This Undiscovered Biotech Has Blockbuster Potential with the Only Fully Human anti-CD3 Monoclonal Antibody in Clinical Development and Sanofi Just Invested Heavily in the Peer Group Through the Acquisition of Provention Bio for $2.9 BILLION DOLLARS…
Introducing Tiziana Life Sciences (NASDAQ: TLSA): a Clinical Stage Biotech Company with a Unique Approach that Specializes in the Developing of Transformative Therapies for Neurodegenerative and Lung Diseases.
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.
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Tiziana Life Sciences (NASDAQ: TLSA)’s drug, foralumab, is the world’s only fully human anti-CD3 monoclonal antibody in clinical development
Tiziana’s 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.
Tiziana Life Sciences is developing a transformational intranasal formulation, switching from traditional routes to alternative routes to enable breakthrough immunomodulation approaches to enhance the functionality of Treg-based therapies.
Tiziana Life Sciences (NASDAQ: TLSA) has the potential to change the way immunotherapies are currently conducted with their revolutionary approach to attacking neurodegenerative and lung diseases
Tiziana Life Sciences (NASDAQ: TLSA) is Gaining Global Recognition for its First In Class asset, foralumab, a unique Intranasal monoclonal antibody:
- Forbes Article: March 16, 2023 - “New T Cell Antibody Treatment Improves Outcomes For Covid Patients”
- PNAS Highlight: https://www.pnas.org/
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- Jama Network Article: Published March 22, 2023: https://jamanetwork.com/journals/jama/fullarticle/2802889
Market Potential:
Neurodegenerative diseases such as Multiple Sclerosis and Alzheimer’s have risen globally due to the aging population. The NIH projects that in the United States, as many as 6.2 million people may have Alzheimer’s disease.
Neurodegenerative diseases occur when nerve cells in the brain or peripheral nervous system lose function over time and ultimately die. Treatments may help relieve some of the physical or mental symptoms associated with neurodegenerative diseases, however, slowing their progression is not currently possible, and no cures exist.
This rising problem is driving market growth with the neurodegenerative diseases market projected to reach USD $53 Billion by 2030 and grow steadily at a CAGR of 3.2%.
Currently, there are only three measures the FDA considers validated for Multiple Sclerosis and Tiziana Life Sciences is studying all of them
With an impressive team and board of scientists, Tiziana Life Sciences aims to disrupt biopharma with their potentially breakthrough therapies to patients in need
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.
Greetings Investors,
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.
Now more than ever we are in need of companies like Tiziana Life Sciences, whose focus is on developing drugs with a unique approach for these hard to treat but rising diseases.
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
Company Overview
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.
Strategy
- Continue the clinical development of intranasal administration of foralumab for neurodegenerative disease indications:
- Secondary Progressive, Multiple Sclerosis
- Alzheimer's
- Amyotrophic Lateral Sclerosis (ALS)
- Submit an Investigational New Drug Application (IND) to conduct a Phase 2 study intranasal foralumab in Alzheimer's disease patients.
- Seek orphan drugs fast track or breakthrough designation for our product candidates where warranted.
Foraluamb
Foralumab is the Only Fully Human anti-CD3 mAb in Clinical Trials
CD3-specific Monoclonal Antibodies in Clinical Development
Foralumab is a fully human anti-CD3 monoclonal antibody (mAb) for the treatment of Crohn’s and neurodegenerative diseases. This is administered to mucosal surfaces in the nose (intranasal) to boost regulatory T-cell (T-reg) responses with the aim of controlling autoimmune disease progression in central nervous system (CNS) indications like multiple sclerosis (MS) and Alzheimer's disease (AD).
Tiziana has recently completed its Phase 1 clinical trial using intranasal foralumab and is poised to start Phase 2 for its non-active secondary progressive MS indication with nasal administration in Q3 2023.
Intranasally Administered Foralumab in Non-Active SPMS Patients
Two patients were dosed with intranasal foralumab M-W-F for two weeks with a subsequent 1-week washout period (regimen then repeated).
Positive Results: The regimen was well-tolerated with associated beneficial clinical and biomarker changes.
Foralumab has demonstrated ability to activate regulatory T cells that systemically circulate to elicit targeted immunomodulation providing therapeutic benefit to patients.
Tiziana has 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.
Gabriele Cerrone
Executive Chairman Mr 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 Officer Dr. 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.In Conclusion
Tiziana Life Sciences (NASDAQ: TLSA) is a revolutionary, clinical stage biotechnology company that specializes in developing transformative therapies for neurodegenerative and lung diseases. The Company is gaining global attention in the media, and was most recently (March, 2023) highlighted in Forbes and Bloomberg.
Most excitingly, the Company’s furthest advanced clinical trial is centered on Foralumab, which is the world’s only fully human anti-CD3 monoclonal antibody for the treatment of Crohn’s and neurodegenerative diseases, and the first administered intranasally. Investors should take note of M&A in the space with a close peer, Provention Bio Inc. (Nasdaq: PRVB), which was recently acquired by Sanofi for $2.9B.
Other blockbuster monoclonal drugs such as Humira, have performed as the best selling drugs in the world with $200 billion in revenue. Big Pharma is paying attention to these drugs and TLSA is standing out from the competition with its unique application through nasal inhalation.
TLSA is dedicated to developing drugs to service diseases that currently have no cure but a major medical need. With three clinical trials across neurodegenerative, autoimmune, and lung disease indications, the company is attacking multiple indications.
Tiziana Life Sciences (NASDAQ: TLSA) is a first in class biotechnology company with the world’s only fully human anti-CD3 monoclonal antibody in clinical development making the company a very exciting player to have on your watch list
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