Tiziana Life Sciences Ltd (NASDAQ: TLSA) said it published a scientific paper in the peer-reviewed journal Frontiers in Immunology showing a favorable safety profile for intranasally administered foralumab and immunological activity in humans.
Titled “Nasal administration of anti-CD3 monoclonal antibodies modulates CD8+ effector T cell function and induces a regulatory response in T cells in human subjects,” the results support Tiziana’s foralumab intranasal monoclonal antibody platform in as a new treatment modality for autoimmunity and central nervous system (CNS diseases).
Researchers from Brigham and Womens Hospital (BWH) and Harvard Medical School have completed the study, according to Tiziana.
READ: Tiziana to focus near-term on intranasal drug development to treat CNS-based autoimmune diseases
The objective of the study was to evaluate the safety and immune effects of a previously uncharacterized fully human nasal anti-CD3 mAb (foralumab) in humans and its stimulatory properties in vitro. The company said it was the first anti-CD3 mAb that did not show anti-drug antibodies (immune response) in humans.
Tiziana’s chief medical officer, Dr. Matthew Davis, said the paper provides a wealth of scientifically rigorous immunological data on intranasal foralumab.
“The finding that immune effects were primarily observed at the 50 ug dose rather than the lower and higher doses studied was intriguing. Our current non-active secondary progressive multiple sclerosis study uses a 50 ug dose and our planned multicenter, placebo-controlled Phase 2 study will also include a 50 ug 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), 50 ug, or 250 ug daily for five days or a placebo. Safety was assessed and immune parameters were measured on Day 1 (pretreatment) and Days 7, 14 and 30 by fluorescence-activated cell sorting (FACS) and single-cell RNA sequencing (cRNAseq), the company said. .
Tiziana said no adverse events or safety signals were found when foralumab was dosed at amounts of 10ug, 50ug and 250ug given for five consecutive days, adding that no anti-drug antibodies in the man was 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. He said his intranasal monoclonal antibody (mAb) technology is applicable to commercial mAbs, which are currently only available by IV subcutaneous administration, addressing huge market potential.
A notable finding from this research is that the biological effect of intranasal anti-CD3 is different from IV anti-CD3. The company said nasal foralumab acts locally while intravenously administered anti-CD3 acts systemically.
Confirming these results, in animal studies it was observed that nasal anti-CD3s were localized to the cervical lymph nodes and, as in human studies, nasal anti-CD3s were not observed in the animals’ bloodstream. , according to the company.
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