Novaccess Global Inc. · OTC:XSNX
Novaccess Global — World Orphan Drug Congress USA 2023
19 slides from Novaccess Global's conference presentation, May 24, 2023
Slide 1: World Orphan Drug Congress USA 2023
World Orphan Drug Congress USA 2023 Dwain Irvin, PHD, MPH CEO May 24th, 2023, 12:30PM Confidential and Proprietary. Copyright 2022 NovAccess Global, Inc. All Rights Reserved.
Slide 2: Forward-Looking Statements
Forward-Looking Statements This information package contains forward-looking statements, which includes forecasts and timelines. Often, but not always, forward-looking statements can be identified by the use of words such as “plans”, “will”, “proposes”, “expects”, “estimates”, “intends”, “anticipate
Slide 3: About Us
About About Us Us Pre-IND stage biotech company developing novel, personalized immunotherapies for brain cancers, glioblastoma Orphan drug-designation, all malignant brain tumors, TLR-AD1 Glioblastoma, 2027, US, 2.9 Billion Market Size (GlobalData Inc. 2019) An expert scientific and managerial team
Slide 4: Our Focused Mission
Our Focused Mission Growth by acquisition of cutting-edge assets Enhance and accelerate bringing to market novel brain Utilization of our expert tumor immunotherapies executive and scientific advisory board 4 Confidential and Proprietary. Copyright 2022 NovAccess Global, Inc. All Rights Reserved.
Slide 5: Glioblastoma Facts
Glioblastoma Facts • More than 21,000 brain tumors diagnoses are estimated annually in the U.S. • Glioblastoma is the most common primary adult brain tumor (e.g. Ted Kennedy, John McCain) • Five-year survival rates are less than 5% for Glioblastoma • Despite 40-year advances in Chemotherapy and Radi
Slide 6: Immunotherapy for Glioblastoma
Immunotherapy for Glioblastoma Problem: No brain cancer immunotherapy in market, to date • Standard of Care: Surgical resection followed by radiation and chemotherapy • 15-month median survival • No Cures: Significant unmet need Opportunities: • Immunotherapy: 3 Major Types 1. Dendritic Cell (DC) 2.
Slide 7: Dendritic Cell Vaccine (1st Generation)
Immunotherapy for Glioblastoma Dendritic Cell Vaccine (1st Generation) • Improves survival in responders (Phase I and II) • Reduces chance of Glioblastoma recurrence • 3rd gen in development – improvement in survival & outcome 7 Confidential and Proprietary. Copyright 2022 NovAccess Global, Inc. All
Slide 8: 3rd Gen vs. 1st Gen Vaccine
3 Gen vs. 1 Gen Vaccine rd st Preclinical Survival Optimization of 3rd Gen TLR-AD1 Vaccine Human Clinical trial on 1st Gen TLR-AD1 vs 1st gen Median Survival P < 0.05 35% • 1st/2nd Gen: 6-7 months longer life 60 81 • 3rd Gen TLR-AD: 13-25 months longer life! *Wheeler et.al. Cancer Res. 2008;68(14):5
Slide 9: Immunotherapy for Glioblastoma: Clinical Procedure
Immunotherapy for Glioblastoma Clinical Procedure: Neurosurgeon isolates Tumor and TUMOR Immune Cells - Sends to Lab TUMOR ANTIGEN CELLS BLOOD ANTIGEN- PRESENTING CELLS (Dendritic Immune Cells) 9 Confidential and Proprietary. Copyright 2022 NovAccess Global, Inc. All Rights Reserved.
Slide 10: Immunotherapy for Glioblastoma
Immunotherapy for Glioblastoma Generation 1 TUMOR CELL FRAGMENTS (Bulk Tumor Lysate Antigen) + IMMUNE CELLS (Dendritic, APC Cells) 10 Confidential and Proprietary. Copyright 2022 NovAccess Global, Inc. All Rights Reserved.
Slide 11: Immunotherapy for Glioblastoma
Immunotherapy for Glioblastoma Step 3: 1st Generation Glioblastoma Vaccine Administered Glioma Tumor Cell Lysate Antigen specific or antigens derived from bulk lysate combined. ‘Intelligence-Briefed’ Immune Cells Introduced into Bloodstream T-Cells Trained to Identify Tumor and Anti-Tumor Response I
Slide 12: Immunotherapy for Glioblastoma
Immunotherapy for Glioblastoma Generation 3 TUMOR CELL FRAGMENTS (Bulk Tumor Lysate Antigen) + IMMUNE CELLS (Dendritic, APC Cells) + IMMUNE BOOSTERS (Proprietary TLR-AD1) 12 Confidential and Proprietary. Copyright 2022 NovAccess Global, Inc. All Rights Reserved.
Slide 13: Immunotherapy for Glioblastoma
Immunotherapy for Glioblastoma Step 3: TLR-AD1 Glioblastoma Vaccine Administered Glioma Tumor Cell Lysate Antigen specific or antigens derived from bulk lysate combined with Toll- like receptor (TLR) adjuvants ‘Intelligence-Briefed’ Immune Cells Introduced into Bloodstream T-Cells Trained to Identif
Slide 14: GBM
A B C GBM § IDH1 binds to and enzymatically modifies the CD8 coreceptor on T cells (A), enhancing their killing of tumors. § IDH1 overexpression by a mouse glioma increases and IDH1 mutation decreases its sensitivity to vaccine treatment (B). § The level of IDH1 in glioblastoma tumor tissue discrimi
Slide 15: Summary
Summary • Parent immunotherapy shows improvement in patient survival over standard of care (chemotherapy and radiation) in Phase I and II Human Clinical trials. • TLR-AD1 out-performs parent immunotherapies in pre-clinical animal trials. • FDA provides Orphan Drug designation for TLR-AD1, covering a
Slide 16: Immunotherapy for Glioblastoma: Market Analysis
Immunotherapy for Glioblastoma Market Analysis: • 2018, Global, $700M Glioblastoma Treatment Market, CAGR 9.3% (GlobalData Inc. 2019) • 2027, US, $2.9B Glioblastoma Treatment Market (GlobalData Inc. 2019) • Unmet need - No current immunotherapy for brain tumors • Presumed significant market opportun
Slide 17: Investor Highlights
Investor Highlights Orphan Drug-Designation in October 2022 Announce Manufacturing Partner 2023 Complete Manufacturing Data for IND Application 2023 File IND application with FDA in 2023 Confidential 2022 17 Confidential and Proprietary. Copyright 2022 NovAccess Global, Inc. All Rights Reserved.
Slide 18: Our Team
Our Team Each Contributor, an Expert in their Field - Highly Focused, yet Adaptable Management Board of Directors Scientific Advisory Board John Cassarini Andrew Norris Ph.D. Portfolio Management Renard Currie MBA Co-Founder, Midvale Group Dwain Irvin Ph.D., MPH Executive, XSNX Board Manages product
Slide 19: Thank You!
Thank You! Confidential and Proprietary. Copyright 2022 NovAccess Global, Inc. All Rights Reserved. novaccessglobal.com
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