Tiziana Life Sciences to Administer Foralumab to First Moderate Alzheimer’s Patient

NEW YORK, June 26, 2024 – Tiziana Life Sciences Ltd. (Nasdaq: TLSA), a biotechnology firm pioneering immunomodulation therapies via innovative drug delivery methods, has announced that the U.S. Food and Drug Administration (FDA) has approved the use of intranasal foralumab under an Expanded Access (EA) Investigational New Drug application (IND) for a patient with moderate Alzheimer’s disease. This approval enables patients to access investigational treatments for serious conditions lacking satisfactory therapeutic options.

Dr. Howard L. Weiner, the Principal Investigator, Chairman of Tiziana’s Scientific Advisory Board, and Co-director of the Ann Romney Center for Neurologic Diseases at Brigham and Women's Hospital, expressed enthusiasm about initiating treatment with nasal foralumab for the first patient with moderate Alzheimer’s disease. Dr. Weiner pointed out that there are no other viable treatment options for these patients, even with newly approved anti-amyloid drugs. He is optimistic that the anti-inflammatory properties of nasal foralumab, previously observed in patients with advanced progressive multiple sclerosis (MS), may slow the cognitive decline associated with Alzheimer’s disease. Tiziana plans to collaborate closely with the FDA to monitor the patient's response while gearing up for a Phase 2 study on patients with early symptomatic Alzheimer’s Disease.

Gabriele Cerrone, Chairman, acting CEO, and founder of Tiziana Life Sciences, highlighted the significance of this FDA clearance, which supplements their previously approved Phase 2a study for early symptomatic Alzheimer’s Disease. This additional approval permits the exploration of intranasal foralumab for patients with moderate Alzheimer’s who are ineligible for existing therapies. Cerrone emphasized that foralumab’s potential to address neuroinflammation and the underlying pathology of Alzheimer’s disease could make it a groundbreaking treatment.

Foralumab’s mechanism involves modulating T cell function by binding to the T cell receptor, which dampens inflammation across various immune cell subsets. This anti-inflammatory effect has been demonstrated in clinical settings involving patients with COVID-19, multiple sclerosis, and healthy subjects. The Phase 2 trial for non-active secondary progressive multiple sclerosis (SPMS) using intranasal foralumab started patient screening in November 2023. The use of nasal anti-CD3 monoclonal antibody (mAb) for immunomodulation represents a promising new approach for treating neuroinflammatory and neurodegenerative diseases.

Tiziana Life Sciences is a clinical-stage biopharmaceutical company dedicated to developing revolutionary therapies through innovative drug delivery technologies. The company’s nasal delivery method aims to enhance the efficacy, safety, and tolerability of immunotherapy compared to traditional intravenous delivery. Tiziana’s leading candidate, intranasal foralumab, the only fully human anti-CD3 mAb, has shown a favorable safety profile and positive clinical responses in trials so far. Tiziana holds several patents for its alternative immunotherapy delivery technologies, with additional applications pending, paving the way for a broad range of therapeutic applications.