Biotechnology company Tiziana Life Sciences is initiating a programme to develop intranasal foralumab for the treatment or prevention of type 1 diabetes.
“With the FDA approval of the humanised anti-CD3 mAb TZIELD (teplizumab-mzwv injection) and then its subsequent announced acquisition of Provention Bio by Sanofi for $2.9 billion, CD3 has emerged as an established and attractive target for type 1 diabetes,” commented Gabriele Cerrone, Executive Chairman, Founder and interim Chief Executive Officer of Tiziana. “We believed that having a fully human CD3 antibody may offer benefits to patients across many different chronic disease indications.”
Foralumab is the only fully human anti-CD3 monoclonal antibody (mAb), which binds to the T cell receptor and dampens inflammation by modulating T cell function, suppressing effector features in multiple immune cell subsets.
“The potential of not requiring an injection or infusion and having a take-home self-administered nasally delivered therapy would offer additional benefit and convenience to sufferers of type 1 diabetes,” stated Matthew W Davis, Chief Medical Officer of Tiziana.
“Although given intranasally, our fully human anti-CD3 mAb foralumab has shown to release anti-inflammatory T regulatory cells throughout the body while returning pro-inflammatory effector T cells to their naïve state. We are actively discussing various study designs with our Key Opinion Leaders as well as with an internationally known network of dedicated diabetes physicians.”
Further Phase II trials are expected to start in the third quarter of 2023 in patients with non-active secondary progressive multiple sclerosis (SPMS).