antikörpers von Tiziana, Foralumab, effektiv die Neuroinflammation reduzierte und die Genesung verbesserte.
Die Forschung, geleitet von Dr. Saef Izzy am Brigham and Women's Hospital, zeigte, dass die Therapie IL-10-produzierende regulatorische T-Zellen induziert, die ins Gehirn migrieren und die Aktivität der Mikroglia modulieren. Wichtige Verbesserungen, die im präklinischen Modell beobachtet wurden, umfassten:
- Verringerte Angst
- Weniger kognitiver Rückgang
- Verbesserte motorische Fähigkeiten
Die Studie validiert den Wirkmechanismus von Foralumab und dessen potenzielle Anwendung zur Behandlung verschiedener neuroinflammatorischer Erkrankungen, einschließlich Multipler Sklerose, Alzheimer-Krankheit und ALS. Dieser Durchbruch ist besonders bedeutend, da es derzeit keine wirksamen Behandlungen für TBI gibt, was eine große unerfüllte medizinische Notwendigkeit darstellt.
- First potential effective treatment for traumatic brain injury, addressing major unmet medical need
- Successful preclinical results showing reduced neuroinflammation and improved recovery
- Validated mechanism of action with potential applications in multiple neurological conditions
- Publication in prestigious Nature Neuroscience journal enhancing scientific credibility
- Study still in preclinical stage, requiring further clinical trials
- No data on human efficacy or safety yet available
Insights
Tiziana Life Sciences' publication in Nature Neuroscience represents a significant scientific advancement in the treatment of traumatic brain injury (TBI), a condition with no FDA-approved therapies despite affecting approximately 1.5 million Americans annually with an estimated global market of
The study demonstrates that Tiziana's intranasal foralumab induces IL-10 producing regulatory T cells that cross the blood-brain barrier - a critical advantage over traditional systemic immunotherapies. This mechanism effectively modulates neuroinflammation while preserving the brain's natural repair processes, addressing TBI's complex pathophysiology in ways conventional approaches cannot.
For investors, this publication provides three key value drivers:
- Scientific validation from one of neuroscience's most selective journals (
8% acceptance rate), significantly de-risking the technology - Expansion of foralumab's potential beyond its current Phase 2 multiple sclerosis program, creating multiple shots on goal
- Unique intranasal delivery platform that could revolutionize emergency medicine by enabling rapid administration without specialized equipment
With Tiziana's market cap under
The broader implications extend to other neuroinflammatory conditions like stroke, intracerebral hemorrhage, and neurodegenerative diseases - collectively representing a
- Traumatic brain injury is a leading cause of death and disability
- Currently, there is no treatment to prevent the long-term effects of traumatic brain injury
- Findings could translate into treating intracerebral hemorrhage or stroke
NEW YORK, Feb. 27, 2025 (GLOBE NEWSWIRE) -- Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies with its lead development candidate, intranasal foralumab, a fully human, anti-CD3 monoclonal antibody, today announced the publication of a landmark study in Nature Neuroscience demonstrating that nasal administration of Tiziana’s anti-CD3 monoclonal antibody significantly reduced neuroinflammation and improved recovery. Modulating the neuroinflammatory response correlated with improved neurological outcomes. These included, less anxiety, less cognitive decline, and improved motor skills, in a preclinical model of traumatic brain injury (TBI).
The study was led by Saef Izzy, MD, FNCS, FAAN, a neurologist and head of the Immunology of Brain Injury Program at Brigham and Women’s Hospital (BWH), a founding member of the Mass General Brigham healthcare system. The publication revealed that nasal anti-CD3 therapy induces IL-10 producing regulatory T cells (Tregs) that migrate to the brain and modulate microglia activity. These Tregs were found to play a pivotal role in reducing chronic microglial inflammation and enhancing their phagocytic function, ultimately mitigating CNS damage and behavioral deficits associated with TBI.
“This study highlights the critical role of immune modulation in improving recovery time and outcomes after traumatic brain injury,” said Dr. Saef Izzy, lead author and neurologist at Brigham and Women’s Hospital. “We found that nasal anti-CD3 therapy effectively harnesses the body’s own immune system to counteract the damaging effects of neuroinflammation while enhancing the brain’s reparative mechanisms. These findings offer exciting potential for developing a much-needed therapeutic approach for TBI patients.”
TBI remains a major unmet medical need, with no effective treatments currently available to reduce CNS injury and promote recovery. The study demonstrated that blocking the IL-10 receptor abrogated the benefits of nasal anti-CD3, confirming the pivotal role of IL-10 in the therapeutic effect. Moreover, the adoptive transfer of IL-10 producing Tregs restored the benefits, further validating the mechanism of action.
“The positive results from this study provide strong support for advancing nasal anti-CD3 (foralumab) as a novel and promising treatment for traumatic brain injury,” said Dr. Howard L. Weiner, Co-Director of the Ann Romney Center for Neurologic Diseases at BWH. “By modulating the immune system through simple nasal delivery, we are tapping into a unique and innovative way to treat neuroinflammation and improve outcomes for TBI patients, which could be in a hospital, at the road side after an accident or on the playing field in contact sports.”
“The Company’s proprietary nasal anti-CD3 monoclonal antibody platform has already demonstrated potential in multiple neuroinflammatory and autoimmune diseases. These results further validate the mechanism of action of foralumab and Tiziana’s commitment to further develop transformative therapies for neuroinflammatory conditions such as Multiple Sclerosis, Alzheimer’s disease and ALS,” said Ivor Elrifi, CEO of Tiziana Life Sciences. “We believe nasal foralumab has the potential to be a game-changer in the treatment of traumatic brain injury and other acute brain injuries, addressing a critical unmet need in medicine.”
Publication title: “Nasal anti-CD3 monoclonal antibody ameliorates traumatic brain injury, enhances microglial phagocytosis and reduces neuroinflammation via IL-10-dependent Treg–microglia crosstalk” Izzy, S., et al. Nature Neuroscience. DOI: 10.1038/s41593-025-01877-7
Link to publication: https://www.nature.com/articles/s41593-025-01877-7
About Foralumab
Foralumab, a fully human anti-CD3 monoclonal antibody, is a biological drug candidate that has been shown to stimulate T regulatory cells when dosed intranasally. At present, 10 patients with Non-Active Secondary Progressive Multiple Sclerosis (na-SPMS) have been dosed in an open-label intermediate sized Expanded Access (EA) Program (NCT06802328) with either an improvement or stability of disease seen within 6 months in all patients. The FDA has recently allowed an additional 20 patients to be enrolled in this EA program. In addition, intranasal foralumab is currently being studied in a Phase 2a, randomized, double-blind, placebo-controlled, multicenter, dose-ranging trial in patients with non-active secondary progressive multiple sclerosis (NCT06292923).
Activated T cells play an important role in the inflammatory process. Foralumab, the only fully human anti-CD3 monoclonal antibody (mAb) currently in clinical development, binds to the T cell receptor and dampens inflammation by modulating T cell function, thereby suppressing effector features in multiple immune cell subsets. This effect has been observed in patients with COVID and with multiple sclerosis, as well as in healthy normal subjects. The non-active SPMS intranasal foralumab Phase 2 trial (NCT06292923) began screening patients in November of 2023. Immunomodulation by nasal anti-CD3 mAb represents a novel avenue for treatment of neuroinflammatory and neurodegenerative human diseases.[1],[2]
About Tiziana Life Sciences
Tiziana Life Sciences is a clinical-stage biopharmaceutical company developing breakthrough therapies using transformational drug delivery technologies to enable alternative routes of immunotherapy. Tiziana’s innovative nasal approach has the potential to provide an improvement in efficacy as well as safety and tolerability compared to intravenous (IV) delivery. Tiziana’s lead candidate, intranasal foralumab, which is the only fully human anti-CD3 mAb currently in clinical development, has demonstrated a favorable safety profile and clinical response in patients in studies to date. Tiziana’s technology for alternative routes of immunotherapy has been patented with several applications pending and is expected to allow for broad pipeline applications.
For more information about Tiziana Life Sciences and its innovative pipeline of therapies, please visit www.tizianalifesciences.com.
Forward-Looking Statements
Certain statements made in this announcement are forward-looking statements. These forward-looking statements are not historical facts but rather are based on the Company's current expectations, estimates, and projections about its industry, its beliefs, and assumptions. Words such as 'anticipates,' 'expects,' 'intends,' 'plans,' 'believes,' 'seeks,' 'estimates,' and similar expressions are intended to identify forward-looking statements. These statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties, and other factors, some of which are beyond the Company's control, are difficult to predict, and could cause actual results to differ materially from those expressed or forecasted in the forward-looking statements. The Company cautions security holders and prospective security holders not to place undue reliance on these forward-looking statements, which reflect the view of the Company only as of the date of this announcement. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties related to market conditions and other factors described more fully in the section entitled ‘Risk Factors’ in Tiziana’s Annual Report on Form 20-F for the year ended December 31, 2023, and other periodic reports filed with the Securities and Exchange Commission. The forward-looking statements made in this announcement relate only to events as of the date on which the statements are made. The Company will not undertake any obligation to release publicly any revisions or updates to these forward-looking statements to reflect events, circumstances, or unanticipated events occurring after the date of this announcement except as required by law or by any appropriate regulatory authority.
For further inquiries:
Tiziana Life Sciences Ltd
Paul Spencer, Business Development, and Investor Relations
+44 (0) 207 495 2379
email: info@tizianalifesciences.com
[1] https://www.pnas.org/doi/10.1073/pnas.2220272120
[2] https://www.pnas.org/doi/10.1073/pnas.2309221120
FAQ
What are the key findings of Tiziana's (TLSA) new traumatic brain injury study?
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What makes TLSA's nasal anti-CD3 therapy unique for traumatic brain injury treatment?
