Tiziana Life Sciences Ltd. announced that a study related to its lead candidate, foralumab, was highlighted in Neurology today®?, the official news source of the American Academy of Neurology (AAN), in an article titled, "Anti-CD3 Antibody Foralumab Shows Promise in PIRA, Measured by Novel PET Ligand." The study is authored by Tarun Singhal, M.B.S., M.D., Director, PET Imaging Program in Neurologic Diseases at Brigham and Women's Hospital, a founding member of Mass General Brigham Healthcare System, and Associate Professor of Neurology at Harvard Medical School, and shows that foralumab, a fully human anti-CD3 monoclonal-antibody, attenuates microglial activation in non-active secondary progressive multiple sclerosis (na-SPMS) patients with progression independent of relapse (PIRA). A systemic review published in JAMA Neurology in October 2023 found that PIRA is the most frequent manifestation of disability accumulation across the full spectrum of traditional multiple sclerosis (MS) phenotypes. The study assesses the effect of intranasal foralumab on microglial activation in na-SPMS patients with PIRA as measured by positron emission tomography (PET) imaging via radiology marker [F-18]PBR06-PET, a novel, long-half-life ligand used in PET scanning.

The study is designed to be open-label and is based on data from the Expanded-Access Program evaluating foralumab in na-SPMS patients that is currently underway. In this study, five of six patients (83%, 95% confidence interval 44%-97%) showed a qualitative reduction on [F-18]P BR06-PET in multiple brain regions after both 3 and 6 months of nasal foralumab treatment. Data from the study was presented at a platform session at the Annual Meeting of the American Academy of neurology being held in Denver, Colorado.

The abstract is entitled, "T Treatment of PIRA with Nasal Foralumab Dampens Microglial Activation and Stabilizes Clinical Progression in Non-Active Secondary Progressive MS." The link to the full Neurology Today®? article can be found here: PostID=211: Activated T cells play an important role in the inflammatory process. Foralumab, the only fully human anti-CD3monoclonal 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. The non-active SPMSintranasal foralumibody Phase 2 trial 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.