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Tiziana Life Sciences & Renaissance Partner on Nasal Foralumab Production

Aim to optimize the current formulation of intranasal foralumab and develop a comprehensive plan for its scalable production in a nasal device.

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By: Charlie Sternberg

Associate Editor, Contract Pharma

Tiziana Life Sciences Ltd., a biotechnology company pioneering breakthrough immunomodulation therapies, has entered a collaborative agreement with Renaissance Lakewood LLC, a Contract Development and Manufacturing Organization (CDMO) specializing in nasal drug delivery. This partnership aims to optimize the current formulation of intranasal foralumab, a fully human, anti-CD3 monoclonal antibody, and develop a comprehensive plan for its scalable production in a nasal device. Intranasal foralumab is currently in the development phase, with the potential to treat neurodegenerative and inflammatory diseases or conditions.

Under this agreement, Renaissance will use its 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.”

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