Tiziana Life Sciences Announces Immunologic Analysis of Nasal Foralumab in Moderate Alzheimer's Patient
Tiziana Life Sciences (NASDAQ:TLSA) has reported promising immunologic findings from treating a moderate Alzheimer's Disease patient with intranasal foralumab, their lead immunomodulation therapy. The analysis revealed significant immune modulatory effects in white blood cells, including changes in CD4 cells, CD8 cells, and monocytes.
Key findings include a marked reduction in brain inflammation confirmed by microglia PET scans and an unexpected increase in phagocytosis markers in classical monocytes, suggesting potential for enhanced amyloid plaque clearance. The treatment was well-tolerated with no side effects, and the patient will continue therapy for an additional 6 months.
Tiziana Life Sciences (NASDAQ:TLSA) ha riportato risultati immunologici promettenti dal trattamento di un paziente con Alzheimer moderato mediante foralumab intranasale, la loro principale terapia di immunomodulazione. L'analisi ha evidenziato significativi effetti modulatori del sistema immunitario nelle cellule del sangue bianco, con variazioni nelle cellule CD4, CD8 e nei monociti.
I risultati chiave includono una netta riduzione dell'infiammazione cerebrale confermata da scansioni PET della microglia e un aumento inaspettato dei marcatori di fagocitosi nei monociti classici, suggerendo un potenziale per una maggiore eliminazione delle placche amiloidi. Il trattamento è stato ben tollerato senza effetti collaterali, e il paziente proseguirà la terapia per altri 6 mesi.
Tiziana Life Sciences (NASDAQ:TLSA) ha informado hallazgos inmunológicos prometedores tras tratar a un paciente con enfermedad de Alzheimer moderada con foralumab intranasal, su principal terapia de inmunomodulación. El análisis reveló efectos moduladores significativos en las células inmunitarias, incluyendo cambios en células CD4, CD8 y monocitos.
Los hallazgos clave incluyen una reducción notable de la inflamación cerebral confirmada por escáneres PET de microglía y un aumento inesperado en marcadores de fagocitosis en monocitos clásicos, lo que sugiere un potencial para una mejor eliminación de placas amiloides. El tratamiento fue bien tolerado sin efectos secundarios, y el paciente continuará la terapia por 6 meses adicionales.
Tiziana Life Sciences (NASDAQ:TLSA)는 중등도 알츠하이머 환자에게 비강 투여 포랄루맙을 사용한 면역학적 연구 결과를 발표했습니다. 이는 그들의 주력 면역조절 치료제입니다. 분석 결과, 백혈구에서 유의한 면역 조절 효과가 나타났으며 CD4 세포, CD8 세포 및 단구의 변화가 관찰되었습니다.
주요 결과로는 미세아교세포 PET 스캔으로 확인된 뇌 염증의 현저한 감소와 고전적 단구에서 식세포 활성 표지자의 예상치 못한 증가가 포함되어, 아밀로이드 플라크 제거 능력 향상 가능성을 시사합니다. 치료는 부작용 없이 잘 견뎌냈으며, 환자는 추가로 6개월간 치료를 계속할 예정입니다.
Tiziana Life Sciences (NASDAQ:TLSA) a rapporté des résultats immunologiques prometteurs suite au traitement d’un patient atteint de la maladie d’Alzheimer modérée avec du foralumab intranasal, leur thérapie principale d’immunomodulation. L’analyse a révélé des effets modulateurs significatifs sur le système immunitaire dans les globules blancs, notamment des modifications des cellules CD4, CD8 et des monocytes.
Les résultats clés incluent une réduction marquée de l’inflammation cérébrale confirmée par des scans PET de la microglie ainsi qu’une augmentation inattendue des marqueurs de phagocytose dans les monocytes classiques, suggérant un potentiel pour une amélioration du nettoyage des plaques amyloïdes. Le traitement a été bien toléré sans effets secondaires, et le patient poursuivra la thérapie pendant 6 mois supplémentaires.
Tiziana Life Sciences (NASDAQ:TLSA) hat vielversprechende immunologische Ergebnisse bei der Behandlung eines Patienten mit mittelschwerer Alzheimer-Krankheit mit intranasalem Foralumab, ihrer führenden Immunmodulationstherapie, berichtet. Die Analyse zeigte bedeutende immunmodulatorische Effekte in weißen Blutkörperchen, einschließlich Veränderungen bei CD4-Zellen, CD8-Zellen und Monozyten.
Zu den wichtigsten Ergebnissen gehört eine deutliche Verringerung der Gehirnentzündung, bestätigt durch Mikroglia-PET-Scans, sowie ein unerwarteter Anstieg der Phagozytose-Marker in klassischen Monozyten, was auf ein Potenzial für eine verbesserte Amyloid-Plaque-Beseitigung hinweist. Die Behandlung wurde gut vertragen, ohne Nebenwirkungen, und der Patient wird die Therapie für weitere 6 Monate fortsetzen.
- Discovery of increased phagocytosis markers suggesting potential amyloid plaque clearance ability
- Treatment demonstrated significant immune modulatory effects across multiple cell types
- Marked reduction in brain inflammation confirmed by PET scans
- Treatment was well-tolerated with no reported side effects
- Patient choosing to continue treatment for additional 6 months
- Study based on single patient data only
- Long-term efficacy and safety data not yet available
Insights
Tiziana's foralumab shows promising immune effects in Alzheimer's patient, potentially addressing both inflammation and amyloid pathology simultaneously.
The preliminary findings from Tiziana's case study with intranasal foralumab in an Alzheimer's patient represent a significant development, though with important limitations. The immunologic analysis revealed broad modulation of immune cells (CD4, CD8, and monocytes) that correlated with reduced microglial inflammation as confirmed by PET scans. Most intriguingly, researchers observed increased phagocytosis markers in classical monocytes, suggesting enhanced capacity to clear amyloid plaques - an unexpected dual mechanism.
This dual action could theoretically address two key pathological processes in Alzheimer's: neuroinflammation and amyloid accumulation. The treatment appears to leverage the same immune-modulating mechanism that showed promise in Multiple Sclerosis trials, suggesting potential platform versatility across neuroinflammatory conditions.
However, this represents data from just a single patient - essentially an anecdotal case report rather than controlled clinical evidence. While the molecular findings are promising, they require validation in larger studies. The subjective behavioral improvements reported by family members, while encouraging, lack standardized cognitive assessment metrics.
The patient's decision to continue treatment for another 6 months provides an opportunity for longer-term safety and efficacy monitoring. As Tiziana advances this program, investors should watch for initiation of formal clinical trials with appropriate controls and patient numbers to determine if these preliminary signals translate to measurable clinical benefits.
NEW YORK, July 21, 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 compelling immunologic findings from the treatment of a moderate Alzheimer's Disease (AD) patient with intranasal foralumab.
Transcriptional analysis of white blood cells before and after foralumab therapy revealed profound immune modulatory effects. Significant changes were observed in CD4 cells, CD8 cells, and monocytes, underscoring the broad impact of nasal foralumab on immune cell profiles. These results are consistent with improvement in microglia PET scans conducted at the time of immune analysis which demonstrated a marked reduction in inflammation following nasal foralumab (Clin Nuclear Med) showing a link between immune effects and resolution of brain inflammation.
In an unexpected discovery, the analysis revealed an increase in phagocytosis markers in classical monocytes, suggesting that nasal foralumab may enhance their ability to clear amyloid plaques. This unexpected effect may open new avenues for treating Alzheimer's Disease by targeting both inflammation and amyloid accumulation.
Dr. Howard Weiner, Co-Director of the Ann Romney Center for Neurologic Diseases at the Brigham and Women’s Hospital (BWH), a founding member of the Mass General Brigham healthcare system, commented on the findings: "The observed reduction in microglial inflammation and the unique immune changes seen in this Alzheimer's patient treated with nasal foralumab are highly promising. This study represents a step forward in understanding the potential therapeutic role of foralumab across neuroinflammatory diseases."
Ivor Elrifi, CEO of Tiziana Life Sciences, emphasized the implications of these results: "We are thrilled by the outcomes of this immunologic analysis, which demonstrate for the first time in Alzheimer's Disease the profound immune modulatory effects of nasal foralumab. Beyond its established benefits in other conditions, such as Multiple Sclerosis, this study suggests that nasal foralumab could offer a dual benefit of reducing brain inflammation and potentially influencing amyloid pathology."
Furthermore, the treatment was well tolerated with no reported side effects. Encouraged by these results and the observed behavioral improvements reported by the patient's family, the patient and his wife have chosen to continue nasal foralumab therapy for an additional 6 months.
The findings from this study mark a significant milestone in the development of novel therapies for Alzheimer's Disease and underscore Tiziana Life Sciences' commitment to advancing transformative treatments for patients suffering from neurodegenerative disorders.
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. 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).
Foralumab is the only fully human anti-CD3 monoclonal antibody (mAb) currently in clinical development. The non-active SPMS intranasal foralumab Phase 2 trial (NCT06292923) began screening patients in November of 2023. Immunomodulation by intranasal foralumab represents a novel avenue for the 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.
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 TLSA's foralumab treatment in Alzheimer's Disease?
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