SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
Commission File Number: 0001723069
Tiziana Life Sciences plc
(Exact Name of Registrant as Specified in Its Charter)
11-12 St James’s Square
London SW1Y 4LB
(Address of registrant’s principal executive office)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F ☒ Form 40-F ☐
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ☐
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ☐
INFORMATION CONTAINED IN THIS REPORT ON FORM 6-K
On March 11, 2020, Tiziana Life Sciences plc (the “Company”) issued a regulatory news service announcement in the United Kingdom Reporting the Expedition of Development of its Fully Human Anti-Interleukin-6-Receptor Monoclonal Antibody, a Potential Treatment of Certain Patients Infected with Coronavirus COVID-19 (the “RNS Announcement”).
The RNS Announcement is furnished herewith as Exhibit 99.1 to this Report on Form 6-K. The information in the attached Exhibit 99.1 is being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, or otherwise subject to the liabilities of that Section, nor shall it be deemed incorporated by reference in any filing made by the Company under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, except as otherwise set forth herein or as shall be expressly set forth by specific reference in such a filing.
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
|TIZIANA LIFE SCIENCES PLC|
|Date: March 11, 2020||By:||/s/ Kunwar Shailubhai|
|Title:||Chief Executive Officer|
|99.1||Regulatory News Service Announcement, dated March 11, 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® 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®, Sanofi and Regeneron are currently exploring Kevzara®, 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® and Kevzara® for treatment of COVID-19. The recent decision by researchers in China to add Actemra® 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.
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.|
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
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.
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-6Rα on the cell membrane. The receptor IL-6Rα can be shed in soluble form, sIL6Rα, 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.
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.
Tiziana Life Sciences plc
Chairman and founder
|+44 (0)20 7495 2379|
Cairn Financial Advisers LLP
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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