Tiziana Life Sciences Ltd (NASDAQ:TLSA) has reported “exciting” pre-clinical data on the effects of intranasal anti-CD3 monoclonal antibody (mAb) in a model of intracerebral hemorrhage (hemorrhagic stroke), demonstrating a behavioral outcome improvement at one month.
“Less than 10% of people who have hemorrhagic stroke completely recover, and most are left with a disability that could include lasting effects on their speech and physical function. Intranasal anti-CD3 monoclonal antibody showed improved motor and cognitive outcomes at one-month post-intracerebral hemorrhage which is very exciting,” commented Gabriele Cerrone, executive chairman and interim chief executive officer of Tiziana in a statement.
“We are actively exploring the clinical development pathway in intracerebral hemorrhage using intranasal foralumab, the first-ever fully human anti-CD3 monoclonal antibody in patients suffering from a hemorrhagic stroke. This new exciting finding further validates our decision to focus on the clinical development of our lead asset, intranasal foralumab. This potential immunomodulatory therapy represents a novel avenue for treatment of inflammatory diseases,” he added.
READ: Tiziana Life Sciences says anti-CD3 mAb research for treatment of Alzheimer's disease to be presented at international conference
Activated T cells play an important role in the inflammatory process. Foralumab, the only fully human anti-CD3 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-19 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 secondary progressive multiple sclerosis (SPMS). Immunomodulation by nasal anti-CD3 mAb represents a novel avenue for treatment of inflammatory human diseases.
Tiziana Life Sciences is a clinical-stage biopharmaceutical company developing breakthrough therapies using transformational drug delivery technologies to enable alternative routes of immunotherapy. The company’s innovative nasal, oral and inhalation approaches in development have 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, has demonstrated a favorable safety profile and clinical response in patients in studies to date. The company’s technology for alternative routes of immunotherapy has been patented with several applications pending and is expected to allow for broad pipeline applications.
Contact the author at jon.hopkins@proactiveinvestors.com