Tiziana Life Sciences Ltd (NASDAQ:TLSA) has announced the initiation of a program to develop intranasal Foralumab as a treatment or prevention method for type 1 diabetes.
The move comes after the US Food & Drug Administration approved the humanized anti-CD3 monoclonal antibody, TZIELD (teplizumab-mzwv), a new injected drug for the condition.
Shortly after, Sanofi (NASDAQ:SNY) launched a US$2.9bn bid for Provention Bio (NASDAQ:PRVB), TZIELD owner, establishing CD3 as an attractive commercial target for type 1 diabetes.
Tiziana's first-in-class, fully human CD3 antibody, Foralumab, is believed to offer benefits across various chronic disease indications.
Self-administered and nasally delivered, the therapy may provide added convenience to type 1 diabetes patients, according to Matthew Davis, Tiziana’s chief medical officer.
The company said it is in "active discussions" with key opinion leaders and an international network of diabetes experts regarding various study designs.
Type 1 diabetes affects 8.4mln people worldwide, according to figures compiled by the Lancet, the world-renowned medical journal.
Estimates suggest the treatment market is worth an annual US$13.6bn and is growing at a compound annual rate of 7.6%.
Foralumab, the only fully human anti-CD3 monoclonal antibody (mAb), binds to the T cell receptor and modulates T cell function to reduce inflammation.
In patients with Covid and multiple sclerosis, as well as healthy individuals, this effect has been demonstrated to suppress effector features in multiple immune cell subsets.
Intranasal Foralumab phase II trials are slated to commence in the third quarter for patients with non-active secondary MS.