Tiziana Life Sciences Announces $4 Million Grant Awarded by National Institutes of Health to Study Anti-CD3 in Alzheimer's Disease

“Alzheimer's disease is the most common form of dementia, affecting more than 6 million people in the United States alone. Despite extensive research, effective treatments remain limited, and the need for innovative therapeutic approaches is urgent,” commented Howard L. Weiner, M.D., 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, a founding member of Mass General Brigham healthcare system.

The NIH grant will allow the acceleration of ongoing research efforts, including the advancement of preclinical studies and preparations for clinical trials. Specifically, the research will focus on the potential of anti-CD3 to modulate immune system activity, reduce neuroinflammation, and ultimately slow the progression of Alzheimer's disease. The company's proprietary formulation of anti-CD3 is administered intranasally where it binds to the T cell receptor, which then stimulates T regulatory cells for delivery to the central nervous system.

Ivor Elrifi CEO of Tiziana Life Sciences commented, “We are thrilled to be able to progress our pipeline with this prestigious NIH grant, which underscores the potential of our anti-CD3 therapy to address a critical unmet need in Alzheimer's disease. This funding will enable us to expand our research and move one step closer to developing a new therapeutic option for patients and families impacted by this debilitating condition. At Tiziana, we remain committed to advancing science that could improve the quality of life for patients through groundbreaking immunotherapies.”

The NIH grant represents a major milestone in Tiziana's development pipeline and is part of the company's broader strategy to explore the use of anti-CD3 in a range of autoimmune and inflammatory diseases. Tiziana's team of scientists and clinical researchers are eager to build upon promising preclinical data that suggest anti-CD3 has the potential to alter disease progression in Alzheimer's by targeting immune pathways involved in neurodegeneration.

The company expects to initiate first-in-human clinical trials in Alzheimer's Disease patients using its intranasal anti-CD3 monoclonal antibody in the coming months, marking an important step toward regulatory approval and commercialization.

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 a Phase 2a, 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 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: [email protected]

[1] https://www.pnas.org/doi/10.1073/pnas.2220272120

[2] https://www.pnas.org/doi/10.1073/pnas.2309221120