Research & Development
Tiziana Initiates Phase 1 Clinical Trial with Nasal Administration of Foralumab, a Fully Human Anti-Cluster Definition 3 Monoclonal Antibody (anti-CD3 mAb), in Healthy Volunteers
4 December 2018 - - UK-based biotechnology company Tiziana Life Sciences plc (NASDAQ: TLSA) (AIM: TILS) has submitted an Investigational New Drug application on 1 June 2018 to the US Food and Drug Administration.

Following approval of the IND application by the FDA, the company announces that a first-in-human Phase 1 clinical trial in healthy volunteers has been initiated at the Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.

The company also plans to submit a similar IND for a Phase 1b clinical trial with encapsulated and enteric-coated formulation of Foralumab in healthy volunteers to evaluate safety and tolerability in the first quarter of 2019.

A well-established panel of blood biomarkers will be examined to assess potential of orally administered Foralumab for treatment of autoimmune and inflammatory diseases such as non-alcoholic fatty liver disease and Crohn's disease," said Kunwar Shailubhai, CEO and CSO of Tiziana.

Dr. Howard L. Weiner is the Robert L. Kroc Professor of Neurology at the Harvard Medical School, director and Founder of the Partners Multiple Sclerosis Center and Co-director of the Ann Romney Center for Neurologic Diseases at Brigham and Women's Hospital 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 tumors.

Weiner has also pioneered the investigation of the mucosal immune system for the treatment of autoimmune and other diseases and the use of anti-CD3 to induce Tregs for the treatment of these diseases.

Brigham and Women's Hospital is located adjacent to Harvard Medical School, of which it is the second largest teaching affiliate. 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.

BWH conducts the second largest hospital-based research program in the world, with an annual research budget of more than USD 630m.

Pioneering milestones include the world's first successful heart valve operation and the world's first solid organ transplant.

Autoimmune diseases constitute a major medical problem and include diseases such as multiple sclerosis, type 1 diabetes, rheumatoid arthritis and inflammatory bowel disease.

Other diseases that have inflammatory components include diseases such as NASH, atherosclerosis and stroke.

The induction of regulatory cells at mucosal surfaces by the oral or nasal administration of antigens has been shown to treat a large variety of autoimmune and inflammatory diseases in animal models with minimal toxicity. Foralumab was developed by Novimmune and was acquired by Tiziana.

Foralumab (formerly NI-0401), the only entirely human anti-CD3 mAb, shows reduced release of cytokines after IV administration in patients with Crohn's disease with decreases in the classic side effects of cytokine release syndrome and improves the overall safety profile of Foralumab.

In a humanised mouse model (NOD/SCID IL2γc-/-) developed in Dr. Kevan Herold's laboratory, it was shown that while targeting the T cell receptor, orally administered Foralumab modulates immune responses of the T cells, enhances Tregs and thus provides therapeutic benefit in treating inflammatory and autoimmune diseases without the occurrence of potential adverse events usually associated with parenteral mAb therapy (Ogura M. et al., 2017).

Based on animal studies, the nasal and oral administration of Foralumab offers the potential for the immunotherapy of autoimmune and inflammatory diseases in a safe manner by the induction of Tregs.

Tiziana is a UK biotechnology company that focuses on the discovery and development of novel molecules to treat human disease in oncology and immunology. In addition to milciclib, the company is also developing Foralumab for liver diseases.

Foralumab is the only fully human anti-CD3 mAbs in clinical development in the world.

This compound has potential application in a wide range of autoimmune and inflammatory diseases, such as nonalcoholic steatohepatitis, primary biliary cholangitis, ulcerative colitis, multiple sclerosis, type-1 diabetes, inflammatory bowel disease, psoriasis and rheumatoid arthritis, where modulation of a T-cell response is desirable.
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