Pds Biotechnology Corporation · NASDAQ:PDSB
Pds Biotechnology — Investor Presentation (March 2023)
21 slides from Pds Biotechnology's investor presentation, Mar 14, 2023
Slide 1: Precision Designed Science For Immunotherapy
Precision Designed Science For Immunotherapy INVESTOR PRESENTATION NASDAQ: PDSB | March 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 Company Overview Who we are: Leveraging our first-in-class T cell activating platform and our antibody conjugated immuno-cytokine platform to develop safer, more effective and longer lasting immunotherapies to treat cancer and infectious disease Clinical Partnerships: Merck, National Cancer In
Slide 4: Oncology Platform Overview
Designed to address limitations of current immunotherapy with potential efficacy over immune checkpoint inhibitors (ICI) and ICIs in combination with chemotherapy Versamune® Versamune® + IgG1 IL-12 PDS0301 (tumor-targeting, antibody conjugated IL-12) turns “cold tumors” into “hot tumors” which are m
Slide 5: Versamune Oncology Platform
Versamune® Oncology Platform
Slide 6: PDS0101 and Mechanism of Action
3 6 PDS0101 and Mechanism of Action Comprised of cationic lipids (R-DOTAP) co-administered with proprietary HPV16-specific tumor antigens, delivered via subcutaneous injection R-DOTAP spontaneously assembles into virus-like nanoparticles promoting efficient uptake by immune system Delivers antigen t
Slide 7: Pipeline
Combination PDS Biotech Funded Partner Co-Funded PDS0104 (TRP2) TBD Arm 1: ICI naïve 1st line treatment Arm 2: ICI refractory 2nd or 3rd line treatment PDS0101 (HPV16) VERSATILE-002 Fast Track Designation PDS0101 (HPV16) IMMUNOCERV PDS0102 (TARP) PDS0103 (MUC1) Candidate Indication PC P1 P2 P3 R Par
Slide 8: PDS0101 Market Opportunity
More than 46,0002 patients were estimated to have been diagnosed last year with HPV-associated cancers in the US1,2 HPV vaccination is not expected to impact the rate of HPV-related cancer incidence for decades3 Existing immunotherapies cost $150,000+ annually per patient1 US HPV-associated cancer i
Slide 9: PDS0101 Phase 1 Clinical Trial
CIN lesion regression at 1-3 months (retrospective) 60% 20% 20% 9 PDS0101 HPV16-Targeted Immunotherapy * When treated with selected human clinical trial dosage (1mg and 3mg Versamune®) References: L. Wood et al. A Novel Enantio-Specific Cationic Lipid R-DOTAP + HPV16 E6 & E7 Antigens Induces Potent
Slide 10: PDS0101 Appears to Induce Clinically Beneficial T Cells
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 cervical cancers (NCT04580771); SITC 2022 10 PDS0101 activates the immune system to generate killer T cells (CD8+ T
Slide 11: PDS0101 + KEYTRUDA Preliminary Results
119% objective response rate with KEYTRUDA® monotherapy reported in KEYNOTE-048 study 212-month overall survival of 49% with KEYTRUDA® monotherapy reported in KEYNOTE-048 study 317% of patients had treatment related grade 3 and higher adverse events with KEYTRUDA® monotherapy reported in KEYNOTE-048
Slide 12: Phase 2: PDS0101 + KEYTRUDA (VERSATILE-002)
Phase 2: PDS0101 + KEYTRUDA® Company-sponsored trial for the potential treatment of HPV16-positive metastatic/recurrent head and neck cancer (VERSATILE-002) 12 Complete Response (CR) Partial Response (PR) Stable Disease (SD) Progressive Disease (PD) N=17 Subjects w/Imaging Data OR (2 CR + 5PR) 7 (41
Slide 13: Versamune + IgG1 IL-12 Oncology Platform
Versamune® + IgG1 IL-12 Oncology Platform
Slide 14: PDS0301: Tumor-Targeted IgG1 IL-12 Immuno-Cytokine
14 PDS0101 HPV16-Targeted Immunotherapy 60% 20% 20% Tumor sections revealed that IgG1 IL-12 binds to exposed cell nuclei within necrotic regions of murine tumors. PDS0301 (IgG1 IL-12) is a first-in-class immuno-cytokine fusion protein composed of two molecules of IL-12 fused to each of the heavy cha
Slide 15: Phase 1 PDS0301 Monotherapy Trial
15 PDS0101 HPV16-Targeted Immunotherapy 20% Safety Results - PDS0301 Most adverse events were low grade self-limiting (Grade 1 & 2 toxicities) Grade 3 toxicities included aspartate transaminase/alanine transaminase [AST/ALT] elevation (1/13), flu-like symptoms (1/13), decreased white blood cell coun
Slide 16: Triple Combination: PDS0101 + PDS0301 + Checkpoint Inhibitor
*73% grade 3 and higher adverse events reported in KEYNOTE-048 Burtness 2019 https://doi.org/10.1016/S0140-6736(19)32591-7 Goswami 2022 http://dx.doi.org/10.1136/jitc-2022-SITC2022.0695 16 Immunology/immune correlates, (SITC), November 2022: Greater than two-fold increase in HPV16-specific T cells i
Slide 17: Triple Combination Results in ICI Refractory Cancer
17 Phase 2 Results in Recurrent Metastatic ICI Refractory HPV-Positive Cancer (PD-L1 agnostic) Compared to Published Data Triple Combination: PDS0101 + PDS0301 + Checkpoint Inhibitor Advanced HPV16-positive cancer patients who are checkpoint inhibitor refractory N=29 Objective Response (ORR) in high
Slide 18: Triple Combination Results in ICI Naive Head and Neck Cancer
18 PDS0101 HPV16-Targeted Immunotherapy Phase 2 Results in Recurrent Metastatic ICI Naïve Head and Neck Cancer (CPS>0; PD-L1 agnostic) Compared to Published Data Triple Combination: PDS0101 + PDS0301 + Checkpoint Inhibitor Advanced HPV16-positive cancer patients who are checkpoint inhibitor naive *D
Slide 19: Projected Milestones Through 3Q 2023
Projected Milestones Through 3Q 2023* *Based on current enrollment and forecast modeling as of December 2022. Subject to change. 19 2Q22 3Q22 4Q22 1Q23 2Q23 PDS0101 Preliminary data from IMMUNOCERV (MD Anderson) Estimated IND filing in MUC1-related cancers PDS0103 Anticipate preliminary efficacy dat
Slide 20: Company Overview
1 2 4 Company Overview Who we are: Leveraging our first-in-class T cell activating platform and our antibody conjugated immuno-cytokine platform to develop safer, more effective and longer lasting immunotherapies to treat cancer and infectious disease Clinical Partnerships: Merck, National Cancer In
Slide 21: Precision Designed Science For Immunotherapy
Precision Designed Science For Immunotherapy INVESTOR PRESENTATION NASDAQ: PDSB | March 2023
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