Tiziana Life Sci PLC - Clinical Study with Nasally Administered Foralumab
("Tiziana" or the "Company")
Tiziana to Conduct a Clinical Study with Nasally Administered Foralumab, a Fully Human Anti-CD3 Monoclonal Antibody, for Treatment of COVID-19 Patients in
Nasal Adminsteration of Foralumab is a potentially transformative approach for treating patients with COVID-19.
· Clinical study anticipated to start in the next few weeks with clinical data potentially available before the end of 2020
· Scientific rationale for use of Foralumab as a treatment for COVID-19 patients is to help modulate the human immune system to suppress a possible "Cytokine storm" and to potentially reduce respiratory failure in COVID-19 patients
The "Cytokine storm" (aka cytokine release syndrome) 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 T regulatory cells (Tregs) is prominently reduced in severely ill COVID-19 patients (2), which could be one of the reasons for the hyperactivated immune system and damaged lungs in these patients. Since the reduction in Tregs and activation of the immune system are commonly observed in patients with Middle Eastern Middle Respiratory Syndrome (MERS), Severe Acute Respiratory Syndrome (SARS-CoV-1), COVID-19 and Acute Respiratory Distress Syndrome (ARDS), we believe that stimulation of Tregs is a highly innovative approach for the treatment of patients with these diseases.
The Company has developed a robust formulation for delivery of Foralumab using a nasal spray device and has successfully completed a Phase 1 clinical trial demonstrating that the treatment was well-tolerated up to 250 microg/day and that it stimulated Tregs (https://www.tizianalifesciences.com/news-item?s=2018-11-28-tiziana-announces-initiation-of-phase-1-clinical-trial-with-nasal-administration-of-foralumab-a-fully-human-anti-cluster-definition-3-monoclonal-antibody-anti-cd3-mab-in-healthy-volunteers). Thus, we believe the clinical strategy with nasal administration of Foralumab either alone or in combination with dexamethasone to treat COVID-19 patients is highly innovative and scientifically very sound.
"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," commented Dr.
"Our proprietary immunotherapeutic approach, employing nasal administration of Foralumab to modulate the immune system, aims to supercharge Tregs to suppress inflammation, and to dampen cytotoxic CD8+ T cell responses in the nasal and respiratory tract, the primary sites of Covid-19. In view of the importance and urgency to develop an effective therapy for COVID-19 immediately, our
THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION FOR THE PURPOSES OF ARTICLE 7 OF REGULATION (EU) NO 596/2014
The person who arranged for the release of this announcement on behalf of the Company was Dr
1. Huang C, Wang Y, Li X, et al. Clinical features of patients infected with 2019 novel coronavirus in
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
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.
Certain statements made in this announcement are forward-looking statements. These forward-looking statements are not historical facts but rather are based on the Company's current expectations, estimates, and projections about its industry; its beliefs; and assumptions. Words such as 'anticipates,' 'expects,' 'intends,' 'plans,' 'believes,' 'seeks,' 'estimates,' and similar expressions are intended to identify forward-looking statements. These statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties, and other factors, some of which are beyond the Company's control, are difficult to predict, and could cause actual results to differ materially from those expressed or forecasted in the forward-looking statements. The Company cautions security holders and prospective security holders not to place undue reliance on these forward-looking statements, which reflect the view of the Company only as of the date of this announcement. The forward-looking statements made in this announcement relate only to events as of the date on which the statements are made. The Company will not undertake any obligation to release publicly any revisions or updates to these forward-looking statements to reflect events, circumstances, or unanticipated events occurring after the date of this announcement except as required by law or by any appropriate regulatory authority.
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