Foralumab is a fully human anti-CD3 monoclonal antibody (mAb) for the treatment of Crohn’s and neurodegenerative diseases. We have recently completed two Phase 1 clinical trials: one for progressive MS indication with nasal administration and the other for Crohn’s disease indication, with enteric coated capsules administered orally. We also completed a Phase 2 trial treating mild to moderate non-hospitalized COVID-19 patients in Brazil with intranasal foralumab with positive results1. Currently, Six secondary progressive MS patients are being treated at Brigham and Women’s Hospital, Boston MA, with intranasal foralumab under Expanded Access INDs with signs of clinical benefit. EA1 has completed Twenty months of treatment and the EA2 has completed Thirteen months. Foralumab has demonstrated ability to activate regulatory T cells that systemically circulate to elicit targeted immunomodulation providing therapeutic benefit to patients.
Tiziana has submitted a patent application on potential use of Foralumab, to improve success of chimeric antigen receptor T cells (CAR-T) therapy for cancer and other human diseases. The patent application covers inventions related to improving CAR-T expansion and/or survival. Foralumab administered alone or co-administered in combination with co-stimulatory molecules, such as an anti-IL-6 receptor monoclonal antibody, an anti-CD28 monoclonal antibody or specific inhibitors of signaling pathways of phosphatidylinositol 3-kinase (PI3K), protein kinase B (AKT), or mammalian target to improve success of CAR-T therapy.
1. Moreira, T. G., et al. (2021) Nasal Administration of Anti-CD3 Monoclonal Antibody (Foralumab) Reduces Lung Inflammation and Blood Inflammatory Biomarkers in Mild to Moderate COVID-19 Patients: A Pilot Study. Front Immunol 12, 709861