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Tiziana Life Sciences Ltd. (NASDAQ: TLSA) is a progressive clinical-stage biotechnology company committed to developing transformative therapies targeting neurodegenerative and lung diseases. The company leverages innovative drug-delivery technologies to create novel treatments aimed at improving patient outcomes.
Key to Tiziana's portfolio are two prominent compounds: Milciclib and Foralumab. Milciclib, an inhibitor of cyclin-dependent kinases, is in Phase II clinical trials for thymic carcinoma, aiming to provide new hope for patients who have exhausted chemotherapy options. Foralumab, noted for being the only fully human-engineered anti-CD3 monoclonal antibody, is in various stages of clinical development for multiple sclerosis, autoimmune, and inflammatory diseases.
In a significant advancement, Tiziana recently reported positive clinical outcomes from its Expanded Access Program (EAP) for non-active secondary progressive multiple sclerosis (na-SPMS). Intranasal administration of Foralumab led to remarkable improvement in fatigue symptoms in 70% of patients over six months, as measured by the Modified Fatigue Impact Scale (MFIS). These results signify a groundbreaking step in addressing an unmet need in MS treatment.
The company's commitment to innovation is backed by strategic partnerships with prestigious institutions like Harvard Medical School and Brigham and Women's Hospital. Tiziana’s leadership team brings extensive experience in drug development and commercialization, ensuring a firm trajectory toward regulatory approvals and market entry.
Moreover, Tiziana’s pipeline includes potential therapies for conditions like ALS, Alzheimer's, and Crohn's Disease, underscoring its dedication to tackling a broad spectrum of debilitating conditions. The company’s forward-looking approach aims to revolutionize treatment paradigms through enhanced drug delivery systems that promise increased efficacy and reduced side effects.
With a robust clinical pipeline, strategic collaborations, and innovative technologies, Tiziana Life Sciences Ltd. remains at the forefront of biopharmaceutical research, poised to make significant strides in the field of immunomodulation therapies.
Tiziana Life Sciences (TLSA) announced that all resolutions were passed at the General Meeting on October 2, 2020. Key dates regarding the demerger of Accustem Sciences Limited, which will re-register as Accustem Sciences Plc, are outlined, including a court hearing on October 14 and completion of the demerger on October 30. The company received clearance from HMRC confirming that the demerger is for bona fide commercial reasons, ensuring shareholders will not face capital gains tax liabilities from receiving Accustem shares. Full voting results will be available on the company’s website.
Tiziana Life Sciences plc (NASDAQ: TLSA) announced an interview with CEO Dr. Kunwar Shailubhai, set to air on The RedChip Money Report on September 27, 2020. The discussion will cover the spinout of StemPrintER into a new entity, Accustem Sciences, and the upcoming clinical study of Foralumab for COVID-19 in Brazil. Tiziana is also advancing phase 2 studies for the orally and nasally administered Foralumab, targeting various autoimmune diseases, while working on an anti-IL6R mAb for COVID-19 treatment.
Tiziana Life Sciences (NASDAQ: TLSA) has announced a new analyst research note published by H.C. Wainwright & Co., available on their website. The company focuses on developing novel therapies for oncology, inflammation, and infectious diseases. Tiziana is advancing its pipeline, including phase 2 studies for foralumab, a human anti-CD3 monoclonal antibody targeting Crohn’s Disease and multiple sclerosis. They are also accelerating development of an anti-IL6R monoclonal antibody aimed at treating IL6-induced inflammation, particularly in COVID-19 patients.
Tiziana Life Sciences (NASDAQ: TLSA) announced a collaborative clinical study for the nasal administration of Foralumab in COVID-19 patients in Brazil, aimed at reducing severe symptoms associated with the disease. The study is anticipated to start soon, with preliminary data expected by the end of 2020. Foralumab, a fully human anti-CD3 monoclonal antibody, has shown promise in modulating the immune system, particularly in mitigating cytokine storms that lead to respiratory failure. The innovative approach may significantly impact COVID-19 treatment strategies.
Tiziana Life Sciences (TLSA) announced plans to demerge its StemPrintER asset into Accustem Sciences Limited, an independently listed public company. StemPrintER, a genomic-based assay, is noted for its 40% higher accuracy compared to the Oncotype DX assay for predicting breast cancer recurrence. A shareholder meeting is scheduled for October 2, 2020, with a record date for a 1:1 share dividend on October 30, 2020. Accustem aims for a late Q4 2020 listing on the London Stock Exchange and plans to seek CE Mark approval in November.
Tiziana Life Sciences Plc (LSE: TILS, NASDAQ: TLSA) announced a strategic demerger of its genomics-based business, StemPrintER, into a new company named Accustem Sciences Limited. This decision aims to enhance the commercialization of the StemPrintER platform with an approximate cash reserve of £1 million. The demerger requires court-approved capital reduction and involves a series of meetings and hearings planned for October 2020. Shareholders will receive shares in Accustem based on their holdings in Tiziana during the demerger record time, promoting better focus on both entities' growth strategies.
Tiziana Life Sciences plc (Nasdaq: TLSA / AIM: TILS) clarified its filing of a corrected amendment registration statement on Form F-6, which is not for a capital raise but to increase the number of American Depositary Shares (ADSs) for shareholder exchange. Each ADS represents two ordinary shares, and the trend of ordinary shares being exchanged for ADSs has grown recently. The company is also focused on developing drugs for various diseases, including Crohn’s disease and COVID-19, through its novel therapeutic candidates.
Tiziana Life Sciences (TLSA) announced a CEO interview detailing recent patent issuances, including anti-CD3 monoclonal antibodies for Crohn’s Disease and anti-IL-6 monoclonal antibodies for COVID-19. Key points discussed include the clinical pipeline for Foralumab and TZLS-501, intended for treating severe COVID-19 and hepatocellular carcinoma using Milciclib. Tiziana emphasizes its unique position with the fully human monoclonal antibody Foralumab in clinical development. The company is advancing its drug candidates aimed at various diseases.
Tiziana Life Sciences (Nasdaq: TLSA) announced the grant of a patent (No. 10,759,862) by the USPTO for its fully human monoclonal antibody, TZLS-501, aimed at treating COVID-19 and other pulmonary diseases. This antibody targets both IL-6R and IL-6, potentially alleviating cytokine storms in patients. The company plans to expedite clinical development, including GMP manufacturing and toxicology studies, to file an IND for clinical trials by Q1 2021. The patent strengthens Tiziana's IP portfolio as it seeks to utilize inhalation delivery for effective treatment.
Tiziana Life Sciences (Nasdaq: TLSA) announced that the USPTO granted a patent for the combination use of Milciclib with tyrosine kinase inhibitors (TKIs) for treating hepatocellular carcinoma (HCC). This patent (No. 10,758,541) will be published on September 1, 2020. Recent presentations at ASCO2020 highlighted Milciclib's favorable tolerance and promising activity in sorafenib-resistant HCC patients. The company aims to advance clinical evaluations for advanced and recurrent HCC cases. Dr. Shailubhai emphasized the need for combination therapies to overcome drug resistance in HCC.
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