Tiziana Life Sciences Ltd (NASDAQ:TLSA) has announced that Brigham and Women's Hospital (BWH) will receive a grant to explore the use of intranasal anti-CD3 monoclonal antibody (mAb) in the nervous system disease Amyotrophic Lateral Sclerosis (ALS).
The company said the Lawrence & Isabel Barnett Drug Development Program Grant will be awarded to the Ann Romney Center for Neurologic Diseases at BWH by the ALS Association for the study of an intranasal anti-CD3 mAb in an animal model of ALS.
The ALS Association's Barnett Drug Development grant program supports preclinical drug discovery and development of new or repurposed treatments for ALS, for which there is an urgent need for new and improved therapies, as there is still no cure.
"This prestigious research grant will be used to further study the role of intranasal anti-CD3 mAb in dampening the microglial activation which amplifies ALS disease progression. This research follows our recently presented positive findings on intranasal anti-CD3 mAb in Alzheimer's Disease preclinical models of neuroinflammation,” Howard L Weiner, MD, co-director of the Ann Romney Center and chairman of Tiziana's scientific advisory board, said in a statement.
READ: Tiziana Life Sciences says study using nasal anti-CD3 (Foralumab) presented at the Alzheimer's Association International Conference
“Additionally, we are currently studying foralumab, the first entirely human anti-CD3 mAb, in patients with secondary progressive multiple sclerosis," Weiner added.
Gabriele Cerrone, executive chairman and interim chief executive officer of Tiziana, remarked: "Intranasal foralumab has demonstrated potential across multiple central nervous system (CNS) indications. We are encouraged by the preclinical research using an intranasal anti-CD3 mAb in the neuroinflammatory related diseases of ALS and Alzheimer's, as well as the impressive clinical benefits we have already shown for foralumab in patients with multiple sclerosis.
“While our initial focus is on our ongoing MS program which will continue to generate clinical read-outs, we are excited by foralumab's potential to help highly debilitated ALS patients with limited therapeutic options and high unmet need," Cerrone added.
Foralumab (formerly NI-0401), the only entirely human anti-CD3 mAb, has shown reduced release of cytokines after intravenous (IV) administration in healthy volunteers and in patients with Crohn's disease.
In a humanized mouse model, it was shown that while targeting the T-cell receptor, orally administered foralumab modulates immune responses of the T-cells and enhances regulatory T-cells (Tregs), thereby providing therapeutic benefit in treating inflammatory and autoimmune diseases without the occurrence of potential adverse events usually associated with parenteral mAb therapy.
Once-a-day treatment for 10 consecutive days with intranasal foralumab was both well tolerated and produced clinical responses in COVID-19 patients. Based on these studies, the intranasal and oral administration of foralumab offers the potential to become a well-tolerated immunotherapy for autoimmune and inflammatory diseases by the induction of Tregs, Tiziana said.
Matthew W Davis, MD, RPh, chief medical officer of Tiziana, commented: "We have now seen the potential of intranasal foralumab to dampen microglial activation in three major neuroinflammatory-related diseases, which creates significant optionality for exploring its benefits in some of the most important and burdensome medical conditions of our time."
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 two lead candidates, intranasal foralumab, the only fully human anti-CD3 mAb, and milciclib, a pan-CDK inhibitor, have both 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