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Tiziana Life Sciences Announces Study Results from Intranasal Anti-CD3 Foralumab in Multiple Sclerosis Patients with PIRA Highlighted in Neurology Today®
Tiziana Life Sciences announced study results from Intranasal Anti-CD3 Foralumab in Multiple Sclerosis Patients with PIRA highlighted in Neurology Today®. The study shows that foralumab attenuates microglial activation in non-active secondary progressive multiple sclerosis patients with progression independent of relapse. The positive results suggest potential benefits for patients with this difficult-to-treat form of MS. The study, presented at the Annual Meeting of the American Academy of Neurology, demonstrates the effect of intranasal foralumab on microglial activation in na-SPMS patients using PET imaging. This breakthrough therapy has the potential to address the unmet need for disease-modifying treatments in progressive MS patients.
Tiziana Life Sciences ha annunciato i risultati di uno studio sull'Anti-CD3 Foralumab intranasale in pazienti con Sclerosi Multipla e PIRA evidenziati su Neurology Today®. Lo studio dimostra che il foralumab attenua l'attivazione microgliale in pazienti con sclerosi multipla secondariamente progressiva non attiva con progressione indipendente dalla ricaduta. I risultati positivi suggeriscono benefici potenziali per i pazienti con questa forma difficile da trattare di SM. Lo studio, presentato all'Incontro Annuale dell'Accademia Americana di Neurologia, mostra l'effetto del foralumab intranasale sull'attivazione microgliale in pazienti con SM-SP na utilizzando l'imaging PET. Questa terapia innovativa ha il potenziale per soddisfare il bisogno insoddisfatto di trattamenti che modificano la malattia nei pazienti con SM progressiva.
Tiziana Life Sciences anunció los resultados de un estudio sobre el Foralumab Anti-CD3 intranasal en pacientes con Esclerosis Múltiple y PIRA destacados en Neurology Today®. El estudio muestra que foralumab atenúa la activación microglial en pacientes con esclerosis múltiple secundariamente progresiva no activa con progresión independiente de la recaída. Los resultados positivos sugieren beneficios potenciales para los pacientes con esta forma de EM difícil de tratar. El estudio, presentado en la Reunión Anual de la Academia Americana de Neurología, demuestra el efecto del foralumab intranasal sobre la activación microglial en pacientes con EM-SP na utilizando imágenes PET. Esta terapia innovadora tiene el potencial de abordar la necesidad no cubierta de tratamientos modificadores de la enfermedad en pacientes con EM progresiva.
Tiziana Life Sciences는 뉴롤로지 투데이®에 하이라이트된 다발성 경화증 환자를 대상으로 한 비강용 Anti-CD3 포랄루맙에 대한 연구 결과를 발표했습니다. 연구 결과에 따르면 포랄루맙은 재발과 무관한 비활성 2차 진행성 다발성 경화증 환자의 미세교세포 활성화를 감소시킵니다. 긍정적인 결과는 이 어려운 형태의 MS를 가진 환자들에게 잠재적인 이점을 제공할 수 있음을 시사합니다. 미국신경학회 연례 회의에서 발표된 이 연구는 PET 이미징을 사용하여 na-SPMS 환자에서 비강 포랄루맙의 미세교세포 활성화 효과를 보여줍니다. 이 획기적인 치료법은 진행성 MS 환자의 미충족된 질병 수정 치료 요구를 해결할 잠재력을 가지고 있습니다.
Tiziana Life Sciences a annoncé les résultats d'une étude sur l'Anti-CD3 Foralumab intranasal chez les patients atteints de sclérose en plaques (MS) avec PIRA, mis en évidence dans Neurology Today®. L'étude révèle que le foralumab atténue l'activation microgliale chez les patients atteints de sclérose en plaques secondairement progressive non active avec une progression indépendante de la rechute. Les résultats positifs suggèrent des avantages potentiels pour les patients atteints de cette forme difficile à traiter de MS. L'étude, présentée à la réunion annuelle de l'Académie américaine de neurologie, montre l'effet du foralumab intranasal sur l'activation microgliale chez les patients atteints de SPMS na en utilisant l'imagerie PET. Cette thérapie révolutionnaire a le potentiel de répondre au besoin non satisfait de traitements modifiant la maladie chez les patients atteints de MS progressive.
Tiziana Life Sciences gab Studienergebnisse von Intranasalem Anti-CD3 Foralumab bei Multiple-Sklerose-Patienten mit PIRA bekannt, die in Neurology Today® hervorgehoben wurden. Die Studie zeigt, dass Foralumab die Mikroglia-Aktivierung bei nicht-aktiven sekundär progressiven Multiple-Sklerose-Patienten mit von Schüben unabhängiger Progression abschwächt. Die positiven Ergebnisse deuten auf potenzielle Vorteile für Patienten mit dieser schwer zu behandelnden Form der MS hin. Die Studie, die auf der Jahrestagung der Amerikanischen Akademie für Neurologie vorgestellt wurde, demonstriert die Wirkung von intranasalem Foralumab auf die Mikroglia-Aktivierung bei na-SPMS-Patienten unter Verwendung von PET-Bildgebung. Diese bahnbrechende Therapie hat das Potenzial, den ungedeckten Bedarf an krankheitsmodifizierenden Behandlungen bei progressiven MS-Patienten zu adressieren.
Positive
Foralumab demonstrates the ability to attenuate microglial activation in non-active secondary progressive multiple sclerosis patients with progression independent of relapse.
The study highlights the potential benefits of foralumab for patients with this challenging form of multiple sclerosis.
Intranasal foralumab shows promising results in dampening microglial activation and stabilizing clinical progression in non-active secondary progressive MS.
The study presents initial evidence that fully human anti-CD3 has the potential to benefit patients with PIRA, a condition with a major unmet need in multiple sclerosis treatment.
Negative
None.
Insights
The investigational use of foralumab, an anti-CD3 monoclonal antibody, in managing non-active secondary progressive multiple sclerosis (na-SPMS) manifests a promising avenue in treating a condition with currently no approved disease-modifying therapies. The molecular target CD3 is part of the T-cell receptor complex which plays a vital role in adaptive immune response. The observed attenuation of microglial activation, as evidenced by [F-18]PBR06-PET imaging, suggests a reduction in the inflammatory processes typically associated with multiple sclerosis progression. As microglia are the primary immune cells in the brain, their regulation could potentially ameliorate neuroinflammation and consequent disability progression in MS patients. For investors, this represents a potential opportunity for Tiziana to carve a niche in this unmet medical area, possibly translating into a competitive advantage and a favorable long-term value proposition if clinical efficacy and safety are demonstrated in larger trials.
Tiziana Life Sciences' focus on a novel therapeutic approach for a subtype of multiple sclerosis that lacks targeted treatments could impact the company's financial trajectory positively. Data indicating an efficacy signal—even from an early-stage study—can spur investor optimism, prompting upward movements in stock price in anticipation of future successes. It is important, however, for investors to weigh the risks inherent to biotech investments, such as regulatory hurdles, the need for extensive capital for continued research and the long timeframe for drug development. The retail investor should remain cognizant of these factors while evaluating the potential growth stemming from Tiziana’s pipeline advancements.
From a market perspective, the successful development of foralumab could disrupt the existing treatment landscape for MS, specifically addressing the PIRA patient subset. The current standard of care in MS involves therapies that predominantly target relapsing forms of the disease, leaving a segment of the patient population underserved. Tiziana's intranasal delivery approach also underscores a broader industry trend toward improving patient compliance through user-friendly drug administration routes. The market receptivity to innovative delivery systems, coupled with the company's targeting of an unmet medical need, could be significant factors in the commercial success of foralumab, should it proceed to market authorization.
- Intranasal foralumab attenuated microglial activation in patients with non-active secondary progressive multiple sclerosis and progression independent of relapse (PIRA) - - Data presented in a platform session at the Annual Meeting of the American Academy of Neurology in Denver, Colorado -
NEW YORK, April 19, 2024 (GLOBE NEWSWIRE) -- Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies via novel routes of drug delivery, today announced that a study related to its lead candidate, foralumab, was highlighted in Neurology Today®, the official news source of the American Academy of Neurology (AAN), in an article titled, “Anti-CD3 Antibody Foralumab Shows Promise in PIRA, Measured by Novel PET Ligand.”
The study is authored by Tarun Singhal, M.B.B.S., M.D., Director, PET Imaging Program in Neurologic Diseases at Brigham and Women’s Hospital, a founding member of Mass General Brigham Healthcare System, and Associate Professor of Neurology at Harvard Medical School, and shows that foralumab, a fully human anti-CD3 monoclonal-antibody, attenuates microglial activation in non-active secondary progressive multiple sclerosis (na-SPMS) patients with progression independent of relapse (PIRA). A systemic review published in JAMA Neurology[1] in October 2023 found that PIRA is the most frequent manifestation of disability accumulation across the full spectrum of traditional multiple sclerosis (MS) phenotypes.
“PIRA is a condition that poses a major unmet need for patients with multiple sclerosis,” stated Dr. Singhal. “Currently, there are no disease-modifying therapies approved for this category of progressive MS patients. This study provides initial evidence that this fully human anti-CD3 has the potential to benefit this type of MS, which is the most difficult form to treat.”
“We do not have any recognized approaches to try to alter microglial activation at present, which everyone agrees at this point in time is relevant throughout the life of a patient with MS. Even ocrelizumab [Ocrevus] for primary progressive MS has modest impact, so the potential here is great, and the proof of principle that you can alter the microglia is a real punchline,” said John Corboy, MD, FAAN, an endowed chair in neurology and director of the Rocky Mountain Multiple Sclerosis Center at the University of Colorado Anschutz Medical Campus.
The study assesses the effect of intranasal foralumab on microglial activation in na-SPMS patients with PIRA as measured by positron emission tomography (PET) imaging via radiology marker [F-18]PBR06-PET, a novel, long-half-life ligand used in PET scanning. The study is designed to be open-label and is based on data from the Expanded-Access Program evaluating foralumab in na-SPMS patients that is currently underway. In this study, five of six patients (83%, 95% confidence interval 44%-97%) showed a qualitative reduction on [F-18]PBR06-PET in multiple brain regions after both 3 and 6 months of nasal foralumab treatment.
Data from the study was presented at a platform session at the Annual Meeting of the American Academy of Neurology being held in Denver, Colorado. The abstract is entitled, “Treatment of PIRA with Nasal Foralumab Dampens Microglial Activation and Stabilizes Clinical Progression in Non-Active Secondary Progressive MS.”
About Foralumab Activated T cells play an important role in the inflammatory process. Foralumab, the only fully human anti-CD3 monoclonal antibody (mAb), 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 demonstrated in patients with COVID and with multiple sclerosis, as well as in healthy normal subjects. The non-active SPMS intranasal foralumab Phase 2 trial 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.[2],[3]
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, 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 further inquiries:
Tiziana Life Sciences Ltd Paul Spencer, Business Development and Investor Relations +44 (0) 207 495 2379 email: info@tizianalifesciences.com
What study results did Tiziana Life Sciences announce related to Intranasal Anti-CD3 Foralumab in Multiple Sclerosis Patients?
Tiziana Life Sciences announced study results showing that foralumab attenuates microglial activation in non-active secondary progressive multiple sclerosis patients with progression independent of relapse.
Where were the study results presented?
The study results were presented at the Annual Meeting of the American Academy of Neurology in Denver, Colorado.
What is the potential benefit of foralumab for patients with multiple sclerosis?
Foralumab shows potential benefits for patients with difficult-to-treat forms of multiple sclerosis, such as PIRA.
How does intranasal foralumab impact microglial activation in non-active secondary progressive MS patients?
Intranasal foralumab demonstrates a qualitative reduction on PET imaging in multiple brain regions, indicating a dampening effect on microglial activation.
