TILS.L Regulatory News (TILS)

Tiziana Life Sciences PLC

("Tiziana" or "the Company")

Tiziana Announces Initiation of Clinical Trial for COVID-19 Patients in Brazil with Nasally Administered Foralumab, a Fully Human Anti-CD3 Monoclonal Antibody

London/New York, 2 November 2020 - Tiziana Life Sciences plc (Nasdaq: TLSA / AIM: TILS) ("Tiziana" or the "Company"), a biotechnology company focused on innovative therapeutics for oncology, inflammation and infectious diseases, announces initiation of a collaborative clinical study investigating nasally administered Foralumab either alone or in combination with orally administered dexamethasone in COVID-19 patients in Brazil. In view of the importance and urgency, scientific teams at the Harvard Medical School, Santa Casa de Misericórdia de Santos Hospital (Jabaquara, Santos, Brazil) and at Tiziana are closely collaborating to facilitate initiation of this study in expedited time frames. This clinical trial will be coordinated by the team at INTRIALS, a leading, full-service Latin America Clinical Research Organisation, (CRO) based in Sao Paulo City, Brazil. The clinical data from this trial is expected to be available by the end of this year.

Dr. Shailubhai, CEO and CSO of Tiziana Life Sciences stated:

· "Brazil has reported almost 5.5 million Coronavirus cases and 159,000 deaths and is considered a global epicenter of the outbreak. Brazil is currently experiencing almost 1,000 deaths per day. Therefore, our clinical study is both timely and a potential life changer for COVID-19 patients. The scientific concept, through activation of nasal mucosal immunity via nasally administered Foralumab, aims to fight the virus in the respiratory tract and lungs". The clinical study will start dosing patients on 3 November 2020 with data expected to be available before the end of 2020

· Since reduced or defective levels of T regulatory (Tregs) cells in the blood seem to be associated with the severity of COVID-19 and acute respiratory distress syndrome (ARDS), nasally administered Foralumab, by acting locally, could potentially suppress a 'cytokine storm' and hyperinflammation in the respiratory tract and lungs of COVID-19 patients

· A patent application was filed in July 2020 to protect the potential use of nasally administered Foralumab for the treatment of COVID-19 either alone or in combination with other anti-viral drugs.

Dr Howard Weiner, who 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 the Brigham & Women's Hospital, and a Scientific Advisor to the Company, commented: "Nasal administration of Foralumab to modulate the human immune system is a potentially transformative approach for treating patients with a variety of human diseases with dysregulated immune systems. Results from studies, conducted in our laboratory have established that nasal administration of anti-CD3 induces Tregs that can suppress inflammation and ameliorate diseases in animal models. Furthermore, nasal anti-CD3 dampens cytotoxic CD8 T cell responses shown to cause lung damage in COVID-19. This scientific advancement provides the basis to move forward with clinical development of nasally administered Foralumab in COVID-19 disease." He continued, "My colleague Dr. Thais Moreira worked very closely with clinicians at the Brazilian hospital and the team at INTRIALS to expedite this highly innovative first-in-class study for treating COVID-19 disease."

Dr. Rogério Dedivitis, the Clinical director of Santa Casa de Santos, stated: "The Santa Casa hospital, the first hospital founded in Brazil almost 500 years ago, is very pleased to be involved in such an important international clinical study. We are excited and confident that this study will contribute to the better understanding of COVID-19 disease, and importantly also benefit our patients."

The cytokine storm and hyperinflammation resulting in severe lung damage, followed by respiratory failure are the main underlying reasons for morbidity and mortality in COVID-19 patients (1). Recent clinical evidence suggests that the level of peripheral Tregs is prominently reduced in severely ill COVID-19 patients (2). The clinical data from a recently completed clinical study indicated that the nasal administration of Foralumab stimulated production of Tregs in healthy volunteers (https://www.tizianalifesciences.com/news-item?s=2019-09-10-tiziana-reports-phase-1-clinical-data-demonstrating-nasal-treatment-with-foralumab-was-well-tolerated-and-produced-positive-trend-in-biomarkers-of-immunomodulation-and-anti-inflammation-in-healthy-volunteers), suggesting that nasal treatment with Foralumab may improve clinical outcome by stimulating Tregs in patients. This is an innovative approach, which could also be useful for treatment of patients with Middle Eastern Respiratory Syndrome (MERS), Severe Acute Respiratory Syndrome (SARS-CoV-1), COVID-19 and Acute Respiratory Distress Syndrome (ARDS) because depletion of functional Tregs is commonly observed in these diseases.

Cited References

1. Huang C, Wang Y, Li X, et al. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet 2020; 395: 497-506. doi:10.1016/S0140-6736(20)30183-5

2. Chen G, Wu D, Guo W, et al. Clinical and immunological features of severe and moderate coronavirus disease 2019. J Clin Invest 2020; 130: 2620-2629. doi:10.1172/JCI137244

About Foralumab

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 (CRS) and improves the overall safety profile of Foralumab. In a humanized mouse model (NOD/SCID IL2γc-/-), it was shown that whilst targeting the T cell receptor, orally administered Foralumab modulates immune responses of the T cells, enhances regulatory T-cells (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.

About Tiziana Life Sciences

Tiziana Life Sciences plc is a dual listed (NASDAQ: TLSA & UK AIMS: TILS) biotechnology company that focuses on the discovery and development of novel molecules to treat human diseases in oncology, inflammation and infectious diseases. In addition to milciclib, the Company will be shortly initiating Phase 2 studies with orally administered Foralumab for Crohn's Disease and nasally administered Foralumab for progressive multiple sclerosis. Foralumab is the only fully human anti-CD3 monoclonal antibody (mAb) in clinical development in the world. This Phase 2 compound has potential application in a wide range of autoimmune and inflammatory diseases, such as Crohn's Disease, multiple sclerosis, type-1 diabetes (T1D), inflammatory bowel disease (IBD), psoriasis and rheumatoid arthritis, where modulation of a T-cell response is desirable. The company is accelerating development of anti-Interleukin 6 receptor (IL6R) mAb, a fully human monoclonal antibody for treatment of IL6-induced inflammation, especially for treatment of COVID-19 patients.

This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014. The person who arranged for the release of this announcement on behalf of the Company was Dr Kunwar Shailubhai, Chief Executive Officer and Chief Scientific Officer of the Company.

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