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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 (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.
Tiziana Life Sciences (Nasdaq: TLSA) has been granted a patent by the USPTO for treating Crohn’s disease with Foralumab, a fully human monoclonal antibody. This patent, effective from September 1, 2020, enhances the company's intellectual property portfolio. Tiziana's Phase 1 trial indicated Foralumab’s oral administration was well-tolerated, leading to plans for a Phase 2 trial for moderate-to-severe Crohn’s patients later this year. The innovative oral and nasal delivery methods aim to reduce toxicity and enhance treatment efficacy.
Tiziana Life Sciences (Nasdaq: TLSA) announced management team participation in the BTIG Biotechnology Conference on August 11, 2020, at 2:30 p.m. EDT. The event can be accessed through a live webcast via registration. Tiziana is focused on developing targeted drugs for cancer, inflammatory diseases, and COVID-19, with foralumab entering phase 2 studies for conditions like Crohn’s Disease and multiple sclerosis.
Foralumab is the world's only fully human anti-CD3 mAb in clinical development, with applications in autoimmune diseases.
Tiziana Life Sciences (Nasdaq: TLSA) announced the closure of a registered direct offering, issuing 11,009,615 American Depositary Shares (ADSs) at $5.20 per share, raising approximately $57.25 million. The proceeds will support clinical development of Foralumab, clinical trials for HCC patients with Milciclib, and expedite development of TZLS-501 for COVID-19. The total number of Ordinary Shares post-offering is now 190,559,823. ThinkEquity acted as the placement agent for the offering.
Tiziana Life Sciences plc (NASDAQ: TLSA) has signed agreements with four contract research organizations (CROs) to expedite the clinical development of TZLS-501, a fully human monoclonal antibody targeting IL-6R for COVID-19 treatment. The company plans to initiate human clinical trials in Q1 2021. Key partners include FHI Clinical, STC Biologics, Sciarra Labs, and ITR Laboratories Canada, which will assist with GMP manufacturing, safety studies, and inhalation technology. TZLS-501 aims to address cytokine release syndrome by depleting IL-6 levels directly in patients' lungs.
Tiziana Life Sciences (NASDAQ: TLSA) has reported issuing 2,043,000 ordinary shares in July 2020 under its ATM sales agreement, raising $4,371,289. The total number of ordinary shares now stands at 168,540,593, with each share providing one vote in company meetings. Tiziana is advancing its clinical programs, including phase 2 studies for Foralumab, a pioneering anti-CD3 monoclonal antibody aimed at treating autoimmune conditions like Crohn's Disease and multiple sclerosis, alongside developing treatments for COVID-19.
Tiziana Life Sciences (NASDAQ: TLSA) announced the submission of a patent application for the nasal administration of Foralumab, an anti-CD3 monoclonal antibody, as a treatment for COVID-19. This innovative method could enhance immune response and reduce cytokine storms in patients. The company also reported successful Phase 1 trials for both nasal and oral administrations of Foralumab, which showed positive immunomodulatory effects and no severe toxicities. Tiziana holds exclusive rights for this delivery method, aligning with its focus on advancing immunotherapeutic approaches to treat various diseases.
Tiziana Life Sciences plc announced its intention to apply for a standard listing of its ordinary shares on the Official List and admission to trading on the London Stock Exchange's main market. The directors believe this move will enhance the company's global profile, increase trading liquidity, and attract a broader base of investors. Importantly, the company will not issue new shares or raise capital through this listing. A formal notice regarding the cancellation of trading on the AIM market will follow, with expectations to publish a prospectus by late Q3 or early Q4 2020.
Tiziana Life Sciences (Nasdaq: TLSA) announced an investor webinar on July 30, 2020, at 4:00 p.m. U.S. Eastern, where CEO Kunwar Shailubhai will discuss the company’s development pipeline and milestones. The webinar includes a live Q&A session. Tiziana focuses on innovative therapeutics for oncology, inflammation, and infectious diseases. Key products include TZLS-501, a monoclonal antibody for COVID-19 treatment, and Foralumab, a fully human anti-CD3 mAb aimed at autoimmune diseases.
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