Full Press Release Details
Tiziana Life Sciences Announces Immunologic
Foralumab in Moderate Alzheimer's Patient
NEW YORK, July 21, 2025 - 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 compelling immunologic
findings from the treatment of a moderate Alzheimer's Disease (AD) patient with intranasal foralumab.
Transcriptional analysis of white blood cells before and after foralumab
therapy revealed profound immune modulatory effects. Significant changes were observed in CD4 cells, CD8 cells, and monocytes, underscoring
the broad impact of nasal foralumab on immune cell profiles. These results are consistent with improvement in microglia PET scans conducted
at the time of immune analysis which demonstrated a marked reduction in inflammation following nasal foralumab (Clin Nuclear Med) showing
a link between immune effects and resolution of brain inflammation.
In an unexpected discovery, the analysis revealed an increase in phagocytosis
markers in classical monocytes, suggesting that nasal foralumab may enhance their ability to clear amyloid plaques. This unexpected effect
may open new avenues for treating Alzheimer's Disease by targeting both inflammation and amyloid accumulation.
Dr. Howard Weiner, Co-Director of the Ann Romney Center for Neurologic
Diseases at the Brigham and Women's Hospital (BWH), a founding member of the Mass General Brigham healthcare system, commented on
the findings: "The observed reduction in microglial inflammation and the unique immune changes seen in this Alzheimer's patient treated
with nasal foralumab are highly promising. This study represents a step forward in understanding the potential therapeutic role of foralumab
across neuroinflammatory diseases."
Ivor Elrifi, CEO of Tiziana Life Sciences, emphasized the implications
of these results: "We are thrilled by the outcomes of this immunologic analysis, which demonstrate for the first time in Alzheimer's
Disease the profound immune modulatory effects of nasal foralumab. Beyond its established benefits in other conditions, such as Multiple
Sclerosis, this study suggests that nasal foralumab could offer a dual benefit of reducing brain inflammation and potentially influencing
Furthermore, the treatment was well tolerated with no reported side
effects. Encouraged by these results and the observed behavioral improvements reported by the patient's family, the patient and his wife
have chosen to continue nasal foralumab therapy for an additional 6 months.
The findings from this study mark a significant milestone in the development
of novel therapies for Alzheimer's Disease and underscore Tiziana Life Sciences' commitment to advancing transformative treatments for
patients suffering from neurodegenerative disorders.
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 (NCT06802328)
with either an improvement or stability of disease seen within 6 months in all patients. 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).
Foralumab is the only fully human anti-CD3 monoclonal antibody (mAb)
currently in clinical development. The non-active SPMS intranasal foralumab Phase 2 trial (NCT06292923) began screening patients in November
of 2023. Immunomodulation by intranasal foralumab represents a novel avenue for the treatment of neuroinflammatory and neurodegenerative
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
For more information about Tiziana Life Sciences and its innovative
pipeline of therapies, please visit www.tizianalifesciences.com.
For further inquiries:
Tiziana Life Sciences Ltd
Paul Spencer, Business Development, and Investor Relations
+44 (0) 207 495 2379
email: info@tizianalifesciences.com