This Undiscovered Biotech Has Blockbuster Potential With The Only Fully Human Anti-CD3 Monoclonal Antibody In Clinical Development
TLSA has closed green 5 of the last 6 and looks to be on the move right now
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We have a new profile for Tuesday’s session.
Pull up TLSA right away.
Historically, monoclonal antibodies, such as blockbuster drug, Humira®, have performed as the best selling drugs in the world. Targeting across multi-indications such as autoimmune disorders and degenerative diseases, these drugs have multi-billion dollar blockbuster potential.
To this day, there is no drug on the market that is a fully human, anti-CD3 monoclonal antibody…and Tiziana Life Sciences (NASDAQ: TLSA) is developing the potential to treat patients in need that suffer from secondary progressive multiple sclerosis.
Tiziana Life Sciences (NASDAQ: TLSA) is a clinical stage biotechnology company that specializes in developing transformative therapies for neurodegenerative and lung diseases. The Company’s clinical pipeline includes drug assets for Secondary Progressive Multiple Sclerosis, ALS, Alzheimer’s, Crohn’s Disease and KRAS+ NSCLC.
Tiziana is led by a team of highly qualified executives with extensive drug development and commercialization experience.The Company is developing transformational formulation technologies, enabling it to switch from traditional routes to alternative routes of immunotherapy to facilitate local sites of action.
Even in our day and age, there is currently still no cure for neurodegenerative diseases such as Alzheimer’s and ALS. The rise of diagnoses can be attributed to the aging population as life expectancy increases.
Neurodegenerative diseases collectively affected 4.7 to 6.0 million individuals in the U.S. between 2016-2017. These diseases were responsible for 272,644 deaths and 3,011,484 disability adjusted life years in 2016.
Not only is this a growing health concern, but the annual cost to the US from Alzheimer’s disease and related dementias and other neurodegenerative diseases was $655 billion in 2020 USD.
Autoimmune diseases are conditions in which your immune system mistakenly attacks your body. A healthy immune system defends the body against disease and infection. But if the immune system malfunctions, it mistakenly attacks healthy cells, tissues, and organs. These attacks can affect any part of the body, weakening bodily function and even become life-threatening. These diseases affect more than 24 million people in the United States.
TLSA is revolutionary in the biotech space as the company works to deliver on its clinical strategy through an exciting pipeline with drug development programs across several degenerative and autoimmune disease indications that have a large unmet need\
TLSA has closed green 5 of the last 6 and looks to be on the move right now.
Investment Highlights:
A revolutionary platform: TLSA is first in class, switching from uncomfortable antibody injections to revolutionary nasal and oral methods of delivery. The benefits of switching to this unique methodology are increased patient compliance, minimized side effects, and anticipated lower cost of goods and administration.
Multiple Indications: TLSA’s focus is across multiple indications such as neurodegenerative diseases like Multiple Sclerosis as well as lung diseases. Similar monoclonal antibody drugs, such as Humira®, have performed extraordinarily well with approximately $200 billion dollars in revenue.
Monoclonal Antibodies: Recently, Provention Bio, a competitor for TLSA, was acquired by Sanofi SA (NASDAQ: SNY) for $2.9 billion. Tiziana stands out from the competition as their drug, foralumab, is administered nasally and is fully human.
Foralumab: Tiziana’s clinical drug, foralumab, a fully human anti-CD3 monoclonal antibody for the treatment of neurodegenerative diseases, works with novel technology to be delivered nasally. This allows the drug to bypass and potentially prevent the toxicities that may be present with non-fully human antibodies making it a revolutionary and very exciting clinical development.
Market Potential: Neurodegenerative diseases are rising which contributes to a growing market market projected to reach USD 53 Billion by 2030 and grow steadily at a CAGR of 3.2%. Beyond that, competitors are catching the attention of big pharma.
Unmet Need: TLSA is dedicated to developing drugs to service diseases that currently have no cure. The company’s clinical trial is across multiple neurodegenerative disease, autoimmune, and lung disease indications.
Gabriele Cerrone, interim chief executive and executive chair. He has a track record of corporate financing having listed nine companies, seven on NASDAQ and two in London. He is the former chair of Trovagene, Gensignia, Rasna, Contravir and Okyo. He is also the co-founder and director of two NASDAQ-listed companies that brought drugs from the discovery through to US Food & Drug Administration approval: Synergy Pharmaceuticals and Siga Technologies.
Foralumab (TZLS-401)
Foralumab is a fully human anti-CD3 monoclonal antibody (mAb) for the treatment of Crohn’ s and neurodegenerative diseases. We have completed two Phase 1 clinical trials: one for progressive MS indication with nasal administration and the other for Crohn’s disease indication, with enteric coated capsules administered orally. We also completed a Phase 2 trial treating mild to moderate non-hospitalized COVID-19 patients in Brazil with intranasal foralumab with positive results (Moreira et al., 2021)*. Currently, two secondary progressive MS patients are being treated at Brigham and Women’s Hospital, Boston MA, with intranasal foralumab under Expanded Access INDs with signs of clinical benefit, we are expecting 12-month data from EA#1 and 6-month data from EA#2 in 4Q-2022. Patient enrolment for the Intermediate-size patient population expanded program has begun. Foralumab has demonstrated ability to activate regulatory T cells that systemically circulate to elicit targeted immunomodulation providing therapeutic benefit to patients.
Tiziana has recently 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. Foralumab administered alone or co-administered in combination with co-stimulatory molecules, such as an anti-IL-6 receptor monoclonal antibody, an anti-CD28 monoclonal antibody or specific inhibitors of signalling pathways of phosphatidylinositol 3-kinase (PI3K), protein kinase B (AKT), or mammalian target to improve success of CAR-T therapy.
* Moreira, T. G., et al. (2021) Nasal Administration of Anti-CD3 Monoclonal Antibody (Foralumab) Reduces Lung Inflammation and Blood Inflammatory Biomarkers in Mild to Moderate COVID-19 Patients: A Pilot Study. Front Immunol 12, 709861
Milciclib (TZLS-201)
Milciclib is a potent, small molecule inhibitor of multiple cyclin-dependent kinases (CDKs), tropomycinreceptor kinases and Src family kinases controlling cell growth and malignant progression of cancer. Milciclib has demonstrated safety and tolerability in 316 patients with advanced solid cancers in Phase 1 and 2 studies and also exhibited positive clinical responses. In two, successfully completed, Phase 2 thymic cancer trials, Milciclib successfully increased overall survival and met both primary and secondary endpoints.
In July and September 2019, we reported positive Phase 2a safety, tolerability and efficacy data of Milciclib as a monotherapy in 28 patients with advanced HCC. The results, presented at ASCO2020, warrants further clinical development. Strong genetic and pharmacological evidence suggests that pan-CDKs inhibitors might have potential to suppress the multiple tumorigenic pathways that are activated due to activation of KRAS gene. Clinical data from a Phase I dose-escalation study with combination of milciclib with gemcitabine showed significant disease stabilization and suggested that milciclib can reverse gemcitabine-resistance in NSCLC refractory solid tumors. The clinical response in the NSCLC patient was particularly very promising. Company is exploring the combination of milciclib and gemcitabine in NSCLC subjects with pan KRAS-positive mutations.
TZLS-501
Tiziana’s Anti IL-6R mAb (TZLS-501), a fully human mAb binds to both membrane-bound and soluble forms of IL-6R, an inflammatory cytokine driving chronic inflammation associated with autoimmune disease and cancer, reducing circulating levels of the IL-6 cytokine. Anti-IL-6R antibody can potentially be used in combination with Foralumab or other anti-inflammatory and anti-infective agents as therapy for idiopathic pulmonary fibrosis (IPF), acute respiratory distress syndrome (ARDS), multiple myeloma, arthritis, lupus and oncology indications. Excessive production of IL-6 is regarded as a key driver of chronic inflammation and is believed to be associated with severe lung damage and chronic fibrosis observed with acute and chronic respiratory illness.
The Company is scaling GMP manufacturing of its anti-IL-6R mAb concurrently with developing a hand-held nebulizer technology for direct delivery of the antibody into the for treatment of patients with IPF, a rare disease indication.
Tiziana Life Sciences Announces Study Results from Intranasal Anti-CD3 Foralumab in Multiple Sclerosis Patients with PIRA Highlighted in Neurology Today®
April 19, 2024 at 7:00 AM EDT
– Intranasal foralumab attenuated microglial activation in patients with non-active secondary progressive multiple sclerosis and progression independent of relapse (PIRA) –
– Data presented in a platform session at the Annual Meeting of the American Academy of Neurology in Denver, Colorado –
NEW YORK, April 19, 2024 (GLOBE NEWSWIRE) — Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies via novel routes of drug delivery, today announced that a study related to its lead candidate, foralumab, was highlighted in Neurology Today®, the official news source of the American Academy of Neurology (AAN), in an article titled, “Anti-CD3 Antibody Foralumab Shows Promise in PIRA, Measured by Novel PET Ligand.”
The study is authored by Tarun Singhal, M.B.B.S., M.D., Director, PET Imaging Program in Neurologic Diseases at Brigham and Women’s Hospital, a founding member of Mass General Brigham Healthcare System, and Associate Professor of Neurology at Harvard Medical School, and shows that foralumab, a fully human anti-CD3 monoclonal-antibody, attenuates microglial activation in non-active secondary progressive multiple sclerosis (na-SPMS) patients with progression independent of relapse (PIRA). A systemic review published in JAMA Neurology[1] in October 2023 found that PIRA is the most frequent manifestation of disability accumulation across the full spectrum of traditional multiple sclerosis (MS) phenotypes.
“PIRA is a condition that poses a major unmet need for patients with multiple sclerosis,” stated Dr. Singhal. “Currently, there are no disease-modifying therapies approved for this category of progressive MS patients. This study provides initial evidence that this fully human anti-CD3 has the potential to benefit this type of MS, which is the most difficult form to treat.”
“We do not have any recognized approaches to try to alter microglial activation at present, which everyone agrees at this point in time is relevant throughout the life of a patient with MS. Even ocrelizumab [Ocrevus] for primary progressive MS has modest impact, so the potential here is great, and the proof of principle that you can alter the microglia is a real punchline,” said John Corboy, MD, FAAN, an endowed chair in neurology and director of the Rocky Mountain Multiple Sclerosis Center at the University of Colorado Anschutz Medical Campus.
The study assesses the effect of intranasal foralumab on microglial activation in na-SPMS patients with PIRA as measured by positron emission tomography (PET) imaging via radiology marker [F-18]PBR06-PET, a novel, long-half-life ligand used in PET scanning. The study is designed to be open-label and is based on data from the Expanded-Access Program evaluating foralumab in na-SPMS patients that is currently underway. In this study, five of six patients (83%, 95% confidence interval 44%-97%) showed a qualitative reduction on [F-18]PBR06-PET in multiple brain regions after both 3 and 6 months of nasal foralumab treatment.
Data from the study was presented at a platform session at the Annual Meeting of the American Academy of Neurology being held in Denver, Colorado. The abstract is entitled, “Treatment of PIRA with Nasal Foralumab Dampens Microglial Activation and Stabilizes Clinical Progression in Non-Active Secondary Progressive MS.”
The link to the full Neurology Today® article can be found here: https://journals.lww.com/neurotodayonline/blog/NeurologyTodayConferenceReportersAANAnnualMeeting/pages/post.aspx?PostID=211
About Foralumab
Activated T cells play an important role in the inflammatory process. Foralumab, the only fully human anti-CD3 monoclonal antibody (mAb), binds to the T cell receptor and dampens inflammation by modulating T cell function, thereby suppressing effector features in multiple immune cell subsets. This effect has been demonstrated in patients with COVID and with multiple sclerosis, as well as in healthy normal subjects. The non-active SPMS intranasal foralumab Phase 2 trial began screening patients in November of 2023. Immunomodulation by nasal anti-CD3 mAb represents a novel avenue for treatment of neuroinflammatory and neurodegenerative human diseases.
Tiziana Life Sciences Announces New Quantitative PET Imaging Data on Foralumab at the Annual Meeting of the American Academy of Neurology
April 18, 2024 at 7:00 AM EDT
Oral presentation of study shows intranasal foralumab attenuates microglial activation and disease progression in multiple sclerosis (MS) patients with PIRA as measured by changes in PET scans
NEW YORK, April 18, 2024 (GLOBE NEWSWIRE) — Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies via novel routes of drug delivery, today announces a platform presentation titled, “Treatment of PIRA with Nasal Foralumab Dampens Microglial Activation and Stabilizes Clinical Progression in Non-Active Secondary Progressive MS” at the Annual Meeting of the American Academy of Neurology in Denver, Colorado. The presentation includes new, encouraging quantitative imaging data from foralumab’s intermediate- size patient population Expanded Access Program. In the presentation, foralumab, a fully human anti-CD3 monoclonal-antibody showed the attenuation of microglial activation in patients with non-active secondary progressive multiple sclerosis (na-SPMS) based on positron emission tomography (PET) imaging and disease stabilization in na-SPMS patients with disease progression independent of relapse (PIRA).
Gabriele Cerrone, Chairman, acting CEO and founder of Tiziana Life Sciences, commented, “Tiziana is taking a leadership role in focusing on this subset of progressive MS where there are no effective treatments. One of the mechanisms thought to contribute to na-SPMS with PIRA is the activation of microglial cells, for which there have historically been no good biomarkers in humans. However, [F18]PBR06-PET is a novel imaging technique using a ligand with a long half-life, and therefore serves as a viable proof-of-concept to show the binding and dampening of active microglia. We are now able to quantify these immunologic changes via PET scan in na-SPMS patients. The mechanism of action seen thus far with foralumab is significant since a major unmet need in MS is developing therapy for na-SPMS with PIRA and being able to dampen associated neuro inflammation.”
The oral presentation, delivered by Tarun Singhal, M.B.B.S., M.D., Director of the PET Imaging Program in Neurologic Diseases at Brigham and Women’s Hospital, a founding member of Mass General Brigham Healthcare System, and Associate Professor of Neurology at Harvard Medical School, assesses the effect of intranasal foralumab on microglial activation in na-SPMS patients with PIRA as measured by positron emission tomography (PET) imaging via [F-18]PBR06-PET, a novel, long-half-life ligand used in PET scanning. The study is designed to be open-label and part of the Expanded-Access Program evaluating foralumab in na-SPMS patients that is currently underway.
Five of six patients (83%, 95% confidence interval 44%-97%) showed a qualitative reduction on [F-18]PBR06-PET in multiple brain regions after both 3 and 6 months of nasal foralumab treatment, which implies that there is in vivo evidence for reduced microglial activation and neuroinflammation following treatment with nasal foralumab. White matter z-scores (a measure of abnormally increased neuroinflammation) were reduced by 26-36% in the foralumab-treated group at 3 and 6 months, which was >4-5-times higher compared to 6% variability in the test-retest group. Clinically, foralumab-treated patients demonstrated a stable EDSS and improvement in the Modified Fatigue Impact Scale (MFIS). Reduction in fatigue as measured by the MFIS is clinically relevant to the lives of na-SPMS patients and will be a key monitoring parameter moving forward.
Nasal foralumab attenuated microglial activation in na-SPMS patients with PIRA at 3 and 6 months, as evaluated by [F-18]PBR06-PET and was associated with clinical symptom stability. Based on these positive results, a double-blind, placebo-controlled, dose-ranging study of nasal-foralumab in na-SPMS with [F-18]PBR06-PET as a primary endpoint with measures of EDSS and MFIS is underway. This trial (NCT06292923) is important because if the potential to slow disease progression is demonstrated this would align with early treatment intervention.
NEWS
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Tiziana Life Sciences Announces Additional Clinical Improvements Among Multiple Sclerosis Patients in its Expanded Access Program
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Tiziana Life Sciences Announces Additional Clinical Improvements Among Multiple Sclerosis Patients in its Expanded Access Program
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Tiziana Life Sciences Announces Study Results from Intranasal Anti-CD3 Foralumab in Multiple Sclerosis Patients with PIRA Highlighted in Neurology Today®
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Tiziana Life Sciences Announces Study Results from Intranasal Anti-CD3 Foralumab in Multiple Sclerosis Patients with PIRA Highlighted in Neurology Today®
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Tiziana Life Sciences Announces Platform Presentation of New Quantitative PET Imaging Data on Foralumab at the Annual Meeting of the American Academy of Neurology
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MANAGEMENT TEAM
Gabriele Cerrone
Executive ChairmanMr Cerrone has a successful track record and extensive experience in the financing and restructuring of micro-cap biotechnology companies. He has founded nine biotechnology companies in oncology, infectious diseases and molecular diagnostics, and has taken six of these companies to the NASDAQ Market and one to the AIM Market in London. Mr Cerrone co-founded Trovagene, Inc. (NASDAQ: TROV), a molecular diagnostic company and served as its Co-Chairman; he was a co-founder and served as Chairman of both Synergy Pharmaceuticals, Inc. (NASDAQ: SGYP) and Callisto Pharmaceuticals, Inc. (OTCMKTS: CLSP), and was a Director of and led the restructuring of Siga Technologies, Inc. (NASDAQ: SIGA). Mr Cerrone also co-founded FermaVir Pharmaceuticals, Inc. and served as Chairman of the Board until its merger in September 2007 with Inhibitex, Inc. Mr Cerrone served as a director of Inhibitex, Inc. until its US$2.5bn sale to Bristol Myers Squibb Co in 2012. Mr Cerrone is the Executive Chairman and Co-Founder of Gensignia Life Sciences, Inc., a molecular diagnostics company focused on oncology using microRNA technology; Chairman and Founder of Tiziana Life Sciences plc (AIM: TILS) an oncology focused therapeutics company; Chairman and Co-Founder of Rasna Therapeutics Limited, a company focused on the development of therapeutics for leukaemias; Co-Founder of ContraVir Pharmaceuticals, Inc. (Nasdaq: CTRV); and founder of BioVitas Capital Ltd.
Matthew W Davis, MD, RPh
Chief Medical Officer and acting Chief Scientific OfficerDr. Davis has extensive experience in new drug application, or NDA, and biologic license application, or BLA, FDA approvals and device clearances. Notable approved brands that Dr. Davis has worked on include Lidoderm®, Sculptra®, Colcrys® and most recently QWO®. Dr. Davis previously served as Chief Scientific Officer and Chief Medical Officer at Endo Pharmaceuticals where he restructured the R&D department and collaborated to obtain BLA approval for QWO®. Additionally, Dr. Davis was Chief Medical Officer for Lupin Inc. and URL Pharma, Inc. where he spearheaded three NDA approvals and was the inventor on all 17 Orange Book listed patents for Colcrys®. He also was on the executive team that sold URL Pharma to Takeda Pharmaceutical Company for approximately $800M combined with over $1B in performance-based contingent earn out payments. Dr. Davis matriculated to the University of Pennsylvania as an undergraduate. He received his Pharmacy Degree from Temple University and his Medical Degree from the Medical College of Pennsylvania. Dr. Davis undertook his surgical training at Brown University and his Urology training at Washington Hospital Center
Keeren Shah
Chief Financial Officer Keeren Shah serves as our Chief Financial Officer. Ms. Shah currently also serves as the Chief Financial Officer of OKYO Pharma Ltd, Accustem Sciences Limited and Rasna Therapeutics Inc., having previously served as the Group Financial Controller for all businesses from June 2016 to July 2020. Prior to joining the Company, Ms. Shah spent 10 years at Visa, Inc. as a Senior Leader in its finance team where she was responsible for key financial controller activities, financial planning and analysis, and core processes as well as leading and participating in key transformation programmes and Visa Inc.’s initial public offering. Before joining Visa, Ms. Shah also held a variety of finance positions at other leading companies including Arthur Andersen and BBC Worldwide. She holds a Bachelor of arts with honors in Economics and is a member of the Chartered Institute of Management Accountants.
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