Tiziana Life Sciences (NASDAQ:TLSA | LSE: TILS) has teamed up with an established business to identify a partner in Japan and other countries in Asia. This new agreement, announced Wednesday, is a major step forward in developing cancer drug Milciclib.
The partnership is with Takanawa Japan, Pharma Team, who will help to further Milciclib’s development in advanced hepatocellular carcinoma (“HCC”) patients in Asian countries where current therapeutic options are “not entirely satisfactory”.
HCC is the most common type of liver cancer worldwide, affecting around 200,000 people a year.
Tiziana’s Milciclib drug has so far successfully completed eight phase 1 and phase 2 trials in HCC, as well as thymic carcinoma and thymoma. These trials demonstrated the drug’s tolerability and positive clinical responses.
The company presented clinical data from a phase 2a trial at the American Society of Clinical Oncology in 2020. These data show Milciclib was well-tolerated and produced positive clinical responses in patients resistant to another cancer drug, Sorafenib.
Recently, the company was awarded a patent to use Milciclib in combination with a tyrosine kinase inhibitor (“TKI”), or other drugs, to treat HCC as well as other cancers.
TKIs are cancer growth blockers, blocking enzymes called tyrosine kinases. Since tyrosine kinases are involved in sending growth signals in cells, blocking them prevents cancer cells from dividing and growing.
Milciclib, meanwhile, is a broad-spectrum cyclin dependent kinase (“CDK”) inhibitor. There is an association between overexpression of CDKs and developing chemotherapy resistance.
A unique feature of Milciclib is that is can reduce microRNAs, miR-221 and miR-222. These promote blood vessel formation and can help spread cancer cells. Consistently, there is an increase in levels of microRNAs in HCC patients, which could contribute towards Sorafenib resistance.
Tiziana stressed the importance of the Takanawa strategic initiative to develop Milciclib as a treatment for advanced HCC “because the prevalence of HCC in Asian countries is large and there are no satisfactory therapeutic options”.
Tiziana chief executive Kunwar Shailubhai said:
“We are pleased and excited to work with Takanawa, a firm with a distinguished history of business development activities in the Japanese pharmaceutical industry, to identify an appropriate partner in Japan for further clinical development of Milciclib”.
In April, Tiziana unveiled plans to list former subsidiary Accustem Sciences in the US on the Nasdaq Stock Market. The spin-off business focuses on commercialising genetic tests for predicting whether breast cancer is likely to come back following treatment.
This spin-off comes alongside the company’s internal development of drugs Foralumab and Anti IL-6R mAb.
Foralumab modulates the immune system, reducing local and systemic inflammation, making it a possible game changer when it comes to treating autoimmune diseases like Crohn’s Disease. Tiziana is also looking into using Foralumab to treat neurodegenerative diseases like progressive multiple sclerosis.
Anti IL-6R mAb binds to the inflammatory cytokine IL-6R, associated with autoimmune diseases and cancer. It also has potential in combination with other drugs to treat Covid-19 as well as arthritis, lupus, and multiple myeloma. Excessive IL-6R production drives chronic inflammation. It is associated with severe lung damage in Covid-19 infections.
China’s National Health Commission has recommended using anti-IL6-R mAbs to treat inflammation and elevated cytokine levels, commonly known as a cytokine storm, in Covid-19.
Value and potential
Shares in Tiziana are currently trading at 80.99p in London. The shares are up 30% on a one-year basis but with a dip year-to-date. Its market cap, meanwhile, stands at around £157 million.
Given the company’s impressive pipeline, including a number of phase 1 and phase 2 trials for Foralumab and Milciclib, this market cap could offer significant re-rate potential.
Indeed, the current dip could offer an excellent investment opportunity. After all, successful phase 3 trials could lead to approvals and, ultimately, a steep share price rise.