Tiziana Life Sciences Ltd · NASDAQ:TLSA
Tiziana Life Sciences — Investor Presentation (March 2023)
20 slides from Tiziana Life Sciences's investor presentation, March 2023
Slide 1: Intranasal Foralumab Update
Intranasal Foralumab Update Enabling Breakthrough Immunomodulation Approaches to Enhance the Functionality of Treg-Based Therapies NASDAQ: TLSA
Slide 2: Disclaimer and Forward-Looking Statement
Disclaimer and Forward-Looking Statement The content of this presentation has been prepared for the purpose of providing general information about, and an overview of, the Company and its business. It is not intended to be a complete review of all matters concerning the Company and nor has it been i
Slide 3: Lead Asset: Foralumab
Lead Asset: Foralumab The only fully human anti-CD3 monoclonal antibody in clinical studies Non-FC binding anti-CD3 antibody mutations expected to have improved safety profile
Slide 4: Foralumab is the Only Fully Human Anti-CD3 mAb in Clinical Trials
Foralumab is the Only Fully Human Anti-CD3 mAb in Clinical Trials CD3-specific Monoclonal Antibodies in Clinical Development MS (Ala-Ala) OKT3 ChAglyCD3 hOKT3γ1 Nuvion Foralumab AD ALS Muromonab* Otelixizumab Teplizumab Visilizumab CAR-T T1D IgG2a IgG1 IgG2 IgG2 IgG1 N297/A L234/A, L235A L234/A, V23
Slide 5: Foralumab Facilitates Locally Targeted Immunomodulation to Improve Tregs Production
Foralumab Facilitates Locally Targeted Immunomodulation to Improve Tregs Production and Enhance their Functionality Our Therapeutic Approach Site targeted local immunomodulation Augment Tregs Enhance Tregs Foralumab intranasal production Functionality administration to facilitate 1 2 3 local activit
Slide 6: Binding of foralumab to the T-cell receptor complex
The binding of foralumab to the T-cell receptor complex, through either the nasal or oral route, results in suppression of effector T-cells involved in various inflammatory and autoimmune diseases along with a reduction in inflammatory cytokines and increase in Tregs anti- inflammatory cytokines.
Slide 7: Intranasal Foralumab
Intranasal Foralumab Safety Profile • 13-week toxicology showed ample safety margin • 26-month toxicology has begun with unaudited data expected Dec 2023 • No significant adverse events have been reported to date in preclinical or human studies Pharmacology • Phase 1 study (healthy subjects) - saw a
Slide 8: Intranasal Foralumab for Treatment of Neurodegenerative Diseases (MS)
LifeSci Venture Partners Provides active guidance and differentiated Intranasal Foralumab for support to enhance portfolio companies’ Fully Human Treatment probability of Neurodegenerative of success Anti-CD3 mAb Diseases (Multiple Sclerosis) Intranasal Local action with improved safety and lowered
Slide 9: Intranasally-Administered Foralumab for Neurodegenerative Diseases
Intranasally-Administered Foralumab for Neurodegenerative Diseases An Innovative Approach to Penetrate the Blood Brain Barrier (BBB) Tiziana Life Sciences Overview | Jan 2023 9
Slide 10: Assessment of Inhibition of Microglial Activation by PET Imaging
Assessment of Inhibition of Microglial Activation by PET Imaging Following Treatment with Nasally Administered Foralumab in First Non- Active SPMS Patient (EA1) Tiziana Life Sciences Overview | Jan 2023 10
Slide 11: Intranasally Administered Foralumab in Non-Active SPMS Patients
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 ch
Slide 12: Clinical Update on EA2
Clinical Update on EA2 2018 – 2021 2022 • Patient’s non-active SPMS disability progressed • Enrolled in the intranasal foralumab Expanded Access Program (EAP) in January 2022 EDSS worsened from 3.5 to 6.0 despite ocrelizumab therapy • EA2 able to walk 100 meters without a cane in September 2022 •
Slide 13: Expanded Access Non-Active MS Program Expanded to 8 Patients
Expanded Access (EA) Non-Active MS Program Expanded to 8 Total Non-Active SPMS Patients Patient Progress EA3 through EA6 EA7 through EA10 (4 patients) (additional 4 patients) All patients enrolled Baseline PET scans finished All patients scheduled Enrollment scheduled to receive first dose for Q2
Slide 14: Phase 2 Planning and Design
Phase 2 Planning and Design TYPE C FDA meeting request for a Phase 2 study in Non-Active Secondary Progressive MS Submitted Jan 2023 Design Endpoints Placebo-controlled 9-Hole Peg Test (9HPT) Multi-center Expanded Disability Status Scale (EDSS) Dose-ranging Improvement in Timed 25-Foot W
Slide 15: Other Potential CNS-related Indications
LifeSci Venture Partners Provides active guidance and differentiated support to enhance portfolio companies’ Other Potential probability of success CNS-related Indications (Alzheimer’s and ALS) Intranasal anti-CD3 provides a unique approach for treating progressive neurologic diseases by modulating
Slide 16: Proof-of-Concept Demonstrated in Alzheimer's Disease
Proof-of-Concept Demonstrated in Alzheimer’s Disease Study Presented at the Alzheimer’s Association International Conference® (AAIC®) “Treatment of Alzheimer’s disease by modulation of microglial neuroinflammation by nasal anti-CD3 mAb” (presented by Weiner, M.D., Co-Director of the Ann Romney Cente
Slide 17: Alzheimer's Disease Plan is Underway
Alzheimer’s Disease Plan is Underway Submit an Investigational Requested 13-Week Received (August 2022) an New Drug Application (IND) toxicology studies affirmative written response to conduct a Phase 2 study completed from the FDA on a intranasal foralumab in Pre-Investigational New Alzheimer's dis
Slide 18: Intranasal Foralumab in Amyotrophic Lateral Sclerosis (ALS)
Intranasal Foralumab in Amyotrophic Lateral Sclerosis (ALS) ALS patients have limited therapeutic options and high unmet need • In September, a Lawrence & Isabel Barnett Drug Development Program Grant was awarded to the Ann Romney Center for Neurologic Diseases at Brigham and Women’s Hospital (BWH)
Slide 19: Near-Term Strategic Focus on Intranasal Foralumab for CNS Diseases
Tiziana Life Sciences Announced Near-Term Strategic Focus on Intranasal Foralumab for Diseases of the Central Nervous System (CNS) Focus on intranasal foralumab allows for efficient use of funds and staff Sufficient cash reserves to perform Phase 2 MS trial • Plan to use non-dilutive funding for Alz
Slide 20: Contact Us
Contact Us US Headquarters (Pennsylvania) Tiziana Life Science Ltd. 601 New Britain Road Building 100, Suite 102 Doylestown PA 18901 UK Headquarters (London) Tiziana Life Sciences Ltd. 14/15 Conduit Street London W1S 2XJ +44 7769 88 4020 hmalik@tizianalifesciences.com
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