Tiziana Life Sciences Ltd is a biotechnology firm dedicated to the research and advancement of novel molecular therapies for human ailments, particularly within oncology and immunology. Its flagship immunology program features Foralumab (TZLS-401), a human anti-CD3 monoclonal antibody under development for a range of conditions including Crohn's disease, graft versus host disease, ulcerative colitis, multiple sclerosis, type-1 diabetes, inflammatory bowel disease, psoriasis, and rheumatoid arthritis. Additionally, the company is progressing Milciclib (TZLS-201), a small molecule inhibitor that targets multiple cyclin-dependent, tropomycin receptor, and Src family kinases to suppress abnormal cell growth and cancer progression. Another significant asset is anti-Interleukin 6 receptor (IL6R) mAb (TZLS-501), a fully human monoclonal antibody intended to mitigate IL6-induced inflammation and treat COVID-19 patients. Founded in 1998, Tiziana Life Sciences is based in London, United Kingdom.
Tiziana Life Sciences Files for Orphan Drug Designation with the FDA for Intranasal Foralumab for the Treatment of Multiple System Atrophy (MSA)
Tiziana Life Sciences has submitted a request to the FDA for Orphan Drug Designation for intranasal foralumab in Multiple System Atrophy, a rare neurodegenerative disease with no approved disease-modifying therapies.
If granted, the designation would provide seven years of market exclusivity upon approval, tax credits for clinical testing, and fee waivers; the FDA aims to complete its review within 90 days.
Foralumab is currently in a Phase 2a open-label trial in MSA patients at Brigham and Women's Hospital led by Dr. Vikram Khurana, and in Phase 2 trials in non-active secondary progressive multiple sclerosis.