Department of Defense Awards Grant to Advance Tiziana Life Sciences Intranasal Anti-CD3 Therapy for Spinal Cord Injury
Tiziana Life Sciences (NASDAQ:TLSA) has received a significant research grant from the U.S. Department of Defense to study intranasal anti-CD3 therapy for traumatic spinal cord injury (SCI). The company will conduct a three-year study focused on acute SCI treatment, complemented by a two-year Stepping Strong Breakthrough Award for chronic phase research.
The research targets a substantial market with 300,000 Americans living with permanent disability and 17,000 new cases annually. Preclinical results at Brigham and Women's Hospital have shown promising motor outcome improvements. The non-invasive intranasal delivery method aims to rebalance the immune system and reduce inflammation in injured spinal cords.
Tiziana Life Sciences (NASDAQ:TLSA) ha ricevuto una significativa sovvenzione per la ricerca dal Dipartimento della Difesa degli Stati Uniti per studiare la terapia intranasale anti-CD3 per lesione traumatica del midollo spinale (SCI). L'azienda condurrà uno studio di tre anni incentrato sul trattamento della SCI acuta, completato da un Stepping Strong Breakthrough Award di due anni per la ricerca nella fase cronica.
La ricerca si propone un mercato sostanziale con 300.000 americani che vivono con disabilità permanente e 17.000 nuovi casi all'anno. I risultati preclinici presso Brigham and Women's Hospital hanno mostrato miglioramenti promettenti nell'esito motorio. Il metodo di somministrazione intranasale non invasivo mira a riequilibrare il sistema immunitario e a ridurre l'infiammazione nel midollo spinale ferito.
Tiziana Life Sciences (NASDAQ:TLSA) ha recibido una importante beca de investigación del Departamento de Defensa de EE. UU. para estudiar la terapia intranasal anti-CD3 para la lesión traumática de la médula espinal (SCI). La empresa llevará a cabo un estudio de tres años centrado en el tratamiento de SCI aguda, complementado por un Stepping Strong Breakthrough Award de dos años para la investigación en la fase crónica.
La investigación apunta a un mercado considerable con 300,000 estadounidenses que viven con discapacidad permanente y 17,000 casos nuevos al año. Resultados preclínicos en Brigham and Women's Hospital han mostrado mejoras prometedoras en los resultados motores. El método de administración intranasal no invasivo busca restablecer el equilibrio del sistema inmunitario y reducir la inflamación en la médula espinal lesionada.
Tiziana Life Sciences (NASDAQ:TLSA) 는 미국 국방부로부터 외상성 척수 손상(SCI)을 위한 비강 내 항-CD3 치료를 연구하기 위한 중요한 연구 보조금을 받았습니다. 회사는 급성 SCI 치료에 초점을 맞춘 3년 간의 연구를 수행하며, 만성 단계 연구를 위한 2년 Stepping Strong Breakthrough Award를 보완으로 받습니다.
연구는 매년 17,000명의 신규 사례와 함께 영구적 장애를 가진 미국인 30만 명이라는 상당한 시장을 겨냥합니다. 브리검 앤 웨먼스 병원(Brigham and Women's Hospital)에서의 전임상 결과는 운동 기능 향상에 대해 유망한 개선을 보였습니다. 비침습적 비강 전달 방식은 면역 체계를 재균형하고 손상된 척수의 염증을 감소시키는 것을 목표로 합니다.
Tiziana Life Sciences (NASDAQ:TLSA) a reçu une importante bourse de recherche du Département de la Défense des États‑Unis pour étudier la thérapie intranasale anti-CD3 en faveur de la blessure traumatique de la moelle épinière (SCI). L'entreprise mènera une étude de trois ans axée sur le traitement de la SCI aiguë, complétée par un Stepping Strong Breakthrough Award de deux ans pour la recherche en phase chronique.
La recherche vise un marché important avec 300 000 Américains vivant avec une incapacité permanente et 17 000 nouveaux cas annuels. Des résultats précliniques à Brigham and Women's Hospital ont montré des améliorations prometteuses des résultats moteurs. La méthode de délivrance intranasale non invasive vise à rééquilibrer le système immunitaire et à réduire l'inflammation dans la moelle épinière blessée.
Tiziana Life Sciences (NASDAQ:TLSA) hat vom US-Verteidigungsministerium einen bedeutenden Zuschuss zur Erforschung der intranasalen Anti-CD3-Therapie bei traumatischen Rückenmarksverletzungen (SCI) erhalten. Das Unternehmen wird eine dreijährige Studie durchführen, die auf die Behandlung der akuten SCI abzielt, ergänzt durch einen zweijährigen Stepping Strong Breakthrough Award für die Forschung in der chronischen Phase.
Die Forschung zielt auf einen beträchtlichen Markt ab, mit 300.000 Amerikanern, die dauerhaft behindert leben, und 17.000 neuen Fällen pro Jahr. Präklinische Ergebnisse am Brigham and Women's Hospital haben vielversprechende Verbesserungen der motorischen Ergebnisse gezeigt. Die nicht-invasive intranasale Verabreichungsmethode zielt darauf ab, das Immunsystem neu zu balancieren und Entzündungen im verletzten Rückenmark zu reduzieren.
تَلَقّت شركة Tiziana Life Sciences (ناسداك:TLSA) منحة بحثية كبيرة من وزارة الدفاع الأمريكية لدراسة العلاج بالأن-CD3 عبر الأنف لإصابة الحبل الشوكي الناتجة عن الصدمة. ستجري الشركة دراسة لمدة ثلاث سنوات تتركز على علاج SCI الحاد، مع منحة Stepping Strong Breakthrough Award لمدة عامين للبحوث في المرحلة المزمنة.
تستهدف البحث سوقاً كبيراً يضم 300,000 أمريكي يعيشون بإعاقة دائمة و 17,000 حالة جديدة سنوياً. أظهرت النتائج قبل السريرية في Brigham and Women's Hospital تحسينات واعدة في النتائج الحركية. طريقة التوصيل عبر الأنف غير الجراحية تهدف إلى إعادة توازن الجهاز المناعي وتقليل الالتهاب في الحبل الشوكي المصاب.
Tiziana Life Sciences（纳斯达克股票代码：TLSA） 已获得美国国防部的一项重要研究资助，用于研究经鼻给予抗CD3治疗创伤性脊髓损伤（SCI）。公司将进行为期三年的研究，聚焦于急性SCI治疗，并辅以为期两年的 Stepping Strong Breakthrough Award，用于慢性阶段的研究。
研究面向一个相当大的市场，即有 30万名美国人患有永久性残疾，以及 每年17,000名新增病例。在Brigham and Women's Hospital的前临床结果显示在运动功能方面有有希望的改善。经鼻给予的非侵入性递送方式旨在重新平衡免疫系统并降低受伤脊髓的炎症。
- None.
- No immediate revenue potential as research is still in early stages
- Faces significant clinical development and regulatory hurdles ahead
Insights
DoD grant validates Tiziana's intranasal anti-CD3 platform, expanding into spinal cord injury treatment with promising commercial potential.
The Department of Defense grant award represents a significant validation for Tiziana's intranasal anti-CD3 platform technology. This funding supports expansion beyond the company's current focus on autoimmune and neuroinflammatory conditions into traumatic spinal cord injury (SCI), a substantial unmet medical need affecting nearly 300,000 Americans with 17,000+ new cases annually.
The market opportunity here is compelling given the complete absence of approved disease-modifying treatments for SCI. Current standard of care remains largely supportive, leaving patients with permanent disabilities and ongoing complications from persistent inflammation. This creates a potential first-mover advantage for Tiziana if their approach proves successful.
What makes this particularly interesting is the delivery mechanism. The intranasal administration route represents a non-invasive approach that could significantly improve patient compliance and quality of life compared to surgical interventions or infusions. The preliminary preclinical results showing improved motor outcomes suggest potential for meaningful functional recovery, which would be transformative in this patient population.
The dual funding approach—DoD support for acute phase research and the Stepping Strong award for chronic phase studies—creates a comprehensive development pathway. This multi-phase research strategy enhances the probability of identifying effective treatment windows and optimizing the therapy's impact across the disease continuum. The three-year timeline suggests we'll see meaningful data readouts in the 2026-2028 timeframe, potentially accelerating Tiziana's clinical development in this indication.
BOSTON, Sept. 15, 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 the U.S. Department of Defense (DoD) has awarded a research grant to study the use of intranasal anti-CD3 therapy in traumatic spinal cord injury (SCI). This funding builds on Tiziana’s strategy to expand the therapeutic potential of its intranasal anti-CD3 platform beyond autoimmune and neuroinflammatory diseases into large, underserved neurological indications.
The DoD award will support a three-year study of intranasal anti-CD3 in the acute phase of SCI, aimed at patients who present to the hospital immediately following injury. Complementing this, a two-year Stepping Strong Breakthrough Award will expand research into the chronic phase, focusing on patients living with persistent neurological deficits.
Traumatic SCI is a major unmet medical need, with nearly 300,000 Americans living with permanent disability and more than 17,000 new injuries annually. Current standard of care remains supportive, with no approved therapies that improve neurological recovery or prevent the chronic complications caused by persistent spinal cord inflammation. The Company believes this represents a significant commercial opportunity in a market with high disease burden and no disease-modifying treatments.
Researchers in the Immunology of CNS Injury Program at Brigham and Women’s Hospital, a founding member of Mass General Brigham, have previously reported promising preclinical results using intranasal anti-CD3 demonstrating benefits in motor outcomes, suggesting potential to improve independence and quality of life. This non-invasive therapy, delivered through the nose—avoiding surgery or infusions, is designed to rebalance the immune system, reduce microglial-driven inflammation in the injured spinal cord, and support functional recovery. The same mechanism may be relevant in other acute CNS injuries.
“SCI is not a one-time event—it is a chronic inflammatory disease. Our findings suggest that intranasal anti-CD3 could change the trajectory of injury by addressing the immune cascade that continues to damage the spinal cord long after the initial trauma,” commented Saef Izzy, MD, FNCS, FAAN, Critical Care Neurologist at Mass General Brigham, and head of the program. “With support from the Department of Defense and Stepping Strong, we are moving from discovery to translation. Our goal is to build the data needed to bring a safe, practical therapy to people living with spinal cord injury.”
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.
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, 2024, 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
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