Tiziana Life Sciences (Tiziana) has announced that the Ann Romney Center for Neurologic Diseases at the Brigham and Women’s hospital (BWH) will receive a grant to study the use of an intranasal anti-CD3 monoclonal antibody (mAb) in an animal model of amyotrophic lateral sclerosis (ALS).
The ALS Association’s ‘Lawrence & Isabel Barnett Drug Development Program Grant’ supports preclinical drug discovery and the development of new or repurposed treatments for ALS, a disease for which there is still no cure.
ALS affects as many as 30,000 people in the US, with 5,000 new cases diagnosed each year. Characterised by a progressive degeneration of motor nerve cells in the brain and spinal cord, it is estimated that ALS is responsible for approximately five of every 100,000 deaths in people aged 20 years and older.
The research follows the company’s recently presented positive findings on intranasal anti-CD3 mAb in Alzheimer’s disease preclinical models of neuroinflammation.
Howard Weiner, co-director of the Ann Romney Center for Neurologic Diseases at BWH and chairman of Tiziana’s Scientific Advisory Board, outlined that the grant will be used to “further study the role of intranasal anti-CD3 mAb in dampening the microglial activation which amplifies ALS disease progression”.
“Additionally, we are currently studying foralumab, the first entirely human anti-CD3 mAb, in patients with secondary progressive multiple sclerosis (MS),” Weiner added.
Foralumab has also shown reduced release of cytokines after intravenous administration in healthy volunteers and in patients with Crohn’s disease.
In a humanised 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.
‘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 in a statement.
Gabriele Cerrone, executive chairman and interim chief executive officer of Tiziana, said: “Intranasal foralumab has demonstrated potential across multiple Central Nervous System (CNS) indications.
“…While our initial focus is on our ongoing MS programme 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.”