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’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) is Gaining Global Recognition for its First In Class asset, foralumab, a unique Intranasal monoclonal antibody:
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%.
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.
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.
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.
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.
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.
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