Tiziana Life Sciences makes patent application covering nasally-administered and orally taken Foralumab; shares spike 24%

Tiziana Life Sciences PLC (LON:TILS) (NASDAQ:TLSA) shares were up strongly after news the group has submitted a patent application covering the potential use of nasally-administered and orally taken Foralumab for the treatment of COVID-19 either alone or in combination with other antiviral drugs. The methods of delivering the fully human anti-CD3 monoclonal antibody (mAb) could potentially modulate or stimulate the immune system to suppress cytokine storms and therefore reduce respiratory failure in coronavirus patients, the company said. Its researchers believe its combination with other anti-viral drugs could improve efficacy. Tiziana has an exclusive licence for the nasal administration of Foralumab and other anti-CD3 mAbs for the treatment of neurodegenerative and other diseases. It has also developed a “robust formulation” and nasal delivery system that was shown in a phase I trial to be well tolerated as well as producing “immunomodulatory effects”. A second early-stage clinical study assessing the oral use of Foralumab concluded it had no discernible side effects. The fact the drug has already undergone two formal clinical safety assessments is a potential “game-changer” for Tiziana as it would allow the firm to go directly into human testing for COVID-19, analysts said. Meanwhile, the ability to inhale Foralumab or take it by mouth overcomes the severe toxicities sometimes associated with the intravenous delivery of rival human anti-CD3 monoclonal antibodies. The drug has a “global effect on the immune response and modulates many cell types and cytokines, not just one”, said Harvard professor Howard Weiner, chairman of Tiziana’s scientific advisory board. He added that nasal and oral administration of Foralumab are “potentially transformative” new approaches. Explaining the mode of action, Tiziana chief executive, Dr Kunwar Shailubhai, said nasal inhalation and oral administration stimulate or modulate the immune system so that T regulatory cells are then “supercharged” to inhibit inflammation. “The common underlying concept in these alternative delivery approaches is to strengthen one’s own body defence to fight against inflammation in these diseases,” he added. “Being a fully human anti-CD3 mAb, Foralumab is most suitable for immunotherapies, as it does not produce an immune response, unlike other humanised anti-CD3 mAbs.” The shares rose 24% to 236p, valuing the business at almost £400mln.  -- Adds share price --