Publications And Positive Data From Multiple Trials: Six Months In Review For Tiziana Life Sciences (NASDAQ: TLSA)

Tiziana Life Sciences TLSA is a biotechnology company establishing itself in a cutting-edge position in the market with its breakthrough immunomodulation therapies. The past six months have been an exciting time for the company, whose main drug candidate is the intranasally-delivered foralumab. Foralumab is the first fully human anti-CD3 monoclonal antibody (mAB), and it is able to effectively suppress neuroinflammation in the central nervous system.

The global market for mAB treatments was worth $210 billion in 2022, and it is expected to grow at a compound annual growth rate (CAGR) of 11% between 2023 and 2030. In 2023 a major development in the mAB market came when Sanofi SNY agreed to acquire Provention Bio for $2.9 billion for the anti-CD3 mAB, teplizumab. This acquisition revealed the biomedical market’s serious interest in anti-CD3 mAB therapies. 

Tiziana is currently focusing on foralumab’s potential to treat non-active Secondary Progressive Multiple Sclerosis (na-SPMS), as currently there are no Food and Drug Administration (FDA)-approved treatments for this condition available on the market. However, there are indications the drug has the potential to treat other central nervous system (CNS) diseases.  

Six Months In Review

Though movement in the drug development space is notoriously slow, Tiziana has met a series of major milestones in the past six months. The company has been running an open-label expanded access (EA) program for nonactive SPMS (naSPMS) patients, and it increased program enrollment from two to six patients in late 2022.

EA Program Results:

• In January, the second EA patient (EA2) saw significant clinical improvement (measured by EDSS), which was a validated endpoint used for FDA MS therapy approvals. From January 2022 to December 2022, this patient went from needing a cane to walk 100 feet to walking without a cane for over 200 feet — and eventually returned to work in January 2023 and still is working.
• In June, a 3-month brain scan revealed improvements in brain inflammation in five of the six EA patients. The scan showed a reduction in microglia activation in the brain, which is associated with neural inflammation. 
• Encouraged by these positive results, the company announced it is starting a phase 2a trial for na-SPMS in the third quarter of 2023.

Other Applications For Foralumab: 

Tiziana also made a series of important announcements about other potential applications for foralumab. The company had an article published in the prestigious journal Proceedings of the National Academy of Sciences (PNAS), which dived into intranasal Foralumab’s innovative mechanism of action (MoA) for reducing inflammation. Its MoA means foralumab has the potential to successfully treat a range of diseases.

• In early April, Tiziana published data on Foralumab’s impact on patients with a hemorrhagic stroke, indicating patients’ motor control and cognitive function were improved in one month. Currently, less than 10% of individuals who experience a hemorrhagic stroke achieve complete recovery.
• It also has plans to test foralumab’s efficacy on long COVID, as it is well-documented that patients with long COVID have high levels of activated microglia. Tiziana believes foralumab may reduce inflammation in these approximately 9 million patients with long COVID. 
• Tiziana started testing foralumab’s efficacy for patients with type 1 diabetes. The company believes its intranasal delivery would provide an additional benefit to those with type 1 diabetes.
• The company will file an Investigational New Drug (IND) application for foralumab’s treatment of patients with mild to moderate Alzheimer’s. As part of its investigation into this indication, a grant for $3 million in non-dilutive funding from a prestigious Alzheimer’s foundation has been submitted.

Read more news stories about Tiziana Life Sciences on its website.

Featured photo by Hans Reniers on Unsplash.

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