Tiziana Life Sciences Announces $4 Million Grant Awarded by National Institutes of Health to Study Anti-CD3 in Alzheimer’s Disease
Tiziana Life Sciences (NASDAQ: TLSA) has announced a $4 million grant from the National Institutes of Health to study intranasal anti-CD3 for Alzheimer's disease treatment. The grant, awarded to Dr. Howard Weiner at Brigham and Women's Hospital, will fund preclinical and clinical studies over several years. Tiziana's proprietary anti-CD3 formulation, administered intranasally, aims to modulate immune system activity and reduce neuroinflammation in Alzheimer's patients. This funding supports Tiziana's broader strategy to explore anti-CD3 in various autoimmune and inflammatory diseases. The company plans to initiate first-in-human clinical trials for Alzheimer's Disease in the coming months, marking a significant step towards potential regulatory approval and commercialization.
Tiziana Life Sciences (NASDAQ: TLSA) ha annunciato un finanziamento di 4 milioni di dollari da parte dei National Institutes of Health per studiare l'anti-CD3 intranasale per il trattamento dell'Alzheimer. Il finanziamento, assegnato al Dr. Howard Weiner del Brigham and Women's Hospital, supporterà studi preclinici e clinici per diversi anni. La formulazione proprietaria di anti-CD3 di Tiziana, somministrata per via intranasale, mira a modulare l'attività del sistema immunitario e ridurre la neuroinfiammazione nei pazienti affetti da Alzheimer. Questo finanziamento sostiene la strategia più ampia di Tiziana di esplorare l'anti-CD3 in varie malattie autoimmuni e infiammatorie. L'azienda prevede di avviare prove cliniche di fase uno sui primi pazienti per la malattia di Alzheimer nei prossimi mesi, segnando un passo significativo verso una potenziale approvazione normativa e commercializzazione.
Tiziana Life Sciences (NASDAQ: TLSA) ha anunciado una por parte de los National Institutes of Health para estudiar el anti-CD3 intranasal para el tratamiento de la enfermedad de Alzheimer. La subvención, otorgada al Dr. Howard Weiner en el Brigham and Women's Hospital, financiará estudios preclínicos y clínicos durante varios años. La formulación propietaria de anti-CD3 de Tiziana, administrada por vía intranasal, pretende modular la actividad del sistema inmunológico y reducir la neuroinflamación en los pacientes con Alzheimer. Este financiamiento apoya la estrategia más amplia de Tiziana de explorar el anti-CD3 en diversas enfermedades autoinmunes e inflamatorias. La compañía planea iniciar ensayos clínicos de primera vez en humanos para la enfermedad de Alzheimer en los próximos meses, marcando un paso significativo hacia la posible aprobación regulatoria y comercialización.
티지아나 생명과학(Tiziana Life Sciences, NASDAQ: TLSA)은 400만 달러의 보조금을 미국 국립보건원(National Institutes of Health)으로부터 수령하여 알츠하이머병 치료를 위한 비강 내 anti-CD3 연구를 실시한다고 발표했습니다. 이 보조금은 브리검 여성 병원(Brigham and Women's Hospital)의 하워드 와이너 박사에게 수여되며, 수년 동안의 전임상 및 임상 연구를 지원합니다. 티지아나의 독자적인 anti-CD3 제형은 비강 내로 투여되어 면역 시스템 활동을 조절하고 신경 염증을 줄이는 것을 목표로 합니다. 이 자금 지원은 티지아나가 다양한 자가면역 및 염증성 질환에 대한 anti-CD3의 탐색을 확대하려는 더 넓은 전략을 뒷받침합니다. 이 회사는 향후 몇 달 내에 인간 대상 첫 임상 시험을 알츠하이머병을 위해 시작할 계획이며, 이는 잠재적인 규제 승인 및 상용화를 향한 중요한 단계로 평가됩니다.
Tiziana Life Sciences (NASDAQ: TLSA) a annoncé une subvention de 4 millions de dollars des National Institutes of Health pour étudier l'anti-CD3 intranasal pour le traitement de la maladie d'Alzheimer. La subvention, attribuée au Dr. Howard Weiner de l'hôpital Brigham and Women's Hospital, financera des études précliniques et cliniques pendant plusieurs années. La formulation propriétaire d'anti-CD3 de Tiziana, administrée par voie intranasale, vise à moduler l'activité du système immunitaire et à réduire la neuroinflammation chez les patients atteints d'Alzheimer. Ce financement soutient la stratégie plus large de Tiziana d'explorer l'anti-CD3 dans diverses maladies auto-immunes et inflammatoires. L'entreprise prévoit de lancer des essais cliniques de première ligne sur l'homme pour la maladie d'Alzheimer dans les mois à venir, marquant une étape significative vers une éventuelle approbation réglementaire et commercialisation.
Tiziana Life Sciences (NASDAQ: TLSA) hat einen Förderbetrag von 4 Millionen Dollar von den National Institutes of Health angekündigt, um intranasales anti-CD3 zur Behandlung der Alzheimer-Krankheit zu studieren. Die Förderung, die an Dr. Howard Weiner am Brigham and Women's Hospital vergeben wurde, wird mehrere Jahre lang präklinische und klinische Studien finanzieren. Die proprietäre anti-CD3-Formulierung von Tiziana, die intranasal verabreicht wird, zielt darauf ab, die Aktivität des Immunsystems zu modulieren und Neuroinflammation bei Alzheimer-Patienten zu reduzieren. Diese Finanzierung unterstützt Tizianas breitere Strategie, anti-CD3 in verschiedenen Autoimmun- und Entzündungskrankheiten zu erforschen. Das Unternehmen plant, in den kommenden Monaten erstmalige klinische Studien an Menschen zur Alzheimer-Krankheit zu starten, was einen bedeutenden Schritt in Richtung möglicher regulatorischer Genehmigung und Kommerzialisierung darstellt.
- Received $4 million grant from NIH for Alzheimer's disease research
- Potential to develop a novel treatment for a disease affecting over 6 million people in the US
- Plans to initiate first-in-human clinical trials in Alzheimer's Disease patients in the coming months
- Grant validates the potential of Tiziana's anti-CD3 therapy in addressing unmet needs in Alzheimer's treatment
- None.
This
- Focuses on modulating immune system activity and reducing neuroinflammation
- Builds on promising preclinical data suggesting disease-altering potential
- Enables advancement to first-in-human clinical trials
While this grant doesn't guarantee success, it provides important resources for exploring a novel therapeutic avenue in a field with effective treatments. The intranasal delivery method is particularly intriguing, potentially offering targeted central nervous system effects.
This grant is a positive financial development for Tiziana Life Sciences, albeit with caveats:
- Reduces cash burn by offsetting research costs
- Enhances credibility with potential partners and investors
- Doesn't directly impact near-term revenue prospects
The
The exploration of anti-CD3 for Alzheimer's is an innovative approach targeting neuroinflammation, a key factor in AD pathology. Critical aspects:
- Intranasal delivery may enhance blood-brain barrier penetration
- T regulatory cell stimulation could modulate harmful immune responses
- Potential to address multiple AD mechanisms simultaneously
While promising, challenges remain in translating preclinical success to human efficacy. The complex nature of AD has thwarted many previous attempts at novel treatments. This approach's unique mechanism of action, however, offers a fresh perspective in a field desperately needing new ideas. The upcoming clinical trials will be important in determining its true potential.
NEW YORK, Sept. 19, 2024 (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 National Institutes of Health (NIH), National Institute on Aging have awarded a
“Alzheimer’s disease is the most common form of dementia, affecting more than 6 million people in the United States alone. Despite extensive research, effective treatments remain limited, and the need for innovative therapeutic approaches is urgent,” commented Howard L. Weiner, M.D., Principal Investigator, 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.
The NIH grant will allow the acceleration of ongoing research efforts, including the advancement of preclinical studies and preparations for clinical trials. Specifically, the research will focus on the potential of anti-CD3 to modulate immune system activity, reduce neuroinflammation, and ultimately slow the progression of Alzheimer’s disease. The company’s proprietary formulation of anti-CD3 is administered intranasally where it binds to the T cell receptor, which then stimulates T regulatory cells for delivery to the central nervous system.
Ivor Elrifi CEO of Tiziana Life Sciences commented, “We are thrilled to be able to progress our pipeline with this prestigious NIH grant, which underscores the potential of our anti-CD3 therapy to address a critical unmet need in Alzheimer’s disease. This funding will enable us to expand our research and move one step closer to developing a new therapeutic option for patients and families impacted by this debilitating condition. At Tiziana, we remain committed to advancing science that could improve the quality of life for patients through groundbreaking immunotherapies.”
The NIH grant represents a major milestone in Tiziana’s development pipeline and is part of the company’s broader strategy to explore the use of anti-CD3 in a range of autoimmune and inflammatory diseases. Tiziana's team of scientists and clinical researchers are eager to build upon promising preclinical data that suggest anti-CD3 has the potential to alter disease progression in Alzheimer’s by targeting immune pathways involved in neurodegeneration.
The company expects to initiate first-in-human clinical trials in Alzheimer’s Disease patients using its intranasal anti-CD3 monoclonal antibody in the coming months, marking an important step toward regulatory approval and commercialization.
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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