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ANNOUNCEMENT CONTAINS INSIDE INFORMATION FOR THE PURPOSES OF ARTICLE 7 OF REGULATION (EU) NO 596/2014
FOR RELEASE, PUBLICATION OR DISTRIBUTION, IN WHOLE OR IN PART, IN OR INTO OR FROM ANY JURISDICTION WHERE TO DO SO WOULD CONSTITUTE
A VIOLATION OF THE RELEVANT LAWS OF SUCH JURISDICTION
Life Sciences Develops Novel Investigational Treatment For Patients Infected with COVID-19 Utilizing Direct Delivery of Anti-Interlukin-6-Receptor
Monoclonal Antibodies
Has Filed Patent Application in Support of Treatment of COVID-19 Utilizing Anti-IL6R Via Inhaled Delivery
York/London -- April 9, 2020 - Tiziana Life Sciences plc (Nasdaq: TLSA) ("Tiziana" or the "Company"),
a biotechnology company focused on innovative therapeutics for inflammatory and autoimmune diseases, announced today that it has
developed investigational new technology to treat COVID-19 infections, which consists of direct delivery of anti-IL-6 receptor
(anti-IL-6R) monoclonal antibodies (mAbs) into the lungs using a handheld inhaler or nebulizer. Development of this novel technology
is a step forward toward expediting development of TZLS-501, a fully-human anti-interleukin-6 receptor (anti-IL6R) monoclonal
antibody (mAb) for treatment of patients infected with COVID-19 (SARS-CoV-2) coronavirus.
The Company believes the technology could also be applicable for use with other FDA approved mAbs and drugs. The Company has submitted
a provisional patent application for the delivery technology.
delivery of anti-IL-6R mAb to the lungs using a portable handheld inhaler or nebulizer is a rapid and immediate therapy for children
and adults infected with COVID-19. Importantly, this treatment with our fully human anti-IL-6R mAb (TZLS-501) has the potential
to be a long-term therapy to halt progression and reduce mortality in patients with COVID-19, as a portion of the population may
not opt to utilize a vaccine," said Gabriele Cerrone, Chairman of Tiziana Lifesciences.
infected with COVID-19 are known to develop an uncontrolled immune response ("cytokine storm"), which results in excessisive
production of pro-inflammatory cytokines and other proteins such as interleukin-6 (IL-6), tumor necrosis factor-alpha (TNF-a)
and Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF), which in turn causes severe
damage to lung tissue resulting in respiratory failure and eventually death. Among these cytokines, IL-6 seems to be one of the
major culprits underlying coronavirus-mediated respiratory failure. Early clinical studies conducted by doctors in China suggest
that anti-IL6R mAbs may be used in clinical practice for treatment of COVID-19. Consequently, China's National Health Commission
has recommended the use of Roche's blockbuster drug, Actemra and Sanofi's Kevzera for treatment of patients
infected with COVID-19.
production of IL-6 is regarded as a key driver of chronic inflammation and is believed to be associated with the severe lung damage
commonly observed with COVID-19 infections and acute respiratory distress syndrome (ARDS).
Tiziana believes TZLS-501 (anti-IL6R) combined with this newly introduced inhalation technology may rapidly inhibit inflammation
in lungs and in combination with intravenous administration may deplete circulating levels of IL-6 and potentially halt progression
of COVID-19-mediated lung damage and death.
filing of this comprehensive provisional patent application covering treatment with our anti-IL-6R mAb, as well as prophylactic
intervention with a vaccine candidate, designed from Spike (S) protein of COVID-19, is an important step in finding a solution
to the current pandemic. We look forward to providing updates on the development of this product candidate and its introduction
into clinical trials in a real-world setting," said Dr. Kunwar Shailubhai, CEO & CSO of Tiziana Life Sciences.
person who arranged for the release of this information was Dr Kunwar Shailubhai, the Chief Executive Officer of the Company.
a fully human mAb, was acquired from Novimmune, a Swiss biotechnology company, in 2017. The cytokine, IL-6, a major determinant
in the priming of pathogenic T cells to produce an inflammatory response, binds to its receptor subunit IL-6R on the cell
membrane. The receptor IL-6R can be shed as a soluble sIL6R , which binds to circulating IL-6 cytokine in the blood.
The downstream signaling from which sIL-6R is implicated mediates pro-inflammatory effect underlying the inflammatory diseases
such as rheumatoid arthritis (RA) and acute respiratory distress syndrome (ARDS). The Company believes that the novel features
of TZLS-501 consisting of its dual mechanism of action to inhibit signaling by the membrane-bound and soluble IL-6 receptor and
the rapid depletion of circulating IL-6 cytokines, which is the major cause of lung damage, provides this mAb with distinct advantages
for treatment of COVD-19. The Company licensed TZLS-501 from Novimmune, a Swiss biotechnology company, in 2017.
Tiziana Life Sciences
Life Sciences plc 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 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.
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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.
Cerrone, Chairman and founder +44 (0)20 7495 2379
Financial Advisers LLP (Nominated adviser)
Murray / Jo Turner + 44 (0)20 7213 0883
Bossi / Fiona Conroy +44 (0)20 7601 6125