Tiziana Life Sciences Ltd (NASDAQ:TLSA) said it has published a scientific article in the peer-reviewed journal Frontiers in Immunology, showing a favorable safety profile for intranasally administered foralumab and immunological activity in humans.
Entitled “Nasal administration of anti-CD3 monoclonal antibody modulates effector CD8+ T cell function and induces a regulatory response in T cells in human subjects”, the findings support Tiziana’s intranasal foralumab monoclonal antibody platform as a new modality for treating autoimmune and central nervous system (CNS) diseases.
Researchers at the Brigham and Womens Hospital (BWH) and Harvard Medical School completed the study, according to Tiziana.
READ: Tiziana to focus near-term on developing intranasal drug to treat CNS-based autoimmune diseases
The goal of the study was to assess safety and the immune effects of an entirely human, previously uncharacterized nasal anti-CD3 mAb (foralumab) in humans and its in-vitro stimulatory properties. The company said this is the first anti-CD3 mAb that has not shown an anti-drug antibody (immune reaction) in humans.
Tiziana chief medical officer Dr Matthew Davis said the article provides a wealth of scientifically rigorous immunologic data on intranasal foralumab.
“The finding that the immune effects were predominately observed at the 50ug dose rather than the lower and higher doses studied was intriguing. Our current study in non-active Secondary Progressive Multiple Sclerosis is using a 50ug dose and our planned Phase 2 multi-centred placebo-controlled dose-ranging study will also include a 50ug dosing arm,” Davis said in a statement.
The study evaluated 27 healthy volunteers (nine per group) who received either intranasal foralumab at a dose of 10 micrograms (ug), 50ug, or 250ug daily for five days or placebo. Safety was assessed and immune parameters were measured on day one (pre-treatment), and days 7, 14, and 30 by Fluorescence-Activated single Cell Sorting (FACS) and by Single-cell RNA sequencings (cRNAseq), the company said.
Tiziana said no adverse events or safety signals were found when foralumab was dosed at the amounts of 10ug, 50ug and 250ug given for five consecutive days, adding no anti-drug antibodies in humans were detected.
The company concluded that when intranasal foralumab was dosed in humans at the above levels, immunological activity and a favorable safety profile were observed. It said its intranasal monoclonal antibody (mAb) technology is applicable to marketed mAbs, which are currently available only through IV subcutaneous administration, addressing enormous market potential.
A notable finding from this research is that the biologic effect of intranasal anti-CD3 is different from IV anti-CD3. The company said nasal foralumab acts locally while IV administered anti-CD3 acts systemically.
Confirming these findings, in animal studies, it was observed that nasal anti-CD3 localized to the cervical lymph nodes and as with human studies, nasal anti-CD3 was not observed in the bloodstream of animals, according to the company.
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