Tiziana Life Sciences is focused on developing innovative immunotherapies for neurodegenerative diseases, particularly through the use of their lead asset, Foralumab. This fully human anti-CD3 monoclonal antibody is administered intranasally, allowing it to effectively reach the cervical lymph nodes and stimulate the production of anti-inflammatory T regulatory cells (Tregs). These Tregs migrate to the central nervous system (CNS), where they produce interleukin-10 (IL-10), promoting an anti-inflammatory environment that can help mitigate chronic inflammatory damage in conditions such as Non-Active Secondary Progressive Multiple Sclerosis and Alzheimer’s disease. The company is also exploring various administration routes for Foralumab, including subcutaneous and oral formulations, to enhance its therapeutic potential across different indications.

In addition to Foralumab, Tiziana is developing TZLS-501, a fully human monoclonal antibody targeting the IL-6 receptor, aimed at treating lung diseases. The company has a robust pipeline that includes ongoing clinical trials for multiple indications, including Long COVID and ALS, supported by a strong intellectual property portfolio encompassing patents related to formulation technologies and manufacturing processes. Tiziana's commitment to advancing these therapies is underscored by their focus on optimizing health outcomes for patients suffering from serious neuroinflammatory and neurodegenerative conditions.

United Kingdom

Tiziana Life Sciences is a dual-listed* (NASDAQ:TLSA, AIM:TILS) clinical stage biotechnology company that specializes in the developing transformative therapies for autoimmune and inflammatory diseases, degenerative diseases and cancer related to the liver. Our clinical pipeline includes drug assets for  Crohn's Disease, COVID-19 and Progressive Multiple Sclerosis and Hepatocellular Carcinoma. Tiziana is led by a team of highly qualified executives with extensive drug development and commercialization experience.

*Note: Our market cap for TLSA is likely not accurate because its shares are listed on both the London Stock Exchange and the NASDAQ. 

Central Nervous System (CNS)

Endocrine System Diseases

Infectious Diseases

Metabolic Diseases

Nervous System Diseases

Tiziana Life Sciences

Multiple sclerosis

Foralumab (TZLS-401) has significant potential as the only fully human engineered anti-human CD3 antibody in clinical development with advantages of short duration of treatment regimen, reduced immunogenicity and prevention of the life-threatening cytokine release syndrome. We have also developed a novel proprietary oral formulation of foralumab for the treatment of autoimmune and inflammatory diseases based on the concept of oral tolerance. This proprietary oral formulation of foralumab may potentially have broader applications for all anti-CD3 and other monoclonal antibodies. Administration via the oral and nasal routes is expected to mitigate side effects (primarily infusion related reactions) observed when foralumab was administered intravenously.

Intranasal Foralumab (anti-CD3 mAb)

COVID-19

Foralumab (formerly NI-0401), the only &nbsp;entirely human anti-CD3 mAb, shows reduced release of cytokines after IV &nbsp;administration in patients with Crohn's disease with decreases in the &nbsp;classic side effects of cytokine release syndrome and improves the &nbsp;overall safety profile of Foralumab. In a humanized mouse model &nbsp;(NOD/SCID IL2γc-/-), it was shown that whilst targeting the T cell &nbsp;receptor, orally administered Foralumab modulates immune responses of &nbsp;the T cells, enhances regulatory T-cells (Tregs) and thus provides &nbsp;therapeutic benefit in treating inflammatory and autoimmune diseases &nbsp;without the occurrence of potential adverse events usually associated &nbsp;with parenteral mAb therapy (Ogura M. et al., 2017). Based on animal &nbsp;studies, the nasal and oral administration of Foralumab offers the &nbsp;potential for the immunotherapy of autoimmune and inflammatory diseases &nbsp;in a safe manner by the induction of Tregs.
<a href="https://ir.tizianalifesciences.com/news-releases/news-release-details/tiziana-life-sci-plc-positive-data-nasal-administration">Source</a>

Foralumab

Hepatocellular carcinoma

Solid tumor/s

Tiziana’s Milciclib is a potent, small molecule inhibitor of &nbsp;multiple cyclin-dependent kinases (CDKs), tropomycin receptor kinases &nbsp;and Src family kinases controlling cell growth and malignant progression &nbsp;of cancer. Milciclib has demonstrated safety in 316 patients with &nbsp;advanced solid cancers in Phase 1 and 2 studies and shown indications of &nbsp;efficacy. In two, completed, Phase 2 thymic cancer trials, Milciclib &nbsp;successfully increased overall survival and met both primary and &nbsp;secondary endpoints. While the current standard of care for &nbsp;hepatocellular carcinoma (HCC), the most common liver cancer, is only &nbsp;effective in a small percentage of patients, Milciclib has the potential &nbsp;to be broadly effective because it targets the underlying cause of &nbsp;disease.
A unique feature of Milciclib is its ability to reduce microRNAs, &nbsp;miR-221 and miR-222, that promote the formation of blood vessels &nbsp;(angiogenesis) to facilitate the spread of cancer cells. Levels of these &nbsp;microRNAs are consistently increased in HCC patients and may contribute &nbsp;towards resistance to treatment with Sorafenib. In July and September &nbsp;2019, we reported Phase 2a safety, tolerability and efficacy data of &nbsp;Milciclib as a monotherapy in patients with advanced HCC. Milciclib was &nbsp;well tolerated with manageable toxicities and no recorded drug related &nbsp;deaths, thereby meeting the trial's primary endpoint. Both median TTP &nbsp;and PFS were 5.9 months. More than 60% of evaluable patients showed &nbsp;Stable Disease. The Clinical Benefit Rate was &gt;64.3%.
<a href="http://www.tizianalifesciences.com/drug-pipeline/milciclib/">Source</a>

Milciclib (pan-CDK inhibitor)

Crohns disease

Foralumab (TZLS-401) has significant potential as the only fully human engineered anti-human CD3 antibody in clinical development with advantages of short duration of treatment regimen, reduced immunogenicity and prevention of the life-threatening cytokine release syndrome.

Tiziana Life Sciences

Company Details