TILS.L Regulatory News (TILS)

Tiziana Life Sciences plc

(the "Company" or "Tiziana Life Sciences")

Filing of Investigational New Drug application

Tiziana Life Sciences plc (AIM: TILS), a UK biotechnology company that focuses on the discovery and development of novel molecules to treat human disease in oncology and immunology, is pleased to announce submission of an Investigational New Drug ("IND") application to the U.S. Food and Drug Administration in collaboration with the Brigham and Women's Hospital, Harvard Medical School, Boston, MA ("BWH") to Initiate Phase 1 Clinical Trials with Foralumab, to be administered nasally to healthy volunteers, with the objective of demonstrating proof of concept in a potentially revolutionary approach for the treatment of neurodegenerative diseases, such as progressive multiple sclerosis ("MS").

About the study

This is a first-in-human Phase 1 clinical study and is being initiated to evaluate safety, tolerability and immunomodulatory effects of nasally administered Foralumab (TZLS-401) in healthy volunteers using a nasal spray device. Nasal administration with Foralumab is a revolutionary approach which the Company has developed in conjunction with Dr. Howard Weiner at the BWH, to treat patients with neurodegenerative diseases such as progressive multiple sclerosis and amyotrophic lateral sclerosis.

The scientific rationale for this approach originates from years of research work conducted in the laboratories of Dr. Weiner at BWH. Dr. Weiner is a world-renowned pioneer and discovered the concept of oral and nasal administration of anti-CD3 monoclonal antibodies ("mAbs") for treatment of autoimmune and inflammatory diseases. Dr. Weiner is also a member of the scientific advisory board of Tiziana Life Sciences.

In addition to evaluating the safety and pharmacokinetics of the nasally administered Foralumab the data from the study will be used to examine unique biomarkers of immunomodulation and induction of T regulatory cells ("Tregs") to assess the future therapeutic potential of the treatment.

About intranasal delivery

Extensive data in animal studies with intranasal delivery of anti-CD3 mAbs demonstrates that this route of administration induces Tregs in the cervical lymph node that then cross the blood brain barrier and provide an interleukin-10 dependent anti-inflammatory signal that downregulates activated glial cells in the brain and returns them to their normal homeostatic state. This response supports the potential for positive clinical benefits and amelioration of disease.

Targeting the abnormal neuroimmune system (microglia and astrocytes) by activating Tregs is rapidly emerging as an alternative to parenteral routes of administration in treating neurodegenerative diseases.

Gabriele Cerrone, Chairman and founder of Tiziana Life Sciences, said:

"The ability to directly target the central nervous system has been, until now, a formidable and long-standing obstacle in the development of treatments for neurodegenerative diseases. Intranasal delivery of therapeutic anti-CD3 mAbs represents a potential game changer to overcome the barrier of the blood brain obstacle and has the potential for the development of an entirely new class of therapies for treatment of a wide range of human diseases."

The Company also plans to submit an additional IND to administer oral formulation of Foralumab to healthy volunteers in a Phase 1 clinical trial targeted at the treatment of autoimmune and inflammatory diseases such as non-alcoholic steatohepatitis or fatty liver disease (NASH) and Crohn's disease.

This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014.

About Dr. Howard Weiner

Dr. Howard L. Weiner is the Robert L. Kroc Professor of Neurology at the Harvard Medical School, Director and Founder of the Partners MS Center and Co-Director of the Ann Romney Center for Neurologic Diseases at BWH in Boston. He has pioneered immunotherapy in MS and has investigated immune mechanisms in nervous system diseases including MS, Alzheimer's disease, amyotrophic lateral sclerosis, stroke and brain tumours. He has also pioneered the investigation of the mucosal immune system for the treatment of autoimmune and other diseases and the use of anti-CD3 mAbs to induce regulatory T cells for the treatment of these diseases.

About Harvard Medical Centre

BWH is located adjacent to Harvard Medical School. It is the largest hospital of the Longwood Medical and Academic Area in Boston, Massachusetts, USA. With Massachusetts General Hospital, it is one of the two founding members of Partners HealthCare, the largest healthcare provider in Massachusetts. Brigham and Women's Hospital conducts the second largest hospital-based research program in the world, with an annual research budget of more than $630 million. Pioneering milestones include the world's first successful heart valve operation and the world's first solid organ transplant.

About Tiziana Life Sciences

Tiziana Life Sciences is a UK biotechnology company that focuses on the discovery and development of novel molecules to treat human disease in oncology and immunology. We believe Foralumab is the only fully human anti-CD3 mAb in clinical development in the world. This compound has potential application in a wide range of autoimmune and inflammatory diseases, such as NASH, primary biliary cholangitis (PBS), ulcerative colitis, MS, type-1 diabetes (T1D), inflammatory bowel disease (IBD), psoriasis and rheumatoid arthritis, where modulation of a T-cell response is desirable.

Forward-looking statements

This news release contains forward-looking statements that reflect Tiziana Life Science's current expectations regarding future events, including statements regarding financial performance, the timing of clinical trials, the timing and outcomes of regulatory or intellectual property decisions, the clinical benefits of Foralumab and the safety profile and commercial potential of Foralumab. Forward-looking statements involve risks and uncertainties. Actual events could differ materially from those projected herein and depend on a number of factors, including (inter alia), the success of Tiziana Life Science's research strategies, the applicability of the discoveries made therein and the successful and timely completion and uncertainties related to the regulatory process. A further list and description of risks and uncertainties associated with an investment in Tiziana Life Sciences can be found in its filings with the U.S. Securities and Exchange Commission. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Tiziana Life Sciences undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.

For more information go to http://www.tizianalifesciences.com

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