On September 24, 2018 Tiziana Life Sciences plc ("Tiziana", AIM: TILS), the research and clinical stage biotechnology company focussing on proprietary drug candidates to treat cancer and autoimmune diseases, reported its interim results for the six months ended 30 June 2018 (Press release, Tiziana Life Sciences, SEP 24, 2018, View Source [SID1234529857]).
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Highlights during the period:
LEADERSHIP
The Company significantly enhanced its commercial and strategic development strength with the addition of a highly experienced executive to its Board of Directors:
Leopoldo Zambeletti joined as a non-executive director of the Company.
RESEARCH & DEVELOPMENT
CLINICAL PROGRAMMES
Foralumab
TZLS-401
Foralumab is the only fully human anti-CD3 monoclonal antibody (mAb) in clinical development in contrast to the previous non-human or humanized anti-CD3 mABs. Recent data from studies conducted in the laboratories of Prof. Howard Weiner (Harvard University)[1] and Prof. Kevan Herold (Yale University) suggest that oral administration of formalumab has the potential to improve efficacy while minimizing toxicity in the treatment of inflammatory diseases such as NASH (nonalcoholic steatohepatitis), PBS (primary biliary cholangitis) and other autoimmune and inflammatory diseases.
Results from a previous Phase 1 evaluation of foralumab administered via intravenous injection in patients with Crohn’s disease demonstrated foralumab’s immunomodulatory activity in humans. Recent clinical studies conducted by Prof. Yaron Ilan with oral administration of anti-CD3 (OKT3; murine mAb) in hepatitis C virus infected patients and in NASH patients suggested that the treatment was well-tolerated and produced immunologic effects consistent with potential clinical benefits.
Our strategy is to build on these exciting findings to develop foralumab for treatment of NASH, PBC and other liver diseases. Foralumab may also be combined with TZLS-501, a fully human anti-IL-6R mAB, for treatment of rheumatoid arthritis and other diseases.
Milciclib
TZLS-201
The Company’s lead compound, acquired from Nerviano Medical Sciences, is an orally bioavailable, small molecule pan-inhibitor of cyclin-dependent kinases (CDK: 1, 2, 4, 5, and 7) as well as Src family kinases.
The compound was well tolerated by patients with thymoma in Phase I and Phase 2 clinical trials. Interim data analysis from the Phase 2 trial indicated that the treatment was well-tolerated and it produced encouraging clinical responses. In another study, milciclib in combination with gemcitabine was found to be well tolerated, and the treatment improved clinical outcomes in patients with refractory solid tumors.
A unique feature of milciclib is its ability to reduce microRNAs miR-221 and miR-222. These microRNAs are consistently upregulated in hepatocellular carcinoma (HCC) patients and might contribute towards resistance to treatment with sorafenib. Thus, we believe milciclib has potential to be developed as a drug candidate for treatment of HCC either as a monotherapy or in combination with sorafenib.
Our strategy is to first initiate clinical studies as a Phase 2a monotherapy with milciclib, which will be followed immediately by a Phase 2b clinical study in combination with sorafenib.
PRE-CLINICAL PROGRAMMES
Anti IL-6R mAb
TZLS-501, formerly NI-1201
Recently acquired anti IL-6R mAb is a fully human monoclonal antibody targeting the interleukin-6 receptor (IL-6R). Anti IL-6R mAb offers a unique mechanism of action in which, it binds to both the membrane-bound and soluble forms of the IL-6R and depletes circulating levels of the IL-6 in the blood. An excessive production of IL-6 is regarded as a key driver of chronic inflammation, associated with autoimmune diseases such as multiple myeloma and rheumatoid arthritis.
StemPrintER
StemPrintER is a multi-gene signature assay intended for use in patients diagnosed with estrogen-receptor positive ER+/HER2 negative breast cancers. This in-vitro prognostic test will be used in conjunction with clinical evaluation to identify those patients at increased risk for early and/or late metastasis.
Our diagnostic has a unique biological basis, being based on the detection of cancer stem cell markers, uses a reliable platform (qRT-PCR, FFPE), and has been evaluated in an initial retrospective validation study using a consecutive cohort of approximately 2400 patients with breast cancer. The development team is preparing for a retrospective validation study using an independent cohort and has discussed submission plans with the FDA.
FINANCIAL
£1.67m raised through issuance of equity.
For the six months to 30 June 2018 the consolidated Group made a loss of £3.94m (six months to 30 June 2017: £3.87m).
The Group ended the period with £0.1m cash as at 30 June 2018 (31 Dec 2017: £0.1m).
The Company continues to carefully manage its working capital position and continues the process,as referred to below, to seek to raise further funds through the issueof ADSs through a United States Offering.
Highlights post period:
In July 2018, the Company announced the filing of a registration statement on Form F-1 with the U.S. Securities Exchange Commission ("SEC") relating to a proposed initial public offering of its American Depositary Shares ("ADSs"), representing ordinary shares of nominal value £0.03 each in the capital of the Company ("Ordinary Shares"), in the United States (the "Offering").
On August 16, 2018 – the Company announces the submission of an Investigational New Drug ("IND") application to the U.S. Food and Drug Administration in collaboration with the Brigham and Women’s Hospital, Harvard Medical School, Boston, MA ("BWH") to Initiate Phase 1 Clinical Trials with Foralumab, to be administered nasally to healthy volunteers, with the objective of demonstrating proof of concept in a potentially revolutionary approach for the treatment of neurodegenerative diseases, such as progressive multiple sclerosis ("MS").