Tiziana Life Sciences Announces Agreement for Product Development Services with Renaissance Lakewood, LLC
Tiziana Life Sciences (NASDAQ: TLSA) has announced a product development services agreement with Renaissance Lakewood , a Contract Development and Manufacturing Organization (CDMO) specializing in nasal drug delivery. The collaboration focuses on optimizing the formulation and scaling up production of intranasal foralumab, Tiziana's lead development candidate.
The partnership aims to advance the development of intranasal foralumab, a fully human anti-CD3 monoclonal antibody, for treating neurodegenerative and inflammatory diseases. Renaissance will leverage its expertise in pharmaceutical-nasal product development and manufacturing to ensure compliance with quality and regulatory requirements.
Recent studies have shown that intranasal foralumab can activate regulatory T cells that cross the blood-brain barrier, reducing neuroinflammation in conditions like Alzheimer's disease and multiple sclerosis. This collaboration represents a strategic step toward clinical development and potential commercialization of the treatment.
Tiziana Life Sciences (NASDAQ: TLSA) ha annunciato un accordo per servizi di sviluppo prodotto con Renaissance Lakewood, un'organizzazione di sviluppo e produzione a contratto (CDMO) specializzata nella somministrazione di farmaci nasali. La collaborazione si concentra sull'ottimizzazione della formulazione e sull'aumento della produzione di foralumab intranasale, il principale candidato allo sviluppo di Tiziana.
Il partenariato mira a promuovere lo sviluppo di foralumab intranasale, un anticorpo monoclonale anti-CD3 completamente umano, per il trattamento di malattie neurodegenerative e infiammatorie. Renaissance sfrutterà la sua esperienza nello sviluppo e nella produzione di prodotti farmaceutici nasali per garantire la conformità ai requisiti di qualità e normativi.
Studi recenti hanno dimostrato che il foralumab intranasale può attivare le cellule T regolatorie che attraversano la barriera emato-encefalica, riducendo la neuroinfiammazione in condizioni come il morbo di Alzheimer e la sclerosi multipla. Questa collaborazione rappresenta un passo strategico verso lo sviluppo clinico e la potenziale commercializzazione del trattamento.
Tiziana Life Sciences (NASDAQ: TLSA) ha anunciado un acuerdo de servicios de desarrollo de productos con Renaissance Lakewood, una Organización de Desarrollo y Fabricación por Contrato (CDMO) especializada en la entrega de medicamentos nasales. La colaboración se centra en la optimización de la formulación y el aumento de la producción de foralumab intranasal, el principal candidato en desarrollo de Tiziana.
La asociación tiene como objetivo avanzar en el desarrollo de foralumab intranasal, un anticuerpo monoclonal anti-CD3 completamente humano, para el tratamiento de enfermedades neurodegenerativas e inflamatorias. Renaissance aprovechará su experiencia en el desarrollo y la fabricación de productos farmacéuticos nasales para garantizar el cumplimiento de los requisitos de calidad y normativos.
Estudios recientes han demostrado que el foralumab intranasal puede activar células T reguladoras que cruzan la barrera hematoencefálica, reduciendo la neuroinflamación en condiciones como la enfermedad de Alzheimer y la esclerosis múltiple. Esta colaboración representa un paso estratégico hacia el desarrollo clínico y la posible comercialización del tratamiento.
티치아나 라이프 사이언스(Tiziana Life Sciences) (NASDAQ: TLSA)는 르네상스 레이크우드(Renaissance Lakewood)와 제품 개발 서비스 계약을 체결했다고 발표했습니다. 르네상스 레이크우드는 비강 약물 전달을 전문으로 하는 계약 개발 및 제조 조직(CDMO)입니다. 이 협력은 티치아나의 주요 개발 후보인 비강 포랄루맙(intranasal foralumab)의 제형 최적화 및 생산 확대에 중점을 두고 있습니다.
이 파트너십은 신경퇴행성 및 염증성 질환 치료를 위한 완전 인간 항-CD3 단클론 항체인 비강 포랄루맙의 개발을 촉진하는 것을 목표로 합니다. 르네상스는 품질 및 규제 요구 사항 준수를 보장하기 위해 제약 비강 제품 개발 및 제조에 대한 전문성을 활용할 것입니다.
최근 연구에 따르면 비강 포랄루맙은 혈액-뇌 장벽을 넘어가는 조절 T 세포를 활성화하여 알츠하이머병 및 다발성 경화증과 같은 질환에서 신경 염증을 줄일 수 있습니다. 이 협력은 임상 개발 및 치료의 잠재적 상업화를 위한 전략적 단계로 간주됩니다.
Tiziana Life Sciences (NASDAQ: TLSA) a annoncé un accord de services de développement de produits avec Renaissance Lakewood, une Organisation de Développement et de Fabrication sous Contrat (CDMO) spécialisée dans l'administration de médicaments par voie nasale. La collaboration se concentre sur l'optimisation de la formulation et l'augmentation de la production de foralumab intranasal, le principal candidat au développement de Tiziana.
Ce partenariat vise à faire progresser le développement du foralumab intranasal, un anticorps monoclonal anti-CD3 entièrement humain, pour le traitement des maladies neurodégénératives et inflammatoires. Renaissance mettra à profit son expertise dans le développement et la fabrication de produits pharmaceutiques nasaux pour garantir le respect des exigences de qualité et réglementaires.
Des études récentes ont montré que le foralumab intranasal peut activer des cellules T régulatrices qui traversent la barrière hémato-encéphalique, réduisant ainsi la neuroinflammation dans des conditions telles que la maladie d'Alzheimer et la sclérose en plaques. Cette collaboration représente une étape stratégique vers le développement clinique et la commercialisation potentielle du traitement.
Tiziana Life Sciences (NASDAQ: TLSA) hat eine Vereinbarung über Produktentwicklungsdienstleistungen mit Renaissance Lakewood bekannt gegeben, einer Vertragsentwicklungs- und Produktionsorganisation (CDMO), die sich auf die nasale Arzneimittelabgabe spezialisiert hat. Die Zusammenarbeit konzentriert sich auf die Optimierung der Formulierung und die Hochskalierung der Produktion von intranasalem Foralumab, dem führenden Entwicklungs-kandidaten von Tiziana.
Die Partnerschaft zielt darauf ab, die Entwicklung von intranasalem Foralumab, einem vollständig humanen anti-CD3-Monoklonalen Antikörper, zur Behandlung von neurodegenerativen und entzündlichen Erkrankungen voranzutreiben. Renaissance wird sein Fachwissen in der Entwicklung und Herstellung von pharmazeutischen Nasenprodukten nutzen, um die Einhaltung von Qualitäts- und Regulierungsanforderungen sicherzustellen.
Neueste Studien haben gezeigt, dass intranasales Foralumab regulatorische T-Zellen aktivieren kann, die die Blut-Hirn-Schranke überwinden und so die Neuroinflammation bei Erkrankungen wie Alzheimer und Multipler Sklerose reduzieren. Diese Zusammenarbeit stellt einen strategischen Schritt in Richtung klinische Entwicklung und potenzieller Kommerzialisierung der Behandlung dar.
- Strategic partnership with established CDMO for manufacturing optimization
- Progress toward commercialization of lead drug candidate
- Development of innovative drug delivery method for treating neurodegenerative diseases
- None.
Insights
This manufacturing agreement marks a pivotal transition for Tiziana Life Sciences, signaling a strategic advancement in their commercialization pathway for intranasal foralumab. The selection of Renaissance Lakewood, a specialized nasal drug delivery CDMO, is particularly noteworthy for several reasons:
The partnership addresses three critical aspects of drug development:
- Formulation optimization, which is essential for ensuring consistent drug delivery and therapeutic efficacy
- Manufacturing scale-up planning, a important step that bridges the gap between clinical trials and commercial production
- Regulatory compliance, which is fundamental for eventual FDA approval
The timing of this agreement is strategically significant. By securing a manufacturing partner at this stage, Tiziana is proactively addressing one of the most challenging aspects of drug commercialization. This forward-looking approach could potentially reduce time-to-market and associated risks in the manufacturing transfer process.
From a competitive standpoint, the partnership with a specialized CDMO in nasal drug delivery provides Tiziana with access to critical expertise and infrastructure without the substantial capital investment required to develop these capabilities internally. This capital-efficient approach is particularly important for a small-cap biotech company, helping to preserve cash while advancing toward commercialization.
However, investors should note that while this agreement represents positive operational progress, significant milestones remain before commercial revenue generation, including successful completion of clinical trials and regulatory approvals. The focus on manufacturing preparation suggests management's confidence in their clinical program, but does not guarantee clinical or commercial success.
NEW YORK, Feb. 21, 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 a product development services agreement with Renaissance Lakewood LLC (“Renaissance”), a leading Contract Development and Manufacturing Organization (CDMO) focused on nasal drug delivery. This collaboration aims to optimize the current formulation and develop a comprehensive plan for the scale-up of foralumab in a nasal device. Intranasal foralumab is currently under development for treating neurodegenerative and inflammatory diseases or conditions.
Under this agreement, Renaissance will use its extensive expertise in pharmaceutical-nasal product development and manufacturing to support the production of intranasal foralumab, ensuring compliance with the highest quality and regulatory requirements. This collaboration is a critical step in Tiziana's strategy to expedite clinical development and potential commercialization of intranasal foralumab.
Intranasal foralumab offers a novel therapeutic approach by modulating the immune system to reduce neuroinflammation, a key factor in the progression of diseases such as Alzheimer's disease and multiple sclerosis. Recent studies have demonstrated its potential to activate regulatory T cells that cross the blood-brain barrier, dampening microglial activation and providing therapeutic benefits to patients.
Ivor Elrifi, CEO of Tiziana Life Sciences, commented, “Partnering with Renaissance is a significant milestone in our mission to bring intranasal foralumab to patients in need. Their proven track record in pharmaceutical manufacturing will be invaluable as we advance our clinical programs and prepare for potential market entry.”
This collaboration aligns with Tiziana's commitment to addressing unmet medical needs through innovative therapies. It represents a pivotal advancement in the Company's efforts to deliver effective treatments for debilitating neurodegenerative and inflammatory conditions.
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 Phase 2a, a 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 Renaissance Lakewood, LLC (“Renaissance”)
Renaissance is a US-based contract development and manufacturing organization (CDMO) for pharmaceutical and biotech. With over 20 years of experience in nasal sprays and sterile dosage forms, Renaissance has a consistent track record of providing exceptional service and resources to clients from the development stage through commercial launch. Learn more about Renaissance at: www.renpharm.com.
Renaissance Media Contact
732-730-3262
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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