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Tiziana Announces Positive Data on Intranasal Anti-CD3 Monoclonal Antibody in Intracerebral Hemorrhage Tiziana planning to advance foralumab, the only fully human anti-CD3 monoclonal antibody, into human testing for hemo

Key Takeaway: Tiziana Life Sciences Ltd. has announced positive pre-clinical data regarding its intranasal anti-CD3 monoclonal antibody, foralumab, in the context of intracerebral hemorrhage. Improved motor and cognitive outcomes were observed one month post-treatment in a relevant animal model, leading the company to plan for human clinical trials. This therapy is particularly significant as it addresses the limited recovery rates in hemorrhagic stroke patients. Foralumab is noted for being the first fully human anti-CD3 monoclonal antibody and may represent a breakthrough in immunomodulation therapy.

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POSITIVE FACTORS

  • Demonstrated behavioral improvement in pre-clinical data.
  • Potential to advance intranasal foralumab into human testing.
  • Represents a novel approach for treating inflammatory diseases.
  • Has shown a favorable safety profile and clinical response.

Full Press Release Details

Announces Positive Data on Intranasal Anti-CD3 Monoclonal Antibody in Intracerebral Hemorrhage
YORK, April 04, 2023 -- 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 pre-clinical data on the
effects of intranasal anti-CD3 monoclonal antibody in a model of intracerebral hemorrhage (hemorrhagic stroke) demonstrating a behavioral
outcome improvement at one month.
than 10% of people who have hemorrhagic stroke completely recover, and most are left with a disability that could include lasting effects
on their speech and physical function. Intranasal anti-CD3 monoclonal antibody showed improved motor and cognitive outcomes at one-month
post-intracerebral hemorrhage which is very exciting." commented Gabriele Cerrone, Executive Chairman and interim Chief Executive
Officer of Tiziana. "We are actively exploring the clinical development pathway in intracerebral hemorrhage using intranasal foralumab,
the first-ever fully human anti-CD3 monoclonal antibody in patients suffering from a hemorrhagic stroke. This new exciting finding further
validates our decision to focus on the clinical development of our lead asset, intranasal foralumab. This potential immunomodulatory
therapy represents a novel avenue for treatment of inflammatory diseases1"
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.
Intranasal foralumab Phase 2 trials are expected to start in the third quarter of 2023 in patients with non-active SPMS. Immunomodulation
by nasal anti-CD3 mAb represents a novel avenue for treatment of inflammatory human diseases.1
Life Sciences is a clinical-stage biopharmaceutical company developing breakthrough therapies using transformational drug delivery
technologies to enable alternative routes of immunotherapy. Tiziana's 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. Tiziana's
lead candidate, intranasal foralumab, which is the only fully human anti-CD3 mAb, has demonstrated a favorable safety profile and clinical
response in patients in studies to date. Tiziana's technology for alternative routes of immunotherapy has been patented with several
applications pending and is expected to allow for broad pipeline applications.
Spencer, Business Development and Investor Relations
+44 (0) 207 495 2379
LifeSci Advisors, LLC

Frequently Asked Questions

What is Tiziana Life Sciences known for?

Tiziana Life Sciences specializes in developing innovative immunomodulation therapies.

What is the effect of intranasal anti-CD3 monoclonal antibody?

It has shown improved motor and cognitive outcomes in a model of intracerebral hemorrhage.

When will Phase 2 trials for intranasal foralumab begin?

Phase 2 trials are expected to start in the third quarter of 2023.

Why is intranasal foralumab significant?

It is the first fully human anti-CD3 monoclonal antibody for hemorrhagic stroke patients.

How does foralumab affect T cells?

Foralumab modulates T cell function, reducing inflammation by suppressing immune responses.

Last updated: Apr 4, 2023