Tiziana Life Sciences Announces Positive Results in Treating Spinal Cord Injury With Nasal Anti-CD3
Tiziana Life Sciences (NASDAQ: TLSA) announced positive results from studies using nasal anti-CD3 monoclonal antibody in treating traumatic spinal cord injury (SCI). The preclinical model demonstrated notable improvements in motor functions after treatment with nasal anti-CD3.
The research showed the treatment's effectiveness in modulating microglial inflammation associated with SCI and dampening microglial activation. This advancement is significant given that approximately 300,000 individuals live with SCI in the U.S., with over 17,000 new cases annually.
The company is expanding its nasal foralumab technology from applications in neurologic diseases like secondary progressive multiple sclerosis to include spinal cord injury treatment, addressing a significant unmet medical need.
Tiziana Life Sciences (NASDAQ: TLSA) ha annunciato risultati positivi da studi che utilizzano un anticorpo monoclonale anti-CD3 nasale per il trattamento del trauma del midollo spinale (SCI). Il modello preclinico ha mostrato notevoli miglioramenti nelle funzioni motorie dopo il trattamento con l'anticorpo anti-CD3 nasale.
La ricerca ha dimostrato l'efficacia del trattamento nella modulazione dell'infiammazione microgliale associata all'SCI e nel contenimento dell'attivazione microgliale. Questo progresso è significativo dato che circa 300.000 individui vivono con SCI negli Stati Uniti, con oltre 17.000 nuovi casi all'anno.
La società sta espandendo la sua tecnologia foralumab nasale dalle applicazioni in malattie neurologiche come la sclerosi multipla secondaria progressiva per includere il trattamento del trauma del midollo spinale, affrontando un significativo bisogno medico non soddisfatto.
Tiziana Life Sciences (NASDAQ: TLSA) anunció resultados positivos de estudios que utilizan un anticuerpo monoclonal anti-CD3 nasal en el tratamiento de lesiones traumáticas de la médula espinal (SCI). El modelo preclínico demostró mejoras notables en las funciones motoras después del tratamiento con anti-CD3 nasal.
La investigación mostró la efectividad del tratamiento en la modulación de la inflamación microglial asociada con SCI y en la reducción de la activación microglial. Este avance es significativo dado que aproximadamente 300,000 individuos viven con SCI en los EE. UU., con más de 17,000 nuevos casos anuales.
La empresa está ampliando su tecnología de foralumab nasal de aplicaciones en enfermedades neurológicas como la esclerosis múltiple secundaria progresiva para incluir el tratamiento de lesiones de la médula espinal, abordando una necesidad médica importante no satisfecha.
티지아나 라이프 사이언스 (NASDAQ: TLSA)는 외상성 척수 손상(SCI) 치료를 위해 비강 항-CD3 단클론 항체를 사용한 연구에서 긍정적인 결과를 발표했습니다. 전임상 모델은 비강 항-CD3로 치료한 후 운동 기능의 눈에 띄는 개선을 보여주었습니다.
연구는 이 치료가 SCI와 관련된 미세아교세포 염증 조절 및 미세아교세포 활성 억제에서 효과적임을 보여주었습니다. 이는 미국에서 약 30만 명이 SCI와 함께 살고 있으며, 매년 1만 7천 건 이상의 신규 사례가 발생하는 점에서 중요합니다.
회사는 신경학적 질환인 이차 진행형 다발성 경화증의 적용에서 척수 손상 치료까지 비강 포랄루맙 기술을 확장하여 중요한 의료 수요를 충족하고 있습니다.
Tiziana Life Sciences (NASDAQ: TLSA) a annoncé des résultats positifs d'études utilisant un anticorps monoclonal anti-CD3 nasal dans le traitement des lésions traumatiques de la moelle épinière (SCI). Le modèle préclinique a montré des améliorations notables des fonctions motrices après traitement avec l'anti-CD3 nasal.
La recherche a démontré l'efficacité du traitement dans la modulation de l'inflammation microgliale associée à la SCI et dans la réduction de l'activation microgliale. Cette avancée est significative étant donné qu'environ 300 000 individus vivent avec la SCI aux États-Unis, avec plus de 17 000 nouveaux cas par an.
L'entreprise élargit sa technologie foralumab nasal des applications dans les maladies neurologiques telles que la sclérose en plaques secondaire progressive pour inclure le traitement des lésions de la moelle épinière, répondant ainsi à un besoin médical important non satisfait.
Tiziana Life Sciences (NASDAQ: TLSA) hat positive Ergebnisse aus Studien vorgestellt, die monoklonale Antikörper gegen CD3 zur Behandlung von traumatischen Rückenmarksverletzungen (SCI) verwenden. Das präklinische Modell zeigte bemerkenswerte Verbesserungen der motorischen Funktionen nach der Behandlung mit nasalem anti-CD3.
Die Forschung zeigte die Wirksamkeit der Behandlung bei der Modulation der mikroglialen Entzündung, die mit SCI assoziiert ist, und der Dämpfung der mikroglialen Aktivierung. Dieser Fortschritt ist bedeutend, da in den USA etwa 300.000 Personen mit SCI leben und jährlich über 17.000 neue Fälle auftreten.
Das Unternehmen erweitert seine nasale Foralumab-Technologie von Anwendungen in neurologischen Erkrankungen wie der sekundär progressiven Multiplen Sklerose, um die Behandlung von Rückenmarksverletzungen einzubeziehen und damit eine bedeutende, unerfüllte medizinische Notwendigkeit zu adressieren.
- Successful preclinical results showing motor function improvements in SCI treatment
- Potential market opportunity with 300,000 existing SCI patients and 17,000 new cases annually in the US
- Technology platform expansion from multiple sclerosis to spinal cord injury applications
- Results are only from preclinical studies, indicating long pathway to commercialization
- No specific efficacy metrics or comparative data provided
Insights
The positive preclinical results for Tiziana's nasal anti-CD3 monoclonal antibody in treating spinal cord injury (SCI) represent a significant scientific breakthrough with substantial market potential. The approach of targeting microglial inflammation through intranasal delivery is particularly innovative for several reasons:
First, the intranasal delivery method is a key differentiator, as it potentially offers better central nervous system penetration while minimizing systemic side effects - a important advantage for chronic conditions requiring long-term treatment. This builds on Tiziana's existing success with foralumab in secondary progressive multiple sclerosis, suggesting a broader platform potential in neurological conditions.
The market opportunity is compelling:
- Current U.S. patient population: 300,000 individuals with SCI
- Annual new cases: 17,000 in the U.S.
- Lifetime healthcare costs for SCI patients can range from
$1.5 million to$4.8 million
Particularly noteworthy is the dual benefit observed in the preclinical studies:
- Reduction in microglial activation (addressing the underlying inflammation)
- Improvement in motor function (demonstrating functional recovery)
The endorsement from Harvard Medical School faculty and the Ann Romney Center for Neurologic Diseases adds significant credibility to these findings. However, investors should note that while preclinical results are promising, the path to commercialization will require extensive clinical trials and regulatory approvals. The company's experience with foralumab in other indications could potentially expedite this process through established safety data and regulatory relationships.
This development could position Tiziana as a leader in the emerging field of neurological immunomodulation, potentially expanding their addressable market beyond their current focus areas. The technology platform's versatility across multiple neurological conditions (MS and now SCI) suggests potential applications in other neuroinflammatory diseases, representing significant long-term value creation opportunities.
NEW YORK, Jan. 23, 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 results from studies using a nasal anti-CD3 monoclonal antibody in traumatic spinal cord injury (SCI).
Spinal cord injury is a devastating global health issue with profound implications for both mortality and morbidity. The inflammatory response mediated by microglia is a critical component in the pathogenesis of SCI. In these studies, the preclinical model was subjected to a spinal cord injury and then was treated with nasal anti-CD3, resulting in notable advancements in motor functions.
Furthermore, spinal cord injuries (SCIs) are complex neurotraumatic wounds affecting military Service members, their families, Veterans, and the general population. These are serious injuries with long-term consequences requiring lifelong care. It is estimated that about 300,000 individuals are living with an SCI, and this number continues to grow as over 17,000 new cases occur in the U.S. each year (https://cdmrp.health.mil/scirp/default).
“Our pre-clinical findings underscore the pivotal role of nasal anti-CD3 in modulating microglial inflammation associated with spinal cord injury,” 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.
Dr. Saef Izzy, Associate Professor of Neurology at Harvard Medical School, commented, “Treatment with nasal anti-CD3 not only dampened microglial activation but also led to marked improvements in motor function among the injured models. These results hold promise for a transformative therapeutic approach in SCI.”
CEO of Tiziana Life Sciences, Ivor Elrifi, highlighted the strategic implications, stating, "We are swiftly advancing towards expanding our nasal foralumab technology from successful applications in neurologic diseases like secondary progressive multiple sclerosis to now encompass spinal cord injury. This underscores our commitment to pioneering treatments that address significant unmet medical needs."
About Foralumab
Foralumab is a fully human anti-CD3 monoclonal antibody that has been shown to stimulate T regulatory cells when dosed intranasally. 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. 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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