Tiziana Life Sciences develops oral foralumab formulation

Clinical stage biotechnology company Tiziana Life Sciences announced the development of a novel, proprietary, oral formulation of foralumab on Wednesday.

The AIM-traded firm described foralumab as a fully human anti-CD3 monoclonal antibody (mAb), to be used in upcoming clinical studies in patients with non-alcoholic steatohepatitis (NASH) and other inflammatory diseases.

It claimed it was the first-ever development of an oral formulation suitable for therapy with foralumab.

“Oral immunotherapy with an anti-CD3 mAb is expected to be a preferred approach for targeted immunomodulation without eliciting immunosuppression throughout the body,” said Tiziana chairman Gabriele Cerrone.

“However until now, oral administration has not been pursued due to the expectation of mAbs being inactivated by the harsh conditions in the gastrointestinal tract.

“The development of this proprietary oral formulation is a breakthrough in novel dosing formulation and we believe that this technology may have broad additional therapeutic utility with other mAbs.”

Kunwar Shailubhai, CEO and CSO of Tiziana Life Sciences, said oral administration with biologics such as mAbs was a “potential game changer” for immunotherapies, enhancing drug safety while potentiating immunomodulation to provide clinical responses.

“Recently we demonstrated, using humanized mice models, that orally administered foralumab is biologically effective to produce immunomodulatory activity.

“Thus, successful development of the oral formulation of foralumab is a major milestone, and it opens up a novel avenue for treatment of NASH and other autoimmune diseases.”