Pds Biotechnology Corporation · NASDAQ:PDSB
Pds Biotechnology — Investor Presentation (January 2023)
15 slides from Pds Biotechnology's investor presentation, Jan 19, 2023
Slide 1: Precision Designed Science For Immunotherapy
Precision Designed Science For Immunotherapy Oncology Platforms and Clinical Data Summary NASDAQ: PDSB | January 2023
Slide 2: Forward-Looking Statements
2 Certain information in this presentation may include forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning PDS Biotechnology Corpo
Slide 3: Company Overview
1 2 4 5 6 Company Overview Clinical-stage Company developing proprietary targeted immunotherapies to treat cancer and infectious disease Versamune® based platforms leverage the body’s own defense systems to induce tumor-specific killer T cells to overcome immune suppression and attack cancer Exclusi
Slide 4: Oncology Platforms based on Independently Validated Science with Translation to Humans
Oncology Platforms based on Independently Validated* Science with Translation to Humans 4 Proprietary Versamune® T cell activating platform Pure biologically active R-enantiomer of positively charged lipid that specifically activates the Type I Interferon signaling pathway known to be essential for
Slide 5: Phase 2 Clinical Data To Date
Phase 2 Clinical Data To Date 5 Versamune® Technology Platform: In-vivo tumor-specific killer (CD8+) T cell induction HPV-positive head and neck cancer: PDS0101 + KEYTRUDA® (standard of care) in patients whose cancer has returned or spread after treatment 41% (7/17) Objective response rate (ORR)1 89
Slide 6: Versamune Based T Cell Immunotherapies
Promotes clinically effective antigen-specific killer (CD8+) T cell induction Versamune® Based T Cell Immunotherapies 6 PDS Biotech’s Versamune® technology platform has shown the ability to overcome a critical limitation of current immuno-oncology to induce active CD8+ T cells in vivo In oncology cl
Slide 7: PDS0101 + CRT Induce 100% (9/9) Response Rate in Cervical Cancer
PDS0101 + CRT Induce Clinical Efficacy with 100% (9/9) Response Rate in Cervical Cancer Patients Having Tumors Over 5cm 1Residual traces of the cancer were detected in one patient who only received 3 of the schedule 5 doses of PDS0101 2In agreement with published preclinical findings that Versamune®
Slide 8: PDS0101 Induces Tumor-Infiltrating CD8+ T cells & Elimination of Circulating Tumor DNA
PDS0101 Induces Tumor-Infiltrating CD8+ T cells & Elimination of Circulating Tumor DNA in High-Risk Cervical Cancer 1Yoshida-Court et al,, IMMUNOCERV, an ongoing Phase II trial combining PDS0101, an HPV-specific T cell immunotherapy, with chemotherapy and radiation for treatment of locally advanced
Slide 9: PDS0101 + KEYTRUDA Phase 2 Data Shows 41% Response Rate
PDS0101 + KEYTRUDA® Preliminary Phase 2 Data Shows 41% Response Rate vs. 19% in Published Results for CPI Monotherapy 9 Complete Response (CR) Partial Response (PR) Stable Disease (SD) Progressive Disease (PD) N=17 Subjects w/Imaging Data Best Overall Response and % Change from Baseline by Investiga
Slide 10: Versamune IL-12 (PDS0301) Platform Addresses Advanced, Refractory Cancers
Versamune® IL-12 (PDS0301) Platform Addresses Advanced, Refractory Cancers 10 In Phase 2 clinical trials PDS Biotech’s Versamune® IL-12 combination platform has shown the ability to overcome the I-O limitation of more broadly overcoming immune suppression in advanced cancer Overcomes immune suppress
Slide 11: Active Against Diverse HPV16 Cancers: Best Overall Response
Best Overall Response Active Against Diverse HPV16 Cancers PDS0101 + Higher PDS0301 dose + CPI Induces Tumor Shrinkage in Advanced CPI Refractory HPV16-Cancers 11 *HNSCC – head and neck squamous cell carcinomas Higher PDS0301 Dose Cervical Vaginal/Vulvar Anal HNSCC* Percentage Change Weeks Baseline
Slide 12: PDS0101 HPV16-Targeted Immunotherapy Efficacy Data
1Objective response rates with standard of care < 10% 2No tumor shrinkage in HPV16-negative subjects (ASCO 2021) – Suggests critical role of PDS0101-induced HPV16-specific CD8+ T cells 3Historical median overall survival in the population is 3-4 months 12 Checkpoint inhibitor refractory patients Eff
Slide 13: PDS0101 + PDS0301 + Checkpoint Inhibitor Shows Encouraging Safety Profile
136% objective response with Keytruda + chemotherapy reported in KEYNOTE-048 study 212-month overall survival of 51% with KEYTRUDA® + chemotherapy reported in KEYNOTE-048 study 373% treatment related grade 3 and higher adverse events with KEYTRUDA® + chemotherapy reported in KEYNOTE-048 study 13 Par
Slide 14: Next Steps Towards Registrational Trials and New Oncology Indications
Next Steps Towards Registrational Trials and New Oncology Indications 14 VERSATILE-002 (PDS0101 + KEYTRUDA): FDA Fast Track; FDA alignment on key elements of a registrational trial; Protocol development in progress; Initiation anticipated 2023and/or Triple Combination (PDS0101 + PDS0301 + CPI): Meet
Slide 15: Precision Designed Science For Immunotherapy
Precision Designed Science For Immunotherapy Oncology Platforms and Clinical Data Summary NASDAQ: PDSB | January 2023
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