Tiziana Life Sciences strengthens intranasal foralumab development with Renaissance Lakewood partnership

Tiziana Life Sciences, Ltd. (Nasdaq: TLSA), a clinical-stage biotechnology company focused on immunomodulation therapies, has announced a strategic partnership with Renaissance Lakewood LLC, a leading contract development and manufacturing organization (CDMO) specializing in nasal drug delivery. This collaboration is set to optimize the formulation and scale-up of intranasal foralumab, Tiziana’s lead development candidate, designed to treat neurodegenerative and inflammatory diseases.

How Will Renaissance Lakewood Support Tiziana’s Intranasal Foralumab Development?

Renaissance Lakewood will apply its extensive expertise in pharmaceutical manufacturing to refine the nasal formulation of intranasal foralumab and support its large-scale production. As a CDMO with a strong track record in nasal drug delivery technologies, Renaissance is well-positioned to ensure that Tiziana Life Sciences meets regulatory standards while preparing for potential commercialization.

Tiziana’s decision to partner with Renaissance aligns with its long-term strategy of accelerating clinical development and ensuring that its immunomodulation therapy reaches patients as efficiently as possible. The collaboration marks a significant step in advancing intranasal foralumab development, a drug that has demonstrated immune-modulating properties by stimulating regulatory T cells (Tregs). This mechanism helps dampen inflammation, a key driver in neurodegenerative disease progression.

What Is Intranasal Foralumab and How Does It Work?

Intranasal foralumab is the only fully human anti-CD3 monoclonal antibody currently in clinical development. The therapy works by binding to the T cell receptor, which helps regulate the immune response and reduce inflammatory activity. This mechanism has been observed in patients with multiple sclerosis, COVID-19, and other immune-related disorders.

Tiziana’s intranasal drug delivery platform offers an innovative approach that bypasses the need for intravenous (IV) administration, which can often lead to unwanted immune system complications. The nasal route provides a direct pathway for modulating neuroinflammation, a key driver of neurodegenerative diseases such as multiple sclerosis, Alzheimer’s disease, and amyotrophic lateral sclerosis (ALS).

By enabling Treg stimulation, intranasal foralumab has shown the potential to mitigate inflammatory responses associated with neurodegeneration, potentially slowing disease progression. This novel immunotherapy approach represents a paradigm shift in the treatment of autoimmune and neuroinflammatory conditions.

What Are the Latest Clinical Developments in Tiziana’s Expanded Access Program?

Tiziana has been actively expanding its clinical research on intranasal foralumab, particularly in the treatment of non-active secondary progressive multiple sclerosis (na-SPMS). The company has been conducting an intermediate-size Expanded Access Program (EAP), in which 10 patients have already received treatment. Early data has shown that within six months, all enrolled patients exhibited either disease stability or improvement.

Following these promising results, the United States Food and Drug Administration (FDA) has permitted the enrollment of an additional 20 patients into the expanded access program. The move highlights growing confidence in intranasal foralumab’s therapeutic potential for patients with na-SPMS, a population with limited treatment options.

Additionally, Tiziana is conducting a Phase 2a clinical trial (NCT06292923) to further evaluate the efficacy and safety of intranasal foralumab. This randomized, double-blind, placebo-controlled study began patient screening in November 2023 and aims to provide further clinical validation of the therapy’s immunomodulatory benefits.

How Does Intranasal Foralumab Compare to Traditional Immunotherapy?

Traditional monoclonal antibody therapies are typically administered intravenously (IV), requiring systemic circulation that can lead to immune-related adverse effects. In contrast, intranasal delivery allows for a more targeted immune response, reducing the risk of systemic immune suppression.

Studies indicate that intranasal foralumab offers a safer and more effective alternative for modulating neuroinflammation. By enabling immune regulation through a non-invasive nasal route, the therapy has the potential to significantly improve treatment outcomes while enhancing patient convenience.

This nasal drug delivery method could be particularly beneficial in treating progressive neurodegenerative disorders, where reducing chronic inflammation is a critical therapeutic goal. The potential ability of intranasal foralumab to cross the blood-brain barrier and directly target neuroinflammation makes it a compelling candidate for future immunotherapy applications.

What Does This Collaboration Mean for Tiziana’s Future?

Tiziana’s strategic alliance with Renaissance Lakewood underscores the company’s commitment to bringing intranasal foralumab to market. By leveraging Renaissance’s pharmaceutical expertise, Tiziana aims to streamline drug development, optimize formulation techniques, and ensure regulatory compliance.

Ivor Elrifi, Chief Executive Officer of Tiziana Life Sciences, emphasized that the collaboration is a critical step forward in advancing intranasal foralumab development. He stated that Renaissance’s strong track record in pharmaceutical manufacturing will be instrumental in ensuring the highest quality standards as Tiziana prepares for potential market entry.

With ongoing clinical trials, an expanded access program, and an innovative drug delivery platform, Tiziana is positioning itself as a leader in immunotherapy innovation. The company’s commitment to developing alternative treatment options for neurodegenerative diseases aligns with the growing demand for safer, more effective therapies in the field of biopharmaceutical research.

What’s Next for Tiziana Life Sciences?

Tiziana remains focused on expanding its research and development efforts to further explore the clinical applications of intranasal foralumab. The company is also evaluating additional pipeline candidates that utilize nasal immunotherapy technology, potentially broadening the therapeutic scope beyond multiple sclerosis to other chronic neuroinflammatory conditions.

By prioritizing scientific innovation, regulatory compliance, and strategic partnerships, Tiziana is reinforcing its long-term vision of bringing transformational therapies to patients suffering from neurodegenerative diseases. The collaboration with Renaissance Lakewood marks a pivotal milestone in this journey, setting the stage for further breakthroughs in immunotherapy development.