Tiziana Life Sciences Announces Review Article Published in Nature Highlighting Foralumab's Potential in the Treatment of Neurological Disease
Tiziana Life Sciences (NASDAQ: TLSA) announced the publication of a review article in Nature Reviews Neurology highlighting the therapeutic potential of their lead candidate, intranasal foralumab, in treating various neurodegenerative diseases. The article emphasizes how the immune system plays a important role in conditions like Multiple Sclerosis (MS), Alzheimer's, ALS, and Parkinson's disease.
The review discusses how foralumab targets components of the peripheral immune system and dampens microglia activation in MS. Dr. Howard Weiner, Chairman of Tiziana's Scientific Advisory Board, highlighted that intranasal foralumab represents a promising treatment approach, noting its ability to act without apparent side effects and ease of administration.
The article explores how microglia, monocytes, and T cells contribute to disease pathogenesis and their potential as shared therapeutic targets across multiple neurological conditions.
Tiziana Life Sciences (NASDAQ: TLSA) ha annunciato la pubblicazione di un articolo di revisione in Nature Reviews Neurology che evidenzia il potenziale terapeutico del loro candidato principale, foralumab intranasale, nel trattamento di varie malattie neurodegenerative. L'articolo sottolinea come il sistema immunitario svolge un ruolo importante in condizioni come la sclerosi multipla (SM), l'Alzheimer, la SLA e il morbo di Parkinson.
La revisione discute come il foralumab agisce su componenti del sistema immunitario periferico e attenua l'attivazione della microglia nella SM. Il Dr. Howard Weiner, Presidente del Consiglio Consultivo Scientifico di Tiziana, ha sottolineato che il foralumab intranasale rappresenta un approccio terapeutico promettente, notando la sua capacità di agire senza effetti collaterali apparenti e la facilità di somministrazione.
L'articolo esplora come la microglia, i monoblasti e le cellule T contribuiscono alla patogenesi delle malattie e il loro potenziale come obiettivi terapeutici condivisi in diverse condizioni neurologiche.
Tiziana Life Sciences (NASDAQ: TLSA) anunció la publicación de un artículo de revisión en Nature Reviews Neurology que destaca el potencial terapéutico de su candidato principal, foralumab intranasal, en el tratamiento de diversas enfermedades neurodegenerativas. El artículo enfatiza cómo el sistema inmunológico juega un papel importante en condiciones como la , el Alzheimer, la ELA y la enfermedad de Parkinson.
La revisión discute cómo el foralumab se dirige a componentes del sistema inmunológico periférico y reduce la activación de la microglía en la EM. El Dr. Howard Weiner, presidente del Consejo Asesor Científico de Tiziana, destacó que el foralumab intranasal representa un enfoque terapéutico prometedor, señalando su capacidad de actuar sin efectos secundarios aparente y su facilidad de administración.
El artículo explora cómo la microglía, los monocitos y las células T contribuyen a la patogénesis de las enfermedades y su potencial como objetivos terapéuticos compartidos en múltiples condiciones neurológicas.
티치아나 라이프 사이언스 (NASDAQ: TLSA)는 다양한 신경퇴행성 질환 치료에 있어 그들의 주요 후보인 비강 내 포랄루맙의 치료 잠재력을 강조하는 네이처 리뷰 신경학에 리뷰 기사를 발표했다고 발표했습니다. 이 기사는 다발성 경화증 (MS), 알츠하이머, 루게릭병(ALS), 파킨슨병과 같은 상태에서 면역 시스템이 중요한 역할을 한다는 점을 강조합니다.
리뷰에서는 포랄루맙이 말초 면역 시스템의 구성 요소를 표적으로 하여 MS에서 미세아교세포 활성화를 감소시킨다고 설명합니다. 티치아나 과학 자문 위원회 의장인 하워드 와이너 박사는 비강 내 포랄루맙이 뚜렷한 부작용 없이 작용하고 투여가 용이한 치료 접근법이라고 강조했습니다.
이 기사는 미세아교세포, 단핵구 및 T 세포가 질병 발병에 어떻게 기여하는지와 여러 신경학적 조건에서 공유 치료 목표로서의 잠재력을 탐구합니다.
Tiziana Life Sciences (NASDAQ: TLSA) a annoncé la publication d'un article de revue dans Nature Reviews Neurology mettant en avant le potentiel thérapeutique de leur candidat principal, le foralumab intranasal, pour le traitement de diverses maladies neurodégénératives. L'article souligne comment le système immunitaire joue un rôle important dans des conditions telles que la sclérose en plaques (SEP), la maladie d'Alzheimer, la SLA et la maladie de Parkinson.
La revue discute de la façon dont le foralumab cible des composants du système immunitaire périphérique et atténue l'activation des microglies dans la SEP. Le Dr. Howard Weiner, président du Conseil consultatif scientifique de Tiziana, a souligné que le foralumab intranasal représente une approche thérapeutique prometteuse, notant sa capacité à agir sans effets secondaires apparents et sa facilité d'administration.
L'article explore comment les microglies, les monocytes et les cellules T contribuent à la pathogénèse des maladies et leur potentiel en tant que cibles thérapeutiques partagées à travers plusieurs conditions neurologiques.
Tiziana Life Sciences (NASDAQ: TLSA) gab die Veröffentlichung eines Übersichtsartikels in Nature Reviews Neurology bekannt, der das therapeutische Potenzial ihres Hauptkandidaten, intranasales Foralumab, zur Behandlung verschiedener neurodegenerativer Erkrankungen hervorhebt. Der Artikel betont, wie das Immunsystem eine wichtige Rolle bei Erkrankungen wie Multipler Sklerose (MS), Alzheimer, ALS und Parkinson spielt.
Die Übersicht erörtert, wie Foralumab Komponenten des peripheren Immunsystems anspricht und die Aktivierung von Mikroglia bei MS verringert. Dr. Howard Weiner, Vorsitzender des Wissenschaftlichen Beirats von Tiziana, hob hervor, dass intranasales Foralumab einen vielversprechenden Therapieansatz darstellt und bemerkte, dass es ohne offensichtliche Nebenwirkungen wirkt und einfach zu verabreichen ist.
Der Artikel untersucht, wie Mikroglia, Monozyten und T-Zellen zur Pathogenese der Erkrankungen beitragen und ihr Potenzial als gemeinsame therapeutische Ziele in mehreren neurologischen Erkrankungen.
- Publication in prestigious Nature Reviews Neurology validates foralumab's therapeutic potential
- Foralumab shows promise for multiple high-value indications (MS, Alzheimer's, ALS, Parkinson's)
- Treatment demonstrates favorable safety profile with no apparent side effects
- Intranasal delivery method offers easy administration advantage
- None.
Insights
This publication in Nature Reviews Neurology represents a significant scientific validation of Foralumab's therapeutic potential. The paper's focus on shared immune targets across multiple neurodegenerative diseases suggests a broader market opportunity than previously considered. Intranasal Foralumab's mechanism of dampening microglial activation could potentially address multiple sclerosis, Alzheimer's, ALS and Parkinson's - representing a combined market exceeding <money>50 billion</money> annually.
The drug's unique intranasal delivery system provides two key advantages: reduced side effects and improved patient compliance. This could position Foralumab as a preferred treatment option, particularly for chronic conditions requiring long-term management. The involvement of Dr. Howard Weiner, a leading figure in neurological research, adds substantial credibility to these findings.
Think of microglial cells as the brain's immune system guardians - when overactive, they can cause damage. Foralumab acts like a thermostat, helping to regulate these cells back to normal functioning levels across multiple neurological conditions.
With a modest market cap of <money>74.7 million</money>, TLSA appears significantly undervalued given Foralumab's expanding therapeutic potential. The publication in Nature, one of the most prestigious scientific journals, typically triggers increased institutional interest and can catalyze partnerships with major pharmaceutical companies.
The multi-indication potential of Foralumab is particularly compelling from a commercial perspective. Rather than being to a single condition, the drug's mechanism of action could allow for multiple approved indications, each representing a separate revenue stream. The intranasal delivery method also provides a strong competitive advantage in terms of patent protection and market exclusivity.
For context, successful CNS drugs targeting multiple indications often achieve peak annual sales exceeding <money>1 billion</money>. The current market valuation suggests the market is significantly underpricing the probability of clinical and commercial success.
NEW YORK, Jan. 08, 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 that a review article titled “Immune mechanisms and shared immune targets in neurodegenerative diseases” was published in Nature Reviews Neurology, highlighting the therapeutic potential of intranasal foralumab in various neurodegenerative diseases including Multiple Sclerosis (MS), Alzheimer’s disease, ALS, and Parkinsons disease.
The immune system plays a significant role in neurodegenerative diseases. In some, such as multiple sclerosis, it is the primary driver of the disease. In others, such as Alzheimer’s disease, amyotrophic lateral sclerosis, and Parkinson disease, it has an amplifying role. Immunotherapeutic approaches that target the adaptive and innate immune systems are being explored for the treatment of almost all neurological diseases, and the targets and approaches are often common across diseases. Therapeutic approaches target components of the peripheral immune system, such as regulatory T cells and monocytes, which in turn act within the CNS. Microglia are the primary immune cells in the brain that contribute to disease pathogenesis and are consequently a common immune target for therapy. The article highlights the dampening of microglia activation in MS by intranasal Foralumab.
The Review considers in detail how microglia, monocytes and T cells contribute to the pathogenesis of multiple sclerosis, Alzheimer disease, amyotrophic lateral sclerosis and Parkinson disease, and their potential as shared therapeutic targets across these diseases. The microbiome is also highlighted as an emerging therapeutic target that indirectly modulates the immune system. Therapeutic approaches being developed to target immune function in neurodegenerative diseases are discussed, highlighting how immune-based approaches developed to treat one disease could be applicable to multiple other neurological diseases.
Article Author, Dr. Howard Weiner, Chairman of Tiziana’s Scientific Advisory Board and co-director of the Ann Romney Center for Neurologic Diseases at Brigham and Women’s Hospital, a founding member of Mass General Brigham healthcare system, commented, "The intranasal delivery of Foralumab represents one of the most promising approaches for the treatment of several of the most important neurodegenerative diseases including MS, Alzheimer’s disease, ALS and Parkinson’s disease. This novel approach acts by dampening microglial activation, a key driver of disease in all these neurologic conditions. Furthermore, intranasal Foralumab acts without apparent side effects and is easily administered. It is a promising therapeutic avenue for patients with neurologic diseases that have limited treatment options."
Tiziana’s CEO, Ivor Elrifi, added, "We are encouraged by the insights presented in this article, which underscore the potential of Foralumab as a groundbreaking therapy for neurodegenerative diseases. At Tiziana, we are committed to advancing innovative treatments that address significant unmet medical needs, and this publication reinforces our dedication to improving patient outcomes in progressive MS and other neurological diseases."
The full Review Article can be accessed here: https://www.nature.com/articles/s41582-024-01046-7
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 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
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