Pds Biotechnology Corporation · NASDAQ:PDSB
Pds Biotechnology — Technical Presentation (October 2019)
23 slides from Pds Biotechnology's technical presentation, Oct 22, 2019
Slide 1: Background and Clinical Development Plan for PDS0102 in Prostate Cancer
Background and Clinical Development Plan for PDS0102 in Prostate Cancer October 2019Contact: Frank Bedu-Addo, President/CEO fbeduaddo@pdsbiotech.com
Slide 2: Table of Contents
2 Table of Contents Introduction to PDS0102 Slide 3 Priming and activation of T-cells by Versamune® Slide 8 Confirmation of Antigen-Specific Killer T-cell Induction in Humans Slide 17 Studies supporting Development Path for PDS0102 Slide 19 *L. V. Wood et al et al, Oncoimmunology, 2016, Vol. 5 (8)
Slide 3: Introduction to PDS0102 Immunotherapy for Prostate Cancer
3 Introduction to PDS0102 Immunotherapy for Prostate Cancer The immunotherapy is being developed as a combination therapy to exploit the demonstrated synergies between the Versamune® technology and checkpoint inhibitorsCheckpoint inhibitors have shown confirmed clinical efficacy and have demonstrate
Slide 4: Synergy of Versamune + Tumor Antigen and Checkpoint Inhibitor in B16 Melanoma Model
Synergy of Versamune® + Tumor Antigen and Checkpoint Inhibitor: Demonstrated in Aggressive & Difficult-to Treat B16 Melanoma Model 4 Versamune® + TRP2 (PDS0104) injection demonstrates strong synergy in combination with a checkpoint inhibitor in B16 melanoma – Provides significantly prolonged surviva
Slide 5: PDS0102 Immunotherapy for Prostate Cancer
5 PDS0102Immunotherapy for Prostate Cancer PDS0102 is based on two key components:The novel and proprietary TARP protein, a tumor antigen identified by the National Cancer Institute (NCI) that is expressed in about 90% of prostate cancers at all stages of the disease. In a human clinical trial the N
Slide 6: Versamune-Based Immunotherapies
6 Versamune®-Based Immunotherapies The defining characteristics of the Versamune® platform are the following:The ability to overcome a major limitation of current immunotherapy, by facilitating cross-presentation of tumor antigens to effectively prime CD8+ (killer) T-cells. In extensive in vitro and
Slide 7: PDS0102: Immunotherapy for Prostate Cancer
PDS0102: Immunotherapy for Prostate Cancer 7 Versamune® Nanoparticles: Composed of the proprietary immune activating lipid R-DOTAP Proprietary TARP Tumor Antigens PROPRIETARY VERSAMUNE® IMMUNE ACTIVATING NANOPARTICLES AND A MIXTURE OF TARP TUMOR ANTIGENSThe mixture is administered by subcutaneous in
Slide 8: How Does Versamune Work to Program our T-cells to Recognize and Attack Cancer cells?
How Does Versamune® Work to Program our T-cells to Recognize and Attack Cancer cells? 8
Slide 9: R-DOTAP+ Antigens: Addressing Limitations of Immuno-Oncology
R-DOTAP+ Antigens*: Addressing Limitations of Immuno-Oncology 9 1. SUPERIOR IN-VIVO TRAINING OF THE BODY’S SOLDIERS (KILLER T-CELLS) TO RECOGNIZE THE ENEMY (TUMOR CELLS) Injection SiteInitiation of the immunological events Versamune® design & size promotes high uptake of the immunotherapy by dendrit
Slide 10: Versamune Promotes Superior Ability to Process & Present the Antigen into the Endosome
10 Versamune® Promotes Superior Ability to Process & Present the Antigen into the Cell’s Endosome A B C D Treated withR-DOTAP+DQ-OVA Versamune®-induced processing/ breakdown of the protein results in green fluorescence Versamune®-induced accumulation of processed protein in the endosome (red fluores
Slide 11: R-DOTAP + Antigens: Addressing Limitations of Immuno-Oncology
R-DOTAP + Antigens: Addressing Limitations of Immuno-Oncology 11 2. SUPERIOR ARMING OF THE TRAINED TUMOR-RECOGNIZING SOLDIERS TO KILL THE CANCER (ACTVATION AND PROLIFERATION OF THE T-CELLS) Lymph NodesLocalized immune activation and expansion Versamune® activates the Type I interferon (IFN I) pathwa
Slide 12: Versamune Turns On the Type I Interferon Genes
12 Versamune® Turns On the Type I Interferon Genes Resulting in Effective T-Cell Induction & Activation Activated dendritic cells from the lymph nodes after a single injection of R-DOTAP were analyzed for gene expression. The study identified expression of Interferon–alpha 1 (IFNα1) and interferon-b
Slide 13: Versamune-Induced Chemokine Production Causes Increasing T-Cell Infiltration into Lymph Nodes
13 Versamune®-Induced & Sustained Chemokine Production Causes Increasing T-Cell Infiltration into Lymph Nodes For Several Days S. Gandhapudi et al, Journal of Immunology, 2019 (202), 1215 40.8% 16.6% 18.9% Polyfunctional/most potent killer T-cells Versamune® (R-DOTAP) induces superior quantities and
Slide 14: De-Camouflaging of the Tumor's Environment by Influx of Killer T Cells
14 3. ADDITIONAL DE-CAMOUFLAGING OF THE TUMOR’S ENVIRONMENT BY THE INFLUX OF ARMED, TRAINED KILLER T CELL SOLDIERS, MINIMIZING THETUMOR’S IMMUNE SUPPRESSIVE CAPABILITY Tumor SiteActivated T-cells perform killing functions R-DOTAP+ Antigens: Addressing Limitations of Immuno-Oncology Potent killer and
Slide 15: R-DOTAP + Antigen Significantly Alters the Tumor Microenvironment
15 R-DOTAP + Antigen Significantly Alters the Tumor Microenvironment Significant lowering of the Treg to Tumor-Specific (RF9) Killer T-Cell ratio (P<0.01) causes tumors to be less immuno-suppressive and thus more susceptible to killing by T-cellsTreg/RF9 (Antigen) Ratio S. Gandhapudi et al, Journal
Slide 16: PDS0101: Versamune + HPV Antigens Eliminates HPV-Positive TC-1 Tumors
PDS0101: Versamune® + HPV Antigens Promotes Unique Ability to Eliminate HPV-Positive TC-1 Tumors with Sustained T-Cell Response 16 0 5 40 45 0 250 750 1000 1250 10 15 20 25 30 35 D a y s P os t Tu m or Im p la nt T um or v o lum e ( m m 3 ) 1500 N a iv e V a c c in a t io n P D S 0101 H PV1 6 + G M
Slide 17: Confirmation of Versamune's Safety and Ability to Prime Antigen-Specific Killer T-cells in Humans
Confirmation of Versamune®’s Safety and Ability to Prime Potent Antigen-Specific Killer T-cells in Humans 17
Slide 18: R-DOTAP + HPV Antigens: Clearance of HPV-Positive CIN Lesions in 60% of Patients
R-DOTAP + HPV Antigens: HPV-Specific T-Cell Induction Resulted in Clearance* of HPV-Positive CIN Lesions in 60% of Patients 18 Dose Cohort Evaluable Patients** Clearance of CIN lesions12 Months Post Treatment*** N = N = % of Evaluable 1 mg 3 of 3 2 67% 3 mg 2 of 3 1 50% 10 mg 5 of 6 3 60% Total 10 6
Slide 19: Preclinical and Clinical Studies Supporting the Clinical Development Path for PDS0102
Preclinical and Clinical Studies Supporting the Clinical Development Path for PDS0102 in Prostate Cancer 19
Slide 20: Clinical Development of PDS0102
20 Clinical Development of PDS0102: PDS Biotechnology has signed a collaborative research and development agreement (CRADA 03039) with the National Cancer Institute to co-develop PDS0102 (NCI-patented TARP cancer antigen with R-DOTAP): Checkpoint inhibitors have shown confirmed clinical efficacy and
Slide 21: R-DOTAP May Provide Superior In-Vivo Anti-TARP Killer T-Cell Response
21 R-DOTAP May Provide Superior In-Vivo Ability to Generate Significantly Enhanced Anti-TARP Killer T-Cell Response* *Ongoing preclinical development at PDS Biotechnology CFA + TARP (1-20) R-DOTAP + TARP (1-20) Number of TARP-Specific T-cells (Interferon-γ spot forming cells per million splenocytes)
Slide 22: Planned PDS0102 Clinical Development Timeline
22 Formulation Optimization GMP Manufacturing Peptide, R-DOTAP IND Filing Initiation of Phase 2 Trials Late Q1, 2020 Q4, 2020 Planned PDS0102 Clinical Development Timeline* *Assumes additional funding to support development.
Slide 23: Background and Clinical Development Plan for PDS0102 in Prostate Cancer
Background and Clinical Development Plan for PDS0102 in Prostate Cancer October 2019
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