Tiziana Life Sciences confident of advancing drug development pipeline

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Tiziana Life Sciences PLC (NASDAQ:TLSA) (LON:TILS) said it is confident that it is well positioned to advance its drug development programs “to their next respective value inflection points”.

In final results on Tuesday the company said it continued to progress a pipeline of drugs to treat rare cancers and autoimmune and inflammatory diseases.

One of these is an investigational new technology to treat COVID-19 infections by using a nasal delivery system to directly deliver monoclonal antibodies (mAbs) into the lungs.

Preclinical studies are ongoing and Tiziana said it hopes to begin a trial investigating the delivery of an anti-IL-6R mAb to the lungs using a portable nasal delivery system. 

“This treatment could be useful for different variants of COVID-19 and we are exploring these in an upcoming preclinical study,” it said.

Tiziana also plans to develop subcutaneous delivery of anti_IL-6R mAb for treatment of acute respiratory distress syndrome (ARDS) and other inflammatory conditions.

On Foralumab, the company’s lead product candidate in immunology, Phase 2 studies are due to shortly begin with orally administration of the drug for Crohn’s Disease and nasally administered Foralumab for progressive multiple sclerosis.

For Milciclib, where intellectual property has been in-licensed from Nerviano Medical Sciences, a Phase 2b clinical trial is planned in people with hepatocellular carcinoma (HCC) with Milciclib in combination with a Tyrosine kinase inhibitors such as Regorafenib or Sorafenib. 

The company said it also intends to evaluate Milciclib in combination with standard of care treatments for other solid tumour indications.

An agreement was recently made with Takanawa Japan for a strategic business development plan to identify a clinical partner for further clinical development of Milciclib for treatment in advanced HCC patients.

“We believe the positive clinical activity in advanced HCC and other cancers warrant immediate further development in Japan and other Asian countries where the prevalence of this cancer is relatively high, and the current available therapies are not entirely satisfactory,” the company said.

The accounts showed cash of £48.2mln in the bank at the end of December, after a year when the company made a loss before tax of £21.8mln as R&D and operating costs increased.

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