Florbetapir F-18

NEW YORK, May 15, 2025 (GLOBE NEWSWIRE) -- 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 the publication of a new study in the Journal of ‘Clinical Nuclear Medicine’ demonstrating that intranasal administration of foralumab significantly dampened microglial activation in a 78-year old patient with moderate Alzheimer's disease (AD) treated as part of a Food and Drug Administration (FDA) expanded access program. The findings, published in the prestigious ‘Clinical Nuclear Medicine’ journal, highlight a promising avenue in the treatment of neurological disorders. This case represents the first use of 18F-PBR06-PET in a patient with moderate AD dementia and the first published report of an AD patient treated with nasal-foralumab. The study, led by Dr. Tarun Singhal and Dr. Howard Weiner of Brigham and Women’s Hospital, a founding member of the Mass General Brigham healthcare system, utilized advanced PET imaging with the [F-18]PBR06 tracer to assess microglial activation before and after treatment. The findings revealed a notable reduction in neuroinflammation following intranasal foralumab administration. Figure 1. Image Source: Singhal T et al. Dampening of Microglial Activation with Nasal Foralumab Administration in Moderate Alzheimer’s Disease Dementia. Clinical Nuclear Medicine 2025 May 13. doi: 10.1097/RLU.0000000000005955. Online ahead of print.A, 18F-PBR06-PET shows significant decreased standardized uptake value (SUV) after 3 months of treatment (bottom row) with nasal-foralumab as compared to baseline (top row). B, SUV-ratio (SUVR) images demonstrate a decrease in PET signal following treatment, particularly in bilateral precuneus, posterior cingulate, bilateral parietal cortices and cerebellum (bottom row) as compared with pre-treatment baseline (top row). C, A baseline amyloid-positive 18F-Florbetapir-PET scan in the patient D, z-score maps of 18F-PBR06-PET focusing on the precuneus, posterior cingulate, and anterior cingulate regions show abnormally increased microglial activation in these regions (left) before treatment, which decreased following treatment with nasal-foralumab (right). “The marked decrease in microglial PET signal following nasal-foralumab treatment provides preliminary evidence that intranasal foralumab can modulate microglial activity in Alzheimer's disease. This supports the potential efficacy of nasal foralumab in targeting microglial activation in AD,” said Tarun Singhal, M.B.B.S., M.D., Associate Professor of Neurology at Harvard Medical School, Director of the PET Imaging Program in Neurologic Diseases, and Associate neurologist and nuclear medicine physician at Brigham and Women’s Hospital. “Given the role of microglia in neurodegeneration, these results are encouraging and warrant further investigation in larger, controlled studies with additional quantitative approaches.” “These findings from Dr. Singhal et al, are consistent with our previously reported effects of nasal- foralumab in decreasing microglial activation in non-active secondary progressive multiple sclerosis patients,” Commented Ivor Elrifi, CEO of Tiziana Life Sciences. “There are currently no approved disease-modifying therapies for moderate Alzheimer’s Disease, and it is clearly an area of unmet need. A phase-2a study of nasal-foralumab in mild Alzheimer’s is being initiated.” Foralumab is the only fully human anti-CD3 monoclonal antibody in clinical development for intranasal delivery. By modulating T cell function, it aims to reduce inflammation in the central nervous system. Previous studies have shown its potential in multiple sclerosis and other neuroinflammatory conditions. The full study is available online in Clinical Nuclear Medicine at: https://journals.lww.com/nuclearmed/Fulltext/9900/dampening_of_microglial_activation_with_nasal.1721.aspx. 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 (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 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, 2024, 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 LtdPaul Spencer, Business Development, and Investor Relations+44 (0) 207 495 2379email: info@tizianalifesciences.com [1] https://www.pnas.org/doi/10.1073/pnas.2220272120 [2] https://www.pnas.org/doi/10.1073/pnas.2309221120 A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/cd486638-7caa-40f2-8c97-1c9c48a3ea9e

Standardized digital test will expand early diagnosis capabilities to more primary care physicians NEW YORK, April 29, 2025 /PRNewswire/ -- The Alzheimer's Drug Discovery Foundation (ADDF)'s Diagnostics Accelerator (DxA) today announced a significant investment that will support clinical validation for the digital version of the Montreal Cognitive Assessment (MoCA), MoCA Solo, an automatically scored test for tablet devices utilizing AI-enabled avatars, requiring only minimal supervision. The original MoCA is a one-page 30-point pen-and-paper cognitive test that is administered in ten minutes and used worldwide by trained professionals. MoCA Solo does not require trained administration, and if successful, MoCA Solo could be more widely used as a scalable tool for assessing mild cognitive impairment (MCI), especially in primary care clinical settings. "Combining the MoCA Solo assessment with blood biomarkers has the potential to enable earlier detection of Alzheimer's disease by identifying individuals with MCI who are most likely to benefit from specialist care," said Howard Fillit, MD, Co-Founder and Chief Science Officer of the ADDF. "A scalable, accessible, and standardized assessment that can be easily administered across a variety of clinical settings empowers primary care physicians to play a more prominent role in the front lines of diagnosing and treating Alzheimer's. As the Alzheimer's population continues to grow, exceeding the capacity of specialists, conducting assessments at the primary care level is a critical step towards getting patients and their families the support they need sooner." Given the success of recently approved Alzheimer's drugs, Leqembi and Kisunla, comprehensive diagnosis and evaluation require both biomarker testing and cognitive testing to provide a holistic assessment of a patient's Alzheimer's and disease progression. While blood-based biomarkers are most likely to become the gold standard for the early diagnosis and detection of Alzheimer's-related biology, the addition of digital standardized cognitive assessment will provide complementary information on a patient's cognitive state, helping to determine which individuals are in the earliest stages of the disease and would benefit from referral to specialist care. Development of and access to standardized assessment and diagnostic tools is a foundational goal of the ADDF's Diagnostics Accelerator. Pairing cognitive assessment with individual biomarkers paves the way for early diagnosis and helps inform combination therapies that will allow us to treat Alzheimer's via precision medicine. "As new Alzheimer's therapies come to market, it's more important than ever to have reliable, standardized, easy-to-deploy tools for early detection," said Niranjan Bose, Managing Director of Health and Life Sciences at Gates Ventures. "Digitizing the widely used MoCA test empowers primary care physicians to detect cognitive decline earlier and reduce bottlenecks with specialist referrals. When paired with blood biomarker testing, the information gives doctors a more complete picture of an individual's condition, enabling timely and targeted intervention." "This investment by the ADDF underscores their commitment to innovation in digital diagnostics and expanding access to accurate, efficient cognitive testing at a national scale," said Dr. Ziad Nasreddine, creator of the MoCA, and CEO of MoCA Cognition. "We are proud to partner with the ADDF to help address the growing challenge of Alzheimer's disease." The gold standard pen-and-paper MoCA, developed in 1996 and clinically validated in 2005, demonstrated 90% sensitivity and 87% specificity for detecting MCI. The assessment includes questions designed to assess short-term memory, visuospatial skills, executive function, language, attention, concentration, working memory, and orientation. Today, the MoCA is the most widely used cognitive assessment for early detection and has been translated into 200+ languages and dialects. It is regularly cited in scientific articles and is used by both specialists and primary care physicians. A 2023 global Delphi consensus of experts published in Alzheimer's & Dementia ranked the MoCA as the preferred tool for detecting MCI and early AD among 53 cognition scales considered (Ellison et al., 2023). A validated and automated digital version will reduce the need for human administrators and enable further adoption, especially within primary care. About The Alzheimer's Drug Discovery Foundation (ADDF) Founded in 1998 by Leonard A. and Ronald S. Lauder, the Alzheimer's Drug Discovery Foundation is dedicated to rapidly accelerating the discovery of drugs to prevent, treat and cure Alzheimer's disease. The ADDF is the only public charity solely focused on funding the development of drugs for Alzheimer's, employing a venture philanthropy model to support research in academia and the biotech industry. The ADDF's leadership and contributions to the field have played a pivotal role in bringing the first Alzheimer's PET scan (Amyvid®) and blood test (PrecivityAD®) to market, as well as fueling the current robust and diverse drug pipeline. Through the generosity of its donors, the ADDF has awarded more than $370 million to fund 765 Alzheimer's drug discovery programs, biomarker programs and clinical trials in 21 countries. To learn more, please visit: . About the Diagnostics Accelerator (DxA) The Diagnostics Accelerator, created in July 2018, is a $100 million global research initiative from partners including ADDF Co-Founder Leonard A. Lauder, Bill Gates, Jeff Bezos, MacKenzie Scott, the Dolby family, the Charles and Helen Schwab Foundation, The Association for Frontotemporal Degeneration, among others, to develop novel biomarkers for the early detection of Alzheimer's disease and related dementias. This research initiative is dedicated to accelerating the development of affordable and accessible biomarkers to diagnose Alzheimer's disease and related dementias and advance the clinical development of more targeted treatments. Through translational research awards and access to consulting support from industry experts, this program will challenge, assist and fund the research community in both academia and industry to develop novel peripheral and digital biomarkers. 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