Tiziana’s therapeutic focus is on the treatment of neurodegenerative, gastrointestinal and lung diseases.
Foralumab is the only fully human anti-CD3 monoclonal antibody (mAb) in clinical development in the world. This compound has potential applications in a wide range of neurodegenerative and autoimmune diseases where modulation of a T-cell response is desirable. Oral foralumab dosing can be used to treat Crohn’s disease while nasally administered foralumab can be used for treatment of progressive multiple sclerosis and other autoimmune disease indications. The Company intends to initiate a phase 1b trial with 'take-home' oral capsules in mild to moderate Crohn's disease patients in 2Q 2022. Additionally, the company is continuing its' IAP study with intranasally administered foralumab for SPMS and aims to have 3-month readout data on the second patient in 2Q 2022.
Anti-IL-6R mAb can potentially be used in combination with Foralumab or other anti-inflammatory and anti-infective agents as therapy for idiopathic pulmonary fibrosis (IPF), acute respiratory distress syndrome (ARDS), multiple myeloma, arthritis, lupus and oncology indications.
Milciclib is a potent, small molecule inhibitor of multiple cyclin-dependent kinases (CDKs), tropomycinreceptor kinases and Src family kinases controlling cell growth and malignant progression of cancer. Clinical data from a Phase I dose-escalation study with combination of milciclib with gemcitabine showed significant disease stabilization and suggested that milciclib can reverse gemcitabine-resistance in NSCLC refractory solid tumors. The company is exploring the combination of milciclib and gemcitabine in NSCLC subjects with pan KRAS-positive mutations.