TIDMTILS
RNS Number : 6926F
Tiziana Life Sciences PLC
11 March 2020
THE INFORMATION CONTAINED IN THIS ANNOUNCEMENT IS INSIDE
INFORMATION FOR THE PURPOSES OF ARTICLE 7 OF EU REGULATION
596/2014
Tiziana Life Sciences plc
("Tiziana" or the "Company")
Tiziana Life Sciences plc To Expedite Development of its Fully
Human Anti-Interleukin-6-Receptor Monoclonal Antibody, a Potential
Treatment of Certain Patients Infected with Coronavirus
COVID-19
New York/London, March 11, 2020 - Tiziana Life Sciences plc
(Nasdaq: TLSA; AIM: TILS) ("Tiziana" or the "Company"), a
biotechnology company focused on innovative therapeutics for
inflammatory and autoimmune diseases, announced today that it is
expediting development of TZLS-501, a novel, fully human
anti-interleukin-6 receptor (anti-IL6R) monoclonal antibody (mAb)
for treatment of patients infected with coronavirus COVID-19
(SARS-CoV-2). Tiziana plans to administer TZLS-501 using a
proprietary formulation technology. The Company entered into a
world-wide license for composition-of-matter of TZLS-501, a fully
human mAb targeting IL-6R, with Novimmune, SA, a Swiss
biotechnology company in 2017.
Certain patients infected with coronavirus COVID-19 may develop
an uncontrolled immune response ("cytokine storm") resulting in
severe damage to lung tissue which could lead to respiratory
failure (see Note 1, below). 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(R) for treatment of patients infected
with COVID-19, with serious lung damage and elevated IL-6 levels.
Actemra was first approved by the FDA in 2010 for rheumatoid
arthritis. Besides Actemra(R), Sanofi and Regeneron are currently
exploring Kevzara(R), an FDA-approved anti-IL-6 receptor therapy
for rheumatoid arthritis, for treatment of severe COVID-19.
Tiziana's anti-IL-6R mAb binds to both the membrane-bound and
soluble forms of IL-6R and rapidly depletes circulating levels of
IL-6 in the blood (see Note 2, below). An excessive production of
IL-6 is regarded as a key driver of chronic inflammation and is
believed to be associated with severe lung damage observed with
COVID-19 infections and acute respiratory illness. A recent Chinese
study also reported that COVID-19 infection caused clusters of
severe respiratory illness such as severe acute respiratory
distress syndrome ( ARDS ) (see Note 3, below).
"We believe that the features of TZLS-501 consisting of its dual
mechanism of action to inhibit signaling by the membrane-bound and
soluble IL-6 receptors along with rapid depletion of circulating
IL-6 cytokine, a major cause of lung damage, provides TZLS-501 with
distinct advantages for treatment of COVID-19 over other anti-IL-6R
mAbs such as Actemra(R) and Kevzara(R) for treatment of COVID-19.
The recent decision by researchers in China to add Actemra(R) to
treatment guidelines for coronavirus patients with serious lung
damage confirms the utility of anti-IL6R mAb. We are excited to
move forward with our clinical development plan to expedite
evaluation in patients as soon as possible", said Dr. Kunwar
Shailubhai, CEO & CSO of Tiziana Life Sciences.
Notes
Reference is made above to the following third-party
publications:
1. Chaolin Huang, et al., Clinical features of patients infected
with 2019 novel coronavirus in Wuhan, China. The Lancet, volume
395, pages 497-506. 2020. Published online January 24, 2020.
2. Lacroix, M. et al., Novel Insights into Interleukin 6 (IL-6)
Cis- and Trans-signaling Pathways by Differentially Manipulating
the Assembly of the IL-6 Signaling Complex.
J Biol Chem . 2015 Nov 6; 290(45): 26943-26953.
3. Chan, Jasper Fuk-woo et. al., A familiar cluster of pneumonia
associated with the 2019 novel coronavirus indicating
person-to-person transmission: a study of a family cluster. The
Lancet, volume 395, pages 514-523. 2020. Published online January
24, 2020.
The person who arranged for the release of this announcement was
Dr. Kunwar Shailubhai, CEO & CSO of Tiziana Life Sciences.
About TZLS-501
TZLS-501, a fully human mAb, was acquired from Novimmune, SA, 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<ALPHA> on the cell membrane. The receptor
IL-6R<ALPHA> can be shed in soluble form, sIL6R<ALPHA>,
which binds to circulating IL-6 cytokine in the blood. The
downstream signaling from this complex mediates pro-inflammatory
effects underlying inflammatory diseases such as rheumatoid
arthritis (RA) and acute respiratory distress syndrome (ARDS). The
Company believes that the 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, a major cause of lung damage, provides TZLS-501
with distinct advantages for treatment of COVID-19.
About Tiziana Life Sciences
Tiziana 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 monoclonal
antibody 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.
Forward-Looking Statements
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.
Contacts :
Tiziana Life Sciences plc
Gabriele Cerrone,
Chairman and founder +44 (0)20 7495 2379
Cairn Financial Advisers LLP (Nominated
adviser)
Liam Murray / Jo Turner + 44 (0)20 7213 0883
Shore Capital (Broker)
Antonio Bossi / Fiona Conroy +44 (0)20 7601 6125
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END
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