ð¨Trade Alert ð¨ TLSAÍ â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Í â Trading at around $1, TLSA is a biotech company that is sitting on what may be the next WONDER DRUG! Greetings All, The biotech sector is filled with promising companies. Investors hunt high and low for those in the space that are trending and/or have exciting developments. One little-known company trading on the NASDAQ has such developments and has been seeing its trading volume explode compared to normal! Hurry and add Tiziana Life Sciences Ltd. (NASDAQ: TLSA) to your radar. []( Tiziana Life Sciences Ltd. is a biotech company that is beginning to catch major Wall Street attention for its latest news and a drug candidate it is developing that could turn into a âwonder drugâ in healthcare. This is the kind of drug that could really shake things up in the trillion-dollar healthcare space! Covid-19 dominated headlines for years and while the topic is not as loud as it was, the virus is still very much out there. It also has caused many people to have long Covid. Whatâs scary is that it can hit any time and has even affected people who were barely affected by the virus when they initially contracted it. [More than 200 symptoms]( have been identified with impacts on multiple organ systems. While Moderna became a biotech darling on the heels of developing its covid vaccine, what about a company that could have a treatment for long Covid? Thatâs where TLSA enters the equationâ¦. The company had huge news this month announcing that it is pursuing the development of intranasal foralumab (its lead drug candidate) for the treatment of Long COVID. Foralumab is the worldâs only fully human, anti-CD3 mAb in clinical development! This alone makes the company one to keep a VERY CLOSE EYE ON! How important is anti-CD3 mAb? Well, it was recently announced in March that Provention Bio is being [acquired by Sanofi]( for $2.9 billion for the company's humanized anti-CD3 monoclonal antibody drug, teplizumab⦠TLSA chief medical officer Dr. Matthew Davis says the company intends to enter into a three-month Phase 2a placebo-controlled clinical trial to research how foralumabâs well-established role in de-activating microglia cells could treat or reduce the symptoms of Long COVID. You can watch more about that here: [( Long COVID remains a high unmet need causing a myriad of complications for patients and costing the U.S. healthcare system an estimated $2.6 trillion! The role of activated microglia is well-established in the pathogenesis of Long COVID and TLSAâs first-in-class intranasal foralumab dampens activated microglia. This is all very promising news but isnât the only big market for foralumab. London-based TLSA is also focusing its research on foralumab's potential for treating late-stage MS. ANDâ¦. the drug has the potential to treat multiple other diseases. With [a price target of $3.10]( there could be substantial upside ahead for this quietly trading company that may have the next revolutionary drug to enter the healthcare market. Foralumab is even gaining recognition across the scientific community with features in medical media that include Pharmacy Times. It was recently highlighted positively in a Forbes article that can be read [HERE.]( The exciting potential for this treatment was also recently picked up in an article from the premier scientific journal, [Proceedings of the National Academy of Sciences (PNAS).]( PNAS reported on a recent trial where the treatment reduced inflammation in patients with both COVID-19 and MS patients. What else makes TLSA stand out? The company is developing transformational formulation technologies, enabling to switch from traditional routes to alternative routes of immunotherapy to facilitate local site of action. If the company succeeds in these alternative routes of immunotherapies, it has the potential to change the way immunotherapies are currently conducted! In other words, TLSA could disrupt the immunotherapies market significantlyâ¦. The companyâs clinical pipeline is aiming to help central nervous system (CNS) diseases and includes drug assets for Secondary Progressive Multiple Sclerosis, ALS. Alzheimer's, Crohn's Disease, and KRAS+ NSCLC. âWe look forward to leveraging the exciting clinical and preclinical results from our very promising formulation of intranasal foralumab that we have generated so far in CNS-based autoimmune diseases to guide our pipeline investment. We aim to become a leading company pioneering intranasal therapies for CNS-based diseases.â - Gabriele Cerrone, executive chairman and interim CEO of Tiziana. Insider ownership stands at a staggering 41% indicating that the companyâs team has complete faith in their lead candidate Foralumab turning it into the next biotech darling. AND⦠the company has plenty of cash on hand to continue its clinical studies and to move closer to getting its drug candidates commercialized and into markets. TLSA ended the period with cash]( as at 30 June 2022. There could be phenomenal growth potential here as Wall Street continues to learn about TLSAâs lead immunotherapeutic candidate Foralumab! Company Overview Tizianaâs innovative nasal, oral and inhalation approaches in development have the potential to provide an improvement in efficacy as well as safety and tolerability compared to intravenous (IV) delivery. Its technology for alternative routes of immunotherapy has been patented with several applications pending and is expected to allow for broad pipeline applications. The companyâs mission is to bring breakthrough therapies to patients with the aim of treating Secondary Progressive Multiple Sclerosis, ALS, Alzheimer's, and other CNS indications. Crohn's Disease, lung diseases and optimizing health outcomes. Clinical Candidates TLSAâs major clinical assets are supported by extensive worldwide issued patents and pending patent applications covering composition of matter, formulation technologies, manufacturing processes and disease indications. -
Foralumab - Foralumab is a fully human anti-CD3 monoclonal antibody (mAb) for treatment of Crohnâ s Disease and neurodegenerative indications. -
Anti IL-6 Receptor mAb (IL-6R:TZLS-501) - The company is developing a fully human monoclonal antibody (mAb) targeting the receptor for IL-6 as a potential treatment for lung diseases. -
Milciclib - Milciclib is the Companyâs clinical candidate for the treatment in cancer indications. The company is exploring the combination of milciclib and gemcitibine in NSCLC patients with pan KRAS+ mutations. Lead Drug Candidate - Foralumab The companyâs lead candidate, intranasal foralumab, is the only fully human anti-CD3 mAb, and has demonstrated a favorable safety profile and clinical response in patients in studies to date. This unique intranasal monoclonal antibody is currently in clinical development to treat multiple sclerosis (MS) and a range of other neurodegenerative diseases. TLSA isnât in R&D⦠the company is already in the clinical stage and has completed two pivotal Phase 1 clinical trials with foralumab: - One for progressive MS indication with nasal administration - One for Crohnâs disease indication, with enteric-coated capsules administered orally Crohnâs disease affects between 400,000 and 600,000 people in North America. Current estimates for Northern Europe have ranged from 27â48 people per 100,000. Multiple sclerosis (MS) is a chronic inflammatory and neurodegenerative disease affecting approximately 400,000 people in the United States and 2.1 million people worldwide. The company also completed a Phase 2 trial treating mild to moderate non-hospitalized COVID-19 patients in Brazil with intranasal foralumab with positive results. Initial Results Announced with Further Trials Planned in Q3 2023 The drug has already been tested on six non-active secondary progressive MS patients in an open-label expanded access (EA) program. The program evaluated patient progress on the expanded disability status scale (EDSS). The scale measures the severity of MS symptoms, with lower numbers representing less severe symptoms. While using ocrelizumab, the second expanded access patient (EA2) had deteriorated from a 3.5 to a 6.0 by October 2018. This EDSS score meant he couldn't walk 200 meters without a cane, and ocrelizumab treatment was discontinued in 2021. However, after 11 months of using foralumab in 2022, EA2 had his EDSS score fall to 5.0. He recovered lost motor neuron control and was able to walk 200 meters without a cane. Positron emission tomography scans (PET scans) of the brain also revealed decreased neural damage across the brain. The company is excited by this development, especially in a late-stage, non-active SPMS patient, as no other drugs have been approved by the FDA for this condition. Tiziana will begin its [phase 2 trial in the third quarter of 2023](. This will be a three-month, randomized, placebo-controlled trial, and its primary endpoint will be measured via PET scan. Other Markets Investigators under Tizianaâs umbrella have performed additional work using the anti-CD3 foralumab in Alzheimerâs disease (AD), Amyotrophic Lateral Sclerosis (ALS) and an undisclosed rare pediatric disease where there are no other treatments showing that there may be a benefit to patients. Others have performed studies showing that anti-CD3 may mitigate the severity of diabetes, arthritis, inflammatory bowel disease, and lupus. Foralumab has demonstrated the ability to activate regulatory T cells that systemically circulate to elicit targeted immunomodulation providing therapeutic benefit to patients. Tiziana has additionally submitted a patent application on potential use of Foralumab, to improve success of chimeric antigen receptor T cells (CAR-T) therapy for cancer and other human diseases. The patent application covers inventions related to improving CAR-T expansion and/or survival. In summary⦠Biotech is a red-hot industry with diligent eyes on the arena watching out for the next big thing. The potential for substantial returns makes companies in the space perpetually attractive. Identifying companies with the best chances of developing breakthrough drugs or therapies is paramount to success and TLSA looks like one of them! The company is aiming to bring to market a unique drug candidate that could significantly help millions of people. Thereâs only one reason why insiders would be loading up and thatâs because they believe their company is headed higher⦠The cogs are in motion and Tiziana Life Sciences Ltd. (NASDAQ: TLSA) could be heading toward an FDA green light in its future. Now is the time to have the company high on your radar! Copyright 2022 © SCDalerts.com is owned and operated by the owner of SCD Media LLC. 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