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Tiziana Life Sciences Announces Discovery of New Immune Biomarkers in Multiple Sclerosis Patients Treated with Nasal Foralumab
NEW YORK, Jan. 22, 2025 (GLOBE NEWSWIRE) -- Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (โTizianaโ or the โCompanyโ), a biotechnology company developing breakthrough immunomodulation therapies with its lead development candidate, intranasal foralumab, a fully human, anti-CD3 monoclonal antibody, today announced the discovery of new immune biomarkers in patients with non-active secondary progressive multiple sclerosis (na-SPMS) treated with nasal foralumab. We believe these findings contribute substantially to our understanding of the immune mechanisms underlying the effects of nasal foralumab.
The study identified gene expression changes which were detected beginning three months after intranasal dosing of foralumab in our ongoing ISPPEA (or expanded access program). Key findings include modulation of:
FoxP3 T regulatory cells (Tregs)
CD4+ and CD8+ central memory T cells
CD14+ and CD14- monocytes
Naรฏve B cells
These pathways are known to be associated with antigen presentation, interferon responses, and other regulatory immune mechanisms.
In this study, single-cell RNA sequencing (scRNAseq) of peripheral blood samples taken before and at three and six months after drug administration has revealed relevant gene expression changes associated with nasal foralumab, which has been associated with a reduction in microglial brain inflammation, as measured by advanced microglial PET scans in these same patients.
โWe are excited to announce this breakthrough in understanding how nasal foralumab induces immune modulation in Secondary Progressive MS patients,โ said Dr. Tanuja Chitnis, M.D., Principal Investigator and Professor of Neurology at Harvard Medical School and senior neurologist at Brigham and Womenโs Hospital, a founding member of Mass General Brigham Healthcare System. โThese findings highlight the potential of nasal foralumab in modulating critical immune pathways and offer new insights into its clinical effects. This discovery represents a pivotal step toward personalized treatment strategies for MS. We look forward to submitting these data to a peer reviewed journal.โ
โThe observed clinical stabilization and microglial PET findings are supported by these new biomarker discoveries, providing compelling evidence of nasal foralumab's biological effects,โ said Dr. Howard Weiner, Chairman of Tizianaโs Scientific Advisory Board and co-director of the Ann Romney Center for Neurologic Diseases at Brigham and Womenโs Hospital, a founding member of Mass General Brigham healthcare system. โThe identification of these biomarkers not only strengthens our understanding of the treatmentโs mechanism but also establishes a framework for monitoring its efficacy in future trials and may establish a framework for monitoring a patientโs response to foralumab treatment.โ
โThis data, and its implications, underscores our commitment to advancing innovative therapies for neurodegenerative diseases,โ commented Ivor Elrifi, CEO of Tiziana Life Sciences. โForalumab, the first fully human anti-CD3 monoclonal antibody, is in a Phase 2 trial as a groundbreaking immunomodulatory therapy with applications in autoimmune and neurodegenerative diseases. These findings further confirm its potential and set the stage for broader clinical exploration.โ
The FDA defines a biomarker as a defined characteristic that is measured as an indicator of normal biological processes, pathogenic processes, or responses to an exposure or intervention, including therapeutic interventions. Molecular, histologic, radiographic, or physiologic characteristics are types of biomarkers. A biomarker is not an assessment of how an individual feels, functions, or survives.
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
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1 year ago
NEWS
Tiziana Life Sciences Announces FDA IND Clearance of Intranasal Foralumab for the Treatment of Alzheimerโs Disease
Foralumab to advance into Phase 2 human clinical trials using the worldโs only fully human intranasal anti-CD3 monoclonal antibody
Trial to be overseen by Brigham and Womenโs Hospital, a founding member of Mass General Brigham Healthcare System
NEW YORK, Aug. 15, 2023 (GLOBE NEWSWIRE) -- Tiziana Life Sciences Ltd. (Nasdaq: TLSA) (โTizianaโ or the โCompanyโ), a biotechnology company developing breakthrough immunomodulation therapies via novel routes of drug delivery, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for intranasal foralumab to be studied in Alzheimer's disease. Foralumab could be a potentially groundbreaking treatment for Alzheimerโs disease, given it targets the diseaseโs underlying pathology by addressing the resulting neuroinflammation caused by the accumulation of toxic proteins in the brain.
Gabriele Cerrone, Chairman, acting CEO and founder of Tiziana Life Sciences, stated, "The IND clearance is a significant milestone for Tiziana that highlights the strength and the therapeutic potential of foralumab. We are deeply committed to advancing the field of neurodegenerative diseases and bringing much-needed relief to patients suffering from Alzheimer's with a novel therapeutic approach. We are thrilled to have reached this critical juncture and are eager to move forward with the necessary trials to evaluate the effectiveness of foralumab in Alzheimerโs disease in combination with an FDA approved therapy or as a single agent."
Professor Howard L. Weiner, the Robert L. Kroc Professor of Neurology at the Harvard Medical School, Director and Founder of the Partners Multiple Sclerosis Center and Co-Director of the Center for Neurologic Diseases at Brigham and Womenโs Hospital, a founding member of Mass General Brigham Healthcare System, added "The IND clearance is a significant step forward in the fight against Alzheimer's disease. Foralumab shows great promise in targeting the pathological hallmarks of the disease, and I am optimistic about its potential to offer a breakthrough treatment option for patients suffering from this devastating condition. I look forward to witnessing the progress of this important therapy."
About Foralumab
Activated T cells play an important role in the inflammatory process. Foralumab, the only fully human anti-CD3 monoclonal antibody (mAb), 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 demonstrated in patients with COVID and with multiple sclerosis, as well as in healthy normal subjects. Intranasal foralumab Phase 2 trials are expected to start in the third quarter of 2023 in patients with non-active SPMS. Immunomodulation by nasal anti-CD3 mAb represents a novel avenue for treatment of inflammatory human diseases.1
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. Tizianaโs innovative nasal approach has the potential to provide an improvement in efficacy as well as safety and tolerability compared to intravenous (IV) delivery. Tizianaโs lead candidate, intranasal foralumab, which is the only fully human anti-CD3 mAb, has demonstrated a favorable safety profile and clinical response in patients in studies to date. Tizianaโs technology for alternative routes of immunotherapy has been patented with several applications pending and is expected to allow for broad pipeline applications.
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. 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: info@tizianalifesciences.com
Investors:
Irina Koffler
LifeSci Advisors, LLC
+1 646 970 4681
ikoffler@lifesciadvisors.com
1 https://www.pnas.org/doi/10.1073/pnas.2220272120
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Source: Tiziana Life Sciences Ltd.