Tiziana to Advance TZLS-501 - Its Fully Human IL-6R Monoclonal Antibody
Tiziana Life Sciences (NASDAQ:TLSA) announced plans to advance TZLS-501, its fully human anti-IL-6 receptor monoclonal antibody. The decision follows Novartis' $1.4 billion acquisition of Tourmaline Bio, highlighting increased industry interest in IL-6 pathway therapeutics.
TZLS-501's dual mechanism of action targets both membrane-bound and soluble forms of IL-6R, blocking IL-6R signaling and reducing inflammatory cytokines. The company will pursue non-dilutive funding for TZLS-501's development while maintaining focus on its lead program, intranasal foralumab. The therapeutic shows potential for treating multiple conditions including rheumatoid arthritis, ARDS, pulmonary fibrosis, lupus, and various cancers.
Tiziana Life Sciences (NASDAQ:TLSA) ha annunciato piani per avanzare TZLS-501, il suo anticorpo monoclonale anti-IL-6 receptor completamente umano. La decisione arriva dopo l'acquisizione da 1,4 miliardi di dollari di Tourmaline Bio da parte di Novartis, evidenziando un crescente interesse del settore per le terapie mirate al pathway IL-6.
TZLS-501 ha un meccanismo di azione duale che prende di mira sia la forma legata alla membrana sia quella solubile di IL-6R, bloccando la segnalazione IL-6R e riducendo le citochine infiammatorie. L'azienda cercherà finanziamenti non diluitivi per lo sviluppo di TZLS-501, mantenendo al contempo l'attenzione sul suo programma principale, l’intranasale foralumab. Il trattamento mostra potenziale per il trattamento di diverse condizioni tra cui artrite reumatoide, ARDS, fibrosi polmonare, lupus e vari tumori.
Tiziana Life Sciences (NASDAQ:TLSA) anunció planes para avanzar TZLS-501, su anticuerpo monoclonal anti IL-6 receptor completamente humano. La decisión se produce tras la adquisición de Tourmaline Bio por 1.4 mil millones de dólares por parte de Novartis, destacando un mayor interés de la industria en las terapias de la vía IL-6.
TZLS-501 tiene un doble mecanismo de acción que apunta tanto a las formas de IL-6R unidas a la membrana como a la soluble, bloqueando la señalización IL-6R y reduciendo las citocinas inflamatorias. La compañía buscará financiamiento no dilutivo para el desarrollo de TZLS-501, manteniendo el enfoque en su programa líder, el foralumab intranasal. El fármaco muestra potencial para tratar diversas condiciones, incluyendo artritis reumatoide, ARDS, fibrosis pulmonar, lupus y varios cánceres.
Tiziana Life Sciences (NASDAQ:TLSA)가 완전 인간 유래 IL-6 수용체에 대한 모노클로날 항체 TZLS-501의 개발을 진행하기로 발표했다. 이 결정은 노바티스의 Tourmaline Bio를 14억 달러에 인수한 직후이며, IL-6 경로 치료제에 대한 업계의 관심이 커지고 있음을 강조한다.
TZLS-501의 이중 작용 기전은 IL-6R의 막 결합형과 가용성 형태를 모두 겨냥해 IL-6R 신호를 차단하고 염증성 사이토카인을 감소시킨다. 회사는 TZLS-501 개발을 위한 비희석(non-dilutive) 자금을 모색하되, 주력 프로그램인 비강 투여 포랄루맙(intranasal foralumab)에 대한 집중은 유지한다. 이 치료제는 류마티스 관절염, ARDS, 폐섬유증, 루푸스 및 다양한 암 등 여러 질환에 대한 잠재력을 보인다.
Tiziana Life Sciences (NASDAQ:TLSA) a annoncé des plans pour faire progresser TZLS-501, son anticorps monoclonal entièrement humain dirigé contre le récepteur IL-6. Cette décision survient après l'acquisition par Novartis de Tourmaline Bio pour 1,4 milliard de dollars, soulignant un intérêt croissant de l’industrie pour les thérapies ciblant la voie IL-6.
Le mécanisme d’action double de TZLS-501 vise à la fois les formes membranaire et soluble du IL-6R, bloquant la signalisation IL-6R et réduisant les cytokines inflammatoires. L’entreprise cherchera un financement non dilutif pour le développement de TZLS-501 tout en restant concentrée sur son programme phare, le foralumab intranasal. Le traitement montre un potentiel pour traiter de nombreuses affections, notamment la polyarthrite rhumatoïde, le SDRA, la fibrose pulmonaire, le lupus et divers cancers.
Tiziana Life Sciences (NASDAQ:TLSA) kündigte Pläne an, TZLS-501, seinen vollständig humanen monoklonalen Antikörper gegen IL-6-Rezeptor, voranzutreiben. Die Entscheidung erfolgt nach der Übernahme von Tourmaline Bio durch Novartis für 1,4 Milliarden Dollar, was das wachsende Brancheninteresse an IL-6-Weg-Therapien unterstreicht.
Der duale Wirkmechanismus von TZLS-501 zielt sowohl auf membran- als auch auf lösliche Formen von IL-6R ab, blockiert IL-6R-Signale und senkt entzündliche Zytokine. Das Unternehmen wird eine nicht-dilutive Finanzierung für die Entwicklung von TZLS-501 anstreben, während der Fokus auf dem Leitprogramm, dem intranasalen Foralumab, bleibt. Die Therapie zeigt Potenzial zur Behandlung mehrerer Erkrankungen, einschließlich rheumatoider Arthritis, ARDS, Lungenfibrose, Lupus und verschiedener Krebsarten.
Tiziana Life Sciences (NASDAQ:TLSA) أعلنت عن خطط لتطوير TZLS-501، وهو جسم مضاد أحادي النسيلة بشري بالكامل ضد مستقبل IL-6. جاء القرار عقب استحواذ نوفارتس على Tourmaline Bio مقابل 1.4 مليار دولار، مما يبرز زيادة الاهتمام الصناعي بعلاجات مسار IL-6.
آلية TZLS-501 المزدوجة تستهدف كل من الشكلين الغشائي والمذيب لـ IL-6R، مما يعيق إشارات IL-6R ويقلل من السيتوكينات الالتهابية. ستسعى الشركة للحصول على تمويل غير مخفض لتطوير TZLS-501 مع الحفاظ على التركيز على برنامجها الرائد، فورالوماب عن طريق الأنف. يُظهر العلاج إمكانات لعلاج عدة حالات بما في ذلك التهاب المفاصل الروماتويدي، وARDS، وتليف الرئة، والذئبة، وأنواع مختلفة من السرطان.
Tiziana Life Sciences（纳斯达克股票代码：TLSA）宣布计划推进 TZLS-501，这是其完全人源化的 IL-6 受体单抗。此决定紧随诺华以 14 亿美元收购 Tourmaline Bio 之举，凸显业界对 IL-6 通路治疗的兴趣上升。
TZLS-501 的双重作用机制同时靶向 IL-6R 的膜结合型与可溶性形式，阻断 IL-6R 信号传导并降低炎性细胞因子。公司将寻求用于 TZLS-501 开发的 非稀释性融资，同时保持对主导计划、经鼻给药的福拉鲁单抗（intranasal foralumab）的关注。该治疗对多种疾病具有潜在治疗前景，包括类风湿性关节炎、ARDS、肺纤维化、红斑狼疮以及多种癌症。
- Strategic timing aligns with Novartis' $1.4B Tourmaline acquisition, validating IL-6 therapy market value
- TZLS-501's dual mechanism of action offers unique therapeutic advantages
- Potential for both monotherapy and combination treatments with foralumab
- Non-dilutive funding strategy preserves shareholder value
- Development of TZLS-501 may require significant resources despite non-dilutive funding intent
- Competition in IL-6 therapy space from established players like Novartis
Insights
Tiziana's advancement of TZLS-501, an IL-6R antibody, follows $1.4B Novartis deal in same space, potentially expanding their inflammatory disease portfolio.
Tiziana Life Sciences is strategically expanding its pipeline by advancing TZLS-501, a fully human IL-6 receptor antibody, as its second development asset. This decision follows Novartis' acquisition of Tourmaline Bio for ~$1.4 billion, highlighting significant industry interest in IL-6 pathway therapeutics.
What makes TZLS-501 scientifically distinctive is its dual mechanism of action targeting both membrane-bound and soluble forms of IL-6R. This approach not only blocks receptor signaling but also reduces circulating inflammatory IL-6 cytokines, potentially offering advantages over existing therapies in the management of inflammatory conditions.
The company has identified multiple potential therapeutic applications including rheumatoid arthritis, ARDS, idiopathic pulmonary fibrosis, systemic lupus, and various cancers - all representing significant market opportunities where excessive IL-6 signaling plays a central pathological role.
From a strategic perspective, Tiziana is pursuing non-dilutive funding for TZLS-501's development while maintaining its primary focus on intranasal foralumab, its lead program. This balanced approach aims to expand the company's therapeutic portfolio without diverting critical resources from ongoing clinical trials.
The flexibility to develop TZLS-501 as either a monotherapy or in combination with foralumab and other agents suggests potential for a diversified product strategy. The timing of this announcement, following Novartis' billion-dollar acquisition in the same therapeutic space, positions Tiziana to potentially capitalize on heightened industry interest in IL-6 targeting therapies.
BOSTON, Sept. 25, 2025 (GLOBE NEWSWIRE) -- Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), today announces it will advance its second asset, a fully human anti-IL-6 receptor (“IL-6R”) monoclonal antibody, TZLS-501. There has been heightened industry activity in the IL-6 pathway space, underscored by Novartis’ recent acquisition of Tourmaline Bio for approximately
TZLS-501 is a fully human anti-IL-6 receptor (“IL-6R”) monoclonal antibody (mAb) targeting both the membrane-bound and soluble forms of IL-6R. This dual mechanism of action not only blocks IL-6R signaling but also reduces circulating IL-6 cytokines, which are recognized drivers of inflammation, lung damage, and chronic fibrosis. Tiziana sees potential to develop TZLS-501 as a monotherapy, or in combination with its lead candidate, foralumab, as well as with other anti-inflammatory and anti-infective agents.
The recent acquisition by Novartis further validates the importance of IL-6 therapeutics. Tiziana believes this an opportune time for the parallel advancement of TZLS-501. Accordingly, Tiziana will pursue development of TZLS-501, while not diverting resources or focus from ongoing clinical trials with foralumab.
Excessive IL-6 signaling plays a central role in multiple diseases, including rheumatoid arthritis (RA), acute respiratory distress syndrome (ARDS), idiopathic pulmonary fibrosis (IPF), systemic lupus erythematosus, and various cancers. By reducing both receptor-mediated signaling and circulating cytokine burden, TZLS-501 may offer therapeutic advantages in managing these acute and chronic inflammatory conditions.
Ivor Elrifi, Chief Executive Officer of Tiziana Life Sciences, commented, “Novartis’ recent acquisition of Tourmaline demonstrates how IL-6 therapy is increasingly valued in treating systemic inflammation and related diseases. While intranasal foralumab remains our lead program and primary focus, we are reviewing development opportunities for TZLS-501 as a complementary asset. Our fully human IL-6 mAb has always been an exciting asset. With recent market developments, we feel it is an opportune time to explore TZLS-501’s development. Its unique ability to address both membrane-bound and soluble IL-6 signaling, positions it as a potentially powerful therapy for acute and chronic inflammatory conditions.”
About TZLS-501
TZLS-501, a fully human mAb, was licensed from Novimmune, SA, (Geneva, CH) in 2017. IL-6 is a cytokine that binds to its receptor subunit IL-6Rα on the cell membrane, and is a major determinant in priming of pathogenic T cells to produce an inflammatory response. The receptor IL-6Rα can be shed in soluble form, sIL6Rα, which binds to circulating IL-6 cytokine in the blood. The downstream signaling from this complex mediates pro-inflammatory effects underlying inflammatory diseases. TZLS-501 acts via a dual mechanism by inhibiting IL-6R signaling and depleting circulating levels of IL-6.
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, 14 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. 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.
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
What is TZLS-501 and how does it work?
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