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Tiziana Life Sciences Ltd. develops intranasal foralumab, a fully human anti-CD3 monoclonal antibody, as a clinical-stage biotechnology company focused on neuroinflammatory and neurodegenerative diseases. News for TLSA centers on clinical and preclinical data for intranasal anti-CD3 therapy, including non-active secondary progressive multiple sclerosis, Multiple System Atrophy, Alzheimer’s disease, ALS, Long COVID-associated neuroinflammation, and age-related cognitive decline.
Company updates also cover biomarker work involving CSF proteomics, TSPO-PET and microglial activation, peer-reviewed publications, scientific conference presentations, expanded-access observations, and financing actions such as registered direct offerings of ordinary shares and warrants.
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.
Tiziana Life Sciences (NASDAQ: TLSA) announced the online publication of two abstracts on its drug Milciclib at the ASCO20 meeting. The Phase 2a study showed Milciclib was well-tolerated in sorafenib-resistant hepatocellular carcinoma (HCC) patients, meeting primary endpoints with no drug-related deaths. Results indicated a 61% clinical benefit rate and a median progression-free survival of 5.9 months. Additionally, preliminary data from an ongoing trial combining Milciclib with Regorafenib showed a 20% reduction in AFP levels in liver transplant patients with recurrent HCC.
Tiziana Life Sciences plc (Nasdaq: TLSA) announces a new study on its StemPrintER genomic tool, showing its superiority over Oncotype DX in predicting breast cancer recurrence. Presented by scientists at the European Institute of Oncology at the upcoming ASCO Virtual Conference, the study highlights StemPrintER’s advanced prognostic capabilities in ER+/HER2- breast cancer patients. An additional model, SPARE, further refines distant metastasis predictions. This advancement reinforces Tiziana’s position in precision medicine and opens new business avenues beyond existing therapeutic pipelines.
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