Tiziana Life Sciences is a dual-listed clinical stage biotechnology company focused on the discovery and development of novel molecules to treat human disease in oncology and immunology. Tiziana’s two lead drug candidates, Foralumab and Milciclib, uniquely target the root cause of diseases with large unmet needs in multibillion-dollar markets. Tiziana is accelerating development of anti-IL6 receptor monoclonal antibody (mAb) for treatment of COVID-19 lung inflammation. Foralumab is the only fully human anti-CD3 monoclonal antibody in clinical development in the world. This Phase 2 compound has potential application in a wide range of autoimmune and inflammatory diseases, such as nonalcoholic steatohepatitis (NASH), ulcerative colitis, multiple sclerosis, type-1 diabetes (T1D), Crohn's disease, psoriasis and rheumatoid arthritis, where modulation of a T-cell response is desirable. Tiziana is a market leader in the invention of proprietary technology for oral, nasal and inhaled formulation to transform immunotherapies with Monoclonal Antibodies currently administered intravenously. Also, Tiziana has a robust and growing patent portfolio.
Tiziana Life Sciences: Robust Pipeline with Multiple Near-Term Catalysts
Pipeline Overview & Upcoming Milestones
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.
- Patent filed on use of Foralumab to enhance success of CAR-T therapy
- IND submission in COVID-19 - Q2 2021
- Phase 1b/2 trial with orally administered Foralumab in Crohn’s Disease patients anticipated completion – Q2 2021
- Phase 2 trial with nasally administered Foralumab in progressive multiple sclerosis (pro-MS) patients anticipated completion – Q2 2021
TZLS-501 is a fully human anti IL-6R monoclonal antibody with a novel mechanism of action. The mAb possesses a high affinity for IL-6R and the IL-6/IL-6R complex and effectively blocks the complex even at high IL-6 circulating levels, showing superiority and overcoming the limitations of other IL-6 pathway drugs.
- Development of inhalation technology to deliver stable aerosols directly in lungs – Q2 2021
The Company’s lead compound, milciclib, is a molecule which blocks the action of specific enzymes called cyclin-dependent kinases (CDKs) involved in cell division as well as several other protein kinases.
- Initiate Phase 2b in HCC patients with Milciclib in combination with a TKI – Q3 2021
Tiziana Life Sciences Investor Webinar – January 2021
Transformational platform technologies
- Proprietary oral, nasal and inhaled formulation technologies to transform immunotherapies with Monoclonal Antibodies currently administered intravenously
Phase 2 oral immunotherapy study for Crohn’s Disease (CD)
- Phase 2 clinical study with orally administered Foralumab, a fully human anti-CD3 mAb
- Collaboration with Parexel Biotech
Reported positive top-line data from COVID-19 trial in Jan. 2021
- Innovative technology enables direct delivery of anti-IL6 receptor monoclonal antibodies into the lung using a handheld inhaler or nebulizer
- Could be effective against SARS, MERS, and all variants of coronaviruses
- Planning Phase 2 study in moderate to severe COVID-19 patients
Strong intellectual property protections
- 174 foreign patents and 19 U.S. patents issued
Proven leadership team with ‘bench to market’ experience
- Entrepreneurial success in biotech deals; CEO is co-founder, Synergy Pharma; Executive Chairman founded and chaired two biotechs with $2B+ market caps. Exemplary scientific advisory board with world renowned key opinion leaders
- FDA approved expanded access use for Foralumab treating a Secondary Progressive Multiple Sclerosis patient
- Successfully spun off StemPrintER business in Q4 2020
Tiziana has developed proprietary oral, nasal, and inhaled formulation technologies that could transform immunotherapies with Monoclonal Antibodies currently administered intravenously for multiple indications. Through multiple Phase 2 trials underway and/or planned, the Company is positioned for a steady stream of milestone achievements over the next several quarters, including launch of a Phase 2 COVID-19 trial. Led by a world-class leadership team and scientific advisory board with a collective 76 years of experience in medical technology and more than 100 medical product launches, Tiziana is ideally positioned to execute on its robust corporate strategy.