Tiziana Life Sciences PLC (LON:TILS) (NASDAQ:TLSA) has said it is “aggressively advancing” a potential treatment for COVID-19 alongside a breakthrough method of delivering the inhaled version of this and other similar drugs.
As part of the fast-track process the company has signed an agreement with STC Biologics for the good manufacturing practice (GMP) production of TZLS-501, a class of monoclonal antibody (mAb) called an anti-interleukin-6 receptor, or anti-IL6R for short.
WATCH: Tiziana Life Sciences to fast track development of its coronavirus antibody & inhalation technology
It is also working with a firm called Sciarra Laboratories on a unique technology that sends the drug directly to the lungs using a handheld inhaler or nebuliser.
Tiziana said this new approach, which can be deployed with small molecule drugs such as Gilead Sciences’ (NASDAQ:GILD) Remdesivir, as well as mAbs like Roche Holding’s (SWX:RO) Actemra, has “significant clinical advantages” over the current delivery methods when treating COVID patients
Safety and toxicology studies
In the same announcement, investors were told that safety and toxicology studies of TZLS-501 are expected to get underway imminently and the plan is to submit an investigational new drug application to the US Food & Drug Administration in the first quarter of next year.
Approved for rheumatoid arthritis, anti-IL6R mAbs have been shown to have a role to play in treating COVID patients.
In March, China’s National Health Commission recommended the use of Roche blockbuster, Actemra, which is in the same class as TZLS-501, for patients infected with COVID-19 with serious lung damage and elevated IL-6 levels.
The fact that Tiziana is progressed to GMP production, meanwhile, is seen as a major step forward as it ensures TZLS-501 can be produced and controlled according to quality standards.
The process is designed to minimise the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.
Timely step forward
STC Biologics’ CEO, Dr Magdalena Leszczyniecka, described the move to scaled-up, standardised manufacturing as a “timely step forward toward expediting development of potentially an innovative treatment for COVID-19 patients”.
The latest update from Tiziana heralded another in a series of potentially value-generative initiatives the life sciences company has underway.
Earlier this month it received a US patent for a breakthrough oral formulation of a monoclonal antibody that has been hailed as offering a “transformational avenue for immunotherapies”.
The patent protects the “lyophilised and stabilised free-flowing powder” of Foralumab contained in enteric-coated capsules for oral treatment of disease.
Foralumab is emerging as the jewel in the crown for Tiziana, which has clinical and pre-clinical assets spanning cancers, autoimmune and inflammatory diseases.
It also has a potentially best-in-class cancer diagnostic platform that it is spinning out into a separate company.
Eminent Wall Street analyst Raghuram Selvaraju, of H.C. Wainwright, recently flagged the huge potential value of the business, when he set a price target for the shares US$25, or £5 here in the UK. To put that in perspective, the US-listed American depository shares closed on Friday at US$5.93, while the UK stock ended £1.