Tiziana’s Foralumab is the world’s first and only, fully human anti-CD3 antibody and can be delivered orally, making it a potential game changer in the treatment of Crohn’s Disease and other autoimmune diseases through higher efficacy and reduced toxicity. The United States Patent and Trademark Office has granted a patent covering its proprietary formulation for oral administration. Additionally, Tiziana is employing another revolutionary approach to treat patients with neurodegenerative diseases such as progressive MS (pro-MS) by delivering Foralumab via nasal administration. Foralumab modulates the immune response, reducing inflammation locally and systemically, through interaction with the gastrointestinal and nasal mucosal immune system. Tiziana anticipates the initiation of a Phase 2 trial with nasally administered Foralumab in progressive multiple sclerosis (pro-MS) in Q2 2021. Phase 2 trial with orally administered Foralumab for Crohn’s indication is anticipated to be initiated soon

CD3 specific monoclonal antibodies

On June 19, 2020, Tiziana announced that patent 10,688,186 titled “Anti-CD3 formulations”, Inventor: Kunwar Shailubhai”, is the first-ever to be granted on anti-CD3 formulations and covers oral administration with lyophilized and stabilized free-flowing powder of Foralumab or any other anti-CD3 mAb, encapsulated in enteric-coated capsules, for treatment of human diseases. In addition, the stabilized liquid formulation of Foralumab and other anti-CD3 mAbs for nasal administration is also covered in this patent. These formulation technologies have the potential to transform immunotherapies, which currently can only be administered intravenously or subcutaneously.

Oral to Nasal route for administration