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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 plc (NASDAQ: TLSA / AIM: TILS) announced that all resolutions were passed at its Annual General Meeting held on July 16, 2020. The meeting took place at 10:00 a.m. in London and New York. The results of the proxy voting will be made available on the Company’s website. Tiziana focuses on discovering and developing novel therapeutic molecules for oncology and immunology, including milciclib and foralumab, a fully human anti-CD3 monoclonal antibody currently in clinical development for various autoimmune and inflammatory diseases.
Tiziana Life Sciences (NASDAQ: TLSA) has submitted a patent application for Foralumab, a fully human anti-CD3 monoclonal antibody, aimed at enhancing CAR-T therapy's effectiveness for cancer and other diseases. The application presents methods to improve CAR-T expansion and survival either alone or with other co-stimulatory agents. Foralumab's reduced cytokine release may improve safety profiles in T-cell therapies. The company is advancing Foralumab for Crohn's Disease and progressive multiple sclerosis, as well as developing an anti-IL-6 receptor monoclonal antibody for COVID-19 treatment.
Tiziana Life Sciences plc (NASDAQ: TLSA) announced a change in its sponsored Level 3 American Depositary Receipt (ADR) programme. ADR holders will receive 1.5 additional ADRs for each existing ADR held as of the record date, July 27, 2020, instead of the previously stated 2.5. Existing ADRs remain valid without requiring exchange. The register at JPMorgan will close for issuances and cancellations from July 27, 2020, and will reopen on August 4, 2020. Tiziana focuses on developing novel molecules to treat diseases including oncology and autoimmunity.
Tiziana Life Sciences plc (NASDAQ: TLSA) has announced a ratio change in its sponsored Level 3 American Depositary Receipt (ADR) program, transitioning to a 2.5 for 1 forward split. This adjustment, effective July 31, 2020, alters the ratio from five ordinary shares for one ADR to two ordinary shares per ADR. The change will increase the number of ADSs without affecting the underlying shares or their nominal values. Existing ADR holders will receive 2.5 additional ADRs for each ADR held as of July 27, 2020, the record date.
Tiziana Life Sciences (TLSA) announced an upcoming interview with CEO Kunwar Shailubhai on The RedChip Money Report scheduled for July 12, 2020. The interview will discuss the company's development pipeline and milestones, airing on Bloomberg International and other US channels. Tiziana focuses on innovative treatments for cancer and autoimmune diseases, including Foralumab, a monoclonal antibody in clinical development. The company cautions that forward-looking statements are subject to risks and uncertainties that may affect actual results.
Tiziana Life Sciences announced an agreement with STC Biologics for GMP manufacturing of TZLS-501, a monoclonal antibody targeting IL-6 receptors, developed for COVID-19 treatment. Tiziana is also advancing inhalation technology for direct delivery of TZLS-501 into the lungs, potentially enhancing efficacy against the disease. A patent application for this technology was submitted. The company aims to submit an Investigational New Drug (IND) application in Q1 2021, leveraging the dual mechanism of TZLS-501 to block IL-6 signaling and deplete IL-6 levels to mitigate cytokine storms in COVID-19 patients.
Tiziana Life Sciences (Nasdaq: TLSA) announced the United States Patent and Trademark Office granted a patent for its oral administration technology of Foralumab, a fully human anti-CD3 monoclonal antibody. This patent marks a historic development for immunotherapies, enabling non-intravenous treatments for diseases like Crohn’s and Alzheimer’s. The patent encompasses stabilized formulations for oral and nasal administration, enhancing therapeutic options while minimizing traditional administration toxicities. Tiziana plans to advance clinical trials evaluating Foralumab in moderate-to-severe Crohn’s Disease patients.
Tiziana Life Sciences plc (NASDAQ: TLSA) has announced that Gregor MacRae is stepping down as a director effective immediately. Gabriele Cerrone, the Chairman, expressed gratitude for MacRae's contributions and indicated ongoing efforts to recruit a new non-executive director with significant NASDAQ audit committee experience. The company is hopeful for a formal announcement regarding this new appointment soon. This announcement contains inside information as defined by EU Regulation 596/2014.
Tiziana Life Sciences (TLSA) announced that Dr. Howard Weiner has secured a NIH grant for research on nasal anti-CD3 in Alzheimer’s therapy. Preclinical studies indicate potential for the nasal administration of Foralumab to slow disease progression. The company has an exclusive license for this method from Brigham and Women’s Hospital. Following two completed Phase 1 trials, TLSA plans to initiate Phase 2 trials for Foralumab in treating progressive multiple sclerosis and Crohn’s disease. Alzheimer’s, a leading cause of dementia, underscores the urgency for innovative treatments.
Tiziana Life Sciences (NASDAQ: TLSA) announced plans to demerge its StemPrintER and SPARE genomics-based personalized medicine businesses into a separate entity. This move follows promising trial results from the European Institute of Oncology, indicating StemPrintER's potential as a standalone business. The Board aims to secure funding and allow focused growth for StemPrintER, enhancing shareholder value. Shareholder approval for a capital reduction necessary for the demerger will be sought at the upcoming Annual General Meeting, although there are no guarantees for completion.
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