Tiziana Life Sciences Ltd (NASDAQ:TLSA) has announced that positive data from a study of intranasal anti-CD3 monoclonal antibody (mAb) in an animal model of Alzheimer’s disease will be presented at an international conference this weekend.
It said Dr Howard Weiner, who is chairman of Tiziana’s Scientific Advisory Board, will present the data on April 1, 2023, at the AD/PD 2023 International Conference on Alzheimer’s and Parkinson’s Diseases and Related Neurological Disorders in Gothenburg, Sweden.
In a statement, Dr Weiner, who is co-director of the Ann Romney Center for Neurologic Diseases at Brigham and Women’s Hospital and a founding member of Mass General Brigham, commented: “I believe that the modulation of innate immunity via targeting microglia will play a synergistic role with the currently approved anti-amyloid Alzheimer’s treatments. Our research has demonstrated that intranasal rodent anti-CD3 mAb and intranasal fully human anti-CD3 mAb (foralumab) will decrease microglia activation in rodents and humans, respectively.”
READ: Tiziana Life Sciences plans to accept US FDA recommendations and start Phase 2 study in Q3 2023
Tiziana explained that 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), Tiziana said. Immunomodulation by nasal anti-CD3 mAb represents a novel avenue for treatment of inflammatory human diseases.
“With the FDA approvals of aducanumab and lecanemab, there is a renewed focus on effective Alzheimer’s disease treatments and we have the potential to be a novel, first-in-class neuroinflammatory modulator,” said Gabriele Cerrone, executive chairman and interim chief executive officer of Tiziana. “Our unique intranasal approach has the potential that does not target beta-amyloid or other proteins, but focuses on the neuroinflammatory process itself, which may be complementary or synergistic with existing treatments.”
Dr Matthew W Davis, chief medical officer of Tiziana, added: “Dr Weiner’s lab continues to be at the forefront of neuroinflammatory research and we are fortunate to have a collaboration with Brigham and Women’s Hospital to investigate the potential applications of foralumab.”
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